(24 days)
The Texas T – Plate Distal Radius Plating System is indicated for use in open reduction and internal fixation of fresh fractures, osteotomies, Arthrodesis, and revision procedures of the distal radius.
The Texas T – Plate is an Anatomical Plating System for fractures of the distal radius. All components will be manufactured of 316 LVM Stainless Steel in accordance with ASTM F – 138 standards.
The provided text describes the Biomet Texas T-Plate, a device used for internal fixation of distal radius fractures. The primary evidence presented for its acceptance is a "Non-Clinical cantilever bending test."
Here's an analysis of the acceptance criteria and the study as per your request, based only on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sustain a load during cantilever bending test | Able to sustain a higher load than either the IQL Small Epiphysis Plate or the IQL T-Plate (predicate devices) |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The text only mentions "the Texas T -- Plate device" (singular) and the predicate devices (also singular descriptions: "either the IQL Small Epiphysis Plate or the IQL T - Plate"). It's likely a small number of physical samples were tested, but the exact count is not given.
- Data Provenance: The study was a "Non-Clinical" test. No information is provided regarding the country of origin of the data. It's a laboratory test, not patient data, so "retrospective or prospective" is not applicable in the usual clinical sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical, mechanical bending test. "Ground truth" in this context would be the measured load sustained before failure, which is determined by instrumentation, not expert consensus.
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Adjudication method for the test set:
- Not applicable. As a mechanical test, the results are objectively measured.
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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 a non-clinical mechanical test of a bone plate, not an AI-assisted diagnostic or treatment device involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used:
- The "ground truth" for this non-clinical test would be the direct measurement of load sustained during a cantilever bending test, likely measured by specialized mechanical testing equipment.
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The sample size for the training set:
- Not applicable. This is a non-clinical mechanical test, not a machine learning study that requires a training set.
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How the ground truth for the training set was established:
- Not applicable.
Summary of the Study:
The "study" described is a Non-Clinical cantilever bending test. Its purpose was to compare the mechanical strength (specifically, the ability to sustain a load) of the Texas T-Plate against two legally marketed predicate devices: the IQL Small Epiphysis Plate and the IQL T-Plate. The test found that the Texas T-Plate was able to sustain a higher load than both predicate devices, indicating superior mechanical performance in this specific test. This type of non-clinical data is commonly used for Class II surgical implants to demonstrate substantial equivalence in performance characteristics.
§ 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.