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The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation with post-operative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. HEALIX ADVANCETM Anchors with DYNACORDTM Suture are available in absorbable BR and non-absorbable PEEK materials. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.

The provided text describes the HEALIX ADVANCE™ Anchor with DYNACORD™ Suture, which is a medical device for soft tissue to bone fixation. However, the document does not contain information about specific acceptance criteria or a dedicated study providing quantitative performance metrics by which the device's performance can be explicitly measured against pre-defined criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture) through non-clinical testing. This type of submission relies on showing that the new device has similar technological characteristics and performs comparably to a device already cleared by the FDA, rather than conducting a de novo study against specific acceptance criteria.

Therefore, many of the requested details cannot be extracted from this document. Below is a summary of what is available and what is not:

HEALIX ADVANCE™ Anchor with DYNACORD™ Suture Device Performance Summary

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not specified in the document. The non-clinical testing refers to "anchor fixation testing," "in-vitro testing," "torque testing," "suture testing per USP," "suture approximation force testing," and "in-vivo testing," but the number of samples or specimens for each test is not provided.
• Data Provenance: The testing was "performed on the proposed device and/or its predicates." No information on country of origin or whether it was retrospective or prospective is given. Given the nature of mechanical/biocompatibility testing, it would generally be prospective laboratory testing.

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

• Not applicable for this type of submission. This device is a physical implant, and its performance is evaluated through mechanical, chemical, and biological testing, not by expert review of data like in an AI/imaging study. Ground truth is established by standardized testing methods and measurements.

4. Adjudication Method for the Test Set:

• Not applicable. As noted above, this device's performance is determined by objective physical and biological tests, not by human expert adjudication of interpretations.

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

• No. This is a physical medical device, not an AI or imaging diagnostic tool. MRMC studies are not relevant for this product.

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

• Not applicable. This phrase typically refers to the performance of an AI algorithm in isolation. This is a physical device, and its performance is assessed directly through non-clinical testing.

7. The Type of Ground Truth Used:

• Objective Test Results / Standardized Measurements: Ground truth for this device's performance is established by the results of various non-clinical tests (e.g., tensile strength in Newtons, torque in Nm, presence/absence of bacterial endotoxins within specified limits, biocompatibility as determined by in-vivo models). These are direct measurements or observations against established material and biological standards (e.g., USP standards).

8. The Sample Size for the Training Set:

• Not applicable. This submission does not involve machine learning or AI, so there is no "training set."

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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The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation with post-operative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction , Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

The HEALIX ADVANCETM Anchor with PERMATAPETM Suture consists of a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of one strand of #2 PERMACORDTM suture and one strand of PERMATAPETM suture to bone. HEALIX ADVANCETM Anchors with PERMATAPETM are available in absorbable BR and non-absorbable PEEK materials. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX ADVANCETM Anchor with PERMATAPETM Suture is provided sterile and is for single use only.

The provided text is a 510(k) Summary for the HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture device. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove the device meets those criteria from scratch.

Therefore, the information I can extract regarding acceptance criteria and a definitive "study that proves the device meets the acceptance criteria" is limited to the comparative testing performed to show substantial equivalence. The document doesn't outline a set of predefined acceptance criteria in the same way a de novo clearance or a clinical trial for an AI device might, nor does it conduct a standalone multi-reader multi-case (MRMC) study or a comprehensive standalone algorithm performance study.

However, I can extract the relevant performance testing and safety assessments that were performed to support substantial equivalence.

Here's a breakdown of the information based on your request:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Since this is a substantial equivalence submission for a mechanical device, the "acceptance criteria" are implied by the performance of the predicate devices and general standards for such implants. The reported device performance is based on comparative testing against these predicates.

Study Proving Acceptance Criteria (Substantial Equivalence Study):

The "study" to prove the device meets acceptance criteria in this context is the non-clinical performance testing conducted to support substantial equivalence to predicate devices. This is NOT a study in the sense of a clinical trial or an AI performance study with a test set, experts, and ground truth in the way you might expect for an imaging AI device.

• Study Name: Non-clinical (bench) testing and comparisons to predicate devices.
• Objective: To demonstrate that the HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture is substantially equivalent to legally marketed predicate devices, specifically the K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture and K100012, K073412 Gryphon™ BR Anchor with Orthocord® Suture.

Detailed Responses to Your Specific Questions:

1. A table of acceptance criteria and the reported device performance: Refer to the table above.
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   • Test Set Sample Size: Not explicitly stated in the summary. For bench testing of mechanical properties (pull-out, torque), standard engineering practices would involve a certain number of samples per test condition (e.g., 5-10 units).
   • Data Provenance: The testing is "non-clinical testing" and "in-vitro testing," meaning it was conducted in a lab environment (bench testing) rather than on patients or patient data. Therefore, country of origin of data or retrospective/prospective status is not applicable in the human data sense.
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 is a mechanical device, and ground truth is established by physical measurement tools and engineering standards, not by expert interpretation of medical images or patient outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as this is bench testing of a mechanical implant, not an AI diagnostic device requiring expert 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: Not applicable. This device is a surgical implant, not an AI diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from physical measurements (e.g., force in Newtons for pull-out, torque in N·cm) and material properties testing against established engineering and regulatory standards for mechanical implants, and comparison to the performance of predicate devices.
8. The sample size for the training set: Not applicable. This device does not use a training set as it is not an AI/machine learning product.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Device's Approach to Meeting Criteria:

The HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture demonstrates that it meets the necessary safety and performance criteria by establishing substantial equivalence to existing, legally marketed predicate devices. This is done through:

• Design and Material Similarity: Showing that its intended use, anchor design, materials (absorbable BR and non-absorbable PEEK), suture (PERMATAPE™) which is also similar to a reference device (PERMACORD™), device assembly, sterilization method, and shelf life are comparable to predicates.
• Non-Clinical Performance Testing: Conducting bench-top tests like pull-out testing, insertion and failure torque, and in-vitro testing. The results of these tests indicated the device is "suitable for its intended use" when compared to the performance characteristics expected for such devices and demonstrated by its predicates.
• Safety Testing: Completing bacterial endotoxin testing to ensure biocompatibility and safety regarding endotoxin levels.

The core of this 510(k) submission is to show that the new device does not raise new questions of safety and effectiveness compared to devices already on the market, thereby implying it meets the accepted performance and safety "criteria."

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The HammerFiX device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

The HammerFiX device is a bone fixation device consisting of a sterile, threaded PEEK implant and a set of instruments used for implant site preparation and delivery. The device is offered in small, medium and large implant sizes to allow for use in the proximal interphalangeal (PIP) joints of the lesser toes of the foot.

The provided text describes a 510(k) summary for the HammerFiX device, a bone fixation device. However, it explicitly states that no clinical testing was performed. Therefore, the information requested regarding acceptance criteria and a study proving the device meets them cannot be fully provided from the given document as it pertains to clinical performance. The 510(k) relies on non-clinical bench testing to establish substantial equivalence to predicate devices, rather than clinical efficacy or specific performance criteria from a clinical study.

Here's a breakdown of the available information based on the provided text, acknowledging the lack of clinical study data:

Acceptance Criteria and Study Details for HammerFiX Device (Based on Non-Clinical Testing)

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical study was performed to evaluate performance against clinical acceptance criteria, the table below reflects the non-clinical testing performed and the general statement of equivalence based on those tests. Specific quantitative acceptance criteria or detailed numerical performance metrics from the bench testing are not provided in this summary.

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

• Test Set Sample Size: Not specified in the provided summary. This refers to the number of devices or constructs tested during non-clinical bench testing.
• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, likely at the manufacturer's facility or a contracted testing lab. No country of origin for data is stated, and it is inherently prospective for the specific bench tests conducted to support the 510(k).

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

• Not Applicable. For non-clinical bench testing, "ground truth" as it relates to expert clinical opinion is not established. The "ground truth" for mechanical testing is typically defined by standardized test methods and engineering specifications. The tests compare the device's measured mechanical properties to those of predicate devices or established engineering standards.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods (like 2+1, 3+1) are relevant for clinical studies, especially when multiple readers or experts assess subjective outcomes. For non-clinical mechanical testing, results are typically objective measurements, not subject to adjudication in this manner.

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

• No. The document explicitly states: "No clinical testing was performed." Therefore, no MRMC study was conducted.

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

• Not Applicable. The HammerFiX device is a physical bone fixation implant, not a software algorithm or AI-based device. No standalone algorithm performance evaluation would be relevant.

7. The Type of Ground Truth Used:

• Non-Clinical Mechanical Standards and Predicate Device Performance: For the non-clinical testing, the "ground truth" was established by comparing the HammerFiX device's mechanical properties (pull-out, torque, static, and dynamic bending) against:
  • Applicable engineering standards and test methodologies.
  • The known performance characteristics of the predicate devices identified (K120645, K120165, K073674, K061164, K071498, K120449).

8. The Sample Size for the Training Set:

• Not Applicable. This question is relevant for AI/ML algorithm development. Since the HammerFiX device is a physical implant and no AI/ML component is mentioned, there is no "training set."

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

• Not Applicable. See explanation above for training set.

Summary: The 510(k) clearance for the HammerFiX device was based on non-clinical bench testing demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating human performance or clinical outcomes. The document clearly states that "No clinical testing was performed."

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