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Tactoset® Injectable Bone Substitute is a synthetic, biocompatible bone graft substitute 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 surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process and may be combined with autogenous bone marrow. 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 is an injectable 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 [CaHgO7], hyaluronic acid (HA), and water for injection. At a specified volume, the aqueous setting solution can be combined with autogenous bone marrow, i.e., bone marrow aspirate. Tactoset is provided sterile for single use.

The provided text describes a 510(k) premarket notification for a medical device called Tactoset. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and detailed study results for the device itself. Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment are not present in the provided document.

However, based on the available information, I can extract what is present:

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

The document does not explicitly present acceptance criteria in a quantitative table with specific targets. Instead, it demonstrates "substantial equivalence" to predicate devices through various comparisons, including material composition, physical properties, mechanical testing, and an animal functional study. The closest an explicit performance comparison comes is in the animal study section:

Other aspects like mixing time, working time, setting time, sterility, and pyrogenicity are presented as characteristics that are equivalent to the predicate device, implying that the predicate's performance in these areas serves as an "acceptance criteria" through analogy.

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

• Test Set Sample Size: The document mentions a "rabbit critical sized femoral defect model." It does not specify the number of rabbits or defects used in this study.
• Data Provenance: Not specified in the document.

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 provided in the document. The "new bone formation" and "implant material remaining" would likely require expert assessment (e.g., histopathologist), but the details are absent.

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

• This information is not provided in the document.

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 done, nor is this an AI-powered device. The study described is an animal functional study comparing the device's performance to a predicate device and a control in terms of bone formation and resorption.

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

• This is not an algorithm-only device; it is a bone graft substitute. The standalone performance was assessed in an animal model.

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

• For the animal study, the ground truth for "new bone formation" and "implant material remaining" would likely be derived from histopathology analysis of the retrieved bone sections from the rabbit femoral defects.

8. The sample size for the training set

• Not applicable/Not provided. The document describes a medical device (bone graft substitute), not a machine learning algorithm that requires a training set.

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

• Not applicable/Not provided (as it's not a machine learning algorithm).

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