(100 days)
HEALOS Bone Graft Material ("HEALOS") is intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.
HEALOS is a mineralized collagen matrix processed into lyophilized strips or pads for surgical implantation. The principal components of the HEALOS Bone Graft Substitute are Type I bovine collagen and hydroxyapatite. HEALOS is approximately 30% mineral by weight.
Here's an analysis of the provided text regarding the acceptance criteria and study for the HEALOS Bone Graft Substitute:
Based on the provided text for K081432, there is no specific performance data or a study described that establishes and meets acceptance criteria in the traditional sense of a clinical or analytical performance study with metrics like sensitivity, specificity, or accuracy. This submission falls under the category of a 510(k) "Substantial Equivalence" determination, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.
The key statement is found under "Performance Data": "No performance standards have been established for this type of device." This indicates that the regulatory review for this product did not require a formal study with quantified acceptance criteria and measured device performance against those criteria. Instead, the focus was on the material composition and intended use of the device being comparable to existing, legally marketed predicate devices.
Therefore, many of the requested details about acceptance criteria, sample sizes, experts, and ground truth are not applicable or extractable from this specific 510(k) summary.
Here's what can be inferred and explicitly stated from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined for this 510(k) submission. The focus is on substantial equivalence to predicate devices based on material composition and intended use. | No specific quantitative performance metrics (e.g., success rate, healing time, new bone formation percentage) are reported as part of a formal acceptance criteria study within this document. The device description states it "provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process," implying its expected biological function. |
Explanation: The lack of performance standards for this type of device means there weren't pre-defined, measurable acceptance criteria that the sponsor needed to meet through a dedicated performance study for this 510(k). The regulatory approval stemmed from its similarity to predicate devices.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/Not specified in this 510(k) summary. No specific "test set" for a performance study is mentioned.
- Data Provenance: Not applicable/Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No "test set" and associated ground truth establishment by experts are described for this 510(k) submission.
4. Adjudication method for the test set
- Not applicable. No "test set" and associated adjudication method are described for this 510(k) submission.
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
- Was an MRMC study done? No. This device is a bone graft substitute, not an AI software or imaging device that would involve human readers or AI assistance.
- Effect size of human readers with/without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a bone graft substitute, not an algorithm or AI system.
7. The type of ground truth used
- Not applicable. No ground truth is described as having been established for a performance study within this 510(k) summary. The "ground truth" for marketing approval implicitly relies on the established safety and efficacy of the predicate devices and the biological understanding of the materials used (Type I bovine collagen and hydroxyapatite) in bone regeneration.
8. The sample size for the training set
- Not applicable. No "training set" for an algorithm is described.
9. How the ground truth for the training set was established
- Not applicable. No "training set" for an algorithm is described.
Summary of Device and Approval Basis:
The HEALOS Bone Graft Substitute (K081432) is approved based on its substantial equivalence to previously cleared predicate devices (e.g., HEALOS Bone Graft Substitute K012751, K043308, Novabone Putty K051617, etc.). The device's components (Type I bovine collagen and hydroxyapatite) are well-understood biomaterials for bone grafting. The 510(k) summary explicitly states that "No performance standards have been established for this type of device," meaning regulatory approval for this particular product did not rely on a novel performance study proving specific quantitative endpoints. Instead, it relied on the similarity of its materials and intended use to existing, approved devices.
§ 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.