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The Field Orthopaedics BTES Screw Range is intended for use in the fixation of fractures, osteotomies, and arthrodesis. appropriate for the size of the device, in adults and in both, children (2-12 years) and adolescents (12- 21 years), in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The FO Fenestrated Screws are not for the delivery of bone graft, bone cement, or bone void filler.

The Field Orthopaedics BTES Plate Range and Plate Screws are in the fixation of fractures, osteotomies, and arthrodesis of the hand and other small bones. The system may be used in both adults and pediatric patients.

The Field Orthopaedics Bony Trauma Extremity System (BTES) is an extremity trauma system consisting of a range of screws and a range of plates cleared in K200043.

The BTES screw range consists of a range of screws intended for standalone use, and a range of screws intended to be used with the BTES plate range. The standalone screw range consists of 1.2 mm solid, partially threaded screws of various lengths; 1.5 – 5.0 mm cannulated, partially threaded screws in both headless and headed designs of various lengths; and 2.0 - 3.0 mm Cannulated, fenestrated, partially threaded screws in both headless and headed designs of various lengths. The range of screws intended to be used with the BTES plate range consists of 1.2, 1.5, and 2.0 mm solid, fully-threaded screws of various lengths.

The purpose of this Special 510(k) device modification is to notify FDA of the sterile NX Nail System, which is a line extension to the BTES Screw Range described above and cleared in K200043. NX Nail implants are made from the same titanium alloy using the same manufacturing processes as BTES implants, are non-compressive in design, and are available in lengths ranging from 12 to 90 mm and diameters ranging from 2.0 to 5.0 mm. NX Nail implants are offered nonsterile and sterile (gamma radiation). This Special 510(k) also includes added instruments for implanting NX Nail devices.

Materials: All BTES screws in the Screw Range are made with Titanium alloy ELI (as per ASTM F136). All plates are available as identical configurations in both Titanium alloy ELI (as per ASTM F136) and CP Titanium (ISO 5832-2). Instruments are made from medical grades stainless steel, anodized aluminum, and marked with epoxy resin.

The provided document is a 510(k) summary for a medical device (Bony Trauma Extremity System (BTES) Screw Range, NX Nail System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials or extensive AI performance evaluations.

Therefore, many of the requested elements are not applicable or cannot be extracted directly from this document. The information provided primarily pertains to the physical characteristics of the device and its equivalence to a prior cleared device.

However, I can extract the following information about the performance data related to the device. The "acceptance criteria" here refers to the internal criteria Field Orthopaedics Pty Ltd (or BioVera, Inc., the submitter) established for their verification and validation activities, and the "reported device performance" indicates that these criteria were met.

1. Table of acceptance criteria and the reported device performance

The following information cannot be found in the provided document:

2. Sample sizes used for the test set and the data provenance: The document does not specify sample sizes for any of the engineering analyses or user evaluations. The data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. For a physical device like this, "ground truth" would typically refer to physical and mechanical testing standards, and "experts" might be engineers or surgeons, but details are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to the type of data presented.
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: This is not an AI device, so an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the engineering tests would be established by industry standards (e.g., ASTM standards for material properties, bending strength tests). For the surgeon user evaluation, the "ground truth" would be the subjective assessment of functionality by the surgeons. However, explicit details on these standards or how the "ground truth" was formally established are not in this summary.
8. The sample size for the training set: Not applicable, as this is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not a machine learning or AI device.

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