(208 days)
HEALOS Dental Bone Graft Substitute is intended to fill, augment, or reconstruct periodontal and/or bony defects of the upper or lower jaw. HEALOS is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.
HEALOS Dental Bone Graft Substitute is a mineralized collagen matrix processed into lyophilized strips or pads for surgical implantation. The principal components of the HEALOS Dental Bone Graft Substitute are Type I bovine collagen and hydrox yapatite. HEALOS Dental Bone Graft Substitute is approximately 30% mineral by weight. The subject of this 510(k) is to add additional size configurations. The formulation is identical to the predicate device- HEALOS Dental Bone Graft Substitute. There are no changes to the material, chemical composition, physical structure, or indications for use of the product.
Here's the analysis of the provided information regarding the acceptance criteria and study for the HEALOS Dental Bone Graft Substitute:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No Pre-established Performance Standards | The submission explicitly states: "No performance standards have been established for this type of device." |
| Substantial Equivalence to Predicate Device | "Preclinical testing has been completed to verify the subject device has the same characteristics as the predicate device." |
| "Based on the predicate comparison and testing, the subject device HEALOS Dental Bone Graft Substitute is substantially equivalent to the predicate device." | |
| The FDA's letter confirms: "We have determined the device is substantially equivalent... to legally marketed predicate devices." | |
| Identical Formulation to Predicate | The device description states: "The formulation is identical to the predicate device- HEALOS Dental Bone Graft Substitute." |
| No Changes to Material, Chemical Composition, Physical Structure, or Indications for Use (compared to predicate) | The device description states: "There are no changes to the material, chemical composition, physical structure, or indications for use of the product." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission mentions "Preclinical testing," but no details on the sample size or the nature of the test set (e.g., animal studies, in-vitro tests) are given. Data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Given that the device is a bone graft substitute and the performance evaluation relies on preclinical testing for substantial equivalence, it's unlikely that "experts" in the sense of clinicians establishing ground truth for a diagnostic AI device would be applicable here. The ground truth would likely be based on material science, biological response, or other preclinical endpoints.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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
This is not applicable to this device. This document is for a medical device (bone graft substitute), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance would not have been conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable to this device. As mentioned above, this is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for demonstrating substantial equivalence appears to be based on direct comparison of characteristics and performance to the predicate device. This would likely involve:
- Material composition analysis: Ensuring identical components (Type I bovine collagen and hydroxyapatite) and ratios.
- Physical and chemical property testing: Confirming that the subject device's physical (e.g., structure, porosity) and chemical characteristics match the predicate.
- Biocompatibility and resorption studies (preclinical): Demonstrating similar biological interactions and degradation profiles to the predicate in relevant models.
- Mechanical property testing: If applicable to the scaffold's function, ensuring similar structural integrity.
The document states: "Preclinical testing has been completed to verify the subject device has the same characteristics as the predicate device." The "truth" is established by showing that the new device is functionally and compositionally the 'same' as the already approved predicate.
8. The Sample Size for the Training Set
This information is not provided and is not applicable as this is not an AI/ML device that requires training data in the traditional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable as this is not an AI/ML device.
§ 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.