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The FiberTak DX is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps
Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or
Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of
collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and
MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction
and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,
Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers,
Mid-foot reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,
Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band
Tenodesis

The FiberTak DX is an "all-suture" soft-tissue fixation device. The anchor and connected sutures are impacted into a pilot hole. The sutures are then manually tensioned to set the anchor by "bulging" the suture sleeve within the pilot hole.

The provided text describes a 510(k) premarket notification for a medical device called "FiberTak DX." This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving the device meets specific performance acceptance criteria for an AI/algorithm-based diagnostic device.

Therefore, the requested information regarding acceptance criteria, study design for AI evaluation (sample sizes, expert involvement, ground truth, MRMC study, etc.), and training data for an algorithm cannot be extracted from the provided text.

The "Performance Data" section briefly mentions:

• Pull-out testing: "demonstrated that the pull out displacements of the proposed FiberTak DX met the criteria established by the predicate device."
• Bacterial endotoxin testing: "conducted to demonstrate that the device meets pyrogen limit specifications."

This indicates that a mechanical performance study (pull-out strength/displacement) and a biocompatibility/sterility-related test (bacterial endotoxin) were performed. However, the specific numerical acceptance criteria for these tests and the detailed results are not provided. The document states they "met the criteria established by the predicate device" and "meets pyrogen limit specifications," but does not give the values.

To directly answer your request based on the provided text, I can only indicate what information is not present:

1. Table of acceptance criteria and reported device performance for an AI/algorithm: Not applicable as this is a physical medical device (suture anchor), not an AI/algorithm-based diagnostic device. The document mentions pull-out testing and bacterial endotoxin testing, but no specific numerical acceptance criteria or detailed performance values are given.
2. Sample size for the test set and data provenance: Not applicable for an AI/algorithm. For the physical device tests (pull-out, endotoxin), sample sizes are not specified.
3. Number of experts used to establish ground truth and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used: Not applicable for an AI/algorithm. For the physical device, the "ground truth" would be established by validated mechanical testing methods (for pull-out) and chemical/biological testing methods (for endotoxin), not clinical experts.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance for a physical medical device (suture anchor), not an AI/algorithm diagnostic device. Therefore, the detailed acceptance criteria and study information typically associated with AI/algorithm validation, as requested in your prompt, are not present in this document.

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The Arthrex BioSync Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies, in the ankle and foot, such as:

Cotton and Evans Wedges:

• Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
• Opening wedge of Medial Cuneiform or Cotton osteotomies
• Lateral Column Lengthening (Evans Lengthening Osteotomy of Calcaneal Z Osteotomy)
• Metatarsal/Cuneiform arthrodesis

Midfoot Wedges:

• Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
• Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)

This device is intended for use with ancillary fixation. The Arthrex BioSync Bone Wedge is not intended for use in the spine.

The Arthrex BioSync Bone Wedge is a family of pre-sized implantable titanium porous metal wedges intended to be used for angular correction of small bones in the ankle and foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.

This document is a 510(k) premarket notification for the Arthrex BioSync® Bone Wedge. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this type of submission.

Here's what can be extracted and what cannot:

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

The document does not provide a table of acceptance criteria with specific performance metrics. Instead, it states that "The submitted mechanical testing data, inclusive of static compression, dynamic compression and expulsion testing, demonstrates that the wedge is substantially equivalent to that of the predicate devices." This implies that the 'acceptance criteria' were likely equivalence to the mechanical properties of the predicate devices in these specific tests. No numerical performance results are provided for the Arthrex BioSync Bone Wedge itself.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is not a clinical study assessing a diagnostic or predictive device. The "test set" here refers to the Arthrex BioSync Bone Wedge, which underwent mechanical testing. The document does not specify the sample size of wedges used for these mechanical tests, nor does it discuss data provenance in terms of country of origin or retrospective/prospective nature, as these are typically clinical study considerations.

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. Ground truth for mechanical testing is established by engineering standards and measurement equipment, not by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for human interpretation or clinical outcomes, not for mechanical device testing.

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 bone wedge for surgical fixation, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and AI assistance are not relevant.

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

Not applicable. As above, this is a surgical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the mechanical testing performed, the "ground truth" would be established by the physical and mechanical properties measured against established engineering standards and comparative data from the predicate devices. It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As above, this is not an AI/ML device.

In summary, this 510(k) submission focuses on demonstrating the substantial equivalence of a medical device (Arthrex BioSync® Bone Wedge) to existing legally marketed predicate devices through mechanical testing. It does not involve acceptance criteria in the context of clinical performance, diagnostic accuracy, or AI model validation. The "study" mentioned is mechanical testing (static compression, dynamic compression, and expulsion testing) to show the new device performs similarly to the predicate devices in terms of its physical properties and mechanical resistance.

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