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The HEALIX ADVANCE KNOTLESS BR Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:

Shoulder: Rotator Cuff, Biceps Tenodesis, Deltoid Repair

Knee: Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), Iliotibial (IT) Band Tenodesis

Foot/Ankle: Achilles Tendon Repair

The HEALIX ADVANCE KNOTLESS BR 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 anchor is offered in three sizes, 4.75 mm, 5.5 mm and 6.5mm. The HEALIX ADVANCE KNOTLESS BR Anchors are molded from Biocryl Rapide® (BR) material. The HEALIX ADVANCE KNOTLESS BR Anchor is provided sterile and is for single use only.

This document is a 510(k) Premarket Notification from the FDA regarding the HEALIX ADVANCE™ KNOTLESS BR Anchor. It is a clearance letter and a summary of the device, not a study report or clinical trial. Therefore, it does not contain the specific information required to answer the prompt regarding acceptance criteria and performance data for an AI/ML medical device.

The prompt is asking for details typically found in a clinical study report for an AI/ML-driven device, such as:

1. A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, AUC).
2. Sample size, data provenance, and retro/prospective nature of the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for golden standard.
5. MRMC study details and effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, clinical outcome).
8. Training set sample size.
9. Method for establishing training set ground truth.

This 510(k) summary focuses on the substantial equivalence of a physical medical device (suture anchor) to predicate devices, based on material, design, and mechanical performance (fixation strength, insertion torque). It does not involve any AI/ML components or related performance metrics that would require the establishment of ground truth by multiple experts, MRMC studies, or analysis of sensitivity/specificity for diagnostic tasks.

Therefore, I cannot fulfill the request using the provided document. The document describes a physical medical device and its premarket clearance, not an AI/ML device with associated performance studies.

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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 BR Anchor is manufactured from "biocryl rapide" material.

The provided document does not describe the acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML device.

Instead, this document is a 510(k) summary for a medical device called the "HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5mm)". It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the performance of an AI/ML algorithm against predefined acceptance criteria.

The device in question is a physical bone anchor for soft tissue reattachment, not an AI/ML diagnostic or treatment planning system. Therefore, most of the requested information (like sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this type of medical device submission.

Here's the relevant information that can be extracted, framed within the context of a traditional medical device submission for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are tied to demonstrating that the new device (6.5mm anchor) performs similarly from a safety and effectiveness perspective to the predicate devices (4.75mm and 5.5mm anchors). The "reported device performance" are the results of non-clinical bench testing.

• Insertion Torque tests
• Torque to Failure tests
• Anchor Pullout tests
  Results demonstrated that the proposed device is substantially equivalent to the predicate devices regarding performance and safety. (Specific numerical values or thresholds are not provided in this summary but would be in the full submission). |
  | No new technological characteristics are introduced that would raise new safety/effectiveness concerns. | The proposed 6.5mm anchor has the same design principles and is manufactured from the same "biocryl rapide" material as the predicate 4.75mm and 5.5mm anchors. The only change is size. |

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

• Test Set Sample Size: Not explicitly stated as this is non-clinical bench testing. The "test set" would refer to the number of anchors or test specimens used for the mechanical tests (Insertion Torque, Torque to Failure, Anchor Pullout).
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" comes from laboratory bench testing.

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

• Not applicable. Ground truth in this context is determined by validated engineering test methods and measurements, not expert clinical interpretation.

4. Adjudication method for the test set

• Not applicable. This is not a clinical study involving human readers.

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 not an AI/ML system.

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

• Not applicable. This device is not an AI/ML system.

7. The type of ground truth used

• For the non-clinical testing, the "ground truth" would be established by validated engineering standards and measurement equipment for mechanical properties (e.g., torque, force).

8. The sample size for the training set

• Not applicable. This device is not an AI/ML system.

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

• Not applicable. This device is not an AI/ML system.

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The HEALIX ADVANCE KNOTLESS BR 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 BR ANCHOR is a cannulated, threaded knotless anchor designed to secure soft tissue to bone. The proposed anchor is manufactured from the absorbable material "Biocryl® Rapide™" (15/85% B - TCP/PLA PGA copolymer) loaded on a disposable inserter driver with #2 ORTHOCORD® suture (K040004, K043928). The anchors are offered in two sizes (4.75 mm and 5.5 mm).

The provided text is a 510(k) summary for a medical device (HEALIX ADVANCE KNOTLESS BR ANCHOR) and does not contain the detailed information necessary to answer all aspects of your request. Specifically, it lacks a dedicated "acceptance criteria" section and a detailed study report.

However, based on the Safety and Performance section, we can infer some aspects related to device performance and the type of study conducted to support substantial equivalence.

Here's an attempt to answer your questions based on the available information, with clear indications where information is missing:

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

The document mentions "Performance requirement of the proposed device is to secure soft tissue to bone during soft tissue healing period." It then states that "Fixation force testing was performed under in vitro condition throughout two times of healing period." The conclusion is that "The data shows that the proposed device performs similarly to the predicate devices."

Therefore, the implicit acceptance criteria would be for the device's fixation force to be "similar to the predicate devices" during and after the specified healing period. The reported performance is that it "performs similarly to the predicate devices."

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

This information is not provided in the document. The document only mentions "in vitro condition" for the fixation force 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)

This information is not applicable/provided. The study described is an in vitro performance test, not a clinical study involving human or animal data that would require expert-established ground truth.

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

This information is not applicable/provided. The study described is an in vitro performance test.

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

This information is not applicable. The device is a bone anchor, not an AI-powered diagnostic tool, and therefore no MRMC study involving human readers and AI assistance would be conducted for its clearance.

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

This information is not applicable. The device is a bone anchor, not an algorithm. The "standalone" performance here would refer to the mechanical performance of the anchor itself, which was evaluated as described.

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

For the "fixation force testing," the "ground truth" would be the measured mechanical properties (e.g., maximum load to failure, displacement, stiffness) of the device and its predicate, obtained through controlled engineering tests. For "material biocompatibility," the ground truth would be established through standard biocompatibility testing as per ISO or ASTM standards.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not an algorithm that requires a "training set."

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

This information is not applicable.

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