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The Healix Advance Knotless Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:

Shoulder

Rotator Cuff .
. Biceps Tenodesis

The proposed Healix Advance Knotless Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchors will be offered in a 6.5 mm size. The proposed 6.5 mm Healix Advance Knotless PEEK Anchor is manufactured from PEEK (Polyetheretherketone) material.

The DePuy Mitek HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5mm) is a medical device designed for reattachment of soft tissue to bone. This submission (K131683) is for a larger version (6.5mm) of previously cleared predicate devices (4.75mm and 5.5mm Healix Advance Knotless PEEK Anchors).

Acceptance Criteria and Device Performance Study:

Since this FDA submission is a Special 510(k) based on substantial equivalence to predicate devices, formal acceptance criteria and a single study proving the device meets them in the traditional sense (e.g., a clinical trial with specific performance endpoints) are not presented in the provided documents. Instead, the submission focuses on demonstrating that the new device has the same design, technological characteristics, and safety/performance profile as the predicate devices, despite the size change.

The "Substantial Equivalence" framework in 510(k) submissions relies on showing that the new device is as safe and effective as a legally marketed predicate device. The "acceptance criteria" here can be inferred as showing that the new device performs equivalently or comparably to the predicate in non-clinical tests relevant to its function.

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The "acceptance criteria" are implied by the need to demonstrate substantial equivalence to the predicate devices (4.75mm and 5.5mm Healix Advance Knotless PEEK Anchors). The non-clinical testing performed (Insertion Torque, Torque to Failure, Anchor Pullout) aimed to show that the 6.5mm anchor's mechanical performance is comparable to the predicate devices, thus meeting the "acceptance criteria" for safety and effectiveness in the context of a Special 510(k).

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not explicitly stated. The document mentions "Product Design Verification and Design Validation activities," but does not detail the number of samples used for each test (Insertion Torque, Torque to Failure, Anchor Pullout).
• Data Provenance: The testing was "Non-clinical Testing" performed by the manufacturer, DePuy Mitek. The country of origin of the data is not specified, but it would have been generated in a controlled laboratory setting by the company. It is retrospective in the sense that the testing was conducted prior to submission to demonstrate equivalency.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable in this context. The "ground truth" for non-clinical mechanical testing is derived from the physical properties and performance characteristics of the devices themselves, measured through established engineering and biomechanical methods. No human experts are used to interpret the "ground truth" of these test results; rather, engineers and scientists conduct and analyze the tests against predetermined specifications or predicate performance.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image-based diagnostic evaluations where human interpretation of outcomes is involved. For non-clinical mechanical testing, results are quantitative and objective, and thus do not require an adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data (e.g., radiologists reading mammograms with and without AI assistance). The Healix Advance Knotless PEEK Anchor is an implantable surgical device, and its performance is evaluated through biomechanical testing and clinical outcomes, not through human reader interpretation of data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No, a standalone (algorithm only) study was not done. This type of study is specifically for evaluating the performance of AI algorithms. The device described is a physical surgical implant, not an algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for the non-clinical testing was based on objective, quantitative mechanical measurements (e.g., torque values, force measurements for pullout strength). These measurements establish the intrinsic performance characteristics of the device. The comparison of these measurements to the predicate device's known performance serves as the basis for the substantial equivalence claim.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The concept of a "training set" is relevant to machine learning models.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no training set for this device.

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ORTHOCORD Suture is indicated for use in general soft tissue approximation, and/or ligation, including orthopaedic procedures.

Orthocord® Suture is a synthetic, sterile, braided, composite suture composed of dyed (D&C Violet #2 or D&C Blue #6) absorbable polydioxanone (PDS) and un-dyed non-absorbable polyethylene. The partially absorbable suture is coated with a copolymer of 90% caprolactone and 10% glycolide.

The provided text does not contain a study or detailed performance data that would allow for a complete answer to your request. The document is a 510(k) summary for a medical device (Small Size Orthocord® Suture) seeking substantial equivalence to previously cleared devices.

Instead of a detailed study with acceptance criteria and performance metrics, it states that:

• "The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards."
• "Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP monograph for absorbable sutures, except for oversized diameter."

This indicates that the device's equivalence and safety/performance were established primarily through comparison to existing predicate devices and adherence to general standards, rather than a novel clinical or non-clinical study with specific acceptance criteria and reported device performance as you've requested for AI/software-based devices.

Therefore, I cannot populate the table or answer most of your detailed questions because the information is not present in the provided text.

However, I can extract the following limited information:

1. A table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance: Not applicable. No specific "test set" or data provenance (country of origin, retrospective/prospective) is described for a study in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts is not mentioned for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 device is a surgical suture, not an AI/imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance would be its physical and mechanical properties conforming to established standards and predicate device performance, not clinical ground truth in the AI sense.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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The DePuy Mitek Tibial Tapered Screw and Tibial Sheath are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

The proposed INTRAFIX System consists of two components, a non-absorbable INTRAFIX Expansion Sheath and a non-absorbable INTRAFIX Expansion Screw. Also included within the system is the instrumentation to place devices and establish the tunnel. The device functions by establishing the tunnel and placing the expansion Sheath into the tunnel by the use of Sheath Inserter. This is followed by screwing an Expansion Screw into the Sheath expanding the Sheath which compresses the graft against the tunnel and creating fixation.

The provided text describes a 510(k) summary for the INTRAFIX® PEEK Tapered Screw, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than a separate clinical study with predefined acceptance criteria for the device itself. Therefore, the questions related to clinical study design, sample sizes, expert involvement, and ground truth for a device performance study are not directly applicable in the context of this 510(k) summary.

However, I can extract the information relevant to non-clinical testing which served as the "study" to demonstrate substantial equivalence, and interpret "acceptance criteria" as meeting the performance of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This implies that the PEEK Tapered Screw's performance in these non-clinical tests was comparable to or met the performance standards of the predicate devices. The exact numerical values for these metrics are not provided in this summary, but the conclusion is that equivalence was achieved.

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not specified in the provided summary.
• Data provenance: Non-clinical testing. The country of origin and whether it was retrospective or prospective is not applicable or specified for this type of testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This was non-clinical engineering and mechanical testing, not a study requiring expert clinical ground truth.

4. Adjudication method for the test set

• Not applicable. This was non-clinical engineering and mechanical testing.

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 a medical device for orthopedic fixation, not an AI diagnostic or image analysis device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a medical device for orthopedic fixation.

7. The type of ground truth used

• The "ground truth" for demonstrating substantial equivalence in this context was the established performance (e.g., torque capability, pullout strength) of the predicate devices.

8. The sample size for the training set

• Not applicable. This is a medical device; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

• Not applicable. This is a medical device; there is no "training set."

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