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Bii-GRAFT™ 6140 Bioresorbable Calcium Particles are an osteoconductive biomatrix that approximates the chemical constituent of natural bone. The physical form of the material is particulate particles in the range of 105-250u. The nominal composition is 75 percent HA.
The provided text is a pre-market notification (K960164) for a medical device called Bii-GRAFT™ Bioresorbable Calcium Phosphate Particulate material. This document focuses on demonstrating the substantial equivalence of Bii-GRAFT™ to existing devices and its safety and effectiveness based on a review of prior knowledge, rather than presenting a novel clinical study with clear acceptance criteria for a new device's performance.
Therefore, many of the requested elements (like details about a specific test set, ground truth experts, MRMC studies, or standalone algorithm performance) are not applicable to the information provided in this document.
Here's an analysis based on the available text:
Acceptance Criteria and Device Performance
The "acceptance criteria" for Bii-GRAFT™ in this submission are primarily focused on demonstrating substantial equivalence to existing, predicate devices and adherence to established material specifications. The "performance" is inferred from the established biocompatibility and efficacy of similar calcium phosphate materials.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance (Bii-GRAFT™) |
|---|---|---|
| Material Composition & Structure | Substantial Equivalence: Similar chemical constituent to natural bone. | "Bii-GRAFT™ 6140 is an osteoconductive biomatrix that approximates the chemical constituent of natural bone." |
| Physical Form: Particulate particles in a specified size range. | "The physical form of the material is particulate particles in the range of 105-250u." | |
| Nominal Composition: Specified percentage of HA. | "The nominal composition is 75 percent HA." | |
| Chemical Purity & Specifications | Trace Elements & HA/TCP Content: Meets or exceeds ASTM F-1185 (Ceramic Hydroxylapatite) and F-1088 (Tricalcium Phosphate) specifications for surgical implants. | "Bil-GRAFT™ meets or exceeds specifications for trace elements and HA/TCP content (chemistry), as specified in ASTM F-1185 and F-1088, the Standard Specifications of Ceramic Hydroxylapatite and Tricalcium Phosphate for Surgical Implants." and "Trace element analysis of Bii-GRAFT™ indicates that the material is at or below the limits established in ASTM F-1088 and F-1185 for TCP and HA, respectively." |
| Biocompatibility & Efficacy (Inferred) | Biocompatibility: Well-established profile based on clinical experience of calcium phosphate materials. | "The calcium phosphate materials have a well-established biocompatibility profile, based on many years of clinical experience." (Implied for Bii-GRAFT™ through substantial equivalence) |
| Ability to support bone adaptation: Supported by preclinical studies and clinical usage of similar materials in the size range. | "The ability of calcium phosphate biomaterials in the size range of Bii-GRAFT™ to support bone adaptation is supported by many years of preclinical studies and clinical usage..." (Implied for Bii-GRAFT™ through substantial equivalence) | |
| Efficacy as synthetic bone graft substitute: Indicated by clinical results on similar materials, when used as per guidelines. | "A review of available clinical results on similar materials indicate efficacy as a synthetic bone graft substitute material, when used in accordance with the guidelines provided in the Instructions for Use." (Implied for Bii-GRAFT™). "We have concluded that the Bli-GRAFT™ Bioresorbable Calcium Phosphate Particles are substantially equivalent to the referenced devices and are safe and effective for their stated uses." | |
| Sterilization Impact | No significant effect on material: Sterilization or re-sterilization methods indicated should not alter the material's properties. | "That sterilization or re-sterilization using the methods and cycles indicated have no significant effect on the material." |
| Safety Profile (Known Complications) | Anticipation of adverse conditions: A reasonable attempt has been made to identify potential risks. | "A reasonable attempt has been made to anticipate adverse safety and effectiveness conditions for the submitted device." (Followed by a list of potential complications like migration, infection, inflammation, etc., which are common to this class of implant materials, and attributed potentially to user error if instructions are not followed). |
| Substantial Equivalence to Predicate Devices | Equivalence to Allogeneic Freeze-Dried Bone, Bii-GRAFT™ 1860, Osteograf-LD™: Demonstrated through chemical and physical characteristics and literature review. | "Bil-GRAFT™ 6140 Bioresorbable Calcium Particles are substantially equivalent to allogeneic freeze-dried bone, Bii-GRAFT™ 1860, Osteograf-LD™ synthetic materials. The determination of equivalence has also been based on the chemical and physical characteristics of Bii-GRAFT™" and "Bio-Interfaces. Inc. has conducted a reasonable search of materials research and clinical experience from available published literature and oral communications and presentations at professional forums, as well as private communications with clinicians, regarding the performance of bioresorbable calcium phosphate bone graft substitute materials." |
Further Details (Not Applicable or Inferred from the Provided Text)
The document is a "Pre-Market Notification" for a 510(k) submission, whose primary goal is to establish substantial equivalence to a legally marketed predicate device, rather than to conduct a de novo clinical study with a novel endpoint requiring the type of detailed information requested.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable in the context of a de novo clinical trial. The "test set" here refers to the body of historical data, published literature, and in-vitro testing.
- Provenance: This is derived from "available published literature and oral communications and presentations at professional forums, as well as private communications with clinicians." This suggests a global review of existing knowledge, not a specific, controlled clinical study.
- In-vitro characteristics: Were performed by Bio-Interfaces, Inc. as stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable for establishing a "ground truth" in a clinical trial sense. The "experts" are the authors of the "available published literature," the "clinicians" mentioned in "private communications," and those presenting at "professional forums." Their specific number and detailed qualifications are not enumerated, but they collectively represent the established medical and scientific community's understanding of calcium phosphate materials.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- Not applicable. There was no formal adjudication process for a specific test set of cases as would be done in a clinical trial. The "adjudication" was effectively a literature review and synthesis of existing knowledge by Bio-Interfaces, Inc.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a biomaterial, not an AI-powered diagnostic or assistive tool. There are no "human readers" in the context of AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a biomaterial, not an algorithm.
7. The Type of Ground Truth Used:
- Ground Truth (for material properties): Established by in-vitro characteristics against recognized industry standards (ASTM F-1185 and F-1088 for ceramic hydroxylapatite and tricalcium phosphate).
- Ground Truth (for biocompatibility/efficacy): Established by the "well-established biocompatibility profile" and "many years of preclinical studies and clinical usage" of calcium phosphate materials, as documented in published literature and clinical experience for similar materials. This is effectively expert consensus derived from historical data and clinical outcomes of similar devices.
8. The Sample Size for the Training Set:
- Not applicable in the context of a new device clinical trial. There isn't a "training set" for the Bii-GRAFT™ device itself in the sense of a machine learning model or a de novo clinical study cohort. The "training" for establishing equivalence comes from the vast body of existing scientific literature and clinical experience with calcium phosphate biomaterials.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable in the context of a new device clinical trial. The "ground truth" for the understanding of calcium phosphate materials has been established over many years through scientific research, preclinical testing, clinical trials, and clinical usage of similar materials, which inform the ASTM standards and the general acceptance of these materials in medical practice.
§ 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.