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NEOTIS Plate is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies.

The NEOTIS plate is designed for medial approach High Tibial Osteotomy stabilization. Anatomically shaped, thin and short, the NEOTIS plate enables minimally invasive surgery. The changes brought by the NEOTIS plate are as follows (vs. OTIS-C Plus plate):

• The proximal temporary screw is replaced with a pin that offers a simpler and faster placement of the plate. The area of the cortical bone drilled through the process is also reduced.
• The distal temporary screw is replaced with an AO screw in order to maintain compression. The compression will be maintained by the 4 permanent 6.5 mm screws (OTIS screws).

The provided documentation describes a traditional 510(k) submission for the NEOTIS Plate and Screws, a medical device for bone fixation. Here's a breakdown of the acceptance criteria and the study information as extracted from the text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions a "cadaver study" but does not provide details on the number of cadavers or specimens used.
• Data Provenance: The cadaver study is implied to be laboratory-based (non-clinical performance testing). The document does not specify the country of origin for the cadaver data, nor does it explicitly state if it was retrospective or prospective, though "non-clinical performance testing" typically implies prospective experimental testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• The documentation does not provide information about experts establishing ground truth for the cadaver study. The study appears to be a mechanical performance test rather than one requiring clinical interpretation by experts to establish ground truth.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. The study described is a non-clinical performance test, not a study involving human interpretation with adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The device is hardware (plate and screws), not an AI algorithm or diagnostic tool that would typically undergo an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, this is not applicable. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

• For the cadaver study, the "ground truth" was the level of compression induced by the device during placement. This is a direct physical measurement/observation in a controlled experimental setting, not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

• Not applicable. The device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. The device is not an AI/ML algorithm.

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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 OTIS-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 design of the self-tapping OTIS-C Plus screws (unmodified) allows easy and reliable one step locking, without counter-nut, 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.

This 510(k) submission describes a medical device, not a diagnostic AI/ML device. Therefore, the questions related to AI/ML specific performance criteria, ground truth, and expert evaluation are not applicable.

Here's an analysis of the provided text in the context of device acceptance criteria and study information:

Device Acceptance Criteria and Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The criteria are implicitly derived from the established safety and effectiveness of the predicate.

Study Description:

1. Sample size used for the test set and the data provenance: Not explicitly stated as this is a non-clinical, mechanical testing study. The "test set" would refer to the physical samples of the OTIS-C Plus device and its components used for the performance testing. The provenance of the data is from SCIENCE FOR BIOMATERIALS, a French company. The study is prospective in the sense that the testing was performed on the newly designed modified device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a mechanical engineering study, not an imaging or diagnostic study requiring expert interpretation for ground truth. The "ground truth" is established by the physical laws and engineering principles governing the materials and their interactions.
3. Adjudication method for the test set: Not applicable. This refers to consensus methods for expert opinions, which is not relevant for mechanical testing.
4. 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 not an AI/ML device or a diagnostic device involving human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
6. The type of ground truth used: For the mechanical performance tests (fretting corrosion, torsional yield strength, etc.), the "ground truth" is the established scientific and engineering principles for material properties and device performance under specified conditions, as measured by standard laboratory tests. For the Finite Element Method (FEM) analysis, the "ground truth" or reference for comparison is the mechanical behavior and fretting corrosion of the predicate device (K100604).
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

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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

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.

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