(87 days)
The HALLU® -PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Examples include:
-Hallux rigidus
-Severe hallux valgus (IM angle > 20° and HV angle > 40°)
-Deformity from rheumatoid arthritis
-Failed previous surgical procedure
-Traumatic arthritis
-Neuromuscular instability.
The HALLU® -PLATES are available in two different designs :
- the HALLU®-C PLATE -
- the HALLU®-S PLATE -
The HALLU®-C PLATE and the HALLU® -S PLATE are low profile Titanium plates dedicated to first metatarso-phalangeal arthrodesis. Those implants are pre-bent for optimal anatomical adaptation (10° valgus and 10°dorsiflexion). Their fixation is provided by Titanium SNAP-OFF® screws available in a two diameters: 3.0 and 2.7 mm. They exist in different colors for size identification. The bone contact surface is sand blasted in order to maximize plate stability. The range of HALLU -C PLATE and HALLUS S PLATE include 6 sizes ( 31eft/3right) for optimal anatomic fit. Moreover, the HALLU®-S PLATE has an anatomical design providing optimal bone coverage.
The provided text describes a medical device, the HALLU®-PLATES, and its regulatory clearance based on substantial equivalence to predicate devices, rather than a study proving performance against specific acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI/software device studies (e.g., sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, ground truth for training) is not applicable.
However, I can extract the information related to the device's testing and the standards it met.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Bending Strength | French Standard ISO 9585 | In compliance |
| ASTM Standard F-382-99 | In compliance | |
| Bending Stiffness | French Standard ISO 9585 | In compliance |
| ASTM Standard F-382-99 | In compliance | |
| Fatigue Strength | Not explicitly stated | Risk of rupture is minimal |
Detailed Breakdown of Applicable Information:
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as this was a physical device test, not a data-driven software evaluation. The document mentions "Test 1" and "Test 2," implying multiple samples of the plate were tested for bending and fatigue.
- Data Provenance: The tests were conducted to comply with French Standard ISO 9585 and ASTM Standard F-382-99. This implies the tests were performed in a controlled laboratory setting, likely in the country of origin of the sponsor (France) or a qualified testing facility. The study type is experimental/bench testing, not retrospective or prospective human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the "ground truth" for a physical device test like this is defined by established engineering standards (ISO 9585 and ASTM F-382-99) and the physical properties of the materials and design, not by expert human interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable for a physical device test. The compliance is determined by measurements against predefined standard thresholds.
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, a MRMC comparative effectiveness study was not done. This is a physical bone plate, not an AI or imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone test was done. The device's performance (bending strength, stiffness, fatigue strength) was evaluated independently against established physical standards. This is analogous to a "standalone" test for a physical product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was based on established engineering standards for bone plates: French Standard ISO 9585 and ASTM Standard F-382-99.
8. The sample size for the training set:
- Not applicable. This device underwent physical bench testing, not a machine learning training process.
9. How the ground truth for the training set was established:
- Not applicable. As above, there was no training set for a machine learning model.
§ 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.