Search Results

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

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Origin Anterior Cervical Plate System is interior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvature (i.e., scoliosis, kyphosis), tumor, pseudoarthrosis, and failed previous fusion.

Origin Anterior Cervical Plate System is an anterior cervical fixation system comprised of a titanium plate, and bone screws, both in multiple sizes. The Plate features multiple holes designed to receive and secure bone screws. The Plate System is provided non-sterile and is intended for single use.

This document is a 510(k) summary for the Origin™ Anterior Cervical Plate System, a medical device for spinal fixation. It does not contain information about an AI/ML device or its performance characteristics. Therefore, I cannot provide the requested information about acceptance criteria, study details, ground truth, or multi-reader multi-case studies, as described in the prompt.

The document describes a traditional medical device (an anterior cervical plate system) and its submission for FDA clearance based on substantial equivalence to predicate devices, supported by performance data from mechanical testing.

Ask a specific question about this device