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Cementek® LV is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® LV is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. The putty can be injected into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gaps, Cementek® LV resorbs and is replaced with bone during the healing process.

As an injectable bone substitute, Cementek® LV is packaged as a solid phase and a liquid phase. The liquid and solid phases are mixed in the operating room, then introduced with a syringe into the osseous cavity and allowed to set. This reaction is an athermic reaction resulting in an apatitic calcium phosphate cement. Cementek® LV is marketed in a 16cc dosage.

The provided text is a 510(k) summary for the Cementek® LV bone substitute, a medical device. It does not describe acceptance criteria or a study proving that a device meets such criteria for an AI/ML-based medical device. Instead, it details the device description, intended use, and a summary of technological characteristics compared to a predicate device for a physical medical device (bone void filler).

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, device performance, study details for AI/ML devices, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the provided document.

The document discusses substantial equivalence for a physical product based on comparing its characteristics to a predicate device, not the performance of an algorithm or an AI system.

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Cementek® is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. The putty can be molded to specific shapes and placed into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, Cementek® resorbs and is replaced with bone during the healing process.

As a malleable bone substitute, Cementek® is packaged as a solid phase and a liquid phase. The liquid and solid phases are mixed in the operating room, then introduced as a paste into the osseous cavity and allowed to set. This reaction is an athermic reaction resulting in a apatitic calcium phosphate cement. Cementek is marketed in two different dosages; Cementek® 20 produces 8cc of paste and Cementek® 40 produces 16cc.

This document describes a 510(k) premarket notification for a bone void filler device, Cementek®. The focus of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish strict acceptance criteria through a comprehensive clinical study with performance metrics in the way a PMA (Premarket Approval) would.

Therefore, the provided text does not contain details about acceptance criteria, a specific study proving the device meets those criteria, or most of the requested information regarding study design elements like sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies.

The "study" mentioned is an "animal model" that performed similarly to a predicate device, which is a comparative assessment rather than a performance study against specific acceptance criteria.

However, I can extract the information that is present and indicate what is not available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: Specific quantitative acceptance criteria (e.g., "compressive strength > X MPa") are not stated. The performance is reported in terms of equivalence or similarity to predicate devices.

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not specified in the provided text. The "animal model" is mentioned, but no details on the number or type of animals are given.
• Data Provenance: Not specified.

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

• Not applicable as no human expert-based ground truth establishment for a test set is mentioned. The comparison is against predicate devices and animal model results.

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

• Not applicable; no information on adjudication method is 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. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.

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

• Not applicable. This device is a medical implant, not an algorithm.

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

• The "ground truth" for demonstrating equivalence appears to be derived from comparative testing against predicate devices (for physical properties) and results from an animal model (for in-vivo performance/resorption, implied). No specific pathology or outcomes data from human studies are detailed, as is typical for a 510(k) submission focused on equivalence.

8. The sample size for the training set:

• Not applicable or not specified. This is a medical device, not an AI model requiring a training set. If "training set" refers to data used to develop the device's properties, no specific sample sizes are mentioned.

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

• Not applicable for a medical device in the context of AI. For the device itself, the properties (e.g., composition, strength) are established through standard materials science and biological testing, likely compared to known standards or predicate device properties.

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