(48 days)
The Monster Screw System™ is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device.
The Monster Screw System™ is comprised of bone screws and washers. The Monster Screw is a threaded bone screw offered in 2.0mm to 9.5mm diameters (in 0.5 mm increments) having overall lengths from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are offered having a variety of features with respect to head, thread, tip, cannulation and material. Size-matched washers are also available.
This document is a 510(k) summary for the Paragon 28 Monster Screw System™. It describes the device and its intended use, but it does not contain the kind of detailed performance study data you're asking for regarding acceptance criteria, sample sizes, ground truth (which is typically for diagnostic devices), or comparative effectiveness studies.
This submission is for a bone fixation fastener, which is a hardware device, not a diagnostic AI/ML device. Therefore, the questions about "acceptance criteria and study that proves the device meets the acceptance criteria" are typically addressed through mechanical testing and equivalence to predicate devices, rather than clinical performance metrics, ground truth established by experts, or AI-specific study designs like MRMC or standalone performance.
However, I can extract the information that is present and note where the requested information is not applicable or not provided in this type of document.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not specify formal "acceptance criteria" in terms of clinical performance metrics, as would be common for diagnostic devices. Instead, the performance is demonstrated through theoretical comparisons to predicate devices for mechanical equivalence.
| Criterion Type | Acceptance Criteria (Not explicitly stated in clinical performance terms, but implied for mechanical equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Substantially equivalent to predicate devices (implied standard for 510(k) clearance) | "Theoretical comparisons demonstrated the Monster Screw System™ mechanical performance to be substantially equivalent to the predicate devices." |
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 for Test Set: Not applicable in the context of this 510(k) summary for a mechanical device. The "test set" here refers to theoretical comparisons and bench testing, not a clinical study with a patient sample size.
- Data Provenance: Not applicable. The "theoretical comparisons" would be based on engineering principles and potentially prior testing data of predicate devices.
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. This is not a diagnostic device where "ground truth" would be established by experts interpreting images or clinical outcomes. The equivalence is based on engineering and material science.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There is no adjudication needed for mechanical equivalence testing as described 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
- Not applicable. This is a hardware bone fixation device, not an AI-powered diagnostic tool. An MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device; there is no algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. As noted, "ground truth" as typically defined for diagnostic performance is not relevant for this type of device submission. The "truth" is established through engineering specifications and mechanical testing to demonstrate equivalence.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" or "ground truth" in this context.
§ 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.