(332 days)
Blue Sky Bio TCP Bone Graft Substitute is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.
- Filling of periodontal/infrabony defects .
- Ridge augmentation .
- Filling of extraction sites (implant preparation/placement) .
- Sinus lifts .
- Filling of cystic cavities
The device gradually resorbs and is replaced with bone during the healing process.
Blue Sky Bio TCP Bone Graft Substitute is porous, resorbable, and biocompatible calcium phosphate ceramic consisting of ß-tricalcium phosphate. ß-tricalcium phosphate is an osteoconductive implant that is biodegradeable. Blue Sky Bio TCP Bone Graft Substitute is provided sterile in granular form, pyrogen-free and available in granule sizes up to 2000 μm.
The provided text is a 510(k) summary for the Blue Sky Bio TCP Bone Graft Substitute, a Class II medical device. This document focuses on demonstrating substantial equivalence to already legally marketed devices, rather than establishing acceptance criteria through a clinical study with performance metrics in the way an AI/ML device would.
Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truthing, adjudication methods, MRMC studies, or standalone algorithm performance.
Here's why and what information is available:
- Type of Device: The device is a bone grafting material, not an AI/ML diagnostic tool. Its clearance is based on demonstrating that it is as safe and effective as a legally marketed predicate device, not on specific performance metrics against a defined ground truth derived from a clinical dataset (like sensitivity, specificity, AUC).
- Basis for Substantial Equivalence: The document explicitly states the "Basis for Substantial Equivalence" as meeting established standards for materials, biocompatibility, pyrogenicity, and sterilization. It also compares the device's composition (pure ß-tricalcium phosphate, compliance with ASTM F 1088-04), intended use, indications for use, anatomical site, and performance data to the predicate devices.
- "Acceptance Criteria" in this context: For this type of device, "acceptance criteria" are implied by meeting the standards and demonstrating equivalence to the predicates in terms of material properties, safety (biocompatibility, pyrogenicity), and indications for use.
- "Study that proves the device meets the acceptance criteria": The "studies" mentioned are primarily pre-clinical tests for biocompatibility and material characterization, not patient-based clinical trials with performance metrics.
However, I can extract the following information that is somewhat related to your request, but understand it's not a direct fit for an AI/ML device performance evaluation:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Material Composition | Pure ß-tricalcium phosphate, ≥95% phase purity |
| Material Standard Compliance | Complies with ASTM F1088-04 |
| Biocompatibility | Pass (Cytotoxicity, Intracutaneous Irritation Test, Maximization Sensitization Test, Pyrogen Test, Acute Toxicity) |
| Sterilization | Provided sterile |
| Pyrogenicity | Pyrogen-free |
| Resorbability | Gradually resorbs and is replaced by bone during healing |
| Indications for Use (Equivalence) | Equivalent to predicate devices (Cerasorb® M Dental, ArrowBone-β) for: |
- Filling of periodontal/infrabony defects
- Ridge augmentation
- Filling of extraction sites (implant preparation/placement)
- Sinus lifts
- Filling of cystic cavities |
| Performance Data (Equivalence) | Demonstrates equivalence to predicates regarding dissolution testing and XRD profiles. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This document describes a new medical device seeking 510(k) clearance based on substantial equivalence to existing devices, relying on material characterization and biocompatibility testing, not on clinical performance data derived from a "test set" of patient data in the context of an AI/ML model. The biocompatibility tests would have involved in vitro and in vivo animal studies, but the sample sizes and detailed provenance are not specified in this summary.
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. There is no "ground truth" established by human experts for a "test set" in the context of this device's submission. The "truth" for material properties is established by laboratory analytical methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method for a test set of patient data is described because no such test set was used for performance evaluation in the AI/ML sense.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth (for material properties/safety): Material specifications (ASTM F1088-04), laboratory test results for chemical composition (XRD profiles), dissolution rates, and animal/cellular models for biocompatibility (cytotoxicity, irritation, sensitization, pyrogenicity, acute toxicity).
8. The sample size for the training set:
- Not applicable. No training set for an AI/ML model.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML model.
In summary, the provided document is a regulatory submission for a bone graft substitute, which is a different type of medical device than what your prompt anticipates for AI/ML performance evaluation.
§ 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.