(112 days)
Bone Screw is indicated for ankle fractures, The Biomet metatarsal fusions and metatarsal osteotomies (Hallux Valgus).
The screws are made of a resorbable copolymer comprised of polylactic acid (PLA) and polyglycolic acid (PGA).
This document (K964970) is a summary of safety and effectiveness for a medical device submitted to the FDA. It does not describe an AI/ML powered device, therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for AI/ML devices, is not applicable.
Instead, the document focuses on the biocompatibility and mechanical effectiveness of a resorbable bone screw. I will interpret the request in the context of the provided document, addressing the closest analogues to the requested information.
Here's an analysis based on the provided text, reinterpreting the questions for a non-AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Properties: | |
| Biocompatibility | LactoSorb® material found to be biocompatible in both soft tissue and bone tissue. |
| Resorbability | Completely resorbed by 15 months in vivo in histological animal studies. |
| Degradation Mechanism | Degrades and resorbs in vivo by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. |
| Well-documented Safety | Safety of PLA/PGA material well-documented since early 1970's (FDA approval for sutures). Exact same LactoSorb® material implanted in humans for over 10 years in a ligating clip. |
| Functional Properties: | |
| Effectiveness for Healing | Provided the same healing as a stainless steel screw in an animal model. |
| Mechanical Equivalence | Mechanically comparable to metal and PGA resorbable cancellous screws. |
| Adverse Tissue Response | No adverse tissue response to either the metal or LactoSorb® screws. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the histological animal studies or the mechanical testing. The document states "animal model" but doesn't quantify the number of animals or screws tested.
- Data Provenance: Not specified. It's implied to be prospective for the animal studies and mechanical testing conducted for this submission, but no country of origin is mentioned. The historical data on PLA/PGA sutures and LactoSorb® ligating clips is also not specified by provenance.
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)
- This question is not applicable to this type of device submission. Ground truth for an AI device typically refers to labels assigned by experts. For this bone screw, "ground truth" would be objective measurements or observations (e.g., bone healing, resorption rate, mechanical strength). The evaluation was based on histological analysis by unnamed individuals and mechanical testing outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods are typically used for expert consensus in labeling data, which is not relevant here.
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
- This question is not applicable as this is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as this is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the animal studies, the "ground truth" for biocompatibility and healing was likely based on histological analysis (pathology) and direct observation of healing.
- For mechanical effectiveness, the "ground truth" was mechanical testing data (e.g., strength, torsion, fatigue) comparing the Biomet Bone Screw to stainless steel and PGA resorbable cancellous screws.
- For resorbability, the "ground truth" was histological analysis tracking the degradation over time.
8. The sample size for the training set
- This question is not applicable as there is no "training set" in the context of an AI/ML algorithm. The "training" for this device comes from historical knowledge and previous studies on the material.
9. How the ground truth for the training set was established
- This question is not applicable as there is no "training set." The understanding of the material's properties (biocompatibility, degradation) was established through years of prior research, FDA approvals of similar materials (PLA/PGA sutures), and documented human use of the exact LactoSorb® material in other devices (ligating clips for over 10 years).
§ 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.