Search Results

OsteoGraf/N-700 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, filling of extraction sites, and sinus elevation grafting.

The OsteoGraf/N-700 material is a high purity, high density, nonresorbable, radiopaque, polycrystalline particulate form of hydroxylapatite, the major mineral phase of bone and dental enamel.

The provided text is a 510(k) summary for a medical device called OsteoGraf/N-700, a bone grafting material. This document outlines the device's characteristics, intended use, and its substantial equivalence to previously marketed predicate devices.

However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically understood for performance claims based on clinical or technical parameters. Instead, the summary focuses on substantial equivalence to predicate devices. This means that for this particular device (a bone grafting material), the FDA clearance is based on its similarity to existing, legally marketed devices, rather than a new performance study against specific acceptance criteria.

Therefore, many of the requested sections regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be answered from the provided text.

Here's a breakdown of what can be extracted or inferred based on the document's nature:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as specific performance metrics (e.g., success rate in bone regeneration studies). The primary "acceptance criterion" for this 510(k) is substantial equivalence to predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
   • Reported Device Performance: The document states: "We believe that the prior use of the components of OsteoGraf/N-700 in legally marketed devices, the performance data provided, and biocompatibility support the safety and effectiveness of OsteoGraf/N-700 for the indicated uses." The "performance data provided" is not detailed in this summary.

2. Sample size used for the test set and the data provenance: Not applicable. There's no mention of a "test set" in the context of a performance study with a sample size. The "performance data" mentioned is not described in detail.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no test set or ground truth established by experts mentioned in the document for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 device is a bone grafting material, not an AI-powered 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 or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated. The basis for safety and effectiveness is largely based on the prior use of its components and its similarity to predicate devices already cleared for market. Any "performance data" referred to is not detailed enough to determine the type of ground truth.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary based on available information:

• Same intended use
• Similar technological characteristics
• No new questions of safety or effectiveness. The document also mentions "conforms to applicable industry standards" and that "biocompatibility testing was not necessary" due to prior use of components. |
  | Reported Device Performance | The device's "performance data" (not detailed in this summary) and biocompatibility, supported by the prior use of its components, are stated to support its safety and effectiveness for indicated uses. |
  | Study Type to Meet Acceptance Criteria | The clearance is based on a 510(k) Substantial Equivalence Determination, not a de novo performance study against specific, quantified acceptance criteria for novel claims. |
  | Sample Size (Test Set) | Not applicable; no specific performance test set or sample size mentioned. |
  | Data Provenance (Test Set) | Not applicable. |
  | Number of Experts / Qualifications (Test Set GT) | Not applicable. |
  | Adjudication Method (Test Set) | Not applicable. |
  | MRMC Comparative Effectiveness Study | No. This is not an AI/diagnostic device. |
  | Standalone Performance Study (Algorithm Only) | No. This is not an algorithm/AI device. |
  | Type of Ground Truth Used (for performance evaluation, if applicable) | Not explicitly stated in this summary. The safety and effectiveness are supported by the known characteristics and prior use of the materials. |
  | Sample Size (Training Set) | Not applicable; this is not an AI/ML device. |
  | How Ground Truth for Training Set was Established | Not applicable. |

In conclusion, the K072058 submission for OsteoGraf/N-700 relies on demonstrating substantial equivalence to already cleared predicate devices, rather than presenting a performance study against specific acceptance criteria like those expected for novel technologies or AI/ML-based devices. The "performance data" mentioned is not detailed in this summary.

Ask a specific question about this device

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