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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 collagen matrix, conformable and resorbable, 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. Sizes available include the following:
Dental Sponges: 3.6cm x 1.8cm, 2.5cm x 2.5cm and 2.5cm x 5cm
Dental Cone: Height-17mm Ø Top - 10mm Ø Bottom - 14mm

This document is a 510(k) Pre-market Notification for Collacare Dental, a collagen dental matrix. It's a regulatory submission to the FDA, not a study report with acceptance criteria and performance metrics in the typical sense for an AI/CADe device.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present and not applicable to this type of document.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through a comparison of features and a summary of performance testing related to biocompatibility and viral reduction. It doesn't report on specific clinical performance metrics (e.g., sensitivity, specificity, accuracy) of the device in treating oral wounds or sores, as it's a medical device composed of material rather than a diagnostic algorithm.

Here's a breakdown based on the provided document, addressing what is present and what is not applicable:

1. Table of acceptance criteria and the reported device performance

This document does not define specific quantitative "acceptance criteria" for clinical performance (e.g., statistical thresholds for wound healing rates, reduction in pain, etc.) nor does it report on such device performance. Instead, the "acceptance criteria" for this 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices.

The reported "performance" is more about the device's characteristics and safety aspects, rather than clinical efficacy metrics:

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

• Not Applicable. This document is a 510(k) for a medical device (collagen matrix), not an AI/CADe device. There is no "test set" in the context of diagnostic performance evaluation. The "testing" mentioned is laboratory-based (biocompatibility, viral inactivation) on the device material itself, not human subjects data.

3. 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)

• Not Applicable. See point 2.

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

• Not Applicable. See point 2.

5. 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

• Not Applicable. This is not an AI/CADe device, so MRMC studies are not relevant.

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

• Not Applicable. This is not an AI/CADe device.

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

• Not Applicable. For the biocompatibility and viral reduction tests, the "ground truth" would be established by validated laboratory assays and recognized safety standards for those specific tests, rather than clinical consensus or pathology.

8. The sample size for the training set

• Not Applicable. This is a medical device, not an AI model, so there is no training set.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

Summary of the Study (as described in the document):

The "study" in this context is a series of laboratory-based tests to demonstrate the safety and material properties of the Collacare Dental device, primarily by showing it is substantially equivalent to existing, legally marketed predicate devices.

• Biocompatibility Testing: Included cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogenicity. The conclusion was that there were no new biocompatibility issues compared to the predicate device (Collacare Dental K110388).
• Collagen Type and Purity Evaluation: Conducted to ensure no denaturing occurred during the manufacturing process.
• Viral Reduction Assessments: Performed to demonstrate viral deactivation within an acceptable safety range.

The purpose of these tests was to support the claim of substantial equivalence to predicate devices, thereby meeting the regulatory requirements for premarket notification as defined in CFR21, Part 807. The FDA acknowledged this in the letter dated May 1, 2014, stating that the device is "substantially equivalent."

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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:

1. 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)."
2. Intended Use: The intended uses for Collacare Dental are listed and are presumed to be similar to the predicate devices.
3. 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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