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Tactoset® Injectable Bone Substitute is a synthetic, biocompatible material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgicallycreated osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, selfsetting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process. Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

Tactoset® Injectable Bone Substitute is an injectable, settable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution in separate pre-loaded syringes) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PO4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [C6H8O7], hyaluronic acid (HA), Iohexol (C19H26J3N309) and water for injection. Tactoset is provided sterile for single use.

This document describes the FDA 510(k) premarket notification for the Tactoset® Injectable Bone Substitute. It is a medical device, specifically a resorbable calcium salt bone void filler. The information provided heavily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a clinical study evaluating the performance of an AI/ML powered device.

Therefore, many of the requested criteria regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device (e.g., sample size for test sets, expert ground truth establishment, MRMC studies, standalone performance) are not applicable to this document, as it is about a different type of medical device (a bone substitute) and its premarket clearance process based on substantial equivalence.

However, I can extract information related to the performance testing and comparison for this specific device type, which serves a similar purpose of demonstrating safety and effectiveness.

Here's an analysis of the provided text based on your request, focusing on the available information:

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

The document does not explicitly present "acceptance criteria" in the typical sense of numerical thresholds for a clinical study endpoint for an AI/ML device. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The "performance" is shown by comparing the subject device's properties and animal study results to those of the predicates.

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

The primary "test set" described is the animal functional study using a rabbit critical sized femoral defect model.

• Sample Size: The document does not explicitly state the number of animals used. It refers to "an average new bone formation" and "an average implant material remained," implying a group of animals for each.
• Data Provenance: The study was conducted in a "rabbit critical sized femoral defect model." The country of origin is not specified. It is a prospective study (animal study specifically conducted for this submission).

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

This concept is not directly applicable to an animal study for a bone substitute. The "ground truth" here would be the biological and material outcomes measured in the rabbit model (e.g., new bone formation, remaining implant material). These measurements are typically quantifiable and do not rely on expert consensus in the same way an imaging AI ground truth would.

4. Adjudication method for the test set

Not applicable in the context of this type of animal study.

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. This is not an AI/ML device, and no MRMC study was conducted. The clearance is based on substantial equivalence to existing bone substitute devices.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

For the animal study, the "ground truth" was quantifiable biological and material outcomes measured directly from the animal model (e.g., percentage of new bone formation, percentage of implant material remaining) at specified time points (12 and 26 weeks). This would typically involve histological analysis, imaging, and potentially other standardized measurements.

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no concept of a "training set" for this type of device submission.

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

Not applicable.

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