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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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The ATL Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

• Shoulder: Rotator Cuff Repair, Acromioclavicular Sepair, Bankart Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.

• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Oblique Ligament Repair, Extra Capsular Reconstruction, Illiotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.

· Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.

· Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.

· Hand/Wrist: Scapholunate Ligament Reconstruction, Unar or Radial Collateral Ligament Reconstruction, TFCC.

· Hip: Acetabular labral repair.

The ATL Anchors are press fit suture anchors designed to secure the implant in bone and provide suture fixation. There are two configurations: with and without an eyelet. The devices are made from PEEK, are provided sterile, and pre-mounted on a single-use driver. The devices are provided with USP 0 ultra-high molecular weight polyethylene (UHMWPE) suture. ATL Anchors are used with Artelon® provided cannulated or solid stainless-steel drill bits. The devices are tapped into a pilot hole using a standard mallet (not provided).

The provided text is a 510(k) summary for the ATL Anchors, a medical device for soft tissue to bone attachment. It details the device description, indications for use, technological characteristics, and summary performance data. However, it does not describe an AI/ML-based device or a study involving human readers or expert consensus for ground truth. Therefore, I cannot generate the requested information about acceptance criteria, performance data, sample sizes, expert involvement, or MRMC studies.

The document discusses performance tests for the biomechanical properties of the ATL Anchors, such as insertion strength, pull-out strength, and cyclic loading, to demonstrate equivalence to predicate devices. It also mentions sterilization, shelf-life, and biocompatibility testing. These are typical engineering and safety tests for a physical medical device, not performance evaluations of an AI algorithm.

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

Artelon® FlexBand, FlexPatch, and FlexBand Plus are also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.

Artelon® FlexBand, FlexBand Plus are not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the bone, provide mechanical strength for the tendon repair. Artelon® Tissue Reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

FlexBand™ and FlexBand™ Plus products are a knitted mesh made from ARTELON® fibers. Artelon® fiber is made of polycaprolactone-based polyurethaneurea. The construction permits the mesh to be cut into any desired shape or size without unraveling.
The Flexband Plus™ devices have a suture attached to each end of the ARTELON® mesh strips. The pre-loaded suture is intended to improve usability in the operating room. The sutured FlexBand™ Plus is packaged with two commercial (off-the-shelf) stainless steel passing needles. The device is supplied sterile, one product per package, in double layer peel pouch packaging.
The FlexBand™ and FlexBand Plus™ devices are available in several sizes; 0.03cm, 0.05cm, and 0.07cm widths in lengths of 8cm, 16cm, and 34cm for each width.

The provided document is a 510(k) Premarket Notification from the FDA for a surgical mesh device called "FlexBand Plus." This document describes the device, its intended use, and a comparison to a predicate device ("FlexBand") to demonstrate substantial equivalence.

However, the provided text does not contain any information about a study proving the device meets acceptance criteria related to AI or algorithm performance, nor does it detail typical metrics associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC). The "acceptance criteria" and "study" described in this document refer to the physical and mechanical properties of the surgical mesh and its packaging, and how these perform compared to a previously cleared product.

Specifically, the "performance testing" section lists:

• Suture retention testing
• Suture strength testing
• Dimensional testing
• Transit testing
• Packaging testing

It then states that these tests were performed to ensure "risk acceptability criteria have been met and the risks have been mitigated." The conclusion notes that the "changes made were tested using the same acceptance criteria as the predicate device and demonstrated that there are no new risks and the device is substantially equivalent."

Therefore, I cannot answer most of your specific questions as they pertain to AI/ML device evaluation, as the provided document is for a traditional medical device (surgical mesh) and does not involve AI.

For the parts of your request that can be answered based on the provided document:

1. A table of acceptance criteria and the (reported) device performance

Based on the document, the acceptance criteria are not explicitly detailed in numerical form, but are implied to be "the same as the predicate device" and sufficient to "demonstrate that there are no new risks and the device is substantially equivalent" for the specific physical and mechanical tests mentioned. The document states that the testing demonstrated the device is "as safe, as effective, and performs as well as or better than the legally marketed device."

2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes for any of the performance tests (suture, dimensional, transit, packaging). The provenance of the data is from the manufacturer, International Life Sciences DBA Artelon, and is likely prospective testing specifically conducted for this 510(k) submission. No country of origin for the data is specified, but the submitter is based in Georgia, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a physical mesh, not an AI/ML device requiring expert interpretation of outputs. The "ground truth" here would be the physical properties and performance of the device under mechanical/physical testing, measured by standard engineering methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is related to human interpretation/labeling of data for AI/ML and not a physical device.

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, as this is related to AI/ML device evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is related to AI/ML device evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance evaluation is based on engineering and physical testing standards, such as tensile strength, dimensional accuracy, packaging integrity, and the outcomes of a risk analysis per ISO 14971:2012.

8. The sample size for the training set
Not applicable, as this is related to AI/ML device evaluation. There is no "training set" for a physical surgical mesh in this context.

9. How the ground truth for the training set was established
Not applicable, as this is related to AI/ML device evaluation.

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