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The intended use of OsteoGraf/N-300 is for:

• Treatment of infrabony periodontal defects. .
• Augmentation of bony defects of the alveolar ridge. ●
• Filling of extraction sites.
• Sinus elevation grafting ●

OsteoGraf/N-300 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite. the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 250-420 microns.

The provided 510(k) summary for OsteoGraf/N-300 does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

The document is a premarket notification for a medical device submitted to the FDA. It primarily focuses on:

• Device identification: Submitter, device name, classification, and predicate device.
• Device description: Composition, size, and nature of OsteoGraf/N-300.
• Intended Use: Specific dental and oral surgery applications.
• Comparison to predicate device: Stating that OsteoGraf/N-300 is 100% anorganic hydroxylapatite, its chemical composition, and conformance to ASTM standards.
• FDA determination: A letter from the FDA stating that the device is substantially equivalent to a previously marketed device, allowing it to be marketed.

This type of submission, especially for a device from 1998, often relies on a demonstration of substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria. The equivalence argument is made based on material composition and intended use.

Therefore, I cannot populate the requested table or answer most of the questions because the necessary information is not present in the provided text.

Here's a breakdown of what cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample size used for the test set and the data provenance: Not present; no test set or study data described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present; no ground truth or expert panel described for a study.
4. Adjudication method: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device is a bone-grafting material, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present; no training set described.
9. How the ground truth for the training set was established: Not present.

The 510(k) summary provided is not a clinical study report and thus does not contain the detailed performance data, patient cohort information, or expert evaluation methods that would be required to answer these questions.

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The intended use of OsteoGraf/N-700 is for:

• Treatment of infrabony periodontal defects.
• Augmentation of bony defects of the alveolar ridge.
• Filling of extraction sites.
• Sinus elevation grafting.

OsteoGraf/N-700 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 420-1000 microns.

This 510(k) summary describes a medical device called OsteoGraf/N-700, which is a hydroxylapatite material intended for various dental and orthopedic bone-filling applications. The summary primarily focuses on characterizing the device and establishing its substantial equivalence to a predicate device (Bio-Oss).

The provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets and data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is a regulatory submission (510(k) summary) focused on device description, intended use, and comparison to a predicate device to demonstrate substantial equivalence, not on specific performance studies with acceptance criteria as typically seen for diagnostic or AI-driven devices.

Ask a specific question about this device