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The TeKBrace Solo Soft Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments.

The TeKBrace Solo Soft Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

The TheraMicro TekBrace Solo Soft Tissue Reinforcement Device is a single use device intended to be used for reinforcement of soft tissue. The product is offered in a central tubular weave tape that tapers down to cords at both ends. The implant is available in two sizes. The device will have pockets which provide access to the inside of the tubular section. The product is substantially equivalent in material and manufacturing compared to the Xiros Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K222978 and K220091). TekBrace Solo is similar to the Xiros Infinity-Lock predicate in intended use, material and design, including a central tubular section tapering down to cords at the end.

TekBrace Solo is manufactured from non-absorbable polyethylene terephthalate (PET), commercially known as polyester. The implant is manufactured from fibers of long-chain, linear polyester having recurrent aromatic rings. The device also incorporates Cottony II green PET suture for pocket location visibility.

The provided document is a 510(k) Clearance Letter for a medical device called the "TekBrace Solo Soft Tissue Reinforcement Device." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through performance testing related to mechanical properties and biocompatibility.

Crucially, this document does NOT describe a study involving an AI/Machine Learning device or a diagnostic device that would require the type of acceptance criteria and performance study details described in your prompt (e.g., sensitivity, specificity, MRMC studies, expert ground truth establishment for medical images).

The "TekBrace Solo Soft Tissue Reinforcement Device" is a surgical mesh (a physical implantable device), not a software or AI product. Its clearance is based on:

• Materials: Polyethylene terephthalate (PET)
• Design: Tubular weave tape with cords, pockets for access.
• Manufacturing process.
• Intended Use: Reinforcement of soft tissues in tendon/ligament repair.
• Performance Testing:
  • Tensile testing (ultimate tensile strength, fixation strength)
  • Fatigue testing (tensile strength following fatigue)
  • Endotoxin testing (biocompatibility)

Therefore, I cannot extract the information requested in your prompt (acceptance criteria for AI/ML, sample sizes for test/training sets for AI, expert consensus, MRMC studies, etc.) from this document because it pertains to a different type of medical device and a different regulatory pathway.

To answer your prompt effectively, I would need a 510(k) clearance letter or summary for an AI/ML-driven medical device, ideally one classified as a diagnostic imaging device or similar, that discusses clinical performance studies with metrics like sensitivity, specificity, or AUC.

If you provide such a document, I would be happy to populate the requested table and study details.

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The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments.

The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (Poly-Tape/Infinity-Lock) is a woven tape made from Polyethylene Terephthalate (PET) also referred to as polyester. This a nonabsorbable material that has a long history of use in the orthopedic market. The Poly-Tape/Infinity-Lock is a permanent implantable device for the reinforcement of soft tissues that are repaired by suture or other fixation devices during soft tissue repair surgery.

The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is a non-resorbable surgical mesh intended for reinforcing soft tissues during tendon and ligament repair surgery. The provided text outlines the device's characteristics and references performance testing, but does not specify numerical acceptance criteria or provide detailed results from a formal study proving the device meets those criteria.

Here's an analysis based on the provided input, highlighting what's available and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "The series of tests, listed above, has been conducted and successfully completed," but it lacks the quantitative acceptance criteria (e.g., minimum tensile strength of X Newtons, maximum elongation of Y %, etc.) and the actual measured performance values that would typically be found in a detailed study report.

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

The document lists types of performance testing conducted (Suture Retention, Ultimate Strength, Cyclic, Packaging, Biocompatibility), but does not provide details on the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective or prospective nature).

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 as the device is a physical implant and the testing described is mechanical and biological in nature, not an AI/diagnostic device that requires expert-established ground truth.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3.

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 as the device is a physical implant and not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is a physical implant and not an algorithm.

7. The type of ground truth used

For the mechanical properties (Suture Retention, Ultimate Strength, Cyclic Testing), the "ground truth" would be established by physical measurement standards and engineering principles (e.g., ASTM or ISO standards for material testing).

For biocompatibility, the "ground truth" is established by validated biological tests as defined by ISO 10993 series.

For packaging integrity, the "ground truth" is established by validated packaging test methods (e.g., ASTM standards).

For endotoxin levels, the "ground truth" is established by pharmacopeial methods like the LAL test.

The document states these tests were "successfully completed," implying adherence to established regulatory and scientific standards for "ground truth."

8. The sample size for the training set

This information is not applicable as the device is a physical implant and does not involve a training set as would be used for AI/machine learning.

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

This information is not applicable for the same reasons as point 8.

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