(45 days)
These devices are to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis.
The Biomet® Femoral Locking Nail System is a set of intramedullary nails, designed for both antegrade and retrograde applications. Features include an internal locking/compression mechanism and numerous screw configurations to enable nail fixation.
The provided document is a 510(k) summary for the Biomet® Femoral Locking Nail System. This type of regulatory submission is for a medical device, specifically an orthopedic implant (intramedullary nail), which falls under a different regulatory pathway than software or AI/ML-driven devices. Therefore, the questions regarding acceptance criteria and studies that prove the device meets these criteria, especially those pertaining to AI/ML performance, are not applicable here.
Here's why and what information is provided:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable in the AI/ML context. For this orthopedic implant, "acceptance criteria" generally refers to meeting safety and effectiveness standards, primarily through demonstrating substantial equivalence to a legally marketed predicate device.
- What is reported: The document states that "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This is the core performance claim for this type of device in a 510(k) submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable in the AI/ML context. No "test set" in the sense of AI/ML evaluation (e.g., a dataset of images or patient records) was used.
- What is reported: Non-clinical laboratory testing was performed. This typically involves mechanical testing (e.g., fatigue, static strength) of the device itself, not testing on human subjects or data sets.
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. No ground truth establishment by experts for a test set was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method for a test set was used.
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 an orthopedic implant, not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical implant; there is no algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For this medical device, "ground truth" would relate to the physical and mechanical properties of the implant meeting engineering specifications and performance expectations, which are evaluated through non-clinical laboratory testing in comparison to predicate devices, not through expert consensus on medical data, pathology, or outcomes data in the context of an AI/ML model.
8. The sample size for the training set:
- Not Applicable. No AI/ML model was trained.
9. How the ground truth for the training set was established:
- Not Applicable. No AI/ML model was trained, therefore no ground truth for a training set was established.
In summary, the provided document relates to the regulatory approval of a physical orthopedic implant. The questions posed are designed for AI/ML-driven medical devices, and thus, do not directly apply to this submission.
The "study that proves the device meets the acceptance criteria" in this context is the "Non-Clinical Testing" which involved laboratory testing to demonstrate substantial equivalence to legally marketed predicate devices. The acceptance criteria essentially boil down to demonstrating that the new device is as safe and effective as the predicate devices based on these non-clinical tests.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.