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EquivaBone is a bone graft substitute that combines synthetic calcium phosphate and demineralized bone. It is resorbed and replaced with new bone during the healing process. It is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine) and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

EquivaBone is a biocompatible bone graft substitute material consisting of Calcium Phosphate (CaP3), Carboxymethylcellulose (CMC) and Demineralized Bone Matrix (DBM). EquivaBone is supplied in a single use kit as sterile powders and hydration that are mixed together at the time of use in the operating room to form flowable putty which is implanted manually or can be extruded through a syringe. After implantation the product hardens at body temperature and remodels during the healing process.

The provided text describes a 510(k) premarket notification for a medical device called EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone). The primary purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device.

Regarding acceptance criteria and a study to prove the device meets these criteria, the document focuses on changes to the device's De-mineralized Bone Matrix (DBM) source and a new method for assessing osteoinductivity.

Here's a breakdown of the requested information based on the provided text:

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

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

The document does not explicitly state the sample size for the test set used in the correlation study for osteoinductive potential or for the comparison of DBM sources.

The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is a correlation study comparing an in vitro assay (C2C12) to an in vivo assay (athymic rat implantation) to establish a new test method.

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

The document does not provide information on the number of experts or their qualifications for establishing ground truth. The "ground truth" for the osteoinductive potential correlation study appears to be the in vivo osteoinduction (OI) score of 1 from the athymic rat implantation model for the predicate device.

4. Adjudication method for the test set

The document does not describe any adjudication method.

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

No MRMC comparative effectiveness study was conducted or mentioned in the document. This device is a bone graft substitute, not an AI-assisted diagnostic tool.

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

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

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

For the osteoinductive potential, the ground truth was based on the in vivo osteoinduction (OI) score of 1 from the athymic rat implantation model for the predicate device. For DBM source equivalence, the ground truth appears to be the established chemical composition, physical properties, and performance characteristics of the DBM from the original source (AlloSource).

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of device performance or an algorithm. For the osteoinductive potential correlation study, the document describes a validation effort for a new assay method, but not a separate training set.

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

As there's no mention of a traditional "training set" in the context of a machine learning algorithm, this question is not directly applicable. The correlation study established a relationship between an in vitro assay and a previously accepted in vivo method, where the in vivo results define the benchmark for osteoinductivity.

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EquivaBone is an osteoinductive bone graft substitute that is resorbed and replaced with new bone during the healing process. It is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine) and pelvis that are not intrinsic to the stability of the bony structure. These voids or gaps may result from natural occurring bone disease, traumatic injury or surgical intervention.

EquivaBone is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). It is supplied in a single use kit as sterile powders and hydration solution that are mixed together at the time of use in the operating room to form flowable putty which is implanted manually or can be extruded through a syringe. After implantation the product hardens at body temperature and resorb and remodels during the healing process. Each lot of DBM contained within EquivaBone is assayed for ostcoinductive potential in an athymic nude mouse model. This may or may not be predictive of EquivaBone osteoinductivity in humans.

The provided text is a 510(k) summary for the EquivaBone Osteoinductive Bone Graft Substitute. It does not contain any information about acceptance criteria or a study proving device performance against such criteria for AI/ML-driven medical devices.

Instead, it describes a traditional medical device (a bone graft substitute) and its regulatory submission. The performance data section states: "Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void . Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices." This indicates that the submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria through a clinical study as would be expected for AI/ML devices.

Therefore, I cannot populate the requested tables and information. The document details:

• Device Name: EquivaBone Osteoinductive Bone Graft Substitute
• Intended Use: To fill bony voids or gaps of the skeletal system of the extremities, spine, and pelvis that are not intrinsic to the stability of the bony structure.
• Materials: Synthetic calcium phosphate, carboxymethyl cellulose (CMC), and human demineralized bone matrix (DBM).
• Predicate Devices: CaP Plus (ETEX Corporation, K063050, K080329), EquivaBone Osteoinductive Bone Graft Substitute (ETEX Corporation, K090310), Actifuse™ (ApaTech Limited, K082575), Vitoss Bioactive Foam Bone Graft Substitute (Orthovita, K083033).
• Performance Data Mentioned: Regression testing to show changes to predicate devices do not affect risk profile, and assay for osteoinductive potential in an athymic nude mouse model for DBM.

This type of information is typical for a traditional 510(k) submission for a physical medical device, not an AI/ML clinical decision support system.

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EquivaBone is intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine, and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

EquivaBone is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). It is supplied in a single use kit as sterile powders and hydration solution that are mixed together at the time of use in the operating room to form flowable putty which is implanted manually or can be extruded through a syringe. After implantation the product hardens at body temperature and resorbs and remodels during the healing process. Each lot of DBM contained within EquivaBone is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of EquivaBone osteoinductivity in humans.

This document describes a 510(k) submission for a bone graft substitute, which is a material device, not an AI or imaging device. Therefore, many of the requested fields regarding acceptance criteria related to AI/imaging device performance metrics, such as sensitivity, specificity, MRMC studies, expert ground truth adjudication methods, and training/test set details, are not applicable.

Here's an interpretation of the provided text in the context of material device acceptance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document mentions "Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices."

This indicates that the test set for performance likely involved bench testing and potentially in-vitro or in-vivo animal studies typical for material devices, rather than human clinical data for this Special 510(k). The "athymic nude mouse model" is specifically mentioned for testing DBM osteoinductive potential.

• Sample Size for Test Set: Not explicitly stated in the provided text, but for bench testing, it refers to the number of samples tested according to the referenced guidance. For the "athymic nude mouse model," it refers to the number of animals used.
• Data Provenance: The athymic nude mouse model refers to animal (pre-clinical) data. The specific country of origin is not provided, but it's generated by the manufacturer (ETEX Corporation) or a contracted lab. The data would be prospective in the sense that the studies were designed and executed to test the device's properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a material device. Ground truth for material properties is established through standardized laboratory assays and animal models, interpreted by scientists and technical experts in materials science, biology, and pathology, rather than human image readers or clinical experts in the context of this 510(k). The FDA reviewers are the "experts" who determine if the submitted data supports substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This pertains to human expert review/consensus for diagnostic data, which is not relevant for a material device's performance 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
Not applicable. This is only relevant for diagnostic imaging AI devices.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This applies to AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The type of "ground truth" for this device would be:

• Physical material properties: Measured through standardized laboratory tests (e.g., setting time, mechanical strength, biocompatibility tests).
• Biological properties: Demonstrated through in-vitro assays or in-vivo animal models (e.g., the athymic nude mouse model for osteoinductive potential).
• Biocompatibility data: Often derived from ISO standards testing.
• Resorption and remodeling characteristics: Typically assessed in animal models over time.

8. The sample size for the training set
Not applicable. This applies to AI/machine learning models.

9. How the ground truth for the training set was established
Not applicable. This applies to AI/machine learning models.

Summary for this Material Device:

The acceptance criteria for EquivaBone Osteoinductive Bone Graft Substitute were based on demonstrating substantial equivalence to its predicate devices (CaP Plus, K063050 and K080329). This was achieved through "regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device" to show that proposed changes did not affect the risk profile. Testing included assays for the osteoinductive potential of the DBM component using an athymic nude mouse model. The FDA's final letter confirmed the device met the criteria for substantial equivalence. The concepts of AI performance metrics (sensitivity, specificity, MRMC, training/test sets for algorithms, expert adjudication) are not relevant to this type of device submission.

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