(37 days)
The Synthes 1.0/1.2 mm Plusdrive Screws are intended for fracture fixation in hand surgery and neurosurgery.
The 1.0/1.2 mm Plusdrive Screws are either self-drilling or self-tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths.
The provided document is a 510(k) summary for the Synthes 1.0/1.2 mm Plusdrive Screws. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/software device performance evaluation.
Therefore, the requested information categories related to AI/software device performance (such as sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance, and expert qualifications for ground truth) are not applicable to this type of medical device submission.
Here's an attempt to answer the applicable parts based on the provided document:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, or physical/mechanical thresholds). Instead, the crucial "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to existing legally marketed predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The document states, "Documentation is provided which demonstrates that the Synthes 1.0/1.2mm Plusdrive Screws are substantially equivalent to other legally marketed devices." The FDA letter confirms the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." |
| Intended Use | The device is intended for "fracture fixation in hand surgery and neurosurgery." This matches the general intended use of similar bone fixation fasteners. |
| Device Description (features consistent with predicate) | The device is described as "either self-drilling or self-tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths." This description implies functional similarity to the predicate devices. |
| Classification (consistent with predicate) | Classified under 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation Fastener, which aligns with the predicate device's classification. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a physical medical device (screws), not an AI/software device. The concept of a "test set" with data provenance as understood in AI/ML performance studies does not apply here. The submission relies on comparative analysis with predicate devices and, likely, bench testing and material characterization data which are not detailed in this summary.
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. There is no "ground truth" to be established by experts for a test set in the context of an AI/ML study for this physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or adjudication process as defined for AI/ML performance evaluation.
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 device is not an AI-assisted diagnostic or clinical decision support tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a physical device's substantial equivalence is typically established through a comparison of technological characteristics, materials, mechanical properties, and intended use to existing legally marketed devices, rather than clinical "outcomes data" or "expert consensus" in the AI/ML sense.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.