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The Arthrex PIP Dart is intended to fix small bony or apical chondral fragments in the foot, ankle, upper extremities, hand, and wrist, where such fragments are not under tension or load-bearing. These devices are used in cases of osteochondritis dissecans and osteochondral fragments, fixation of fractures, 1st metatarsal (bunionectomy osteotomies), cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The devices can be used for inherently stable intramedullary stabilization of joint arthroplasty (resection) or fusion for the treatment of digital deformities of the foot or hand. This device is also used in inherently stable long bone fractures such as the femur, fibula, tibia, radius and ulna, including the diaphyseal, epiphyseal, and metaphyseal areas.

The Arthrex PIP Dart is an implant with a barbed design that is inserted between the proximal and middle- phalanges so the barbs fixate on the phalangeal canal of the toe. The PIP Darts are made of PEEK OPTIMA, offered in straight and 10 degree variations, and range from 2.5mm to 3.0mm in diameter and 25mm to 30mm in length.

The document provided is a 510(k) summary for a medical device called the "Arthrex PIP Dart." This type of submission is for demonstrating "substantial equivalence" to a predicate device, not for proving a new level of clinical efficacy or diagnostic performance through extensive clinical studies. Therefore, much of the information typically found in acceptance criteria and study designs for AI/diagnostic devices will not be present.

Based on the provided text, here's what can be extracted:

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

The document focuses on demonstrating substantial equivalence to a predicate device (Arthrex Bio-Pin and others not explicitly named but implied by the comparison wording) rather than setting specific performance acceptance criteria against a defined clinical outcome. The primary "performance" evaluated here is mechanical strength to show it's equivalent to existing devices.

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

The document mentions "shear testing and pull-out testing data" but does not specify the sample size for these tests (e.g., number of darts tested) or the provenance of the data (e.g., in-house lab, external lab, country). These would typically be detailed in the full 510(k) submission, but are summarized here.

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 "ground truth" for this type of device comparison is based on mechanical testing results (quantitative measurements of shear and pull-out forces), not expert interpretation of clinical data or images.

4. Adjudication method for the test set

Not applicable for mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not done. This device is an implantable pin, and the evaluation focuses on its physical and mechanical properties, not its diagnostic or interpretative performance.

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

This is not applicable as the Arthrex PIP Dart is a physical medical device (an implantable pin), not an algorithm or a diagnostic tool that would have standalone performance.

7. The type of ground truth used

The "ground truth" in this context is the measured mechanical properties (shear strength and pull-out force) of the device and its predicate, obtained through validated laboratory testing methods.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence of a physical implant. The testing is for validation of the device's physical properties.

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

Not applicable. As above, there is no training set. The "ground truth" for the mechanical performance comparison was established through standardized mechanical tests conducted in a laboratory environment.

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