(27 days)
The Latarjet Cortical Screw Set is intended to provide the orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries.
The Latariet Cortical Screw Set consists of an implantable fixation screw which is used for fixation of bone grafts or bone fragments to cortical bone in shoulder surgeries. The fixation screws are offered in the following overall range of length: 36mm - 48mm. (features- other than the overall length- are identical on all). The set also includes a threaded bushing which attaches to the proximal end of the fixation screw. Its purpose is to position the screw firmly and safely during the fixation procedure. The bushing is provided in one size. The fixation screw and bushing are supplied in either in Titanium alloy or Stainless Steel. The Latarjet Cortical Screw Set is supplied nonsterile, for single patient use.
This 510(k) submission (K091694) is for a medical device called the "Latarjet Cortical Screw Set," which is a bone fixation screw. The provided documents focus on establishing substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data in the context of an AI/software device.
Therefore, many of the requested categories for AI/software device performance studies, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for training, are not applicable or extractable from this specific submission.
Here's the information that can be extracted from the provided text, primarily based on the comparison to a predicate device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Intended Use | The Latarjet Cortical Screw Set is intended to provide the orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries. | "The Latarjet Cortical Screw Set is intended for the same clinical purpose" (as the predicate). |
| Technological Characteristics | Design and performance for bone fixation in shoulder surgeries. | "With respect to technology, the design is similar as confirmed by comparison, and the performance is the same as verified by validation." |
| Device Materials | Titanium alloy or Stainless Steel. | Device is supplied in Titanium alloy or Stainless Steel. |
| Screw Length Range | 36mm - 48mm. | Fixation screws are offered in the overall range of length: 36mm - 48mm. |
| Non-sterile, Single Patient Use | Device is to be supplied nonsterile, for single patient use. | Device is supplied nonsterile, for single patient use. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission focuses on comparing the new device to a predicate device based on design similarities and validated performance, not on a clinical "test set" in the way an AI/software device would be evaluated. The "validation" mentioned likely refers to mechanical or bench testing to ensure material and functional equivalence to the predicate, not a clinical study on human subjects with a specific sample size for a "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of expert consensus, is not relevant for this type of device submission. The "ground truth" here is the established safety and effectiveness of the predicate device, and the new device's equivalence to it.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method is described as there isn't a "test set" in the AI/software context.
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 medical device (bone fixation screw), not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this substantial equivalence claim is the established safety and effectiveness of the predicate device (K083096), which has been legally marketed and proven safe and effective for its indicated use. The current device is considered substantially equivalent because its design, materials, and intended use are similar, and its performance (likely mechanical/bench testing) is validated to be the same as the predicate.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is a hardware device, not a machine learning model.
9. How the ground truth for the training set was established
- Not Applicable. (See point 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.