(77 days)
The Biomet Variable Locking Plate System is used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.
The Biomet Variable Locking Plate System is an internal fixation system comprised of Ti-6Al-4V and consisting of various-sized plates and screws.
The provided 510(k) summary for the Biomet Variable Locking Plate System (K071325) indicates that no clinical testing was performed to establish substantial equivalence. Instead, the device's substantial equivalence was based on non-clinical engineering analyses comparing it to predicate devices. Therefore, the information requested regarding acceptance criteria, study details, ground truth, and human reader performance is not applicable to this submission.
The summary specifically states:
- "Non-Clinical Testing: Engineering analyses comparing the Biomet Variable Locking Plate System to a predicate device were conducted to determine substantial equivalence. The results indicated that the Biomet Variable Locking Plate System was functional within its intended use."
- "Clinical Testing: None provided as a basis for substantial equivalence."
This means the device's performance was evaluated through engineering tests, not clinical studies involving human or even animal subjects to assess clinical efficacy or safety against specific performance metrics for diagnosis or treatment.
Therefore, for each of your requested points, the answer is "Not Applicable" or "None".
- A table of acceptance criteria and the reported device performance: Not Applicable (no clinical study with performance metrics).
- Sample sized used for the test set and the data provenance: Not Applicable (no clinical test set).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable (no clinical test set requiring expert ground truth).
- Adjudication method for the test set: Not Applicable (no clinical test set).
- 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 (no MRMC study; this is a medical device, not an AI/imaging diagnostic tool).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not Applicable (this is a medical device, not an AI/algorithm-based diagnostic tool).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not Applicable (no clinical study with ground truth).
- The sample size for the training set: Not Applicable (no training set as this is not an AI/machine learning device).
- How the ground truth for the training set was established: Not Applicable (no training set).
§ 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.