(66 days)
CAMCERAM TCP is a bone void filler is a resorbable implant intended to fill bony void 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.
CAMCERAM TCP is a porous calcium phosphate resorbable bone void filler for the repair of bony defects. The product comprises of a beta-Tricalcium Phosphate and is 90% porous. The product is provided sterile available in granules 1-4 mm and a block form.
The provided text is a 510(k) summary for CAMCERAM TCP, a bone void filler. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria.
Instead, the document focuses on demonstrating substantial equivalence through:
- Physico-chemical testing: Confirmed composition and resorption profile.
- Safety and biocompatibility testing: As per general calcium phosphate products.
- Compliance with recognized standards: ASTM F1088.
- Long history of safe clinical use: For the predicate devices.
Therefore, I cannot fulfill all parts of your request as the information about acceptance criteria and a study proving device performance is not present in the provided text.
Here's a breakdown of what can be extracted based on your request, with "N/A" for information not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition: Conformance to Beta-Tricalcium Phosphate composition | CAMCERAM TCP comprised of beta-Tricalcium Phosphate (90% porous) and confirmed by physico-chemical testing to meet composition. |
| Resorption Profile: Similar to predicate devices | Confirmed by physico-chemical testing to have a similar resorption profile to predicate devices. |
| Safety & Biocompatibility: Meets standards for calcium phosphates | Safety and biocompatibility testing performed for calcium phosphates. |
| Standard Compliance: Conforms to ASTM F1088 | Tested to conform to ASTM F1088 "Standard Specification for Composition of Beta-Tricalcium Phosphate for surgical Implantation." |
| Clinical Equivalence: Safe use | Predicate devices (Vitoss scaffold, Conduit TCP) have been used safely for many years in the clinical environment, supporting the safe use of CAMCERAM TCP due to substantial equivalence. |
| Intended Use Equivalence: | Intended use matches predicate devices (filling bony voids in extremities, spine, and pelvis not intrinsic to stability). |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: N/A (No specific "test set" in the context of clinical performance data is mentioned. The testing mentioned refers to physico-chemical and standard compliance.)
- Data Provenance: N/A (The document refers to physico-chemical tests and standard compliance, not specific clinical data with provenance.)
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- N/A (No ground truth established by experts for a test set is mentioned in the context of clinical performance.)
4. Adjudication Method for the Test Set
- N/A (No adjudication method is mentioned.)
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- N/A (No MRMC study is mentioned. This device is a material, not an AI-assisted diagnostic tool for human readers.)
6. If a Standalone (algorithm only without human-in-the loop performance) Study was done
- N/A (This device is a material, not an algorithm.)
7. The Type of Ground Truth Used
- Ground Truth for device characteristics: Based on recognized standards (ASTM F1088) and physico-chemical laboratory testing to confirm composition and resorption profile.
- Ground Truth for safety: Long history of safe clinical use of predicate devices and general knowledge/testing for calcium phosphates.
8. The Sample Size for the Training Set
- N/A (This device is a material, not an AI model, so there is no training set in the typical AI sense.)
9. How the Ground Truth for the Training Set was Established
- N/A (No training set for an AI model is mentioned.)
§ 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.