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FlexBand®, FlexPatch®, and FlexBand® Plus are intended for use in surgical procedures for reinforcement of soft tissue where weakness exists.

FlexBand®, FlexPatch®, and FlexBand® Plus are also 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 tendons, medial collateral ligament, lateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments.

FlexBand®, FlexPatch®, and FlexBand® Plus is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps tendons, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to the bone, provide mechanical strength for the tendon repair. The products reinforce soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

The FlexBand® / FlexPatch® / FlexBand® Plus products are knitted mesh made from ARTELON® fibers. ARTELON® fiber is made of degradable polycaprolactone-based polyurethane urea. The construction permits the mesh to be cut into any desired shape or size without unraveling. FlexBand® Plus devices have suture attached to each end of the knitted mesh strip. The pre-loaded suture is intended to aid in usability in the operating room. The devices are supplied sterile, one product per package in double layer peel pouch packaging.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:

It's important to note that the provided FDA 510(k) summary for FlexBand®, FlexPatch®, and FlexBand® Plus does not detail specific quantitative acceptance criteria with numerical thresholds, nor does it describe a formal "study" in the typical sense of a clinical trial or a statistically powered performance study against such criteria.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "performance data" section primarily describes types of mechanical testing performed to support this equivalence, rather than a direct measurement against predefined numerical acceptance criteria for a new clinical claim.

Therefore, the following information is extracted and presented based on what is explicitly stated or directly implied in the given text. Many fields, particularly those related to clinical studies, will be marked as "Not Applicable" or "Not Provided" because the submission is for substantial equivalence based on in-vitro performance and literature review, not a new clinical efficacy study with specific PIs.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the "Study that Proves the Device Meets the Acceptance Criteria" and other requested details:

As highlighted above, the submission is focused on demonstrating substantial equivalence (SE) to predicate devices by showing that the current device has the same technological characteristics or differences that do not raise different questions of safety and effectiveness. It does not describe a singular, novel study designed to meet specific quantitative performance criteria for a new clinical claim.

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

  • Mechanical Testing (Suture Retention, Tensile Strength): Not explicitly stated. These are in-vitro tests, not human data. The sample size would be for the number of device units tested.
  • Clinical Literature: The "Clinical literature" section refers to existing published studies on "the subject device involving ligament reinforcement procedures." This implies retrospective data analysis from already completed studies, not a new prospective test set for this 510(k). The provenance (e.g., country of origin) of these literature studies is not provided in this summary.

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

  • Not Applicable. For the mechanical testing, ground truth is based on physical measurements of device properties. For the clinical literature, the "ground truth" (clinical effectiveness) would have been established by the authors and expert reviewers of those original published studies, but not specifically for this 510(k) submission.

• 4. Adjudication Method for the Test Set:

  • Not Applicable. No human adjudication of a test set is described.

• 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 mesh, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study involving human readers and AI assistance was performed.

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

  • Not Applicable. This is a physical surgical mesh, not an algorithm.

• 7. The Type of Ground Truth Used:

  • Mechanical Testing: In-vitro physical measurement results (e.g., force in Newtons, displacement in mm) for suture retention and tensile strength.
  • Clinical Literature: Peer-reviewed clinical outcomes and effectiveness data from published studies concerning the device in relevant surgical procedures.

• 8. The Sample Size for the Training Set:

  • Not Applicable. There is no "training set" in the context of this device and submission, as it is not an AI/machine learning device.

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

  • Not Applicable. No training set exists for this device.

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