(164 days)
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
| Acceptance Criteria Category | Predicate Device Performance / Expected Outcome | Reported Device Performance (Apatight-TCP) |
|---|---|---|
| Biocompatibility | Well-tolerated, no inflammation/infection | "well-tolerated" |
| Osteoconductivity / Bone Integration | Bone ingrowth into pores and integration with host bone | "completely integrated into the defect site," "interconnected porosity... completely filled with new bone at the follow-up time points" |
| Resorption & Replacement | Resorbs and is replaced by bone | "The product resorbs and is replaced with bone during the healing process." (from intended use statement, confirmed by "As the implant resorbs, bone grows into the space previously occupied by the bone graft substitute." in device description, and implied by bone filling and integration in animal study). |
| Mechanical Stability (implied) | Not intrinsically unstable | Indicated for "bony voids or gaps that are not intrinsic to the stability of the bony structure." Performance implies it doesn't cause instability. |
| Chemical Composition | Standard for implantable tricalcium phosphate | "The material chemical composition also satisfies an ASTM standard for implantable tricalcium phosphate." |
| Similar Intended Use | Similar to predicate device | "nearly identical in intended use" to the predicate device. |
| Similar Materials | Similar to predicate device | "equivalent in materials" to the predicate device. |
| Similar Configuration | Similar to predicate device | "equivalent in... configuration" to the predicate device. |
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.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.