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Found 42 results
510(k) Data Aggregation
(241 days)
Origin
The Origin™ system is comprised of the Origin™ inline device and Origin™ App. The Origin™ system is indicated for use in conjunction with a compatible drainage system by a trained healthcare professional during postoperative recovery in a hospital setting. The Origin™ inline device is placed between the surgical drainage catheter and reservoir system to continuously measure the pH of drainage fluid to provide additional information on effluent characteristics. The device is not intended to diagnose or treat any clinical condition.
Origin™ is an inline biosensor system that is integrated between an off-the-shelf drainage catheter and reservoir system and is designed to monitor real-time changes in drained effluent characteristics. Origin™ system continuously monitors the pH of wound drainage. Origin™ App is a mobile application for displaying and analyzing data from the Origin™ inline device. Origin™ App is pre-installed on an Android mobile device supplied by FluidAI. The Origin™ inline device connects to Origin™ App via Bluetooth.
The provided FDA 510(k) clearance letter and summary document for the Origin™ system primarily focus on the non-clinical performance of the device, particularly its analytical performance in measuring pH. It does not describe a study involving human readers or multi-reader multi-case (MRMC) comparative effectiveness. Therefore, some of the requested information, particularly related to clinical studies, human expert involvement in ground truth establishment for a test set, and MRMC studies, is not present in the provided text.
However, based on the analytical performance studies described, we can extract the following information:
1. Acceptance Criteria and Reported Device Performance
The document implicitly defines acceptance criteria through the results presented. The "Overall" pH range for linearity, for example, is 0.1446 pH units from 5 to 9, and 0.1 pH units from 4-10 using buffer solutions. For precision, the "Within-Laboratory" precision (total) is 0.0922 SD (1.46% CV) for sample A (pH ~6.3) and 0.1650 SD (2.10% CV) for sample B (pH ~7.85).
Since the document presents the results of studies conducted to demonstrate that the device meets some internal performance goals, we can infer that the reported values met their pre-specified acceptance criteria for analytical performance. However, the specific numerical acceptance thresholds (e.g., "Max Deviation from Linearity must be
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(99 days)
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin
Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System
The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.
The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult and pediatric patients with hepatic steatosis.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The ACUSON Origin and Origin ICE ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications.
The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, cardiac, peripheral vessel, and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems (software version VC10) are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio- effect mechanisms. The function of these ultrasound systems is to transmit, receive, process ultrasound echo data (distance and intensities information about body tissue) in various modes of operation and display it as ultrasound imaging, anatomical and quantitative measurements, calculations, analysis of the human body and fluid flow, etc. These ultrasound systems use a variety of transducers to provide imaging in all standard acquisition modes and also have comprehensive networking and DICOM capabilities.
The provided FDA 510(k) clearance letter and summary discuss the ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems. This document indicates a submission for software feature enhancements and workflow improvements, including an "AI Measure and AI Assist workflow efficiency feature" and "Liver Elastography optimization."
Here's an analysis of the acceptance criteria and the study information provided:
Acceptance Criteria and Reported Device Performance
The submission focuses on enhancements to existing cleared devices rather than a de novo AI device. Therefore, the "acceptance criteria" discussed are primarily related to the performance of the Liver Elastography optimization using phantom testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Liver Elastography Optimization: The system's performance in measuring stiffness within calibrated elasticity phantoms for pSWE, Auto pSWE, and 2D SWE modes must meet manufacturer's accuracy and variability criteria. | The verification results for Liver Elastography optimization using calibrated elasticity phantoms met the acceptance criteria for accuracy and variability. Specific numerical values for accuracy and variability are not provided in this document. |
| Software Feature Enhancements and Workflow Improvements (including AI Measure and AI Assist): The modifications should not raise new or different questions of safety and effectiveness, and the features should continue to meet their intended use. | "All pre-determined acceptance criteria were met." The document states that the modifications do not raise new or different questions of safety and effectiveness, and the devices continue to meet their intended use. Specific performance metrics for the AI Measure and AI Assist features themselves are not detailed as quantitative acceptance criteria in this document. |
| General Device Safety and Effectiveness: Compliance with relevant medical device standards (e.g., IEC 60601 series, ISO 10993-1, IEC 62304, ISO 13485) and FDA guidance. | The device complies with a comprehensive list of international and FDA standards, and non-clinical verification testing addressed system-level requirements, design specifications, and risk control measures. |
Study Details for Liver Elastography Optimization (SWE Performance Testing)
The primary study mentioned in the document for performance evaluation is related to the Liver Elastography optimization.
-
Sample Size Used for the Test Set and the Data Provenance:
- Test Set: Calibrated elasticity phantoms. The specific number of phantoms used is not stated beyond "calibrated elasticity phantoms."
- Data Provenance: Not explicitly stated, but implies laboratory testing using commercially available or manufacturer-certified phantoms. Transducers listed were DAX, 5C1, 9C2, 4V1, and 10L4.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts:
- Ground Truth Establishment: The ground truth for the test set (phantom stiffness) was established by the phantom manufacturer, as they were "calibrated elasticity phantoms certified by the phantom manufacturer."
- Number/Qualifications of Experts: The document does not specify the number or qualifications of experts involved in the phantom's certification process or in the actual testing of the Siemens device. The testing appears to be objective, relying on the calibrated properties of the phantoms.
-
Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. Phantom testing typically relies on quantitative measurements against known phantom properties, not human adjudication of results.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted according to this document. The submission focuses on technical enhancements and phantom validation for elastography, and system safety/effectiveness.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The "SWE Performance Testing" with phantoms could be considered a form of standalone performance assessment as it evaluates the device's measurement capabilities against a known standard. However, the AI Measure and AI Assist features are described as "workflow efficiency features" where measurements are "automatically launched" after classification, implying an interaction with a human user rather than a fully standalone diagnostic output. No specific standalone performance metrics for the AI Measure/Assist components are provided.
-
The Type of Ground Truth Used:
- Ground Truth: For the elastography testing, the ground truth was the known stiffness values of the calibrated elasticity phantoms.
-
The Sample Size for the Training Set:
- Training Set Sample Size: The document does not provide information about a training set size for the AI Measure and AI Assist features or the elastography optimization. This type of 510(k) submission typically focuses on validation and verification of changes to an already cleared product, rather than detailing the initial development or training data for AI algorithms.
-
How the Ground Truth for the Training Set Was Established:
- Training Set Ground Truth: Not applicable, as information on a specific training set is not provided in this document.
Summary regarding AI components:
While the document mentions "AI Measure" and "AI Assist" as workflow efficiency features (e.g., launching relevant measurements after cardiac view classification), it does not provide detailed performance metrics, test set sizes, ground truth establishment, or clinical study information specifically for these AI components. The 510(k) emphasizes that these are "software feature enhancements and workflow improvements" that, along with other changes, do not raise new questions of safety and effectiveness, leading to substantial equivalence with the predicate device. The only detailed "performance testing" described is for the Liver Elastography optimization using phantoms. This suggests that the AI features themselves might have been validated through internal software verification and validation activities that are not detailed in this public summary, or their impact on diagnostic performance was considered incremental and not requiring specific clinical comparative studies for this particular submission.
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(217 days)
Origin Cemented Hip Stem
Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:
- Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
- Inflammatory joint disease including rheumatoid arthritis
- Correction of functional deformity including congenital hip dysplasia
- Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
- Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
Signature Orthopaedics' Origin, Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.
Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), and Origin Cemented femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.
Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.
Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:
- Acute femoral head or neck fracture
- Fracture dislocation of the hip
- Avascular necrosis of the femoral head
- Non-union of femoral neck fractures
- Certain high subcapital and femoral neck fractures in the elderly
- Degenerative arthritis involving only the femoral head
Signature Orthopaedics' Origin™ Cemented Hip Stems are manufactured from nitrogen stainless steel per ASTM F1568 and ISO 5832-9. The subject stem is straight and tapered with a lateral chamfer. The Cemented Origin™ stem is polished and intended for cemented use in total hip arthroplasty. It features a 12/14 taper which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components including the Signature CoCr Femoral Heads (K121297 and K163081), Signature Ceramic Femoral Heads (K190704), Signature BiPolar Head (K133370 and K163081) and Evolve UniPolar Head (K143184). Compatible acetabular cups and liners including the Logical Cup (G-Series K121297, PX-Series K121297 and C-Series K153131) and the Logical Liners (Neutral and 10º Hooded, Lateralised K121297), Logical Liners (20º Hooded, Lateralised 20º Hooded K153131), Logical Constrained Liners (K153131) and Logical Liners Vit-E (Neutral and 10º Hooded, Lateralised, 20º Hooded, Lateralised 20º Hooded, High Wall, 10º Face Changing (K241690).
Based on the provided FDA 510(k) Clearance Letter for the Origin™ Cemented Hip Stem, there is no information present regarding acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of an AI/human reader performance study.
This document is a 510(k) clearance for a physical medical device (a hip stem), not a software or AI-enabled device that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance. The "Performance Testing" section refers to non-clinical mechanical and fatigue testing of the physical hip stem, not a clinical or human-in-the-loop study as described in your request.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, sample sizes for test sets, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment for AI/human reader studies.
If you have a document related to an AI/software device, please provide that, and I would be happy to analyze it against your criteria.
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(165 days)
Origin TT Stem
Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:
- · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
- · Inflammatory joint disease including rheumatoid arthritis
- · Correction of functional deformity including congenital hip dysplasia
- · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
- Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
Signature Orthopaedics' Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.
Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), Origin Cemented femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.
Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.
Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi- hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:
- · Acute femoral head or neck fracture
- · Fracture dislocation of the hip
- · Avascular necrosis of the femoral head
- · Non-union of femoral neck fractures
- · Certain high subcapital and femoral neck fractures in the elderly
- · Degenerative arthritis involving only the femoral head
The Signature Orthopaedics Origin™ TT Stem is intended for single use and cementless fixation. It is manufactured from titanium alloy as per ISO 5832-3 and has a proximal plasma spray coating of titanium as per ASTM F1580 and hydroxyapatite as per ISO 13779-2. It features a 12/14 taper and is compatible for use with Signature CoCr Femoral Heads (K121297 and K163081), Ceramic Femoral Heads (K190704), Logical™ PX, G and C Series Acetabular Cups (K121297 and K153131), Logical™ Liners (K121297, K153131 and K241690), Logical™ Constrained Liners (K153131), BiPolar Heads (K133370 and K163081) and Evolve™ UniPolar Heads (K143184).
The provided text describes the regulatory review for a medical device called the "Origin™ TT Stem," which is a femoral hip prosthesis. However, the document does not contain any information regarding acceptance criteria, study methodologies for device performance, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.
The document primarily focuses on:
- Regulatory classification and product codes for the device.
- Indications for Use of the hip replacement system, including various components beyond just the Origin™ TT Stem.
- Comparison to predicate devices to establish substantial equivalence.
- Non-clinical performance testing (Range of Motion, Stem and Neck Fatigue FEA, Stem and Neck Fatigue Testing) conducted according to established ISO and ASTM standards to demonstrate the strength and safety of the device.
Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets acceptance criteria, as this information is not present in the provided text.
The document states:
- "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Signature Orthopaedics Origin™ TT Stem is adequate for anticipated in-vivo use."
- "The results of non-clinical testing show that the strength of the Signature Orthopaedics Origin™ TT Stem is sufficient for their intended use and substantially equivalent to the legally marketed predicate device."
This indicates that internal testing was performed, but the details of the "acceptance criteria" and the specific data from these tests are not provided in the 510(k) summary. The document focuses on demonstrating that the device meets existing standards (ISO, ASTM) and is substantially equivalent to predicate devices, rather than presenting a clinical study with detailed performance metrics against specific acceptance thresholds.
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(88 days)
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin
Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System
ACUSON Sequoia and Sequoia Select
The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.
The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult and pediatric patients with hepatic steatosis.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
ACUSON Origin and Origin ICE
The ACUSON Origin and Origin ICE ultrasound imaging systems are intended to provide images of. or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric. OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications.
The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, cardiac, peripheral vessel, and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The ACUSON Sequoia, Sequoia Select, Origin and Origin ICE Diagnostic Ultrasound Systems are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bioeffect mechanisms. The ultrasound system function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging (except Origin), Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, Custom Tissue Imaging, 3D/4D Volume lmaging or Harmonic Imaging on a Display and provide cardiac anatomical and quantitative function software applications.
This document describes the acceptance criteria and study that proves the device called ACUSON Sequoia Diagnostic Ultrasound System from Siemens Medical Solutions USA, Inc. meets the acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The submission details two AI features: "AI Abdomen" and "Trace AI."
AI Abdomen
| Feature/Metric | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| View Classification | Not explicitly stated as a numerical criterion, but the overall expectation is a high accuracy and usefulness. The summary indicates a focus on specific view types. | Achieved a success rate of 77.8% for view classification when aggregated across all 17 view types. When eliminating CBD and pancreas sagittal from the aggregated results, the accuracy increased to 82.5%. |
| Semi-automated Measurements | Individual Equivalence Coefficient (IEC) below a prespecified success criterion of 0.25. (This indicates that the algorithm's measurements are very close to the ground truth, likely meaning a low difference/high agreement). | The IEC fell below the prespecified success criterion of 0.25 for all 12 measurements, with and without users editing the landmark locations. |
Trace AI
| Feature/Metric | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| DICE Coefficient for Orifice-type Structures | The 90th percentile shall have a minimum DICE coefficient of at least 80% with 90% confidence. (DICE coefficient is a measure of similarity between two images or segmentations, with 1 being perfect overlap and 0 being no overlap). | The lower 90% confidence bound for the 90th percentile is 0.95, which is greater than the requirement of 0.8, therefore, the test passes. |
2. Sample Size Used for the Test Set and Data Provenance
AI Abdomen:
- Sample Size: 105 exams from individual patients, resulting in 1,785 images extracted (15 B-Mode images per view and per transducer).
- Data Provenance: Retrospective, collected from 3 institutions in the United States.
Trace AI:
- Sample Size: 10 different adult patients, from which 24 volumes were extracted.
- Data Provenance: Retrospective, collected from three institutions in the US, Mexico, and Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
AI Abdomen:
- Number of Experts: Three clinical users.
- Qualifications: All registered Clinical Sonographers with ARDMS accreditation (or equivalent), each with at least 3 years of clinical experience.
Trace AI:
- Number of Experts: Three clinical users.
- Qualifications: All registered Clinical Sonographers with ARDMS accreditation (or equivalent), each with at least 3 years of clinical experience.
4. Adjudication Method for the Test Set
AI Abdomen:
- For view classification, the ground truth was associated with each image at the time of imaging using a system protocol, implying a single determination at the point of acquisition.
- For semi-automated measurements, ground truth measurements were provided by three clinical users. The document does not explicitly describe an adjudication method (like 2+1 or 3+1 consensus) for these measurements, but the acceptance criterion of Individual Equivalence Coefficient (IEC) suggests a comparison of the algorithm's results against these expert measurements.
Trace AI:
- Ground truth measurements were provided by three clinical users. Each sonographer independently refined the initial circle provided by Trace AI to annotate the underlying orifice structure. They could only see their own annotations. The contour created by sonographers (Ground Truth) was then compared with the contour detected by Trace AI (Detection Truth). This implies a comparison against each expert's delineation, potentially implying an aggregation or statistical analysis of agreement rather than a formal consensus adjudication before comparison with the AI.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was explicitly mentioned in the provided text, and therefore, no effect size of human readers' improvement with AI vs. without AI assistance can be determined from this information. The studies described are performance evaluations of the AI algorithms themselves against ground truth.
6. Standalone (Algorithm Only) Performance Study
- Yes, the studies described for both "AI Abdomen" and "Trace AI" are standalone performance evaluations of the algorithms. They assess the algorithms' accuracy in view classification, semi-automated measurements, and segmentation (DICE coefficient) against established ground truth without a human-in-the-loop component for the performance measurement. The "AI Abdomen" notes testing "with and without users editing the landmark locations" for measurements, implying that the algorithm's initial measurement (standalone) was evaluated. "Trace AI" describes experts refining initial circles given by Trace AI, and then comparing the expert-refined contour to the contour detected by Trace AI algorithm, further confirming a standalone evaluation of the algorithm's output.
7. Type of Ground Truth Used
AI Abdomen:
- View Classification: Ground truth view labels were associated with each image at the time of imaging using a system protocol. This suggests a form of expert labeling or pre-categorization at the point of data capture.
- Semi-automated Measurements: Expert consensus (or at least independent expert measurements) provided by three registered Clinical Sonographers.
Trace AI:
- Expert consensus/independent expert annotations: Ground truth measurements (delineations of orifice structures) were provided by three registered Clinical Sonographers independently.
8. Sample Size for the Training Set
- The document does not explicitly state the sample size for the training set for either AI Abdomen or Trace AI. It only focuses on the test set and ensures its independence from the training data.
9. How the Ground Truth for the Training Set Was Established
- The document does not explicitly state how the ground truth for the training set was established. It only mentions that the testing dataset was from different clinical sites than those used for training, to ensure independence.
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(130 days)
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin
Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System
ACUSON Sequoia and Sequoia Select
The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.
The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult and pediatric patients with hepatic steatosis.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
ACUSON Origin and Origin ICE
The ACUSON Origin and Origin ICE ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Pediatric, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures). Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications.
The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, cardiac, peripheral vessel, and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The ACUSON Sequoia, Sequoia Select, Origin and Origin ICE Diagnostic Ultrasound Systems are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bioeffect mechanisms. The ultrasound system function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging (except Origin), Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging or Harmonic Imaging on a Display and provide cardiac anatomical and quantitative function software applications.
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text, specifically for the expansion of the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to pediatrics:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Accuracy: AUROC > 0.80 for correlation with MRI-PDFF | AUROC ≥ 0.87 |
| Clinical Reliability: Test-retest Intraclass Correlation Coefficient (ICC) > 0.75 | ICC ≥ 0.97 |
| Exam Time: Under 60 seconds | Exam time less than 60 seconds |
2. Sample Size Used for the Test Set and Data Provenance
- Number of individual patients: 105 patients.
- 40 patients scanned with the DAX transducer.
- 27 patients with the 5C1 transducer.
- 38 patients with the 9C2 transducer.
- Number of samples: 525 measurements (Five UDFF measurements were obtained per patient).
- Data Provenance: Data were collected from two institutions in the US and France. The studies tested UDFF in children during clinically indicated MRI procedures.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with X years of experience). It only states that "MRI PDFF was used as the reference standard." The interpretation and establishment of ground truth from MRI-PDFF would typically involve qualified medical professionals, but this detail is not provided.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method like 2+1 or 3+1. The reference standard used was MRI-PDFF, which is a quantitative measure and therefore may not have required such an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study directly comparing human readers with and without AI assistance was not reported. The study focused on the performance of the UDFF tool itself against a reference standard.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the testing described appears to be for the standalone performance of the UDFF algorithm. The criteria and results focus on the measurements generated by the UDFF tool (AUROC, ICC, exam time) in comparison to the MRI-PDFF reference standard. While the tool is intended to "aid a physician," the performance metrics presented demonstrate the algorithm's capability independent of direct human interaction in the evaluation setup.
7. The Type of Ground Truth Used
The ground truth used was MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction). Steatosis was defined as MRI-PDFF greater than 5%.
8. The Sample Size for the Training Set
The document explicitly states that the UDFF algorithm remained unchanged and was not retrained for these studies. Therefore, no specific training set sample size for this expansion is provided, as the existing algorithm developed for adults was applied to the pediatric population.
9. How the Ground Truth for the Training Set Was Established
Since the UDFF algorithm was not retrained and remained unchanged, the document does not describe how the ground truth for its original training set was established. It only clarifies that the data from these pediatric studies were considered "test data to evaluate the performance of UDFF in children using MRI PDFF."
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(103 days)
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin
ACUSON Sequoia and ACUSON Sequoia Select
The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic, structures), Cardiac, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.
The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
ACUSON Origin
The ACUSON Origin ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Pediatric, OB/ GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications.
The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The ACUSON Sequoia, Sequoia Select, and Origin Diagnostic Ultrasound Systems are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an onscreen display of thermal and mechanical indices related to potential bio-effect mechanisms. The ultrasound system function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes. Panoramic Imaging. Contrast agent Imaging. Virtual Touch Strain Imaging (except Origin), Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging or Harmonic Imaging on a Display and provide cardiac anatomical and quantitative function software applications.
The provided FDA 510(k) summary describes the Siemens ACUSON Sequoia, ACUSON Sequoia Select, and ACUSON Origin Diagnostic Ultrasound Systems, focusing on new software applications (AI Measure, AI Assist, 2D HeartAI, 4D HeartAI) that incorporate Machine Learning algorithms for cardiac imaging.
The document includes summaries of validation testing for each of these AI features.
1. Table of Acceptance Criteria and Reported Device Performance
| AI Feature | Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|---|
| AI Assist | Overall Success Rate: Percentage of placements requiring no adjustment or only minor adjustment by the user. | 99.3% overall successful placement across all cardiac views and placement locations. For any single placement location, success is 92% or higher. |
| 2D HeartAI | Pearson Correlation Coefficient: With user edits compared to reference standard ground truth. | 0.81 or higher |
| Bland-Altman Bias: With user edits compared to reference standard ground truth. | less than 5.2 (minimal bias) | |
| Performance for Normal BMI subjects ( 25 kg/m2): Pearson Correlation Coefficient. | greater than 0.82 | |
| 4D HeartAI | Pearson Correlation Coefficient: With user edits compared to reference standard ground truth. | 0.87 or higher |
| Bland-Altman Bias: With user edits compared to reference standard ground truth. | less than 13.3 (minimal bias) | |
| Performance for Normal BMI subjects ( 25 kg/m2): Pearson Correlation Coefficient. | greater than 0.81 | |
| AI Measure | Overall Success Rate: Percentage of measurements deemed clinically acceptable (Pass or Pass with/Edit). | 89.6% overall successful performance. For any single acquisition mode, success is 88.1% or higher. |
2. Sample Sizes Used for the Test Set and Data Provenance
| AI Feature | Test Set Sample Size (Patients/Exams/Samples) | Data Provenance |
|---|---|---|
| AI Assist | 12 patients; 14 exams (12 patients, with 2 having additional data); 168 samples (16 frames x 12 cardiac views x 14 exams). | US; Retrospective (collected by a cardiac sonographer who scanned 12 cardiac views included in an Adult Echocardiogram examination). |
| 2D HeartAI | 45 exams; 90 images extracted. | US, Mexico; From 5 different institutions; Retrospective. |
| 4D HeartAI | 32 patients; 64 volumes extracted. | US, Mexico; From 5 different institutions; Retrospective (for 5Z1 (17 TTE) and 6ZT (15 TEE) transducers, with Volume rates > 13.4vps). |
| AI Measure | 32 individual patients; 1354 samples (from 392 images). | US, Mexico; From 5 institutions; Retrospective (the dataset consists of exams from across five institutions, five probes (5V1, 5Z1, 8V3, 10V4, Z6T) and different Sequoia CV Systems. The data collection protocol was standardized across all data collection sites). |
3. Number of Experts and Qualifications for Ground Truth
| AI Feature | Number of Experts | Qualifications |
|---|---|---|
| AI Assist | 3 sonographers | Expert cardiac sonographers (implied by context). |
| 2D HeartAI | 3 examiners | "Examiners" performed all manual contouring and measurements. No specific years of experience mentioned, but expertise is implied for establishing reference standard. |
| 4D HeartAI | 3 examiners | "Examiners" performed all manual contouring and measurements. No specific years of experience mentioned, but expertise is implied for establishing reference standard. |
| AI Measure | At least 3 sonographers | Expert cardiac sonographers (implied by context). |
4. Adjudication Method for the Test Set
| AI Feature | Adjudication Method |
|---|---|
| AI Assist | Consensus-based scoring: Three sonographers scored the results for each placement made by the algorithm. Success was defined as "no adjustment or minor adjustment needed," while "failure" meant a "major adjustment needed." This implies a form of expert consensus without explicit mention of conflict resolution, but rather individual scoring that collectively determined the success rate. |
| 2D HeartAI | Mean value from multiple examiners: Three examiners performed all manual contouring and measurements. Reference standard for each measurement was established by calculating the mean value from the three examiners. Variability was assessed by intraclass correlation (ICC) and inter-reader variability by Pearson correlation and Bland-Altman. This is a form of 3-expert consensus by averaging. |
| 4D HeartAI | Mean value from multiple examiners: Identical to 2D HeartAI. Three examiners performed all manual contouring and measurements. Reference standard for each measurement was established by calculating the mean value from the three examiners. Variability was assessed by intraclass correlation (ICC) and inter-reader variability by Pearson correlation and Bland-Altman. This is a form of 3-expert consensus by averaging. |
| AI Measure | Consensus-based scoring: At least three sonographers scored the results for each measurement made by the algorithm to assess success ("measurements were deemed clinically acceptable"). Similar to AI Assist, this implies a form of expert consensus without explicit mention of conflict resolution. |
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study to measure the effect size of human readers improving with AI vs. without AI assistance. The studies performed focus on the standalone performance of the AI algorithms, often with user edits being factored in, but not a direct comparison of human performance with and without AI.
6. Standalone Performance Study
Yes, standalone performance studies were done for each AI feature:
- AI Assist: Evaluated the algorithm's ability to successfully place Color Box and Doppler Gate based on expert sonographer scoring of its output (99.3% success). This is a standalone assessment of the algorithm's initial placement accuracy.
- 2D HeartAI: Evaluated the accuracy of the 2D HeartAI "as measured by comparison of 2D HeartAI with user edits compared to a reference standard ground truth." While user edits are mentioned, the reported correlation coefficient and bias (0.81 or higher, bias
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(753 days)
Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
Sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs
The Insupen Pen Needle/ Insupen ORIGINAL Pen needle/ Insupen ADVANCED Pen Needle are sterile, single use, single patient pen needles intended for use with pen injector devices for the subcutaneous injection of drugs. Pen needles are used by consumers, caregivers and healthcare professionals. The intended patients for this device is the population from newborn to elderly. The device can be used both in domestic and professional environment. It is considered MR unsafe. The list of drugs tested and intended to be used with Pikdare's pen needle are Insulin, peptic hormone, peptic glucagon-like-1, and drug for the treatment of osteoporosis. All compatibility is checked following the requirements of ISO 11608-2:2012.
The pen needle assembly consists of a double-ended cannula that is assembled into an injection molded hub by gluing. The hub has internal threads which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient end and the cartridge end of the cannula are lubricated using a silicone based lubricant for ease of injection and pen cartridge septum penetration. There is an inner needle shield assembled over the patient end of the cannula to protect the needle tip from damage and accidental needle sticks. Each pen needle is protected with a sealed medical paper which together with the primary container provide a sterility barrier. The pen needle is packaged in boxes and sterilized with ETO. It is intended for single patient and single use only. To use a pen needle, the user needs to remove the medical paper, screw the needle onto the pen injector device. Then the user removes both the outer cap and the inner protective cap to expose the needle and make an injection. After the injection, the needle is unscrewed from the pen injector device and disposed in an appropriate container respecting applicable regulations and laws.
The document describes the acceptance criteria and study results for the Pikdare Insupen Pen Needle, Insupen ORIGINAL Pen Needle, and Insupen ADVANCED pen needle.
1. Table of acceptance criteria and the reported device performance:
| Test Parameter | Acceptance Criteria (Requirement – ISO 11608-2:2012) | Reported Device Performance (Subject Device) |
|---|---|---|
| Materials | The needle shall be made of tubing materials specified in ISO 9626. | Requirement met |
| Dimensions | The tubing features used in the needles shall meet the requirements of ISO 9626. For G34 needle, the limits of stiffness have been chosen to comply with the same limits of G33 TW needle. The needles shall fit the test apparatus specified in item 7.3 of ISO 11608-2. The dimension shall comply with Table 1 of clause 4.2.2 of ISO 11608-2. | Requirement met |
| Determination of flow rate through the needle | The needle was tested in accordance with Annex A to ISO 11608-2 to determine flow rate through the needle. | Requirement met |
| Bond between hub and needle tube | The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2. | Requirement met |
| Needle points | Needle points shall appear sharp and free from featheredges, burrs and hocks when examined under magnification x2.5. The needle point at the cartridge end is designed to minimize coring and fragmentation when penetrating the cartridge set. | Requirement met |
| Freedom from defects | The needle tube shall fulfill the requirements of ISO 7864, clause 11.3. | Requirement met |
| Lubrication | The needle tube should be lubricated at both the patient end and the cartridge end. The lubricant shall not, under normal or corrected-to-normal vision, be visible as droplets of fluid on the outside surface of the needle tube. | Requirement met |
| Dislocation of measuring point at patient end | Dislocation of the cannula point at the patient end shall be in accordance with Table 2 when tested in accordance with Clause 8 (of ISO 11608-2). | Requirement met |
| Determination of functional compatibility with NIS | Compatibility with any NIS (Needle-based Injection System) shall be claimed only after testing in accordance with Clause 11. | Requirement met |
| Ease of assembly and disassembly | Attachment of the needle shall be possible without removing the needle from its opened unit packaging. Compliance is checked according to the requirements of Clause 11. | Requirement met |
| Sterility | The needles in its unit packaging is subjected to a validated sterilization process. (SAL = 10^-6) | Requirement met (SAL = 10^-6 achieved) |
| Pre-conditioning of needles | The needles satisfy all the requirements of ISO 11608-2 after preconditioning according to clauses 6.1, 6.2 and 6.3 of the same standard. | Requirement met |
| Biocompatibility Tests | ||
| Cytotoxicity Study Using the ISO Elution Method | ISO 10993-5 (Tests for in vitro cytotoxicity) | No evidence of causing cell lysis or toxicity. |
| ISO Guinea Pig Maximization Sensitization Test | ISO 10993-10 (Tests for irritation and skin sensitization) | No evidence of causing delayed dermal contact sensitization; not considered a sensitizer. |
| ISO Intracutaneous Study in Rabbits | ISO 10993-10 (Tests for irritation and skin sensitization) | Met the requirements of the test. |
| ASTM Hemolysis Study | ASTM F756 and ISO 10993-4 (Assessment of Hemolytic Properties of Materials) | Non-hemolytic. |
| ISO Two Week Toxicity Study in the Rat | ISO 10993-11 (Tests for systemic toxicity) | No microscopic changes considered test article related; no systemic toxicity. |
| ISO Systemic Toxicity Study in Mice | ISO 10993-11 (Tests for systemic toxicity) | No mortality or evidence of systemic toxicity. |
| USP Rabbit Pyrogen Study, Material-mediated | ISO 10993-11 (Tests for systemic toxicity) | Total rise of rabbit temperatures within acceptable USP limits; non-pyrogenic. |
| USP Pyrogen Study - Material Mediated | USP, General Chapter , Pyrogen Test as recommended by ISO 10993-11 | Nonpyrogenic. |
| EO Residual Values | Maximum EO residual values after degassing and before product release set at 1 mg per device (ISO 10993-7 limit: 4 mg/day, considering 4 uses/day). | Met (values below 1 mg/device). |
| ECH Residual Values | Maximum ECH residual values after degassing and before product release set at 2.25 mg per device (ISO 10993-7 limit: 9 mg/day, considering 4 uses/day). | Met (values below 2.25 mg/device). |
2. Sample size used for the test set and the data provenance:
The document states that "Test were performed on both products, the total availability on sample of the fact that the Predicate Device is manufactured in Pikdare factory in Italy (Pikdare is the contract manufacturer of Droplet G34 Pen Needle)." This implies the testing was done on the actual manufactured products (both the subject device and the predicate device).
- Sample size: Not explicitly stated with a specific number for each test, but it is implied that sufficient samples were used to meet the requirements of the listed ISO standards.
- Data provenance: The predicate device is manufactured in Italy by Pikdare S.p.A. The testing described for both the subject device and the predicate device was presumably performed by or on behalf of Pikdare S.p.A. in Italy. All tests refer to recognized international standards (ISO).
- Retrospective or prospective: The data appears to be prospective, collected specifically for the 510(k) submission to demonstrate compliance with standards and substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a medical device (pen needle) conformity assessment, not an AI or diagnostic imaging study that relies on expert interpretation for ground truth. The "ground truth" here is defined by meeting the objectively measurable criteria specified in ISO and ASTM standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, for the same reason as point 3. The assessment is based on objective measurements against predefined standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" is defined by the technical specifications and performance requirements established by recognized international standards (e.g., ISO 11608-2, ISO 9626, ISO 10993-1, ISO 7864, ASTM F756, USP General Chapter ). The device performance is objectively measured against these established criteria.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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(1 days)
PRESIDENT The Original
PRESIDENT The Original Xtra light body / light body / regular body:
- Correction material for the corrective impression technique
- Injection material for the double mix technique
- Injection material for the dual arch technique»
- Lining impression material
PRESIDENT The Original heavy body:
- Impression material for pick-up impression in the double mix technique
- Tray material for corrective impression technique
- Tray material for dual arch technique
PRESIDENT The Original System 360:
- Impression material for pick-up impression in the double mix technique
- Tray material for corrective impression technique
- Tray material for dual arch technique
PRESIDENT The Original putty / putty soft / putty super soft / fast putty soft
- Impression material for pick-up impression in the double mix technique
- Tray material for corrective impression technique
The subject device family is PRESIDENT The Original which consists of addition type silicone based dental impression materials. PRESIDENT The Original is the relaunch and improved version of the predecessor device PRESIDENT (K811767), which is on the market since 1981.
PRESIDENT The Original is a two base system consisting of base and catalyst that are mixed together before use. The product portfolio of the subject device PRESIDENT The Original can be broadly subdivided into tray materials and wash materials, according to their physical and chemical properties.
The tray materials have a higher tear strength and elasticity than the wash materials. PRESIDENT The Original System 360 devices are surface activated and thixotropic with fast pressure build up so that the wash material is driven into the clinically critical areas. PRESIDENT The Original putties are offered in three different end hardness` for each individual case.
PRESIDENT The Original wash materials are stable but also free-flowing under pressure to capture all details precisely. The hydrophilic properties are effected by surfactants in the material. In contact with moisture these additives move to the surface and decrease the surface tension, resulting in an improved wettability. Furthermore, new colors were added to provide a better contrast between wash and tray materials and to allow a more accurate detail readability.
PRESIDENT The Original family devices are addition type sillicone-based dental impression materials composed of polyvinylsiloxanes, addition type/surface silicone elastomers in various compositions to achieve different viscosities and flow properties depending on the intended use.
To start the curing process the base material needs to be mixed with the corresponding catalyst material. The setting occurs via an addition reaction. The base materials consist of polyvinylsiloxanes, inorganic silicon fillers and other additives (e.g. coloring pigments). In all PRESIDENT The Original family members, except the putty consistencies, surfactants are used to increase hydrophilicity of the impression material.
The document describes the acceptance criteria and the study conducted for the dental impression material, "PRESIDENT The Original," to demonstrate substantial equivalence to the predicate device, "Aquasil® Ultra+."
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states compliance with ISO 4823:2021, which sets forth the requirements and test methods for elastomeric impression materials. The specific acceptance criteria within this standard are not explicitly detailed in the provided text, nor are specific numerical performance values for each criterion. Instead, it states that the device "conforms with ISO 4823."
| Performance Characteristic (based on ISO 4823:2021) | Acceptance Criteria (from ISO 4823:2021 - not explicitly detailed in document, but implied by conformity) | Reported Device Performance (for PRESIDENT The Original) |
|---|---|---|
| Mixing time | Within specified limits for the material type | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Consistency | Within specified limits for the material type | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Working time | Within specified limits for the material type | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Detail reproduction | Meets minimum requirements for detail reproduction (e.g., reproduction of fine lines) | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Linear dimensional change | Within specified limits (e.g., maximum percentage change) | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Elastic recovery | Meets minimum percentage of elastic recovery | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Strain in compression | Within specified limits | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Compatibility with gypsum | Demonstrated compatibility with gypsum models | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Biocompatibility | Conforms with ISO 10993-1, ISO 10993-5, ISO 10993-10 | Device demonstrated conformity through testing |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The document states "extensive testing," but does not provide numbers for the test samples.
- Data Provenance: The testing was conducted by Coltène/Whaledent AG, based in Switzerland. The data is retrospective in the sense that the testing has already been completed to generate the submission data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device and study. The testing for dental impression materials is primarily objective, based on physical and mechanical properties measured in a laboratory setting according to international standards (ISO 4823). It does not involve human interpretation of images or clinical outcomes in the same way an AI diagnostic device would require experts to establish ground truth.
4. Adjudication method for the test set:
Not applicable, for the same reason as point 3. The performance is measured against standardized physical and mechanical properties.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI device or a diagnostic device involving human readers. It is a dental impression material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. The device performance is assessed directly through laboratory testing of its physical and mechanical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is defined by the objective, quantifiable physical and mechanical properties outlined in the international standard ISO 4823:2021, and biocompatibility standards (ISO 10993 series). These standards provide established methodologies and acceptance criteria for these properties.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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(415 days)
Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head
Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the devices are indicated for:
- · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
- · Inflammatory joint disease including rheumatoid arthritis
- · Correction of functional deformity including congenital hip dysplasia
- · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
- · Failed previous hip surgery including internal fixation, reconstruction, hemiarthroplasty, surface replacement, or total replacement
Signature Orthopaedics' Origin, Aria, Remedy, TSI and Pegasus femoral stems and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems are intended for cemented fixation only.
Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:
- · Acute femoral head or neck fracture
- Fracture dislocation of the hip
- · Avascular necrosis of the femoral head
- Non-union of femoral neck fractures
- · Certain high subcapital and femoral neck fractures in the elderly
- · Degenerative arthritis involving only the femoral head
The purpose of this 510(k) application is to extend the compatibility of the subject devices between Signature Orthopaedics and Encore Medical components. The subject devices themselves have not undergone any changes.
The provided document is a 510(k) premarket notification for hip replacement prostheses. It details the device name, regulation, and a claim of substantial equivalence to previously marketed predicate devices. However, it does not describe specific acceptance criteria and a study demonstrating the device meets those criteria, as typically found in clinical performance sections of submissions for new or significantly modified devices.
Instead, this document focuses on extending the compatibility of existing subject devices with other components. The core argument for substantial equivalence is that the devices themselves have not undergone any changes, only their compatibility with other components has been extended. Therefore, the "performance testing" described refers to engineering evaluations to ensure that the performance remains equivalent to predicate devices when used in these new combinations.
As such, many of the requested items related to acceptance criteria, clinical studies, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not present or not applicable in this specific FDA clearance document, as it's not a de novo clearance or a submission for a novel AI/software as a medical device (SaMD).
Here's an analysis based on the information provided, with an emphasis on what is not present given the nature of the document:
1. A table of acceptance criteria and the reported device performance
No explicit "acceptance criteria" table for a clinical performance study is provided. The document states that "engineering evaluations concluded that the performance of the subject devices will remain at least equivalent to the predicate devices when used in combinations as per the expanded compatibility." The performance testing listed appears to be bench testing rather than clinical study.
Performance Testing (Engineering Evaluations/Bench Testing):
| Test | Purpose/Standard | Reported Performance |
|---|---|---|
| Ceramic Head Testing | per ISO 7206-10 | Performance remains at least equivalent to predicate devices when used in expanded combinations. |
| Ceramic Head Fatigue Burst Testing and Rotational Stability | per Ceramtec Protocol | Performance remains at least equivalent to predicate devices when used in expanded combinations. |
| Range of Motion | per ISO 21535 | Performance remains at least equivalent to predicate devices when used in expanded combinations. |
| Rim Impingement | per ASTM-F2582-14 | Performance remains at least equivalent to predicate devices when used in expanded combinations. |
| Stem Body Fatigue | per ISO 7206-4 | Performance remains at least equivalent to predicate devices when used in expanded combinations. |
| Stem Neck Fatigue | per ISO 7206-6 | Performance remains at least equivalent to predicate devices when used in expanded combinations. |
| Articulating Surface Wear | per ISO 14242-1 | Performance remains at least equivalent to predicate devices when used in expanded combinations. |
| Head Constrained Liner Assembly | per Custom Protocol | Performance remains at least equivalent to predicate devices when used in expanded combinations. |
| Head - Constrained Liner Disassembly | per ISO 7206-10 | Performance remains at least equivalent to predicate devices when used in expanded combinations. |
| Head Pull Out | per ISO 7206-10 | Performance remains at least equivalent to predicate devices when used in expanded combinations. |
| Fretting Corrosion Testing | per ASTM-F1875 | Performance remains at least equivalent to predicate devices when used in expanded combinations. |
| Head Pull Out from BiPolar | Not specified | Performance remains at least equivalent to predicate devices when used in expanded combinations. |
| Femoral Head - Constrained Liner Lever-Out Disassembly | Not specified | Performance remains at least equivalent to predicate devices when used in expanded combinations. |
2. Sample sized used for the test set and the data provenance
Not applicable for a clinical study. The testing described appears to be bench/laboratory testing of the physical hip prostheses components. The document does not specify sample sizes for these engineering evaluations, nor does it refer to patient data (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no mention of experts establishing a ground truth for a test set, as this is not a clinical or AI/SaMD performance study.
4. Adjudication method for the test set
Not applicable. No adjudication method is mentioned as there is no test set in the context of a clinical performance study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This document does not pertain to an AI/SaMD device, and therefore no MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not pertain to an AI/SaMD device, and therefore no standalone algorithm performance study was conducted.
7. The type of ground truth used
Not applicable in the context of clinical "ground truth." The "ground truth" for these engineering evaluations would be the established performance characteristics and safety criteria defined by the relevant ISO and ASTM standards (e.g., specific fatigue limits, wear rates, pull-out forces), against which the tested devices' physical properties are measured.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/SaMD device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set.
In summary: This FDA 510(k) clearance document for hip replacement prostheses makes a claim of substantial equivalence based on the fact that the actual devices have not changed, only their compatibility with other components has been extended. The "performance testing" referenced is a series of engineering/bench tests against international standards (ISO and ASTM) to ensure that the performance of the components remains equivalent to predicate devices in these extended combinations. It is not a clinical study involving patients, human readers, or AI/software performance.
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