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The HEALIX ADVANCE SP PEEK Anchor is in the following procedures for reattachment of soft tissue to bone:

Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair

• Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral ligament reconstruction, iliotibial (IT) band tenodesis
  Foot/Ankle: Achilles tendon repair

The HEALIX ADVANCE SP Biocomposite Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:

Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair

• Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral ligament Knee: reconstruction, iliotibial (IT) band tenodesis
• Foot/Ankle: Achilles tendon repair (4.9mm & 5.5mm only)

The proposed HEALIX ADVANCE SP PEEK and BIOCOMPOSITE Anchors is a line extension to the currently marketed HEALIX ADVANCE SP Anchor family. Both versions of the device consist of a two-piece "self-punching" design consisting of a cannulated, threaded anchor (PEEK or BIOCOMPOSITE) and PEEK (Polyetheretherketone) dilator which are permanently implanted into the body. The anchor- dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). Following anchor-dilator implantation, the stay suture is discarded.

The proposed HEALIX ADVANCE SP PEEK and BIOCOMPOSITE Anchors will be available in a new size option, 6.5 mm, molded from either Polyetheretherketone (PEEK) material or Absorbable Biocryl Biocomposite ((Polylactic Acid (PLA) and Tricalcium Phosphate (TCP)) material.

Both the HEALIX ADVANCE SP PEEK Anchor and HEALIX ADVANCE SP BIOCOMPOSITE Anchor are provided sterile via Ethylene Oxide (EO) sterilization and are for single use only.

This FDA 510(k) summary describes a medical device, the HEALIX ADVANCE™ SP PEEK Anchor and HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor. It is a submission for substantial equivalence to previously cleared devices, making it a "line extension." Therefore, the document focuses on demonstrating that the new devices are as safe and effective as the predicate devices, rather than establishing de novo acceptance criteria for an entirely new technology using a clinical study.

Here's an analysis based on the provided text, addressing your questions where applicable:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission for a line extension of an existing product, the "acceptance criteria" are implicitly met by demonstrating that the new device performs equivalently to the predicate devices in specific non-clinical tests. The document doesn't provide explicit numerical acceptance criteria values that the device had to meet (e.g., "pull-out strength must be > X N"). Instead, it states that "Performance testing included evaluation of in-vitro fixation strength at zero, six and twelve weeks, insertion torque, torque to failure and cyclic migration at time zero." and concludes that "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use."

The comparison is made against the predicate devices (K182941 for PEEK and K191242 for BIOCOMPOSITE). The core assertion is that the new 6.5mm size options perform comparably to the already cleared sizes and materials.

Implicit Acceptance Criteria and Reported Performance (derived from text):

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

The document describes non-clinical testing, not human clinical trials. Therefore, the "test set" refers to the samples of the devices used in the mechanical and biocompatibility tests. The specific number of devices (sample size) used for each test (e.g., how many anchors were tested for pull-out strength) is not specified in this summary.

Data Provenance: The data is from "verification activities" and "performance testing" conducted by the manufacturer, DePuy Synthes Mitek, a Johnson & Johnson company. It's retrospective in the sense that it's data collected to support the submission, but it's not retrospective patient data. It's lab-generated, in-vitro test data. The country of origin of the data is implied to be where the testing was performed, likely the United States (where DePuy Synthes Mitek is located) or Switzerland (Medos International SARL).

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

This question is not applicable. For a device like a suture anchor, "ground truth" in the context of clinical outcomes would typically be established in a clinical trial by expert clinicians (e.g., orthopedic surgeons) evaluating patient outcomes, or by pathology reports. However, for a 510(k) submission based on non-clinical testing for substantial equivalence, such expert-established ground truth for a "test set" (meaning patient data) is not relevant or described. The "ground truth" for the non-clinical tests is the measured physical properties of the device.

4. Adjudication Method for the Test Set:

This question is not applicable for non-clinical, in-vitro testing. Adjudication methods (like 2+1, 3+1) are used in clinical studies or evaluations of imaging/diagnostic devices where multiple expert interpretations need to be reconciled to establish a consensus ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where the performance of human readers with and without AI assistance is evaluated across multiple cases. The device in question is a physical surgical implant, not a diagnostic tool requiring human interpretation of medical images.

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

No, this question is not applicable. This device is a physical implant, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used:

For this device, the "ground truth" is based on objective physical measurements from in-vitro mechanical tests (fixation strength, torque, cyclic migration) and validated sterilization/biocompatibility testing against established standards (e.g., ANSI/AAMI/ISO, USP, EP). There is no pathology, outcomes data, or expert consensus (in the sense of clinical decision-making) used for "ground truth" in this 510(k) summary as it is focused on demonstrating substantial equivalence through non-clinical means.

8. The Sample Size for the Training Set:

This question is not applicable. There is no "training set" in the context of this device. Training sets are used for machine learning or AI algorithms, which this device is not.

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

This question is not applicable as there is no training set for this device.

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The HEALIX ADVANCE SP PEEK Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:
• Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair
• Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral collateral ligament reconstruction, iliotibial (IT) band tenodesis
• Foot/Ankle: Achilles tendon repair

The HEALIX ADVANCE SP PEEK Anchor is a two-piece “self-punching” design consisting of a cannulated, threaded anchor and dilator which are permanently implanted into the body. The anchor-dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). During implantation the stay suture may be discarded or incorporated into the repair at the surgeon's discretion. The proposed HEALIX ADVANCE SP PEEK Anchor is offered in two sizes, 4.9 mm and 5.5 mm and is molded from Polyetheretherketone (PEEK) material. The HEALIX ADVANCE SP PEEK Anchor is provided sterile via Ethylene Oxide (EO) sterilization and is for single use only.

Here's an analysis of the provided text regarding the HEALIX ADVANCE™ SP PEEK Anchor, focusing on acceptance criteria and supporting studies.

Based on the provided FDA 510(k) summary for the HEALIX ADVANCE™ SP PEEK Anchor, the device is a medical implant, and the approval process primarily focuses on engineering and biocompatibility performance testing rather than AI/machine learning performance. Therefore, many of the requested categories related to AI/ML studies (such as MRMC, standalone algorithm performance, number of experts for ground truth, sample size for training set, etc.) are not applicable to this specific device and submission.

The acceptance criteria here concern the mechanical integrity, sterility, and biocompatibility of the anchor.

Acceptance Criteria and Reported Device Performance

Details Regarding the Study/Testing:

1. Sample size used for the test set and the data provenance:

   • The 510(k) summary does not specify the exact number of samples (e.g., how many anchors were tested for fixation strength, how many were subjected to cyclic migration). This information would typically be detailed in the full test reports submitted to the FDA, but is summarized here.
   • Data Provenance: The device is manufactured by Medos International SARL in Switzerland (CH 2400, Switzerland), though the submitter is DePuy Synthes Mitek in Massachusetts, USA. The testing would have been conducted by the manufacturer or a contracted lab. The studies are non-clinical (benchtop and lab-based), not human subject data. Therefore, concepts like country of origin for data (in a clinical sense) or retrospective/prospective are not directly applicable.

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

   • Not Applicable. For this type of medical device (suture anchor), "ground truth" is established by engineering standards, material specifications, and validated test methods, not by expert interpretation of clinical data in the way one would for an AI diagnostic algorithm. The "experts" involved would be engineers, materials scientists, and quality assurance specialists.

3. 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 in clinical studies where subjective interpretation is involved. For engineering performance testing, the results are quantitative and objective, based on validated test protocols and measuring equipment.

4. 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 mechanical implant, not an AI diagnostic tool. MRMC studies are used to evaluate diagnostic imaging devices or AI algorithms that assist human interpretation.

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

   • Not Applicable. This device is a mechanical implant with no AI component, so there is no algorithm to test in a standalone manner.

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

   • For mechanical performance tests (fixation strength, torque, migration): The "ground truth" is determined by engineering specifications and validated biomechanical test methods that simulate physiological loads. The objective is to demonstrate that the device meets predefined mechanical thresholds and performance characteristics.
   • For sterilization and biocompatibility: The "ground truth" is established by international standards (ISO, AAMI) and regulatory guidelines (USP, EP), which define acceptable levels for sterility, endotoxin, and material safety.

7. The sample size for the training set:

   • Not Applicable. This device does not use machine learning or AI, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

In summary, the HEALIX ADVANCE™ SP PEEK Anchor is a conventional medical device whose substantial equivalence and safety/effectiveness are demonstrated through non-clinical engineering, material, and sterilization testing, not through AI/ML performance studies or clinical reader studies.

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