OSTEOGRAF/N-300

• K Number: K981182
• Device Name: OSTEOGRAF/N-300
• Manufacturer: CERAMED DENTAL, LLC.
• Date Cleared: 1998-07-02 ( 92 days)
• Product Code: LYC
• Regulation Number: 872.3930
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

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 ●

Device Description

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.

AI/ML Overview

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.

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.