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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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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 soft tissue repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons .

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 or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the bone, provide mechanical strength for the repair.

The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device 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. These devices are permanent implants for the reinforcement of soft tissues that are repaired by suture or other fixation devices during soft tissue repair surgery.

I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device, the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device, and discusses its substantial equivalence to other predicate devices for FDA clearance.

It details:

• Acceptance criteria: Not explicitly stated in terms of clinical performance metrics, but the document implies that "adequate mechanical properties for its use in soft tissue reinforcement" are criteria demonstrated through various tests.
• Device performance: The text states that "The results demonstrate that the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device provide adequate mechanical properties for its use in soft tissue reinforcement." However, specific numerical performance results are not provided.
• Type of study: "Performance Data" section lists several types of tests conducted: Suture Retention Testing, Ultimate Strength Testing, Cyclic Testing, Packaging Testing, and Biocompatibility Testing, along with routine endotoxin (LAL) batch testing. These appear to be laboratory and material science tests, not clinical studies.

The document does not provide information on:

• A table of acceptance criteria and reported device performance with numerical values.
• Sample size used for a test set, data provenance, or whether it was retrospective/prospective.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
• Standalone algorithm performance (as this is a physical medical device, not an AI/software device).
• The type of ground truth used (expert consensus, pathology, outcomes data).
• The sample size for the training set or how ground truth for the training set was established.

Therefore, I cannot generate the requested table or answer most of the questions based on the provided text.

Ask a specific question about this device