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The B-BOP® plate is intended for fixation of osteotomy of the basis of the first metatarsal. Examples include:

• Moderate to severe hallux valgus
• Hallux varus

Newdeal has developed a plate dedicated to the fixation of basal osteotomy of the 1st metatarsal by designing the B-BOP® plate which allow to meet at best the specifications of that kind of surgical procedure.

Characteristics of the plate have taken into account all the requirements associated with basal osteotomy:

• Plantar positioning to obtain the best stability and resistance and allowing to reduce bulk
• Anatomical shape adapted to the plantar curve of the 1st metatarsal (pre-bent), available in right or left side and in two angulations (5° and 10°) for medium or large deformation.

The B-BOP® plate is made from titanium alloy (Ti-6AI-4V ELI) and the part of the plate in contact with bone is sandblasted for a better adherence of the plate.

Plates and screws are also available which are color-coded for ease of identification.

Fixation of the plate is provided by four Snap-Off screws, already present with the HALL 0 -Fix system (cleared under K021626).

With the B-BOP® plate, screws are available in 2 diameters (2.7mm and 3.0mm) and in a length range from 14mm to 26mm (2 mm increment). The screws are provided sterile with the B-BOP® plate.

Here's an analysis of the provided text regarding the acceptance criteria and study for the B-BOP® plate, structured according to your request.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not specify the sample size used for the test set for either the bending strength or fatigue testing.
The data provenance (e.g., country of origin, retrospective/prospective) is also not specified for these tests. It can be inferred that the testing was conducted by or on behalf of Newdeal SAS, a French company, but the specific location of the testing is not stated.

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

This document describes mechanical testing (bending strength and fatigue testing) of a medical device (B-BOP® plate). Mechanical testing does not typically involve human experts to establish ground truth in the same way clinical studies or diagnostic AI algorithms do. Instead, performance is measured against engineering specifications and industry standards. Therefore, this section is not applicable to the type of study described.

4. Adjudication Method for the Test Set

As the study involves mechanical testing and not human interpretation or clinical outcomes, an adjudication method in the sense of expert consensus for ground truth is not applicable. The "adjudication" is inherent in the measurement and comparison against predefined engineering acceptance criteria.

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

No, an MRMC comparative effectiveness study was not done. This document describes mechanical testing of a medical implant and does not involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not Applicable. This document details the mechanical testing of a physical medical device (a plate), not a software algorithm or AI.

7. The Type of Ground Truth Used

The ground truth for this study appears to be predetermined engineering specifications and industry standards for bending strength and fatigue life of bone fixation plates. The document states, "The B-BOP® plate meets our acceptance criteria," implying that these criteria (standards for mechanical performance) served as the "ground truth."

8. The Sample Size for the Training Set

Not Applicable. This document describes mechanical testing of a physical device. There is no "training set" in the context of an AI algorithm or statistical model.

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

Not Applicable. As there is no training set, the method of establishing its ground truth is irrelevant.

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