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The TalarLift STS arthroereisis implant is designed for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequelae. The TalarLift STS is intended for the following pathological conditions resulting from disease, injury, or other trauma:
• Hypermobile pes valgus;
• Posterior tibial tendon dysfunction;
• Severe pronation;
• Subtalar instability;
• Hypermobile flexible congenital flat foot.

The TalarLift STS consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, and corresponding instrumentation to facilitate insertion. The system consists of three configurations, conical, cylindrical, and anatomic. All three devices are manufactured from titanium alloy (Ti-6Al-4V) complying with ASTM F136.

The provided document is a 510(k) Premarket Notification for the TalarLift STS device, which is a subtalar spacer. It describes the device, its intended use, and claims substantial equivalence to predicate devices. This document does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria.

Therefore, I cannot provide the requested information about acceptance criteria or a study that proves an AI/ML device meets those criteria based on the provided text. The document primarily focuses on non-clinical testing for mechanical properties and pyrogenicity of a physical implant. It explicitly states, "No clinical studies were performed."

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The FuzeFix Mini System is intended for use in the stabilization of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Mini System is indicated for: scaphoid fractures, metacarpal fractures, phalangeal fractures, ulnar styloid fractures, small ioint fusions, humeral head fractures, intercarpal fractures, tarsal fusions, patellar fractures, interfragmentary ulnar fractures, small hand and wrist bone fractures, forefoot interfragmentary fractures, trapezial fractures, metatarsal fractures, radial head fractures, osteo-chondral fractures, interphalangeal fractures, malleolar fractures, metaphyseal fractures, interfragmentary radius fractures, distal metatarsal osteotomies, midfoot interfragmentary fractures. Not intended for use in the spine.

The FuzeFix Large System is intended for use in the stabilization and fixation of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Large System is indicated for: joint reconstructions, joint fusions, multiple fragment joint fractures, simple metaphyseal fractures of the wrist, ankle, elbow, and shoulder, metatarsal fractures and other fractures of the foot, ligament fixation of the proximal humerus, malleolar fractures, navicular fractures of the calcaneus, fractures of the talus, arthrodesis of the ankle joint, and fractures of the tarsal region. The devices and implants are not intended for use in the spine.

The FuzeFix Headless FT System is intended for use in the stabilization and fixation of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Headless FT System is indicated for: Osteochondral fragments (talar vault, femoral condyle), apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), cancellous fragments (talus), Carpal, meta-carpal, and small hand bone, tarsal and metatarsals, phalanges, Intra-articular fractures, ankle, proximal and distal humerus, proximal and distal radius, proximal and distal ulna, osteochondral fixation and fractures, Osteochondritis Dissecans, Fixation of fractures and osteotomies about the knee, Oblique fractures of the fibula, Reconstructive surgeries of the foot, and malleolar fixation. Not intended for use in the spine.

The FuzeFix Twist Off System is intended for use in the stabilization of bone fractures. osteotomies, and for bone reconstruction of the hand and foot. The FuzeFix Twist Off System is indicated for: fixation of small bone fragments, Weil osteotomy, mono-cortical fixation, osteotomies and fractures fixation in the foot and hand.

The FuzeFix Screw System consists of headed and headless, partial and full threaded cannulated, self-compressive screws and snap off screws and washers for the management of orthopedic osteotomies and trauma. The screws are self-drilling, self-tapping. The system consists of multiple screw lengths and diameters, and the necessary instruments to facilitate the placement of these implants.

The provided document describes the Fusion Orthopedics, LLC FuzeFix Screw System and its substantial equivalence to predicate devices, based on non-clinical testing. It explicitly states that "No clinical studies were performed." Therefore, the information requested about acceptance criteria and studies proving the device meets them, in the context of clinical performance or AI/software, is not largely applicable or available in this document.

However, I can extract information related to the device's non-clinical performance acceptance criteria and the study that proves it meets them, as documented for regulatory submission.

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

The document does not explicitly present a table of acceptance criteria and reported device performance in terms of specific numerical values for each test. Instead, it lists the types of non-clinical tests performed and states that the "testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device" and "The results of these evaluations indicate that the FuzeFix Screw System is equivalent to predicate devices." This implies that the device met the acceptance criteria for each test by showing equivalence or compliance with established standards.

The underlying acceptance criteria for "equivalence" would be that the device's mechanical properties (torque, pullout, driving/insertion/removal torque) perform within a comparable range or demonstrate similar failure modes and strengths to the established predicate devices, as typically determined through statistical comparison or by falling within a predefined performance envelope during mechanical testing.

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

The document does not specify the sample sizes used for each non-clinical test (e.g., number of screws tested for torque to failure). It also does not explicitly mention data provenance in terms of country of origin for these non-clinical tests, and non-clinical tests are inherently "prospective" in the context of generating new data for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The "ground truth" for non-clinical mechanical and biocompatibility testing is established by conforming to recognized industry standards (e.g., ASTM F543-07 for mechanical tests, and general biocompatibility standards for pyrogenicity). It does not involve expert readers or clinical ground truth determination.

4. Adjudication method for the test set

This question is not applicable as the tests are non-clinical, objective measurements against established standards, not subjective interpretations requiring adjudication.

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

No such study was performed, as stated in the document: "No clinical studies were performed." This is not an AI/software device, but a physical medical implant.

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

This question is not applicable. This is a physical medical implant, not an AI algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is based on:

• Established Industry Standards: ASTM F543-07 Annex A1, A2, and A3 for mechanical properties (torque to failure, axial pullout, driving/insertion/removal torque).
• Biocompatibility Standards: Implicit standards leading to the "recommended maximum endotoxin level of 20 EU per device" for pyrogenicity.
• Predicate Device Performance: The primary comparative "ground truth" for equivalence claims is the performance of the legally marketed predicate devices.

8. The sample size for the training set

This question is not applicable. There is no artificial intelligence or machine learning component mentioned that would require a training set.

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

This question is not applicable. There is no artificial intelligence or machine learning component mentioned.

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