Search Results

Apatight-HA Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight-HA is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product resorbs and is replaced with bone during the healing process.

Apatight-HA Bone Graft Substitute is a porous hydroxyapatite bone graft substitute for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is provided sterile in block and granular forms. Apatight-HA Bone Graft Substitute guides the threedimensional regeneration of bone in the defect site into which it is implanted. When Apatight-HA Bone Graft Substitute is placed in direct contact with viable host bone, new bone grows in apposition to the surfaces of the implant, filling the pores with new bone during the healing process. The product is completely incorporated into the newly formed bone.

This document is a 510(k) Pre-market Notification for a bone graft substitute, Apatight™-HA. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for an AI/CADe device. Therefore, much of the requested information regarding AI/CADe study design (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) is not applicable or cannot be extracted from the provided text.

However, I can extract the acceptance criteria and a description of the study used to claim equivalence for this medical device:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence):

Since this is a 510(k) submission for a bone graft substitute and not an AI/CADe device, the following points are largely not applicable or information cannot be extracted from the provided text.

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

   • N/A. The document mentions "performance testing in an animal model," but does not specify the sample size of animals or their origin. It's a non-human biological study.

2. 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):

   • N/A. Ground truth for animal model performance would typically be established by veterinary pathologists or histologists, but the number and qualifications are not specified.

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

   • N/A. Adjudication methods like 2+1 or 3+1 are relevant for interpreting human diagnostic imaging or clinical data, not typically for animal model histopathology unless multiple pathologists were involved in a blinded review (not specified here).

4. 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:

   • N/A. This is not an AI device, so an MRMC study comparing human readers with AI assistance is irrelevant.

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

   • N/A. This is not an AI algorithm.

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

   • For the animal study, the ground truth would be based on histopathology and observation of tissue integration (new bone formation, absence of inflammation/infection). The text states "completely integrated into the defect site" and "completely filled with new bone," which implies histological analysis.

7. The sample size for the training set:

   • N/A. There is no training set for an AI algorithm.

8. How the ground truth for the training set was established:

   • N/A. There is no training set for an AI algorithm.

Ask a specific question about this device

Apatight-TCP Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight-TCP is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product resorbs and is replaced with bone during the healing process.

Apatight–TCP Bone Graft Substitute is a porous calcium phosphate resorbable bone graft substitute for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is provided sterile in block and granular forms. Apatight-TCP Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Apatight-TCP Bone Graft Substitute is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant, filling the pores with new bone. As the implant resorbs, bone grows into the space previously occupied by the bone graft substitute.

The provided 510(k) summary is for Apatight-TCP Bone Graft Substitute, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria related to diagnostic performance.

Therefore, many of the requested categories in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or extractable from this document as it's not a diagnostic device and doesn't involve AI or image analysis.

However, I can extract the information relevant to the device's performance based on the substantial equivalence paradigm, focusing on a pre-clinical animal study.

Here's an attempt to fill out the table and answer the questions based on the provided text, noting where information is not applicable (N/A) or not provided (NP).

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as "performance testing in an animal model."

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

• Sample size used for the test set: Not explicitly stated as a numerical sample size (e.g., number of animals). The text only refers to "an animal model" and "any Apatight-TCP treated animal."
• Data provenance: Prospective animal study. Country of origin not specified, but the submission is to the U.S. FDA.

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

• Number of experts: Not applicable/Not provided. This was an animal study evaluating direct biological outcomes, not an interpretation of data by human experts for ground truth establishment in a diagnostic context.
• Qualifications of those experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable/Not provided. This refers to consensus among human readers for diagnostic ground truth, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC study: No, this was not an MRMC study. This device is a bone graft substitute, not an AI diagnostic tool, so such a study design is not applicable.
• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

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

• Standalone performance: Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Type of ground truth: Histopathology/In-vivo biological observation from the animal model. The study observed "no signs of inflammation or infection," defects "completely integrated," and "pores completely filled with new bone."

8. The Sample Size for the Training Set

• Sample size for the training set: Not applicable. This is a medical device, not a machine learning model, so there is no training set in the AI sense.

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

• How ground truth for the training set was established: Not applicable.

Ask a specific question about this device