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The Field Orthopaedics BTES Screw Range is intended for use in the fixation of fractures, 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 intended for use in the fixation of fractures, osteotomies and arthrodesis of the hand and other small bones. The system may be used in both adults and paediatric 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.

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 BTES plate range consists of a variety of configurations including straight, L, T, and H frames. Key features of the plate range include anatomical contouring, locking screw, rotational correction, and compression holes. The plate thickness ranges from 0.6 – 1.2 mm with a number of holes ranging from 1 – 16 holes.

Materials: All screws in the screw range are made with Titanium ELI(as per ASTM F136).

All plates are available as identical configurations in both Titanium ELI (as per ASTM F136) and CP Titanium (ISO 5832-2).

The instrumentation is made from medical grades stainless steel, anodized aluminium, and marked with epoxy resin.

The provided document is a 510(k) clearance letter from the FDA for a Bony Trauma Extremity System (BTES) manufactured by Field Orthopaedics Pty Ltd. This document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical performance. It does not describe the development or validation of an AI/ML-based medical device.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study details for an AI/ML device, as the document does not contain any such information.

The document discusses:

• Device Name: Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range.
• Regulation Number/Name: 21 CFR 888.3030 (Single/multiple component metallic bone fixation appliances and accessories)
• Classification: Class II
• Predicate Devices: K051567 (Aptus Titanium Fixation System, Medartis) and K180348 (FO Micro Screw System, Field Orthopaedics Pty Ltd)
• Performance Data: "ASTM F382 static four-point bend testing was performed against predicates. ASTM F543 torsion testing, pullout strength testing and insertion torque testing was performed against predicates. The results of mechanical and user testing, and theoretical analysis demonstrate the Field Orthopaedics Bony Trauma Extremity System to be substantially equivalent to the identified predicate devices. The acceptance criteria for the mechanical testing were all met, supporting the overall conclusion of substantial equivalence for the Bony Trauma Extremity System."

This indicates mechanical performance testing was conducted, not a clinical study involving AI/ML. The "acceptance criteria" mentioned refer to the parameters for these mechanical tests, not statistical performance metrics for an AI algorithm.

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