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The SpeedLock HIP Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone in the hip. Examples of such procedures include:

• Hip capsule repair
• Acetabular labrum reattachment

The SpeedLock HIP Knotless Fixation Implant (SpeedLock HIP) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. With this anchor, surgical knots are not necessary for the fixation of suture to tissue.

The SpeedLock HIP consists of two primary parts: a 3.4 mm PEEK bone anchor and a disposable anchor inserter which is preloaded with the anchor. The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.

The SpeedLock HIP Knotless Fixation System also includes associated instruments for implanting the anchor into bone.

The design modification that is the subject of this Premarket Notification relates to the internal detachment feature of the SpeedLock HIP anchor. The modification does not alter the overall device characteristics or the manner in which the device is used, and there are no changes to the device's cleared indications for use.

The provided document is a 510(k) summary for the ArthroCare® Corporation SpeedLock® HIP Knotless Fixation Implant. It describes a modification to an already cleared device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing. It does not involve studies to establish clinical acceptance criteria or assess AI/human reader performance.

Therefore, most of the requested information regarding acceptance criteria, device performance, ground truth, expert opinions, and AI studies is not applicable to this document. The document explicitly states: "No clinical or animal data are included in this submission."

Here's a breakdown of what can be extracted and what cannot:

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

The document states that "Design Verification testing to demonstrate conformance with device specifications" was performed. This included:

• Functional testing of all aspects of device performance.
• Use of the device with ancillary devices.
• Anchor deployment, bone lock, and suture lock in a foam bone model.
• Insertion testing in a simulated hard bone substrate.
• Side-by-side comparative testing of the modified and predicate devices, including static and cyclic suture and anchor pull testing, as well as elements of standard verification testing.

Acceptance Criteria and Reported Performance (Based on provided text)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document mentions "testing" (e.g., functional testing, insertion testing, side-by-side comparative testing) but does not provide specific sample sizes (e.g., number of anchors tested, number of cycles).
• Data Provenance: The testing appears to be primarily laboratory-based mechanical and functional testing, not data from human or animal subjects. No country of origin is mentioned for the "data," but the submitter is based in Austin, TX, USA.
• Retrospective or Prospective: Not applicable as it's non-clinical, mechanical testing.

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 submission focuses on engineering and mechanical testing, not clinical performance or diagnostic accuracy. Ground truth in the traditional sense for medical imaging or clinical diagnosis is not relevant here. The "truth" would be the measured mechanical properties and functional performance against predefined engineering specifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving interpretation (e.g., by human readers). This document describes non-clinical, objective 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. No MRMC study was performed. The device is a surgical implant, not a diagnostic tool utilizing AI. The document explicitly states: "No clinical or animal data are included in this submission."

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

• Not applicable. This device is a mechanical surgical implant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical testing, the "ground truth" would be defined by engineering specifications, material properties, and established test standards for mechanical performance (e.g., force required for pull-out, number of cycles before failure, successful deployment of anchor).

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set."

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The SpeedLock HIP Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone in the hip. Examples of such procedures include:

• Hip capsule repair
• Acetabular labrum reattachment

The SpeedLock HIP Knotless Fixation Implant (SpeedLock HIP) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The SpeedLock HIP is a knotless fixation device: surgical knots are not necessary for the fixation of suture to tissue.

The SpeedLock HIP consists of two primary parts: a PEEK bone anchor and an anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.

The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.

The SpeedLock HIP Knotless Fixation System consists of the 3.4 mm SpeedLock HIP anchor and associated instruments for implanting the anchor into bone.

The provided text describes the SpeedLock® HIP Knotless Fixation Implant, a bone anchor device. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing, rather than an AI/ML device. Therefore, a direct response to some of the AI/ML-specific questions (like sample sizes for training/test sets, expert adjudication methods, MRMC studies, or multi-reader multi-case studies) is not applicable.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical acceptance criteria for various mechanical tests. Instead, it broadly states that the device "meets all design, performance, and safety specifications" and that the "test results demonstrate... substantial equivalence" to predicate devices. The study performed was a comparative bench test.

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

The document mentions "side by side bench testing" but does not specify the sample size (number of devices tested) for the proposed device or the predicate devices.

• Sample Size: Not specified.
• Data Provenance: The testing was "in vitro" using a "simulated human bone substrate." This indicates laboratory bench testing, not human data.

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

This question is not applicable as the study involved mechanical bench testing of a physical device, not an AI/ML algorithm requiring expert interpretation of data or images to establish ground truth.

4. Adjudication Method for the Test Set

This question is not applicable for a mechanical bench test. The "ground truth" (or reference standard) for mechanical properties would be derived from the testing equipment and established engineering principles, not expert consensus or adjudication.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for a physical medical device (bone anchor), not an AI/ML software.

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

This question is not applicable as the submission is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission was established through mechanical testing data (static and cyclic fatigue testing) against pre-defined engineering and performance specifications, and in comparison to the performance of predicate devices. This is based on objective measurements from laboratory equipment, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This question is not applicable. There is no training set mentioned or implied, as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

This question is not applicable, as there is no training set for an AI/ML device.

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