(53 days)
The ORTHOLOC® 2.0 / 2.4 Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. Examples include:
Metatarsal or metacarpal fractures and osteotomies Phalanges fractures and osteotomies
The design features of the ORTHOLOC® 2.0 / 2.4 System are described below.
- Consists of a variety of flat and pre-contoured plate geometries .
- Plates feature compression slots and locking screw holes .
- Manufactured from Titanium and Titanium Alloy .
- Screws are available in both locking and non-locking designs .
- Screws are available in 2 diameters and 7 lengths in the small diameter and 12 lengths in . the large diameter
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in the request. The document is a 510(k) summary for the ORTHOLOC® 2.0/2.4 System, which is a premarket notification to the FDA.
Here's what can be extracted and why other points cannot be addressed:
1. A table of acceptance criteria and the reported device performance
- Not found: The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against specific acceptance criteria. No such table is included.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not found: No information about a "test set," sample size, or data provenance from a study is provided. The submission relies on "substantial equivalence information, materials information, and analysis data" without specifying the nature or origin of this data in a study context.
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 found: As no test set study is detailed, there's no mention of experts or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not found: No adjudication method is mentioned as there's no detailed study description.
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 found: The device is a bone fixation plate and screw system, which is a physical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study involving human readers and AI is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not found: This point is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not found: No ground truth information is provided, as no specific performance study against a "ground truth" is detailed. The submission relies on substantial equivalence.
8. The sample size for the training set
- Not found: This is not an AI/algorithm device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not found: Not applicable for the reasons mentioned above.
Summary of available information:
The K090692 document is a premarket notification (510(k)) that asserts the ORTHOLOC® 2.0 / 2.4 Plate & ORTHOLOC® 2.0 / 2.4 Screw system is substantially equivalent to legally marketed predicate devices. The basis for this claim is "design features, material, and indications for use." The safety and effectiveness are "adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification," but specifics of performance studies or acceptance criteria beyond this equivalence are not provided in the summary.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.