(56 days)
The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.
The Biomet Headless Compression and Twist-Off Screws consist of bone screws of various lengths and diameters. The Biomet Headless Compression and Twist-Off Screws are also accompanied by dimensionally optimized corresponding instruments which are used to aid in the alignment and stabilization of fractures to the skeletal system. The Biomet Headless Compression Screws are a cannulated headless screw, which is inserted below the bone surface. The Biomet Headless Compression Screw is designed to minimize soft tissue irritation and provides compression due to a dual thread design. The Biomet Twist-Off Screw is a solid one piece screw that has a direct connection to a drill or large diameter pin driver, this allows the screw to break-off cleanly upon contact. The Biomet Twist-Off Screw also has compression capabilities with a thread-free segment that achieves compression at the osteotomy site.
This document does not describe a study that proves the device meets specific acceptance criteria in the way you've outlined for an AI/algorithm-based device.
The provided text is a 510(k) premarket notification summary for Biomet Headless Compression and Twist-Off Screws, which are physical medical devices (bone screws), not an AI algorithm or software. Therefore, many of the requested categories (like MRMC studies, ground truth for training/test sets, expert adjudication, AI improvement effect size) are not applicable to this type of device submission.
However, I can extract the relevant information from the document regarding the device's performance assessment:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from ASTM F543) | Reported Device Performance |
|---|---|
| Torsional properties (e.g., torque to failure) | Met requirements, found substantially equivalent to predicate devices |
| Axial pullout strength | Met requirements, found substantially equivalent to predicate devices |
| Driving torque | Met requirements, found substantially equivalent to predicate devices |
Note: The document states "Results indicate that the subject screws are substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness." It does not provide specific numerical values for the performance criteria, only that they met the standards of ASTM F543 and were comparable to predicate devices.
The following questions are NOT APPLICABLE to this document as it pertains to a physical medical device (bone screws) and not an AI or algorithm-based device:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - N/A (mechanical testing on screws themselves)
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts - N/A
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set - N/A
- 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 - N/A
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done - N/A
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) - N/A (Ground truth for mechanical testing is typically the physical measurement itself against established standards).
- 8. The sample size for the training set - N/A
- 9. How the ground truth for the training set was established - N/A
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.