(80 days)
The Biomet BioDrive Screw System is indicated for alignment and stabilization of small bone fractures.
Specifically:
- Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for . treatment of fractures, non-unions, or mal-unions
- Ligament reconstruction
- Osteochondritis dissecans
- Arthrodesis of the foot, ankle, wrist, elbow and hand
- Small bone osteotomies, including first metatarsal head osteotomy, metatarsal . osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies
These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
The Biomet BioDrive Micro Screw System consists of screws, a micro nail plate and ancillary instruments intended for surgery to aid in alignment and stabilization of fractures of small bones such as those in the foot, elbow, ankle, and hand.
The provided document is a 510(k) Premarket Notification for the Biomet BioDrive Micro Screw System. This type of notification is for medical devices that are substantially equivalent to a legally marketed predicate device, and it does not typically include detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or AI-specific metrics like those requested.
The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, indications, technological characteristics (material, design, sizing), and principles of operation. It explicitly states: "The technological characteristics (material, design, and sizing) of the implants and instruments comprising the BioDrive Micro Screw System are the same as or similar to the predicate devices."
Therefore, most of the requested information regarding acceptance criteria, specific device performance studies, and AI-related metrics cannot be found in this document.
Here's a breakdown of what can be extracted and what is not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not available. The document does not describe specific performance criteria or a study with measured performance outcomes against those criteria. The 510(k) pathway for this device relies on substantial equivalence to predicate devices, not on de novo performance testing against acceptance criteria in the way a novel AI device might.
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/Not available. No clinical test set or data provenance is detailed in this 510(k) summary. Performance is inferred through equivalence to existing predicate devices, which would have undergone their own testing in the past.
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/Not available. As there is no specified test set described for this 510(k), there is no mention of experts establishing ground truth for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available. Similar to above, this information is not relevant to the content of this 510(k) document, which does not describe a performance study with a test set requiring adjudication.
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
- Not applicable/Not available. This device is a bone screw system, not an AI image analysis or diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not available. This device is a physical medical implant (screws and plates), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not available. No ground truth is described as part of this 510(k) submission for performance evaluation, as it relies on substantial equivalence.
8. The sample size for the training set
- Not applicable/Not available. This device is not an AI/ML model, so there is no concept of a training set.
9. How the ground truth for the training set was established
- Not applicable/Not available. This device is not an AI/ML model, so there is no concept of a training set or its ground truth establishment.
In summary, the provided document is a regulatory submission focused on substantial equivalence for a physical medical device, not a performance study for an AI/ML medical device. Therefore, the specific details requested regarding detailed performance evaluations, test sets, expert annotations, and AI-related metrics are not present.
§ 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.