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Exactech Resorbable Room Temperature Bone Paste is intended for use as a bone graft extender (extremities, spine, pelvis) and as a bone void filler for bony voids or gaps of the extremities 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.

Exactech Resorbable Room Temperature Bone Paste may be used with rigid fixation systems.

Exactech Resorbable Room Temperature Bone Paste is a mixture of demineralized bone matrix (DBM) in a bioinert and bioabsorbable polyethylene divcol (PEG) based polymer and is provided as an aseptic manufacture single use, ready to use implantable device derived from a single donor. Exactech Resorbable Room Temperature Bone Paste gradually resorbs and is replaced with new bone during the healing process.

The provided document is a 510(k) summary for a medical device (Exactech Resorbable Room Temperature Bone Paste) and does not describe software or an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate its safety and effectiveness based on the content available.

Here's a breakdown of the information that can be extracted, and where the requested AI/ML specific information is not applicable:

Acceptance Criteria and Device Performance for Exactech Resorbable Room Temperature Bone Paste

This device is a bone void filler and bone graft extender. The safety and effectiveness information is based on its components, manufacturing processes, and biological testing, rather than an AI/ML algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Specific Criterion | Reported Device Performance |
|:--------------------------------------|:--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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| Sterility | Each lot must undergo microbiologic testing for sterility in conformance with 21CFR610.12. | Performed and in conformance. (Each lot of Exactech Resorbable Room Temperature Bone Paste undergoes microbiologic testing for sterility in conformance with 21CFR610.12.) |
| Biocompatibility (DBM carrier) | Human demineralized bone (DBM) is known to be biocompatible. | Demonstrated biocompatible based on long history of use without adverse reactions or complications. |
| Biocompatibility (Polymer carrier)| The polyethylene divcol (PEG) based polymer carrier must be demonstrated to be biocompatible. | Demonstrated biocompatible in accordance with ISO 10993 testing and other in vivo testing. |
| Osteoinductive Potential | A minimum of two implanted samples per lot must demonstrate osteoinductive potential, assessed by histological evidence of endochondral bone formation (cartilage/chondrocytes, osteoblasts, osteoid, newly formed/mineralized bone, marrow/fat cells) in an athymic nude mouse model, in accordance with the ASTM Draft Standard Guide for the Assessment of Bone Inductive Material. | Test samples from each lot were implanted bilaterally into the gastrocnemius muscle of 2 athymic nude mice and demonstrated successful osteoinductive potential. (Note: Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects). |
| Viral Inactivation | The demineralization process used on donor bone must significantly diminish model viruses (HAV, HIV-1, PPV, PrV) to reasonably be anticipated to diminish titers of other viruses. | A viral reduction study demonstrated significant diminution of all four model viruses by the demineralization process. |

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

• Osteoinductive Potential Test:
  • Sample Size: 2 athymic nude mice for each lot tested. Each mouse had samples implanted bilaterally (total of 4 implant sites per lot).
  • Data Provenance: In vivo animal study (athymic nude mice). The country of origin of the data is not specified. This is a prospective animal study for each lot.
• Viral Inactivation Validation Study:
  • Sample Size: Not specified in terms of number of samples, but the study used four virus models directly: Hepatitis A Virus (HAV), Human immunodeficiency virus type 1 (HIV-1), Porcine parvovirus (PPV), and Pseudorabies virus (PrV).
  • Data Provenance: This was a laboratory study conducted by a CLIA certified testing laboratory using virus models. The country of origin of the data is not specified. This is a prospective laboratory study.

(Note: Data provenance for human clinical data is not applicable as this is not a clinical study involving human patients for effectiveness data, but rather a device relying on material properties and established biocompatibility/safety of its components.)

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

• Osteoinductive Potential: The assessment was based on "histological evidence of endochondral bone formation." This implies evaluation by a qualified histopathologist, but the specific number and qualifications of experts are not provided in this summary.
• Viral Inactivation Validation: Conducted by a "CLIA certified testing laboratory." The specific experts involved are not detailed.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for the test sets as it pertains to human interpretation/consensus, which is common in AI/ML studies. The assessments are based on laboratory testing and histological criteria.

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 a physical medical device (bone paste), not an AI/ML powered device. No MRMC study was conducted.

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

• Not Applicable. This is a physical medical device (bone paste), not an AI/ML powered device. No standalone algorithm performance study was conducted.

7. The type of ground truth used

• Osteoinductive Potential: Histological evidence of endochondral bone formation as defined by specific biological markers (cartilage/chondrocytes, osteoblasts, osteoid, newly formed/mineralized bone, marrow/fat cells). This is a biological ground truth established through scientific observation and defined criteria.
• Viral Inactivation Validation: Measurement of viral titers before and after the demineralization process, comparing the reduction against established criteria for viral inactivation. This is a laboratory-based, quantitative ground truth.
• Biocompatibility (DBM): Long history of clinical use without adverse reactions or complications serves as the "ground truth" for biocompatibility.
• Biocompatibility (Polymer): ISO 10993 testing and other in vivo testing results (standardized, objective measures).

8. The sample size for the training set

• This device does not involve an AI/ML model, so there is no concept of a "training set" in the context of machine learning. The "training" for this device would be analogous to continuous quality control and material sourcing, which are ongoing processes.

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

• Not Applicable. As there is no AI/ML training set, this question is not relevant.

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