(83 days)
FRIOS® ALGIPORE® is indicated for:
- Treatment of intrabony defects .
- Augmentation of bony defects of alveolar ridge .
- Filling of extraction sites ●
- Sinus elevation grafting .
FRIOS® ALGIPORE® is a bone filling and augmentation material indicated for use in dental applications. FRIOS® ALGIPORE® is an inorganic, biocompatible calcium phosphate material derived from calcium-encrusted sea algae. The algae are processed in order to develop an apatite material that is analogous to bone apatite. FRIOS® ALGIPORE® is provided sterile in pre-filled vials and has a granular size range from 300 - 2000 microns.
The provided text describes a 510(k) submission for a medical device called FRIOS® ALGIPORE®, a bone filling and augmentation material. The submission aims to demonstrate substantial equivalence to predicate devices, not to meet specific performance acceptance criteria through a clinical study with defined endpoints. Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them cannot be directly extracted from this document, as it's not a performance study report in the typical sense.
However, I can extract information related to the demonstration of equivalence, which is the basis of this 510(k) submission.
Here's a breakdown based on the provided text, addressing the points where information is available or noting its absence:
1. A table of acceptance criteria and the reported device performance
This document does not present specific acceptance criteria in numerical values for performance endpoints that would typically be found in a clinical study report (e.g., success rates, complication rates). Instead, the acceptance criterion for a 510(k) is substantial equivalence to legally marketed predicate devices.
| Acceptance Criterion (for 510(k) Equivalence) | Reported Device Performance/Comparison (FRIOS® ALGIPORE®) |
|---|---|
| Material Composition Equivalence | Equivalent to Interpore® 200 (predicate device) based on ICP-AES and X-Ray Diffraction. Meets ASTM standard specifications for Hydroxylapatite (surgical implants). |
| Chemical Analysis Equivalence | Equivalent to Interpore® 200 (predicate device) based on ICP-AES. Meets ASTM standard specifications for Hydroxylapatite (surgical implants). |
| Mineralogical Composition Equivalence | Equivalent to Interpore® 200 (predicate device) based on X-Ray Diffraction. Meets ASTM standard specifications for Hydroxylapatite (surgical implants). |
| Functionality Equivalence | Substantially equivalent to Interpore® 200 Granular Coralline Hydroxylapatite and CeraMed Dental OsteoGraf® / N-700. |
| Intended Use Equivalence | Substantially equivalent to predicate devices for dental applications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this document. The "test set" here refers to the comparative analytical testing conducted on the material itself, not a clinical study on patients. The document does not specify the number of samples of the material used for ICP-AES and X-Ray Diffraction tests.
- Data Provenance: The analytical comparison testing was performed for the purpose of this submission by FRIADENT GmbH, whose address is in Mannheim D-68229, Germany. The type of data is laboratory comparison testing of material properties, not clinical patient data. Therefore, terms like retrospective or prospective do not apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The "ground truth" for material equivalence was established through objective analytical methods (ICP-AES and X-Ray Diffraction) and comparison to established ASTM standards for Hydroxylapatite, not through expert consensus on clinical outcomes or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for clinical studies or image interpretation by multiple experts. The evaluation of material properties (chemical and mineralogical composition) is determined by analytical instruments and standard comparisons, not expert adjudication.
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 filling and augmentation material, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed or is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a material device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for establishing equivalence was based on analytical laboratory measurements (Inductively Coupled Argon Plasma Atomic Emission Spectroscopy (ICP-AES) and X-Ray Diffraction) compared against ASTM standard specifications for the composition of Hydroxylapatite for surgical implants, and comparison to the known composition and intended use of legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. There is no AI algorithm being trained. The reference to "training set" is irrelevant in this context.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for an AI algorithm.
§ 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.