(103 days)
OTIS-C Plus is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies.
The OTIS-C Plus plate is designed for the stabilization of High Tibial Osteotomy with a medial approach. Anatomically shaped, thin and short, the OTTS-C Plus plate enables mini-invasive surgery. Its locking system provides immediate compression of the graft as well as stable fixation, thus allowing early weight-bearing. The selftapping OTIS-C Plus screws allows easy and reliable one step locking, without counternut, in a simple and concise approach. With its range of twelve screws lengths, fixation can be either mono or bi-cortical, upon the choice of the surgeon.
The provided document is a 510(k) summary for a medical device (OTIS-C Plus) and does not contain information about a study with acceptance criteria often seen for AI/ML-driven devices. Instead, it describes non-clinical performance testing for a traditional metallic bone fixation appliance.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information, ground truth types) are not applicable to the information provided in this document excerpt.
However, I can extract the relevant information regarding the performance claims and the type of testing performed.
1. Table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied by equivalence) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not explicitly stated as acceptance criteria, but implied by regulatory requirements for medical devices. | The device is made of stainless steel, a common material for bone fixation devices. While not explicitly stated as "performance," it's mentioned to be similar to predicates. |
| Mechanical Performance (General) | Perform at least as safely and effectively as predicate devices (K041709 NUMELOCK II SYSTEM and K973812 ARTHREX PUDDU OSTEOTOMY SYSTEM). | Non-clinical performance testing demonstrated that OTIS-C Plus system is "as safe, as effective, and performs at least as safely and effectively as its predicate devices." This is a general statement of equivalence as assessed by the specific tests below. |
| Fretting Corrosion | Performance comparable to or better than predicate devices. | Testing was done, and the results supported the claim of substantial equivalence. No specific numerical values or direct comparison points are given in this summary. |
| Torsional Yield Strength | Performance comparable to or better than predicate devices. | Testing was done, and the results supported the claim of substantial equivalence. No specific numerical values or direct comparison points are given in this summary. |
| Ultimate Torsional Strength | Performance comparable to or better than predicate devices. | Testing was done, and the results supported the claim of substantial equivalence. No specific numerical values or direct comparison points are given in this summary. |
| Insertion Torque | Performance comparable to or better than predicate devices. | Testing was done, and the results supported the claim of substantial equivalence. No specific numerical values or direct comparison points are given in this summary. |
| Removal Torque | Performance comparable to or better than predicate devices. | Testing was done, and the results supported the claim of substantial equivalence. No specific numerical values or direct comparison points are given in this summary. |
| Pull-out Strength | Performance comparable to or better than predicate devices. | Testing was done, and the results supported the claim of substantial equivalence. No specific numerical values or direct comparison points are given in this summary. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document for the non-clinical performance testing. The "test set" in this context refers to the samples of the device components (plates and screws) used for mechanical and corrosion testing, not a clinical data set.
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 is not applicable. The ground truth for mechanical testing is derived from engineering standards and physical measurements, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used for clinical study data, not for non-clinical mechanical testing.
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 is not applicable. This document describes a traditional medical device (bone plate and screws), not an AI/ML-driven diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This describes a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing, the "ground truth" (or reference standard) would be established by engineering standards, material properties, and validated testing methodologies (e.g., ISO, ASTM standards for material testing) to measure the mechanical properties of the device components.
8. The sample size for the training set
This is not applicable. This document describes a traditional medical device, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
This is not applicable. This document describes a traditional medical device, not an AI/ML system.
§ 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.