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The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The VECTOR Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.0mm (cannulated), Ø3.50mm (cannulated and non-cannulated) and Ø4.00mm (cannulated and non-cannulated) and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.

The provided text is a 510(k) summary for the VECTOR™ Hammertoe Correction System. It describes the device, its indications for use, and its equivalence to predicate devices, primarily through engineering analysis. This document does not contain information about an AI/ML powered device, nor does it present acceptance criteria or a study proving device performance in the context of AI/ML.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone (algorithm only) performance data
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document explicitly states: "No FDA performance standards have been established for the Vector Hammertoe Correction System. The following was performed to demonstrate safety per methods of the previous submission: Engineering Analysis comparison of mechanical performance characteristics." This indicates that the safety and effectiveness were demonstrated through mechanical performance characteristics engineering analysis and comparison to predicates, not through clinical or AI/ML performance studies with human readers or AI algorithms.

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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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