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OsteoGraf/LD-300 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filling of extraction sites.

The OsteoGraf/LD-300 material is a high purity, high density, nonresorbable, radiopaque, polycrystalline particulate form of hydroxylapatite, the major mineral phase of bone and dental enamel.

This 510(k) summary (K072057) is for a medical device called OsteoGraf/LD-300, which is a bone grafting material. The provided document does not contain the specific information required to complete the table and answer all questions regarding acceptance criteria and a study proving device performance as it pertains to AI/ML device evaluation.

Here's a breakdown of why and what information can be extracted:

Reasoning for missing information:

• Type of Device: OsteoGraf/LD-300 is a physical bone grafting material, not an AI/ML powered device, an imaging device, or a diagnostic tool that would typically have performance metrics like sensitivity, specificity, or AUC based on algorithmic output.
• 510(k) Summary Nature: A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics, intended use, and sometimes bench/animal testing or clinical data for safety and efficacy. It rarely includes detailed algorithmic performance metrics, ground truth establishment for AI, or MRMC studies.
• Date: This 510(k) is from 2007, a period before AI/ML in medical devices was prevalent and before specific FDA guidance for AI/ML device evaluation was established.

Information that can be extracted or inferred from the document:

Since this device is not an AI/ML device, the requested tabular format for AI/ML performance metrics and many of the specific questions are not applicable. However, I can still provide relevant information from the document in the context of device acceptance.

Device Acceptance (Based on 510(k) Summary Principles for Non-AI/ML Devices):

For a traditional device like OsteoGraf/LD-300, acceptance criteria and proof of meeting them are primarily demonstrated through:

1. Substantial Equivalence: The primary means of "acceptance" in a 510(k) is demonstrating that the new device is substantially equivalent to a legally marketed predicate device. This involves comparing intended use, technological characteristics, and performance data (if applicable for non-clinical studies) to show that it is as safe and effective.
2. Safety and Effectiveness: Performance data usually refers to non-clinical testing (e.g., biocompatibility) and, in some cases, clinical data if necessary to address new questions of safety or effectiveness not raised by the predicate.

Analysis of the Provided Text (K072057):

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria (Inferred from 510(k) Process)	Reported Device Performance (Summary in K072057)
   Substantial Equivalence to Predicate Devices	The device is deemed substantially equivalent to predicate devices OsteoGraf/LD-300 (K960353, K942212). This is the core "acceptance criterion" for a 510(k).
   Safety & Effectiveness (via predicate model)	"We believe that the prior use of the components of OsteoGraf/LD-300 in legally marketed devices, the performance data provided, and biocompatibility support the safety and effectiveness of OsteoGraf/LD-300 for the indicated uses."
   Biocompatibility	"The modifications made to the legally marketed device do not affect biocompatibility. Therefore, it was determined that biocompatibility testing was not necessary." (Implies previous biocompatibility for predicate was acceptable and modifications didn't change this).
   Conformity to Industry Standards	"OsteoGraf/LD-300 conforms to applicable industry standards."
   Intended Use	Treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filling of extraction sites. (Same as predicate devices).
   Technological Characteristics	High purity, high density, nonresorbable, radiopaque, polycrystalline particulate form of hydroxylapatite. Components used in legally marketed devices.

2. Sample size used for the test set and the data provenance: Not applicable. This is a material, not an AI/ML algorithm or a diagnostic test with a test set of data. The "performance data provided" mentioned likely refers to non-clinical data or general accumulated knowledge/literature supporting the material's properties or clinical use, not a specific "test set" in the context of AI/ML validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of "ground truth" establishment in the context of expert review for data labeling, as this is not an AI/ML device.

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 material, not designed to assist human readers or interpreted with AI.

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 (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML context. For a material like this, "ground truth" regarding its effectiveness would typically come from clinical outcomes data from studies (for PMA devices or some clinical studies supporting 510k) or established scientific understanding of the material's properties and clinical performance (for 510k based on substantial equivalence). The statement "prior use of the components... in legally marketed devices" and "performance data provided" serves as the basis for claiming safety and effectiveness by substantial equivalence.

8. The sample size for the training set: Not applicable. This is a material device.

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

Summary:

The provided 510(k) clearance document for OsteoGraf/LD-300 (K072057) is for a traditional bone grafting material, not an AI/ML-powered medical device. Therefore, the questions related to AI/ML specific performance metrics, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable to this device or its clearance pathway. The acceptance criteria for this device were primarily based on its substantial equivalence to existing predicate devices regarding intended use, technological characteristics, and safety and effectiveness, supported by the known properties of its components and existing performance data (likely non-clinical or historical clinical evidence from its predicate).

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

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.

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.

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