(180 days)
Collacare Dental is indicated for the management of oral wounds and sores, including:
- denture sores
- oral ulcers (non-infected or viral)
- periodontal surgical wounds
- suture sites
- burns
- surgical wounds and traumatic wounds
Collacare Dental is a conformable collagen matrix manufactured from purified type I collagen derived from bovine Achilles tendon. Collacare Dental is supplied sterile and non-pyrogenic, in various sizes, and for single use only.
The provided text discusses the Collacare Dental device, its intended use, and its substantial equivalence to predicate devices, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) Summary for a medical device submitted to the FDA. The purpose of a 510(k) submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against specific acceptance criteria through a dedicated study.
Here's a breakdown of what is and isn't present in relation to your request:
Information NOT present in the document:
- Acceptance Criteria for Device Performance: The document does not define any specific performance metrics (e.g., sensitivity, specificity, accuracy, healing rates, etc.) with corresponding acceptance thresholds.
- Study Proving Acceptance Criteria: There is no description of a study designed to test the Collacare Dental device against performance acceptance criteria.
- Reported Device Performance: Since there are no acceptance criteria or a study, there's no reported performance data against such metrics.
- Sample Size for Test Set: No test set is mentioned, thus no sample size.
- Data Provenance: No data from specific tests are presented.
- Number of Experts/Qualifications for Ground Truth: Not applicable as there's no performance study described.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned or referenced.
- Standalone Performance Study: No standalone performance study details are provided.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable.
- Ground Truth Establishment for Training Set: Not applicable.
What the document does describe instead of a performance study against acceptance criteria:
The document focuses on demonstrating Substantial Equivalence based on:
- Materials of Construction: It explicitly states, "Collacare Dental is substantially equivalent in materials of construction to Collagen Sponge (K092805), Collagen Wound dressing - Oral (K040403), Salicept Oral Patch (K012126)..." and later, "...the materials of construction and finished product material match that of Collagen Sponge (K092805)."
- Intended Use: The intended uses for Collacare Dental are listed and are presumed to be similar to the predicate devices.
- Biocompatibility: It states, "There are no new biocompatibility issues arising with the use of Collacare Dental as the materials of construction and finished product material match that of Collagen Sponge (K092805). A complete biocompatibility evaluation was undertaken in line with the requirements of ISO 10993-1." This implies a biocompatibility assessment was done, but it's not a performance study of the device's efficacy against specific clinical outcomes.
Conclusion:
Based on the provided text, the device Collacare Dental gained market clearance through substantial equivalence to existing predicate devices, primarily by demonstrating similar materials of construction, intended use, and a satisfactory biocompatibility assessment. The document does not describe specific performance acceptance criteria or a study designed to prove the device meets such criteria through quantitative performance metrics.
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