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CarriCell® is indicated for filling bone voids or defects of the sketal system (i.e., extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. CarriCell® may be hydrated with saline or autologous blood prior to implantation. CarriCell® is a bone graft substitute that resorbs and is replaced with new bone during process.

CarriCell® Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of hydration solution to form a putty. No mixing is required. The putty can be administered to the treatment site by syringe or manual application. The material can be shaped into a desired form prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a chemical and crystalline structure similar to that of natural bone minerals. CarriCell® Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a quantifiable table of acceptance criteria with specific numerical targets. Instead, it refers to a guidance document for Class II Special Controls and summarizes the findings.

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

• Test Set (In-vivo Study): The document mentions "an in-vivo study was performed as part of the assessment of the subject CarriCell® device" in a "femoral core defect model." It does not specify the sample size (number of animals or defects) used in this study.
• Data Provenance: The document states "an in-vivo study was performed." Animal studies are typically prospective in nature. The country of origin of the data is not specified, but given the FDA submission, it would likely be from studies conducted under US or internationally recognized guidelines.

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

• The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the in-vivo study. It only states the "study concluded that CarriCell® material did perform as intended with proper osteointegration with host bone." This suggests an assessment by relevant scientific or medical professionals, but specifics are absent.

4. Adjudication Method for the Test Set

• The document does not specify any adjudication method for the in-vivo study. It simply states the study concluded with a positive finding regarding performance and osteointegration.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, an MRMC comparative effectiveness study was not done. This document describes a submission for a bone graft substitute material, not an AI or imaging device. Therefore, the concepts of human readers, AI assistance, or effect sizes in that context are not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone algorithm performance study was not done. As mentioned above, this is for a bone graft substitute, not an AI or software device.

7. The Type of Ground Truth Used

• For the in-vivo study, the ground truth would have been established through histological analysis, radiographic imaging, and potentially biomechanical testing performed on the animal models. The conclusion of "proper osteointegration with host bone" implies such biological and structural evidence formed the basis of the assessment.

8. The Sample Size for the Training Set

• This question is not applicable as the device is a bone graft substitute material, not a machine learning or AI algorithm that requires a training set. The "testing" refers to non-clinical bench testing and in-vivo animal studies to demonstrate material properties and biological performance.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable for the same reason as point 8.

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