(83 days)
The NEWDEAL® TTC Plates are intended for use in arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantations of small bones including the foot and ankle.
The NEWDEAL® TTC Plates consists of a plate, available in different sizes, and implanted using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates a single implant/screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.
The provided document is a 510(k) summary for the NEWDEAL® TTC Plates, which are bone fixation devices. It details the device's description, intended use, and substantial equivalence to existing devices.
Crucially, this document describes a medical device clearance based on substantial equivalence, not a study evaluating an AI algorithm's performance. Therefore, many of the requested elements pertaining to AI studies (such as acceptance criteria for AI algorithms, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable and cannot be extracted from this text.
The document only states that "The results of performance tests demonstrate that the TTC Plates have mechanical properties compatible with the predicate devices and intended use." This indicates that mechanical testing was performed to demonstrate an equivalence of physical properties, not diagnostic performance.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Mechanical Properties) | Reported Device Performance (Implied) |
|---|---|
| Mechanical properties compatible with predicate devices | Compatible with predicate devices |
| Mechanical properties compatible with intended use | Compatible with intended use |
Explanation: The document does not provide specific numerical acceptance criteria (e.g., tensile strength, fatigue life) or exact performance values. It only states that the performance tests demonstrated compatibility.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document does not describe a study involving an AI algorithm or a "test set" in the context of diagnostic performance evaluation. The "performance tests" mentioned are mechanical tests of the physical device. Therefore, no information on sample size for a test set or data provenance is provided.
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" to be established by experts for a mechanical bone fixation plate in the context of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No ground truth establishment for a diagnostic test set is mentioned.
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. This is not an AI diagnostic device. No MRMC study was conducted or is relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For a bone fixation plate, "ground truth" relates to its mechanical integrity and biocompatibility, which are assessed through engineering standards and material science, not clinical diagnostic ground truth. The "ground truth" for showing substantial equivalence relies on comparing the device's mechanical properties to those of the predicate devices and demonstrating that they meet the same functional requirements.
8. The sample size for the training set
- Not Applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI algorithm.
In summary: The provided text is a regulatory submission for a medical device (bone fixation plates) seeking clearance based on substantial equivalence. It does not involve an AI algorithm, and therefore the extensive information requested about AI study design and performance metrics is not present in this document. The "study" mentioned refers to mechanical performance tests of the physical device, not an evaluation of diagnostic accuracy.
§ 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.