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510(k) Data Aggregation
(241 days)
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 <= X") are not explicitly stated as separate criteria but are implied by the reported results indicating successful testing.
Table of Acceptance Criteria (Implied by Reported Performance) and Reported Device Performance
| Performance Metric | Implied Acceptance Criterion (from reported performance meeting "non-clinical testing") | Reported Device Performance |
|---|---|---|
| Precision | ||
| Within-Laboratory Precision (Total SD) - pH ~6.3 (Sample A) | $\le$ 0.0922 pH units (or lower)* | 0.0922 pH units |
| Within-Laboratory Precision (Total %CV) - pH ~6.3 (Sample A) | $\le$ 1.46% (or lower)* | 1.46% |
| Within-Laboratory Precision (Total SD) - pH ~7.85 (Sample B) | $\le$ 0.1650 pH units (or lower)* | 0.1650 pH units |
| Within-Laboratory Precision (Total %CV) - pH ~7.85 (Sample B) | $\le$ 2.10% (or lower)* | 2.10% |
| Linearity (Peritoneal Drain Fluid) | ||
| Max Deviation from Linearity (Overall pH 5-9) | $\le$ 0.1446 pH units (or lower)* | 0.1446 pH units |
| Max Deviation from Linearity (pH 5-6) | $\le$ 0.1446 pH units (or lower)* | 0.1446 pH units |
| Max Deviation from Linearity (pH 6-7) | $\ge$ -0.0011 pH units (or higher)* | -0.0011 pH units |
| Max Deviation from Linearity (pH 7-8) | $\ge$ -0.0102 pH units (or higher)* | -0.0102 pH units |
| Max Deviation from Linearity (pH 8-9) | $\le$ 0.1129 pH units (or lower)* | 0.1129 pH units |
| Linearity (NIST Traceable pH Buffer Solutions) | ||
| Max Deviation from Linearity (pH 4-10) | $\le$ 0.1 pH units (or lower)* | 0.1 pH units |
| Interference | No significant source of interference reported | No significant source of interference determined |
| Method Comparison (Mean Bias) | ||
| Mean Bias (pH 5-6) | Within [-0.263, -0.177] pH units* | -0.223 pH units |
| Mean Bias (pH 6-7) | Within [-0.298, -0.207] pH units* | -0.251 pH units |
| Mean Bias (pH 7-8) | Within [-0.177, -0.022] pH units* | -0.102 pH units |
| Mean Bias (pH 8-9) | Within [-0.155, -0.052] pH units* | -0.105 pH units |
Note: The acceptance criteria are "implied" because the document states "Performance testing demonstrates equivalence" and presents these results. It is assumed that these reported values either met or fell within the pre-defined acceptance limits set by the manufacturer for non-clinical analytical performance. The document doesn't explicitly state the thresholds for acceptance, but rather the results that were found acceptable for clearance.
Study Proof of Device Meeting Acceptance Criteria (Non-Clinical Analytical Performance)
The device demonstrates it meets its non-clinical analytical requirements through several studies:
2. Sample Sizes Used for the Test Set and Data Provenance:
-
Precision Study:
- Sample Size: 16 devices x 5 days x 3 runs x 12 replicates = 2880 measurements (total for each pH level, so 5760 samples for both pH levels combined).
- Data Provenance: Single site study, using buffered and spiked donor human peritoneal drainage fluid. Origin of fluid (e.g., country) is not specified, nor is whether it's retrospective or prospective collection (though likely prospective for a controlled lab study).
-
Linearity Study (Peritoneal Drain Fluid):
- Sample Size: Not explicitly stated as a single number, but mentions "peritoneal drain fluid samples collected in the Method Comparison study".
- Data Provenance: Donor human peritoneal drain fluid samples. Origin not specified.
-
Linearity Study (NIST Traceable pH Buffer Solutions):
- Sample Size: Not explicitly stated.
- Data Provenance: NIST traceable pH buffer solutions.
-
Interference Study:
- Sample Size: 2 pH levels x 16 paired observations per pH level = 32 paired observations per interferent. Number of interferents is 16. Total observations are 32 * 16 = 512.
- Data Provenance: Simulated peritoneal fluids.
-
Comparison Studies (Method Comparison):
- Sample Size: 60 donor human peritoneal drain fluid samples.
- Data Provenance: Donor human peritoneal drain fluid samples by a "glass pH probe" as the comparator. Origin not specified.
All these studies appear to be retrospective lab-based analytical studies on collected samples rather than prospective human clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- This information is not applicable/not provided in the context of the described non-clinical analytical performance studies. The "ground truth" for pH measurements in these studies was established by:
- Known concentrations of buffered solutions.
- Measurements from a reference method (e.g., "glass pH probe" as a comparator in the method comparison study).
- Spiked samples with known concentrations of interferents.
- For the linearity study using NIST traceable pH buffer solutions, the NIST standard itself serves as the ground truth.
4. Adjudication Method for the Test Set:
- This information is not applicable/not provided. Adjudication by human experts is typically performed in clinical studies involving interpretation (e.g., imaging diagnostics). For analytical performance, the ground truth is established by the reference method or known properties of the samples, not by expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The provided document describes non-clinical analytical performance studies, not studies involving human readers or comparative effectiveness with or without AI assistance. The device is a "blood gases (PCO2, PO2) and blood pH test system" that measures pH, not an AI-based diagnostic tool for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, the described "Analytical Performance" studies evaluate the device's standalone performance. The Origin™ system (device and app) independently measures pH. The precision, linearity, interference, and method comparison studies assess its direct measurement capabilities without human interpretation or intervention in the measurement process itself, beyond standard laboratory handling. It's a continuous pH monitoring device, and its accuracy is evaluated against known values or reference methods.
7. The Type of Ground Truth Used:
- Analytical/Reference Ground Truth:
- For precision and linearity studies using buffered solutions: Known pH values of the buffers, or measurements by a calibrated reference instrument (like the "glass pH probe" mentioned).
- For linearity using NIST traceable pH buffer solutions: The certified pH values of the NIST traceable buffers.
- For interference study: Known concentrations of spiked interferents in simulated peritoneal fluids.
- For method comparison: Measurements obtained from a "glass pH probe" on donor human peritoneal drain fluid samples served as the comparator/reference.
8. The Sample Size for the Training Set:
- The document does not explicitly describe a "training set" in the context of machine learning or deep learning models for an AI device. The Origin™ system measures pH using a "potentiometric measurement pH" principle with an "Ion-sensitive field-effect transistor (ISFET) electrode". This suggests a sensor-based measurement rather than a machine learning algorithm that requires a "training set" in the typical sense.
- The closest concept would be the data used for the internal development and calibration of the device's measurement algorithm, but this is not detailed in terms of a specific "training set size" in this submission.
9. How the Ground Truth for the Training Set Was Established:
- As above, the concept of a "training set" ground truth is not applicable to the type of device described. The device is a direct pH measurement system, not an AI-interpretive device trained on labeled data. Its "ground truth" for functionality and calibration during development would be established through standard analytical chemistry principles, using reference buffers and comparison to established methods or instruments.
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(217 days)
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)
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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(1025 days)
The ORi feature is intended to be used in patients undergoing surgery as an adjunct to SpO2 for increased monitoring resolution of elevated hemoglobin oxygen saturation levels (e.g., due to the administration of supplemental oxygen).
The ORi feature is indicated for the monitoring of hemoglobin oxygen saturation levels in patients 18 years and older (adults and transitional adolescents) on supplemental oxygen during no-motion conditions perioperatively in hospital environments.
ORi is a device that provides an adjunct oximeter function that extends the monitoring resolution of hemoglobin oxygen saturation at elevated oxygen levels (e.g., due to the administration of supplemental oxygen). The feature is intended to be used in conjunction with SpO2 monitoring provided by a pulse oximeter. The ORi feature utilizes the similar principles of operation as pulse oximetry, utilizing hemoglobin wavelength absorption characteristics to determine relative blood oxygen saturation. Whereas SpO2 monitoring provides visibility to blood oxygen saturation in the transition from normoxia to hypoxia on the hemoglobin oxygen disassociation curve, ORi provides visibility to the transition from normoxia to hyperoxia.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ORi device are not explicitly laid out in a pass/fail table with specific metrics. Instead, the document discusses various performance aspects and mitigation measures for identified risks. However, we can infer some criteria from the "Risks to Health" and "Special Controls" sections, specifically focusing on the clinical performance aspect. The most direct performance claim for ORi is its ability to monitor hyperoxia.
| Acceptance Criterion (Inferred from Risks/Controls) | Reported Device Performance / Study Finding |
|---|---|
| Accuracy of hyperoxia monitoring (Clinical performance testing to evaluate accuracy) | - Adjunct to SpO2 for increased monitoring resolution of elevated hemoglobin oxygen saturation levels (PaO2 100 to 250 mmHg). |
| - AUC > 0.8 in determination of PaO2 for the range 100-250mmHg when compared to SpO2. | |
| - Benefits for detection of changing PaO2 in the range of 100 to 250mmHg better than pulse oximetry alone. | |
| - The trend of ORi values is beneficial to titrate O2 delivery in surgical patients receiving supplemental O2 therapy. | |
| - Labeling mitigates the high intra- and inter-subject ORi variability with respect to PaO2. | |
| No adverse events with concomitant SpO2 monitoring | - No adverse events when the device was used with concomitant SpO2 monitoring in the operating room environment on patients receiving supplemental oxygen. |
| Demonstrated benefits for intended patient populations | - Benefit-risk profile was determined to be favorable for the intended patient populations (adults and transitional adolescents, 18 years and older under surgery with supplemental oxygen). |
| Human factors/usability testing | - Human factors/usability testing must demonstrate that the user can correctly use the device, based solely on reading the instructions for use. (No specific performance metric mentioned beyond this general statement, but it's a requirement). |
| Software verification and validation | - Software documentation for ORi was provided according to the FDA Guidance Document... The software was found to have a Moderate Level of Concern. |
| - ORi validation testing was performed to demonstrate the device software meets its performance requirements using patient data. (Specific performance details of software not quantified in this summary, but overall successful.) | |
| Biocompatibility | - Leveraged from previously cleared device (Masimo Root Monitoring System and Accessories K171121); patient contacting components are identical. (Implies it meets the criterion by proxy). |
| Reprocessing/Cleaning | - Leveraged from previously cleared device (Masimo Root Monitoring System and Accessories K171121). (Implies it meets the criterion by proxy). |
| Electromagnetic Capability & Safety | - Leveraged from a prior 510K submitted for the subject device (Masimo Root Monitoring System and Accessories K171121). (Implies it meets the criterion by proxy). |
| Compatibility with pulse oximeter devices | - Performance testing must demonstrate compatibility with pulse oximeter devices labeled to be compatible with the device. (No specific performance study mentioned for this, but it's a requirement and implies it was met). |
2. Sample Sizes Used for the Test Set and Data Provenance
The clinical studies involved a total of 206 subjects and 2330 data pairs (SpO2, SaO2) used for calculating ORi values.
- Masimo Clinical Lab Study:
- Sample Size (Subjects): 52 healthy volunteers
- Data Pairs: 939
- Provenance: Retrospective (Masimo desaturation laboratory study)
- Ground Truth: Reference PaO2 blood gas values from an ABL blood gas analyzer.
- Loma Linda University Study:
- Sample Size (Subjects): 126 hospitalized participants
- Data Pairs: 1251
- Provenance: Retrospective (Data previously collected prospectively)
- Ground Truth: ABG convenience samples obtained as part of standard of care.
- UC Davis Study:
- Sample Size (Subjects): 28 hospitalized patients
- Data Pairs: 140
- Provenance: Prospective
- Ground Truth: ABG (Arterial Blood Gas) drawn at specific time points.
Overall Data Provenance:
- Country of Origin: Not explicitly stated, but the institutions (Masimo, Loma Linda University, UC Davis) suggest United States.
- Retrospective/Prospective: Two studies were retrospective (Masimo Clinical Lab and Loma Linda), and one was prospective (UC Davis). The retrospective studies utilized data previously collected prospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications used to establish the ground truth. It states that:
- For the Masimo Clinical Lab study and UC Davis study, the reference PaO2 blood gas values were collected by an ABL blood gas analyzer and ABG, respectively. This implies that the ground truth for PaO2 was based on laboratory analysis of arterial blood samples, which is the gold standard, rather than expert consensus on image interpretation or clinical diagnosis.
- For the Loma Linda University study, ABG convenience samples were obtained as part of standard of care.
Therefore, the ground truth was primarily objective physiological measurement via ABG analysis, not expert interpretation.
4. Adjudication Method for the Test Set
There was no "adjudication method" in the sense of multiple experts reviewing and reaching a consensus clinical diagnosis. The ground truth was established by direct physiological measurement (Arterial Blood Gas analysis), which is considered objective and definitive for blood gas values.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described for evaluating human reader improvement with AI vs. without AI assistance. The study focused on the performance of the ORi device itself in relation to PaO2, and its benefit as an "adjunct" to SpO2, implying general clinical utility rather than a direct comparison of human performance with and without ORi assistance. The statement "benefits for detection of changing PaO2 in the range of 100 to 250mmHg better than pulse oximetry alone" suggests a comparison between ORi + SpO2 vs. SpO2 alone, but not specifically quantified for human reader improvement.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was performed. The studies evaluated the performance of the ORi algorithm by comparing its output directly to the reference standard (PaO2 from ABG analysis). This is evidenced by:
- "ORi validation testing was performed to demonstrate the device software meets its performance requirements using patient data."
- "The pooled data demonstrated an AUC >0.8 in determination of PaO2 for the range 100-250mmHg when compared to SpO2." (This is a statistical assessment of the algorithm's output).
- "The percentage of ORi was greater than that of SpO2 for the same PaO2 values."
The device's mechanism of action and the way its output (a numeric index on a 0-1 scale) is calculated based on light absorption implies an algorithm-only function. The ORi is intended to be an adjunct to SpO2 and not a stand-alone diagnostic device, but its performance was evaluated as a standalone output (an index related to PaO2).
7. Type of Ground Truth Used
The primary type of ground truth used was Arterial Blood Gas (ABG) analysis, specifically PaO2 values. This is an objective, physiological measurement and is explicitly referred to as the "gold standard in diagnosis of hypoxemia."
8. Sample Size for the Training Set
The document does not explicitly state the sample size for a separate training set. The studies described are presented as evaluations of the device, implying they are test sets for validation. It is common for device algorithms to be developed and refined using internal datasets before these validation studies are performed, but details of such a training set are not provided here. The 206 subjects and 2330 data pairs are described as being "submitted by the sponsor for calculation of the ORi values," which might imply they were used in part for validating the final algorithm, but not necessarily for initial training.
9. How the Ground Truth for the Training Set was Established
Since a dedicated training set is not explicitly described, the method for establishing its ground truth is also not mentioned. If the validation data itself (or portions of it) was also used for initial algorithm development or parameter tuning, then the ground truth would have been established by Arterial Blood Gas (ABG) analysis as described for the test set.
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(52 days)
OrionXR is a software device for display, manipulation, and evaluation of externally-generated 3D models of patient anatomy through an Augmented Reality Head Mounted Display (HMD) to assist in visualization, planning and communication of treatment options.
OrionXR is indicated for use by qualified healthcare professionals including but not restricted to radiologists, nonradiology specialists, physicians, and technologists.
Digital models viewed through the HMD are for informational purposes only and not intended for diagnostic use. OrionXR is not intended to guide surgical instrumentation and it is not to be used for stereotactic procedures or surgical navigation.
OrionXR software is designed for use with performance-tested hardware specified in the User Manual.
OrionXR includes a server for uploading pre-acquired 3D annotations of patient anatomy and the Microsoft Hololens 2 head mounted display for visualizing the models via a Mixed reality platform. The components of the device include:
-
- Web Server Users can load 3D annotations of anatomy to OrionXR web server which can then be accessed on the Head mounted display.
-
- Head Mounted Display OrionXR is compatible with the Microsoft Hololens 2. A user is able to access 3D digital models on the headset. User can manipulate the model in three dimensions of translational and rotational space.
The OrionXR device is a software device intended for display, manipulation, and evaluation of externally-generated 3D models of patient anatomy through an Augmented Reality Head Mounted Display (HMD) to assist in visualization, planning, and communication of treatment options. It is indicated for use by qualified healthcare professionals.
Here's a breakdown of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text doesn't explicitly state quantitative acceptance criteria with pass/fail thresholds for the performance tests. Instead, it describes general design verification and validation activities conducted. The "Reported Device Performance" column reflects the successful execution and meeting of design input requirements.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Accuracy of 3D Models | Demonstrated successful performance to ensure output specifications meet design input requirements. |
| Optical Performance of Headset Display: - Contrast ratio - Resolution - Field of View - Luminance Uniformity - Eyebox - Distortion - Frame Rate | Demonstrated successful performance across these optical parameters to ensure output specifications meet design input requirements. The display frame rate is specified as 60 fps, matching the predicate. |
| Qualitative Assessment of 3D Anatomic Models | Successfully conducted to ensure output specifications meet design input requirements. |
| Human Factors and Usability Engineering | Human factors and usability engineering testing was performed. No additional use-related risks to the safety or effectiveness of the device were identified. This included simulated use replicative of both the intended use and the intended environment of use. |
| Overall Safety and Effectiveness | Performance data demonstrate that the OrionXR is as safe and effective as the predicate device (IntraOpVSP, K213128), and does not raise new issues of safety or effectiveness. The device is capable of accurately uploading and visualizing 3D anatomic models on an HMD. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size in terms of the number of patient cases or specific instances used for validation, nor does it provide details on data provenance (e.g., country of origin, retrospective/prospective). The performance data section refers to "design verification and validation" generally.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts used or their qualifications for establishing ground truth for any specific test set. The device is a "Medical Image Management And Processing System" that displays externally-generated 3D models for visualization, planning, and communication, rather than performing diagnostic analysis that would typically require expert ground truth labeling.
4. Adjudication Method for the Test Set
No adjudication method is described, as the document does not detail specific expert evaluations of a test set in the manner of diagnostic AI devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not explicitly described or performed. The device's indications for use are for visualization, planning, and communication, not for primary diagnostic interpretation or as an AI aid in a traditional diagnostic workflow.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance data described focuses on the device's technical capabilities, such as dimensional accuracy of 3D models and optical performance of the HMD. This can be considered "standalone" in the sense that these are objective measurements of the device's functionality. However, the device itself is an Augmented Reality Head Mounted Display system, inherently designed for human-in-the-loop interaction by qualified healthcare professionals for visualization and planning, not autonomous decision-making. No isolated "algorithm only" performance for diagnostic or analytical tasks is presented, as the device is not intended for such standalone functions.
7. The Type of Ground Truth Used
Given the device's function (display and manipulation of 3D models for visualization and planning), "ground truth" would likely relate to the accuracy of the displayed 3D models against their source data, and the optical performance of the display. The document mentions "Dimensional Accuracy of 3D Models" and "Qualitative Assessment of 3D Anatomic Models" as part of design verification, implying that the accuracy of the digital models and their representation are the primary "ground truths" being assessed against established specifications or source data. It does not mention pathology, outcomes data, or expert consensus in the context of diagnostic "ground truth," as it is not a diagnostic device.
8. The Sample Size for the Training Set
The document does not provide any information regarding a "training set" or its sample size. This is consistent with the device's function as a display and manipulation tool for pre-existing 3D models, rather than a machine learning or AI algorithm that is trained on a dataset. The device receives "externally-generated 3D models," suggesting it doesn't perform internal model generation that would require a dedicated training phase.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or applicable given the device's nature, the method for establishing ground truth for a training set is not provided.
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(191 days)
The ORIGO system is a software-controlled motorized system that includes attachments and tools for cutting soft tissue and bone and provides irrigation fluid to the surgical site.
The ORIGO system is used in the following surgical fields:
· for cutting and shaping bones and resection of soft and hard tissues in the fields of head & neck/ENT (otology, rhinology, laryngology) and maxillofacial surgeries.
The ORIGO System is a software-controlled electrically-powered surgical system designed to be used in an operating room by a clinician for head & neck, ENT, and maxillofacial surgical procedures in a healthcare facility/hospital setting.
The ORIGO System consists of the ORIGO Control Unit, the ORIGO Foot Pedal, the ORIGO System-compatible micromotors and motorized handpieces with corresponding motor cables, handpieces, attachments, cutting tools, the ORIGO System Irrigation Line, and other accessories.
The ORIGO System transforms electrical energy through micromotors or motorized handpieces and converts it to rotational force to cut bones and resect soft and hard tissues through attached cutting tools.
Four motor subsystems of the ORIGO System include NANO, RAPIDO, OSSEOSTAP, and S120. The NANO and RAPIDO are micromotors. OSSEOSTAP is a motorized microdrill handpiece. S120 is a motorized shaver handpiece that is a microdebrider/microresector.
PM2 Handpieces are intended to be connected to the NANO Micromotor and RAPIDO Micromotor and used in conjunction with PM2 Burs. The PM2 80K Burs and PM2 50K Burs are used for cutting and shaping bones in ENT surgical procedures.
OSSEPSTAP is intended to be used for cutting and shaping bones in ENT surgical procedures, such as stapedotomy or ossiculoplasty. The OSSEOSTAP is used with OSSEOSTAP Burs and OSSEOSTAP Perforator.
S120 is intended to be used for resecting soft and hard tissues in ENT surgical procedures. The S120 is used with S120 Shaver Blades and S120 Shaver Burs.
The ORIGO System is equipped with a peristaltic pump, which delivers saline irrigation solution to surgical sites through a 5m ORIGO System Irrigation Line.
The ORIGO System is a prescription-only device.
The provided text describes the ORiGO System, a software-controlled motorized surgical system. However, it does not contain information regarding objective acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert qualifications, adjudication methods, or separate training/test set details for AI/algorithm-based performance evaluation.
The document outlines performance testing related to design validation, functional verification, usability, electromagnetic compatibility, electrical safety, software life cycle, and biocompatibility, all in conformance with relevant FDA recognized consensus standards and guidance documents. These tests are described as successfully demonstrating that the device performs as designed and is safe and effective when compared to predicate devices.
Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance or provide the detailed study information requested.
The text generally states that the device's performance aligns with relevant standards and shows substantial equivalence to predicate devices, but specific numerical or objective performance criteria and their measured results are not presented in a traditional "acceptance criteria" format.
Here's an overview of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Cannot be generated. The document mentions "functional verification, device performance, and usability" were carried out but does not provide specific acceptance thresholds or quantitative results for these tests. It only states that testing "demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This device is a surgical motor system, not an AI or diagnostic device that typically uses test sets of data (e.g., medical images). The testing described is non-clinical bench testing, and no "test set" in the context of data analysis is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This information pertains to studies involving expert review for establishing ground truth, which is not described for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This pertains to expert review of data, which is not described.
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. The device is a surgical motor system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a surgical motor system, not a standalone AI algorithm. While it is "software-controlled," the performance evaluation described is for the physical device system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable generally. For non-clinical bench testing, "ground truth" typically refers to engineering specifications, physical measurements, and compliance with standards. The document states "conformance of the ORiGO System with applicable international and internal standards was verified" and "successfully demonstrated that the device correctly performs as designed."
8. The sample size for the training set
- Not applicable. This device is not an AI/ML system that undergoes a "training set" of data in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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(342 days)
The ORiGO System is a software-controlled motorized system that includes attachments and tools for cutting bone, and provides irrigation fluid to the surgical site. The ORiGO System is used in the following surgical fields: -For cutting bones in neuro (cranial) and spinal surgeries.
The ORIGO System is a software-controlled electrical surgery system intended to be used in an operating room by a clinician in a healthcare facility/hospital setting for cranial and spinal surgical procedures. The ORIGO System consists of the ORIGO Control Unit, the ORIGO Foot Pedal, the ORIGO System-compatible two micromotors and one motorized handpiece with corresponding motor cables, handpieces, attachments, cutting tools, the ORIGO System Irrigation Line, and other accessories. The ORIGO System transforms electrical energy through motors and converts it to rotational force to shape and cut bones through attached cutting tools. Three micromotor subsystems of the ORIGO System include NANO, RAPIDO, and PM PERFO. The NANO and RAPIDO are micromotors. The PM PERFO is a motorized cranial perforator handpiece. PM2 Handpieces are intended to be connected to the NANO Micromotor and RAPIDO Micromotor. Cranio-Guards are attached to the PM2 Handpieces, and craniotomy is performed using PM2 Craniotomy Burs. Other PM2 80K Burs are attached to the PM2 Handpieces without attachment. The PM2 80K Burs are used for cutting bones in cranial and spinal surgical procedures. PM PERFO is intended to be used for a cranial perforation. The ORiGO System is equipped with a peristaltic pump, which delivers saline irrigation solution to surgical sites through a 5m ORiGO System Irrigation Line. The ORiGO System is a prescription-only device.
The provided text describes a 510(k) premarket notification for the ORiGO System, an electrical surgical system. It details the device's indications for use, technological characteristics, and performance testing to demonstrate substantial equivalence to a predicate device. However, it does not contain the specific information required to complete the detailed table and answer all the questions regarding acceptance criteria and the study proving the device meets those criteria.
The document focuses on demonstrating that the ORiGO System is substantially equivalent to a legally marketed predicate device (OSSEODUO Shaver and Drill System K173066) based on similarities in intended use, technological characteristics, and performance. The performance testing section primarily lists compliance with various international standards, FDA guidance documents, and biocompatibility tests. It does not provide specific acceptance criteria values with corresponding device performance metrics for the device itself or the study that definitively proves the device meets those criteria in a quantitative sense as might be expected for an AI/software-based device performance study.
Here's what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed device performance metrics in a table format. Instead, it states:
- "The conformance of the ORiGO System with applicable international and internal standards was verified during non-clinical bench testing and evaluation."
- "Tests were performed on the subject device, which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device."
- "Together, these verification/validation activities successfully demonstrated that the device correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the predicate devices."
This broadly states that the device met the required standards for safety and effectiveness and is comparable to the predicate. Specific numerical criteria and results are not provided.
| Acceptance Criteria (Not explicitly stated with values in the document) | Reported Device Performance (General statements from document) |
|---|---|
| Conformity with applicable technical standards (IEC 60601-1, 60601-1-2, 60601-1-6, IEC 62304, IEC 62366-1) | Demonstrated conformity |
| Compliance with FDA guidance documents (e.g., Reprocessing Medical Devices, Sterility Information, ISO 10993-1, Software Content, EMC, Cybersecurity) | Demonstrated compliance |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Indirect Hemolysis) | Testing conducted and devices selected in accordance with ISO 10993-1, implying successful completion. |
| Safety and Effectiveness comparable to predicate device | Tests demonstrated device is safe and effective, performs comparably, and is substantially equivalent. |
| Device performs as designed and validated for intended use | Verification/validation activities demonstrated correct performance. |
| Raises no new questions regarding safety or effectiveness | Verification/validation testing supports this. |
Missing Information/Answers to Specific Questions:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document describes non-clinical bench testing, but does not specify sample sizes for test units or any 'data sets' in the context of an AI/software performance study. This is a hardware device; thus, the concept of a "test set" as understood for AI performance is not applicable here in the same way. The provenance of any test data (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This is a hardware surgical device. The document does not describe any human expert review or ground truth establishment relevant to an AI model's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No mentions of adjudication are present as it's not relevant to the type of device and testing described.
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. The document explicitly states: "Clinical testing was not required for a determination of substantial equivalence of the ORiGO System." Therefore, no MRMC study involving human readers or AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. While the device is "software-controlled," the evaluation focuses on the mechanical and electrical safety/performance of the surgical system, not on the standalone performance of an independent algorithm in the context of diagnostic or interpretive tasks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided in the context of AI ground truth. The "ground truth" for this device's performance is compliance with established engineering standards (e.g., electrical safety, software lifecycle, usability, biocompatibility) and its functional performance in cutting bone as designed through bench testing, not through a diagnostic or interpretive ground truth.
8. The sample size for the training set
- Not applicable/Not provided. The device is a hardware surgical system. The concept of a "training set" as used for AI/machine learning models does not apply here.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no training set mentioned, there is no discussion of establishing ground truth for it.
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(100 days)
The ORIO-Ti cervical intervertebral body fusion cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six (6) weeks of non-operative treatment with an intervertebral cage. ORIO-Ti cervical intervertebral body fusion implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. ORIO-Ti cervical intervertebral body fusion implant is to be used with supplemental fixation that has been cleared for use in the cervical spine.
The ORIO-Ti lumbar intervertebral body fusion cage is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had at least six (6) months of non-operative treatment. ORIO-Ti lumbar intervertebral body fusion implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral, or lateral approach. The ORIO-Ti lumbar intervertebral body fusion implants are to be used with supplemental fixation that have been cleared for use in the lumbosacral spine.
The subject devices are intervertebral body fusion devices for use in cervical lumbar spinal surgery. They may also be referred to as interbody fusion devices or interbody cages. The devices are generally boxshaped or trapezoidal shaped with windows or pockets in their design to allow for the placement of autograft or allogenic bone graft. The ORIO-Ti Cage System is a Titanium alloy interbody fusion system comprised of various device configurations based on surgical approach and patient anatomy, and may be implanted via one of the following approaches: as a single device via an anterior cervical (ACDF), bilaterally in pairs via a posterior (PLIF) approach; as a single device via a transforaminal (TLIF) approach; or as a single device via an anterior (ALIF) approach. The exterior of the devices has "teeth" on the superior and inferior surfaces to help prevent the devices from migrating once they are implanted.
The provided text is a 510(k) summary for the ORIO-Ti Intervertebral Body Fusion Cage System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing.
Crucially, the document explicitly states under "8. Clinical Test Summary": "No clinical studies were performed."
Therefore, it is not possible to provide the requested information about acceptance criteria and a study that proves the device meets those criteria, as no clinical studies were conducted for this device. The information provided heavily emphasizes non-clinical testing and comparison to predicate devices, which is common for 510(k) submissions where clinical data is often not required if substantial equivalence can be demonstrated through other means.
Without clinical study data, none of the points you asked for (acceptance criteria table, sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, type of ground truth, training set ground truth establishment) can be answered.
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(288 days)
The ORISE™ ProKnife has been designed to be used with endoscopes and electrosurgical units to cut tissue within the gastrointestinal tract using high-frequency current. The electrosurgical knife also has the capability of delivering saline/ submucosal lifting agent into submucosal tissue layers under direct visualization through an endoscope.
The ORISE™ ProKnife is an electrosurgical knife intended for use in Endoluminal surgery procedures, including but not limited to Endoscopic Submucosal Dissection (ESD). The ProKnife can deliver high frequency monopolar energy to facilitate incision of tissue. The ORISE™ ProKnife also has the capability of delivering saline/submucosal lifting agent through the electrode to maintain a submucosal fluid cushion without the need for a device exchange.
The provided text is a 510(k) summary for the ORISETM ProKnife, an electrosurgical knife. This document primarily focuses on establishing substantial equivalence to predicate devices through bench and ex-vivo testing, electrical safety, and biocompatibility. It does not describe a study involving a "device that uses AI" or "human readers," as indicated by the context of your request.
Therefore, I cannot extract the information requested for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/human reader study because the provided document does not contain such a study design.
The performance data section (Section 8) describes:
- Bench Testing: Functional and performance tests to satisfy design verification requirements, including knife operation with compatible endoscopes, dimension, general durability, and injection capability. All results were "passing" and demonstrated the device met "pre-defined performance specifications."
- Electrical Testing: Evaluated according to IEC 60601 series standards for medical electrical equipment and high-frequency surgical equipment.
- Biocompatibility Testing: Evaluated according to ISO 10993-1 and FDA Guidance.
The document concludes that the non-clinical testing results "demonstrate that the ORISETM ProKnife is considered safe and effective for its intended use" and that it is "substantially equivalent" to predicate devices.
To directly address your specific points based on the provided text's limitations:
-
A table of acceptance criteria and the reported device performance:
The document states: "All results were passing and demonstrate that the proposed device meets its pre-defined performance specifications." However, it does not provide a table with specific quantitative acceptance criteria or detailed reported performance values for each test. It only broadly states that the tests passed. -
Sample size used for the test set and the data provenance:
The document does not specify the sample sizes for the bench or ex-vivo tests. It also does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective, as these are non-clinical tests. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this was not a study involving human interpretation of data or images where expert ground truth would be established. The tests were objective performance evaluations (e.g., durability, electrical safety). -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for non-clinical bench and ex-vivo tests. -
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, an MRMC study was not done, as this is not an AI-assisted device. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is an electrosurgical knife, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests described, the "ground truth" would be established engineering specifications and compliance with recognized standards (IEC, ISO). For example, a "passing" result for electrical safety means the device met the requirements of the cited IEC standards. -
The sample size for the training set:
Not applicable, as this is not a machine learning device that requires a training set. -
How the ground truth for the training set was established:
Not applicable, as this is not a machine learning device.
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(529 days)
The "ORION" Spinal System is a non-cervical, pedicle screw system intended to provide posterior, non-cervical immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine : degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; scoliosis; kyphosis; spinal stenosis; tumor; pseudarthrosis and/or failed previous fusion.
In addition, the "ORION" Spinal System is also indicated for the treatment of the skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, having fusion by autogenous bone graft, with implant fixed or attached to the lumbar and sacral spine (L3 to Sacrum), and for whom the intended to be removed after solid fusion is achieved.
The "ORION" Spinal System is a system that is intended to be used for posterior thoracolumbar fusion procedures. The system is manufactured from Ti-6Al-4V which complies with ASTM F136 and PEEK which complies with ASTM F2026. The components, which are included as part of the system, include screws, rods, links, and accessory connection components.
This is a 510(k) premarket notification for the "ORION" Spinal System. This document does not describe the acceptance criteria and study for an AI/ML device. It's for a traditional medical device (a pedicle screw system). Therefore, the requested information regarding AI/ML device testing criteria, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable and not present in this document.
The document discusses the substantial equivalence of the "ORION" Spinal System to a predicate device based on its indications for use, technological characteristics, and performance data from engineering tests.
Here's what information is provided:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table comparing acceptance criteria and reported device performance in the way typically expected for AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists the types of engineering tests performed on the "ORION" Spinal System:
| Test Mode | Standard |
|---|---|
| Axial Grip | ASTM F1798 |
| Torsional Grip | ASTM F1798 |
| Static Compression Bending | ASTM F1717 |
| Static Torsion | ASTM F1717 |
| Dynamic Compression Bending | ASTM F1717 |
The document states that the "subect device is substantially equivalent to the predicate device," implying that the performance in these tests met the established criteria for substantial equivalence to the predicate device and relevant ASTM standards. However, the specific numerical results or acceptance thresholds from these tests are not detailed in this summary.
2. Sample sized used for the test set and the data provenance: Not applicable. This is an engineering test of a physical device, not an AI/ML algorithm evaluated on a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is an engineering test of a physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is an engineering test of a physical device.
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 an engineering test of a physical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an engineering test of a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. For this device, the "ground truth" implicitly refers to the device's ability to withstand mechanical forces and maintain structural integrity as per relevant ASTM standards, demonstrating substantial equivalence to the predicate device.
8. The sample size for the training set: Not applicable. This is an engineering test of a physical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable. This is an engineering test of a physical device, not an AI/ML algorithm.
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