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Sprytie™ wires are indicated for use in the jaws in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabilization of bony segments, or for wiring the teeth together (maxillomandibular fixation).

The Sprytie™ is a 25, 26, or 27 gauge annealed 316L stainless steel wire 7 inches in length, with a hollow 22TW, 23TW, or 24TW sieeve crimped over one end of the wire, respectively. The Sprytie™ is used in place of traditional light gauge stainless steel surgical wire during the placement of arch bars and splints, direct intraosseous wiring, bridal wire placement, and direct maxillomandibular fixation (ivy loops, risden wires, etc.). The sleeve end is inserted around the teeth first. The stiffness of the sleeve prevents the flexure of the wire.

The provided document is a 510(k) summary for the Sprytie™ device (K092530), which describes a stainless steel wire with a crimped sleeve for maxillary and mandibular fixation. It states that the device is substantially equivalent to predicate devices based on intended use and technical specifications.

However, the document does not contain any information regarding acceptance criteria, device performance studies, test set sample sizes, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, or how ground truth was established.

Based on the content of the provided text, I can only provide the following information from the request:

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

• Acceptance Criteria: Not mentioned in the document.
• Reported Device Performance: The document claims the Sprytie™ "performs as well as or better than predicate devices" and "improves the ease of use of the wire." However, no specific performance metrics or data from a study are provided to substantiate these claims.

Summary of what cannot be provided given the input:

• Sample sized used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. (This is irrelevant for a physical wire device).
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

Reasoning:

The document focuses on demonstrating substantial equivalence to existing predicate devices (Aragon Wiring System, K022821; Erich Arch Bar, K061271) for regulatory purposes rather than presenting a performance study with detailed acceptance criteria and results.

The key statements are:

• "The Sprytie™ has the same intended use as predicate devices, as well as substantially equivalent technical specifications."
• "The modification to a traditional 316L stainless steel wire with the addition of a 304 stainless steel sleeve improves the ease of use of the wire, and does not change the intended use of the wire."
• "The Sprytie™ is as safe, as effective, and performs as well as or better than predicate devices."

These statements are conclusions drawn by the submitter for the 510(k) process, not data points from a specific performance study against defined acceptance criteria. The FDA letter confirms the substantial equivalence determination but does not refer to a performance study with specific metrics.

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This device is used in surgery for the application of wires to the jaws of adults and children. The device can be used to directly wire bony segments together, or for the application of arch bars to the teeth for stabilization of bony fragments or wiring the teeth together (maxillomandibular fixation).

22, 24 and 26 gauge annealed 316LVM stainless steel wire in 5 ft. coils packaged in a thermoplastic cartridge that mounts on forceps

This request cannot be fulfilled. The provided text is a 510(k) summary for a medical device (Aragon Wiring System Wire Cartridge) which outlines its substantial equivalence to existing predicate devices. However, this type of document, particularly for devices like wires for mandibular fixation, typically does not contain acceptance criteria for device performance or the results of a study designed to prove the device meets such criteria.

Medical devices cleared through the 510(k) pathway demonstrate substantial equivalence, meaning they are as safe and effective as a legally marketed predicate device. This often relies on comparing technical characteristics, materials, and intended use to existing devices, rather than conducting new performance studies with specific acceptance criteria and detailed statistical analysis on human subjects that would be typical for a drug or a novel, high-risk medical device.

Therefore, I cannot extract the requested information because it is not present in the provided text. The document explicitly states: "The technical differences between this product and the predicate devices do not adversely affect safety or efficacy," which is the core conclusion for a 510(k) clearance, not a report of meeting specific performance metrics through a study.

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