(400 days)
The S4 Screw System™ is indicated for fixation of small bone fragments, osteochondral fragments and cancellous fragments, appropriate for the device which may include the following: simple metaphyseal fractures; condylar fractures; osteochondritis dissecans; areas where accurate screw placement is vital; apical fragments (patellar); cancellous fragments (talus); osteochondral fragments (talar vault, femoral condyle); intra-articular fractures and osteochondral fixation and fractures.
The S4 Screw System™ is collection of cannulated, headless screws having fenestrations on the head and within the thread pitch.
The provided text describes a 510(k) premarket notification for the "S4 Screw System™". This document is an FDA submission for a medical device, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as one might find for an AI/ML device.
Based on the information provided, here's a breakdown regarding your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the way one might for a diagnostic test with metrics like sensitivity, specificity, accuracy, etc. Instead, performance is demonstrated through mechanical testing against a recognized standard (ASTM F543) and comparison to predicate devices. The acceptance criteria are implicitly that the device's mechanical performance should be substantially equivalent to the predicate devices and meet the requirements of ASTM F543.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Torsion | Substantially equivalent to predicate devices per ASTM F543 | Demonstrated substantial equivalence to predicate devices |
| Insertion | Substantially equivalent to predicate devices per ASTM F543 | Demonstrated substantial equivalence to predicate devices |
| Pushout | Substantially equivalent to predicate devices per ASTM F543 | Demonstrated substantial equivalence to predicate devices |
| Pyrogenicity | Meet specified pyrogenicity limit | Implants found to meet the specified pyrogenicity limit |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "mechanical testing of the worst case S4 Screw System™ and a predicate component." It does not specify the exact sample size (i.e., number of screws or components tested) for this mechanical testing. There is no information regarding data provenance in terms of country of origin or whether it was retrospective/prospective, as this applies more to clinical data which is not the primary focus of this type of submission for a bone fixation device.
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 the S4 Screw System™ submission. This is a physical medical device (bone screw), and its performance is evaluated through mechanical testing, not a diagnostic or AI-driven assessment requiring expert interpretation to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used in clinical studies, especially for diagnostic devices, to resolve disagreements among experts in establishing ground truth. Mechanical testing of a physical device does not involve this type of 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
This question is not applicable. An MRMC study is relevant for diagnostic devices (often AI-assisted) where human readers interpret medical images or data. The S4 Screw System™ is a hardware device for bone fixation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The S4 Screw System™ is a physical screw system, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" is defined by the objective measurements obtained from the ASTM F543 standard tests (torsion, insertion, pushout) and the specified pyrogenicity limit for bacterial endotoxin testing. This is not "expert consensus", "pathology", or "outcomes data" in the typical sense; rather, it's adherence to established engineering and biological standards.
8. The sample size for the training set
This question is not applicable. There is no "training set" for a physical medical device like the S4 Screw System™. Training sets are relevant for AI/ML algorithms.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as #8.
§ 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.