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The PERMALOOP Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue.
The PERMATAPE Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue.

The PERMATAPE™ Suture is a 1.3mm wide, synthetic, sterile, flat braided suture composed of dyed and un-dyed (chromium cobalt aluminum oxide

This document describes the FDA's 510(k) clearance for the PERMALOOP Suture and PERMATAPE Suture, which are non-absorbable polyethylene surgical sutures. The information provided focuses on the substantial equivalence to predicate devices rather than a standalone clinical study with detailed acceptance criteria and performance metrics for a specific algorithm or AI.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable as this isn't a submission for an AI-powered diagnostic device but a traditional medical device (surgical suture).

However, I can extract the available information regarding testing and performance for the sutures.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like sutures, the "acceptance criteria" are typically defined by recognized standards and guidelines, and "device performance" is demonstrated through compliance with these standards.

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

The document does not specify the exact sample sizes for each physical and chemical test mentioned (e.g., how many sutures were tested for tensile strength or how many batches for sterilization validation).

• Data Provenance: The studies were non-clinical (laboratory testing) performed by the manufacturer, Medos International SARL / DePuy Synthes Mitek Sports Medicine.

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

Not applicable. For physical device testing, "ground truth" is established by adherence to recognized engineering and material science standards, not by expert consensus in the same way as, for example, image interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for human-in-the-loop studies or ground truth establishment based on expert disagreement, which is not the case here.

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 not an AI-powered device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance testing described is "standalone" for the device, meaning it evaluates the physical and chemical properties of the suture itself. However, this is not an algorithm, so the term doesn't apply in the common AI/algorithm context.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing of the PERMALOOP and PERMATAPE Suture is established by:

• Performance Standards: Adherence to established standards such as USP (United States Pharmacopeia) for tensile strength and needle attachment strength.
• Sterilization Standards: Compliance with international standards like ANSI/AAMI/ISO 11135 for Ethylene Oxide Sterilization.
• Biocompatibility/Safety Standards: Compliance with standards for EO residuals (AAMI/ANSI/ISO 10993-7) and non-pyrogenicity (ANSI/AAMI ST-72, USP, EP).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. The design, materials, and manufacturing processes are based on established engineering principles and prior validated devices.

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

Not applicable. As noted above, this is not an AI/machine learning 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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PERMATAPE™ Suture is indicated for use in general soft tissue approximation, and/or ligation, including use with allograft tissue for orthopedic procedures.

PERMATAPE™ Suture is a synthetic, sterile, flat braided suture composed of dyed and un-dyed, non-absorbable polyethylene.

This document is a 510(k) summary for a medical device called PERMATAPE™ SUTURE. The document details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, here is the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical AI/ML study would. Instead, it refers to industry standards and predicate device comparisons.

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

This information is not provided in the document. The document describes a physical medical device (surgical suture), not a software or AI/ML device that would typically involve test sets of data. The testing mentioned (USP Tensile Strength, bacterial endotoxin) would involve physical samples of the suture, but the sample sizes for these tests are not specified, nor is the "data provenance" as it would apply to data in an AI context.

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

This information is not applicable to this document. This is a physical medical device submission, not an AI/ML device where "experts" would establish ground truth for a test set. The "ground truth" for a suture would be its physical properties, which are measured using standardized methods.

4. Adjudication method for the test set

This information is not applicable to this document. Adjudication methods like "2+1, 3+1" are relevant for AI/ML device studies where discrepancies in expert labels or model predictions need resolution. For a physical device, performance is measured against established standards.

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 to this document. An MRMC study is relevant for AI/ML devices that assist human readers (e.g., radiologists interpreting images). This device is a surgical suture, which does not involve human "readers" or AI assistance in that context.

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

This information is not applicable to this document. The device is a surgical suture; it is not an algorithm and does not have "standalone" performance in the context of AI.

7. The type of ground truth used

For the physical characteristics of the suture, the "ground truth" is established by adherence to established industry standards and test methods, specifically:

• USP Tensile Strength for Surgical Sutures
• FDA's Special Controls Guidance document for Surgical Sutures
• Requirements for bacterial endotoxin testing

8. The sample size for the training set

This information is not applicable and not provided. This is a physical medical device, not an AI/ML device requiring a "training set" of data in the common sense. The manufacturing process of the suture is the "training" in a very loose analogy, but it's not a data-driven training set.

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

This information is not applicable and not provided. As explained above, this device does not utilize a "training set" in the context of AI/ML. The "ground truth" for the manufacturing process would be established by quality control procedures and specifications for materials and manufacturing methods, but these details are not provided in this regulatory summary.

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