K Number
K960353
Manufacturer
Date Cleared
1996-04-18

(84 days)

Product Code
Regulation Number
872.3930
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

for the filling of periodontal defects and augmentation of bony defects of the alveolar ridge, including tooth extraction sites.

Device Description

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

AI/ML Overview

The provided text describes a medical device called OsteoGraf/LD-300, a hydroxylapatite material intended for bone filling and augmentation. However, the document is a 510(k) summary from 1996 for premarket notification, which focuses on device description, intended use, and comparison to predicate devices to establish substantial equivalence.

Crucially, this document does not contain information about acceptance criteria for device performance in a clinical study, nor does it describe a study proving the device meets such criteria in terms of diagnostic or clinical efficacy.

Instead, the document focuses on:

  • Material composition: "100% anorganic hydroxylapatite, Ca1o(PO4),OH2."
  • Material properties: "X-ray diffraction and infrared analysis (FTIR) show OsteoGraf/LD-300 to be 100% hydroxylapatite."
  • Compliance with standards: "OsteoGraf/LD-300 conforms to the requirements of ASTM standard #F1185, 'Composition of Ceramic Hydroxylapatite for Surgical Implants.'"
  • Physical form: "manufactured as rounded, irregular shaped synthetic hydroxylapatite particles, sized at 250-420 microns."

These are specifications and characterizations of the material itself, not performance metrics derived from a clinical efficacy study with acceptance criteria.

Therefore, I cannot provide the requested information for acceptance criteria and study details because the provided text does not contain them. The 510(k) summary is for a material device, not a diagnostic or AI device that would typically have acceptance criteria related to accuracy, sensitivity, or specificity in a performance study with a test set, ground truth, and expert adjudication.

§ 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.