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Merries K-PHATE is intended to be packed into bony defects of the skeletal system ( extremities, spine, or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.

Merries K-PHATE bone graft substitute is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% hydroxyapatite and 40% ß-tricalcium phosphate. Merries K-PHATE is supplied sterile in various shapes and sizes. The choice of different form or size of the product depends on the type and size of the recipient site. Blocks and wedges are used for large bony defect while granules are used as bone filler for small area.

The provided text describes the 510(k) Premarket Notification Summary for the "Merries K-PHATE Bone graft substitute" (K063157). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, performance metrics, and study design for a clinical effectiveness study is not explicitly present in the provided text.

Specifically, this submission relies on:

1. Material characteristics: The device is a biphasic calcium phosphate ceramic, similar to predicate devices.
2. Function and intended use: It's designed as a resorbable bone void filler, the same as predicate devices.
3. Biocompatibility testing: To ensure safety.
4. Sterilization dose auditing: To ensure sterility.
5. Chemical requirements: Conformance to ASTM standards for ceramic hydroxyapatite and beta-tricalcium phosphate.

Here's an attempt to answer your questions based on the provided text, recognizing that a full clinical study with acceptance criteria for effectiveness is not detailed:

Acceptance Criteria and Device Performance (Based on provided 510(k) Summary)

Since this is a 510(k) submission for a bone graft substitute, the primary "acceptance criteria" discussed are related to substantial equivalence to legally marketed predicate devices, and the device's safety through biocompatibility and material testing. Performance in terms of clinical outcomes (e.g., rate of bone fusion, strength of new bone) is inferred from the predicate devices rather than directly proven through a new comparative clinical study for this specific device in this submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided summary does not detail a clinical "test set" for performance evaluation in the way a clinical trial would. The "tests" reported are primarily bench/laboratory tests for material properties and biocompatibility.

• Sample Size for Bench/Biocompatibility Tests: Not specified in the summary. These tests typically involve a relevant number of samples for each specific test (e.g., cell cultures for cytotoxicity, animal models for irritation/sensitization/implantation).
• Data Provenance: The manufacturing company is based in Taipei, Taiwan (Merries International Inc.). The specific locations where the individual biocompatibility tests were conducted are not stated, but given the company's location, they were likely performed in a certified lab, potentially in Taiwan or another country as required for international standards. These tests are prospective in nature, conducted specifically for this submission.

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 information is not applicable as there is no human-read clinical test set described in this summary to establish a "ground truth" for diagnostic or prognostic performance. The "ground truth" for the material and biocompatibility tests is based on objective scientific measurements and established standards (e.g., cell viability, tissue response, chemical composition as per ASTM).

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

This is not applicable. No clinical test set with human assessment requiring adjudication is described.

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 device is a bone graft substitute, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or is relevant to this type of device.

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

This is not applicable. This device is a bone graft substitute, not an algorithm.

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

For the tests conducted:

• Material Composition: Ground truth is based on physical and chemical analysis techniques confirming compliance with ASTM standards.
• Biocompatibility: Ground truth is based on biological assays and histological examination in animal models, evaluated against established criteria for cytotoxicity, irritation, sensitization, and tissue compatibility.
• Sterility: Ground truth is based on microbiological testing (sterilization dose auditing).

There is no "expert consensus" or "pathology" in the sense of a clinical diagnostic study. Outcomes data (e.g., long-term bone healing) would typically be part of a full clinical trial, which is not detailed here for this 510(k) submission.

8. The sample size for the training set

This is not applicable. This device is a medical implant, not a machine learning model, and therefore does not have a "training set."

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

This is not applicable as there is no training set for this device.

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