(78 days)
The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.
The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques.
The RECON system is a plate and screw system intended for internal fracture fixation. The system consists of the following plates:
- Reconstruction Plates 3.5, ●
- Medialis Plates 3.5, ●
- Universal Plates 3.5
- Universal Plates 3.5, H-shaped .
- USG Plates 3.5 ●
- Interpositioning Arthrodesis Plates ●
- Lapidus Plates ●
- . Dwyer Plates
screws and washers of different sizes and designs.
The plates, screws, and washers are either made of titanium alloy Ti-6AI-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).
The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable.
The provided text describes the RECON system, a plate and screw system for internal fracture fixation, and its substantial equivalence to predicate devices, as reviewed by the FDA in a 510(k) submission. However, this document does not contain acceptance criteria or a study proving that the device meets specific acceptance criteria in the manner described in your request for a medical AI/software device evaluation.
The information provided is typical for a 510(k) submission for a physical medical device (implants), which primarily focuses on demonstrating substantial equivalence to already legally marketed predicate devices through material testing and performance comparison, rather than human-in-the-loop or standalone algorithm performance for AI/software.
Here's an breakdown of why the information you requested cannot be fully extracted and what can be said based on the provided text:
1. Table of acceptance criteria and the reported device performance
- Not Applicable in the provided text. The document describes a physical medical device (implants), not an AI/software device. Therefore, there are no "acceptance criteria" related to AI performance metrics (like accuracy, sensitivity, specificity, AUC) or "reported device performance" in that context.
- Instead, the "performance" demonstrated is mechanical:
- Biocompatibility: Passed all testing per ISO 10993-1.
- Mechanical Properties (Plates): Cross sectional engineering analysis, proof load, bending strength, bending stiffness, equivalent bending stiffness, and fatigue strength were "similar" to predicate devices.
- Mechanical Properties (Screws): Self-tapping performance, driving and removal torque, to failure, and axial pullout were "similar" to predicate devices.
- Washers: Substantially equivalent to previously cleared washers.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes mechanical testing of physical implants, not a clinical study or a study involving a "test set" of patient data for an AI. The "samples" would be the physical plates, screws, and washers subjected to mechanical loads. The document does not specify the number of individual components tested but states "all testing passed" for biocompatibility and that analysis resulted in "similar mechanical properties and performance" for the other tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no "ground truth" establishment by experts in the context of an AI/software evaluation for this device. The "ground truth" for mechanical testing would be the physical properties and performance measured by engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is described because there's no expert interpretation of data relevant to AI performance.
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, an MRMC study was not done. This is a physical implant, not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm to perform a standalone performance evaluation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Mechanical testing standards and measurements. For a physical device, the "ground truth" is typically defined by established engineering and material science standards (e.g., ASTM, ISO). The results of the mechanical tests (e.g., tensile strength, fatigue life) are compared against these standards or against predicate device performance.
8. The sample size for the training set
- Not applicable. No AI "training set" is relevant to this device.
9. How the ground truth for the training set was established
- Not applicable. No AI "training set" or corresponding ground truth establishment is relevant to this device.
Summary of what the document does provide regarding "performance":
The study described is a non-clinical performance evaluation comparing the RECON System's mechanical properties and biocompatibility to predicate devices.
- Tests Conducted:
- Biocompatibility (ISO 10993-1)
- Cross sectional engineering analysis of plates
- Proof load, bending strength, bending stiffness, equivalent bending stiffness, fatigue strength of plates
- Self-tapping performance, driving and removal torque, to failure, axial pullout of screws
- Results: All tests indicated "similar mechanical properties and performance" or that the device "passed." This led to the conclusion of "substantial equivalence" to the predicate devices.
- Clinical Data: No clinical testing was required as the device's indications for use are equivalent to predicate devices with a proven safety and efficacy record on the market for many years.
In conclusion, your request focuses on criteria relevant to the evaluation of AI/software as a medical device. The provided FDA 510(k) document is for a physical orthopedic implant (RECON System) and thus addresses mechanical and biocompatibility testing, not AI performance metrics.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.