(93 days)
Wishbone HA is intended for the following uses:
· Filling of infrabony periodontal defects;
· Filling of periodontal defects in conjunction with products intended for guided tissue regeneration and guided bone regeneration:
· Filling of defects after root resection, apicectomy and cystectomy;
- · Filling of extraction sockets to enhance preservation of the alveolar ridge;
- · Augmentation or reconstructive treatment of the alveolar ridge;
- · Elevation of the maxillary sinus floor;
· Filling of peri-implant defects in conjunction with products intended for guided bone regeneration.
Wishbone HA is a xenograft biomaterial composed of deproteinized hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw.
Wishbone HA is supplied as a mix of cancellous and cortical particles size 0.25 to 1.0 mm) in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
The device is intended to be used in medical procedures, by a qualified physician (academically trained dentists, periodontists and oral surgeons).
This document is an FDA 510(k) summary for the medical device "Wishbone HA," a bone grafting material. It details the device's characteristics, intended use, and a comparison to a predicate device (Geistlich Bio-Oss), along with performance data to support its substantial equivalence.
Based on the provided text, the document describes performance testing for substantial equivalence of a bone grafting material (Wishbone HA) to a predicate device (Geistlich Bio-Oss). This is not an artificial intelligence (AI) or software-as-a-medical-device (SaMD) study, so many of the requested criteria regarding AI model performance, ground truth, and human reader studies are not applicable.
However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate its equivalence.
Here's a breakdown of the information as it relates to the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with reported performance in a quantitative manner for specific benchmarks. Instead, it describes various tests performed to demonstrate "substantial equivalence" to a predicate device. The general "acceptance criteria" here appear to be demonstrating equivalence across several key characteristics and performance aspects.
| Acceptance Criteria (Implied by Study Type) | Reported Device Performance |
|---|---|
| Chemical Analysis (Composition, Purity) | Confirmed for Wishbone HA |
| Phase Composition Analysis | Confirmed for Wishbone HA |
| Protein and Organic Content Analysis | Confirmed for Wishbone HA (0% organic compounds) |
| Morphology Analysis | Confirmed for Wishbone HA (Mix of cancellous and cortical granules) |
| Porosity Analysis | Confirmed for Wishbone HA |
| pH Analysis | Confirmed for Wishbone HA |
| Dissolution Analysis | Confirmed for Wishbone HA |
| Mechanical Evaluation | Confirmed for Wishbone HA |
| Biocompatibility in accordance with ISO 10993 series | Test results confirmed Wishbone HA is biocompatible for the stated intended use. |
| In-vivo performance (canine mandibular defect model) | Biocompatibility and regeneration showed similar results to defects treated with the predicate device (Bio-Oss®) at 26 weeks. |
| Viral Inactivation | Manufacturing processes capable of achieving at least a 6-log viral reduction of selected model viruses. |
| Sterilization (SAL of 10^-6 via gamma irradiation) | Validation of sterilization dose conducted following VDmax method; conforms to EN ISO 11137 series. |
| Shelf Life (36 months) | Shelf life study supports 36 months; confirmed packaging integrity and sterility. |
| Packaging integrity and sterility (various ASTM/EN ISO standards) | Confirmed (validation studies conform to listed standards). |
2. Sample size used for the test set and the data provenance
- Non-Clinical Bench Testing: The document states "Wishbone HA was the subject of the full range of physical and chemical bench testing characterization tests." It does not specify sample sizes for each test but implies adequate testing for characterization.
- Non-Clinical Animal Performance Testing: "A pre-clinical GLP study was performed in canine mandibular defect model system in Beagle dogs." The exact number of dogs is not specified, but "Beagle dogs" implies a cohort. This is prospective animal data.
- Biocompatibility Testing: "Wishbone HA was the subject of a range of biocompatibility tests in accordance with ISO 10993 series." No specific sample sizes given, but implies standardized testing.
- Viral Inactivation Studies: "The results of the viral inactivation studies showed that the raw material and device manufacturing processes...". No specific sample size is given.
- Sterilization, Packaging, Shelf Life Studies: Validation studies were performed according to specified standards. No explicit sample sizes are provided, but these studies typically involve specific sample numbers defined by the standards.
Data Provenance: The studies were performed to support an FDA 510(k) submission, suggesting they were conducted in a controlled environment (e.g., GLP for animal studies) by the manufacturer or their designated testing facilities. The canine study is "pre-clinical GLP," indicating a controlled, prospective animal study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the document describes the substantial equivalence of a physical medical device (bone graft material), not an AI/SaMD product requiring expert ground truth for classification/detection tasks. The "ground truth" here is the physical and chemical properties and biological performance of the device itself and its comparison to a legally marketed predicate. The experts involved would be laboratory scientists, veterinarians (for animal studies), and potentially pathologists for tissue analysis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 refer to a consensus process among human readers, typically for image interpretation in AI/SaMD studies. This document concerns a physical device and its material properties/biological performance, which are evaluated through scientific measurements and observations, not reader consensus.
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
This section is not applicable. This is not an AI/SaMD product, so no MRMC studies involving human readers and AI assistance were performed or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this medical device is established through:
- Physical and Chemical Bench Testing: Direct measurement of material properties (e.g., chemical composition via analytical techniques, porosity, pH).
- Biocompatibility Testing: In vitro and in vivo tests against established ISO standards.
- Animal Performance Testing (Histopathology/Clinical Observations): Evaluation of tissue response, bone regeneration, and local effects in a canine model, likely through histological analysis and other veterinary assessments, compared to the predicate device.
- Sterilization & Packaging Validation: Conformance to recognized international standards (e.g., ISO, ASTM).
Essentially, the ground truth is based on scientific measurements, established international standards, and animal model outcomes.
8. The sample size for the training set
This section is not applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set for an AI model, there is no ground truth for it. The "ground truth" for the device itself is established through the robust testing methodologies described above.
§ 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.