ENDOBON XENOGRAFT GRANULES by BIOMET 3I

Endobon Xenograft Granules consist of bovine derived hydroxyapatite ceramic granules. Endobon - hydroxyapatite xenograft granules are derived from cancellous bovine bone that are used as an implantable material to function as a non-resorbable osteoconductive scaffold for dental applications. A two-step, high-temperature manufacturing process (pyrolysis at a temperature above 900 ℃ and sintering at a temperature above 1200ºC) allows complete deproteinization as well as destruction of potential residual bacteria, virus and prions. The slow resorption rate attributed to Endobon and other similar materials processed in the same manner relates to the crystalline-like structure of 95% of the hydroxyapatite (HA) in Endobon. The resorption rate of hydroxyapatite (HA) increases as crystallinity decreases, and the crystallinity is highly dependent on the sintering temperature. High sintering increase in crystallinity. The precise chemical name of the hydroxyapatite is pentacalcium hydroxide (tris) phosphate [Ca5 (PO4)3 OH].

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for a medical device called "Endobon Xenograft Granules". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria as might be seen for novel devices or PMAs.

Therefore, the document does not contain all the information requested about acceptance criteria and a study proving device performance in the typical sense of a clinical trial. Instead, it focuses on demonstrating equivalence through comparison to an existing device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is not applicable in the traditional sense for a 510(k) submission focused on substantial equivalence. The "acceptance criteria" here relate to demonstrating that the new device (Endobon Xenograft Granules) is as safe and effective as the predicate device (BioOss).

The document states:

"Endobon Xenograft Granules has the same intended use and, physiochemical properties as BioOss."
"Any differences in material, chemical composition, or physical structure, do not raise any new questions of safety or effectiveness."
"Extensive equivalency assessments demonstrates that Endobon Xenograft Granules is as safe and effective as BioOss."

Therefore, the "acceptance criteria" implicitly are that the new device's properties and performance are comparable to the predicate device to the extent that no new questions of safety or effectiveness are raised. The "reported device performance" is that it meets this equivalency.

A table of chemical composition is provided comparing Endobon and Bio-Oss, which serves as part of the "reported device performance" for demonstrating physicochemical similarity:

	Ca		P		Na		Si		Mg		Cl
	Wt %	At %	Wt %	At %	Wt %	At %	Wt %	At %	Wt %	At %	Wt %	At %
Endobon	68.2	61.3	26.4	30.6	1.6	2.5	0.6	0.7	3.3	4.9	0	0
Bio-Oss	64.4	59.3	27.2	31.4	2.9	4.5	1.6	2.0	1.6	2.4	0.4	0.4

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states "Nonclinical Performance Data: N/A" and "Clinical Data: N/A". This indicates that no specific new test set or clinical study was conducted for this 510(k) submission. The assessment relies on comparison to the predicate device and potentially prior literature, as mentioned in the conclusion "literature review and equivalency assessment".

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. As no new test set or clinical data was generated, there was no need for experts to establish ground truth in the context of this submission. The chemical comparison data is from a published study (Jensen et al. 1996).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new test set requiring adjudication was used.

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 grafting material, not an AI software. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a bone grafting material, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is based on the established safety and effectiveness of the predicate device (BioOss), which is legally marketed. The submission aims to demonstrate that Endobon Xenograft Granules are sufficiently similar to BioOss to infer the same safety and effectiveness. The chemical composition data from Jensen et al. 1996 provides empirical evidence for this similarity.

8. The sample size for the training set

Not applicable. No training set was used as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

Regulation Number and Section

§ 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.