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MBCP™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. MBCP™ can be used with autograft as a bone graft extender. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

MBCP™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.

When packed into a bony site, MBCP™ gradually resorbs and is replaced with bone during the healing process.

In addition, when used with appropriate opening osteotomy system devices, plates and screws. MBCP™ is intended to be used as a bone void filler in femoral or tibial osteotomies. MBCP™ is to be used in association with adequate post-operative immobilization.

MBCP™ is a bone graft substitute. MBCP™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (ß-TCP). MBCP™ is available in various shapes and sizes.

MBCP™ may be used with physiological saline, patient's own serum, whole blood, or bone marrow aspirate (BMA).

MBCP™ is provided sterile for single patient use.

The provided 510(k) summary for MBCP™ (K043005) does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics.

Instead, this submission is a Premarket Notification (510(k)) which focuses on demonstrating substantial equivalence to a predicate device, rather than performing clinical trials to establish device performance against predefined acceptance criteria. The document explicitly states:

"The safety and effectiveness of MBCP™ Bone Graft Substitute as modified in this submission is adequately supported by the substantial equivalence information, safety and performance data provided within this Premarket Notification." (Page 2)

And also, regarding predicate devices:

"The intended use and material composition of MBCP™ Bone Graft Substitute is the same as previously cleared MBCP™ (K032268). MBCP™ Bone Graft Substitute and the predicate devices are substantially equivalent in design, materials of construction and function." (Page 2)

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for proving device performance against specific metrics is not available in this document. The focus of a 510(k) is to show that the new device is as safe and effective as another legally marketed device, not to prove novel performance through a new clinical study with acceptance criteria.

However, based on the provided text, I can infer some points related to the equivalence claim:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria for 510(k) (Inferred): Substantial equivalence in intended use, material composition, design, materials of construction, and function to the predicate device (K032268).
   • Reported Device Performance: The document claims the device "is adequately supported by the substantial equivalence information, safety and performance data provided within this Premarket Notification." (Page 2). Specific quantitative performance metrics (e.g., bone growth rate, resorption rate) that would typically be evaluated against acceptance criteria are not detailed as part of a new study in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable / Not provided. The document does not describe a clinical study with a "test set" in the context of new device performance assessment. The "data" refers to the information supporting substantial equivalence, likely from existing data on the predicate device or bench/animal testing if new non-clinical data was submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable / Not provided. Ground truth establishment for a test set of data is not described as part of this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable / Not provided.

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 device is a bone void filler, not an AI-assisted diagnostic or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a bone void filler, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable directly to a new performance study. For a 510(k), the "ground truth" for demonstrating equivalence would be the established safety and effectiveness profile of the predicate device (K032268), which would have been based on clinical data, material testing, and other evidence at the time of its clearance.

8. The sample size for the training set:

   • Not applicable / Not provided. No training set for an algorithm is mentioned.

9. How the ground truth for the training set was established:

   • Not applicable / Not provided.

In summary: This 510(k) submission for MBCP™ is a substantial equivalence submission. It does not present a new study with explicit acceptance criteria for device performance. Instead, it leverages the established safety and effectiveness of a predicate device (K032268) to demonstrate that the current device is equally safe and effective.

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