(113 days)
TheriRidge™ Block Bone Graft Substitute is indicated and intended for the augmentation of deficient maxillary and mandibular alveolar ridges.
The TheriRidge™ Block device consists of hydroxylapatite material, the primary mineral content of human bone, with porosity and geometric features that encourage tissue in-growth. The device will be available in three (3) basic sizes: small (approximately 10.4 mm x 5.6 x 5.0), medium (approximately 10.4 mm x 10.0 x 5.0), and large (approximately 20.0 mm x 10.0 x 5.0).
The provided text describes Therics' TheriRidge™ Block, a bone graft substitute, and its substantial equivalence to a predicate device, Interpore's Pro Osteon® 200. This is a 510(k) summary, which generally focuses on demonstrating equivalence rather than establishing new acceptance criteria or conducting a comprehensive study with the detailed elements requested in the prompt for AI/diagnostic devices.
Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of submission.
Here's an analysis based on the provided text, highlighting what is available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present specific "acceptance criteria" for the device in the context of passing a diagnostic test or achieving a particular performance threshold against a ground truth. Instead, it compares the physical and chemical characteristics of the new device (TheriRidge™) to a predicate device (Pro Osteon® 200) to demonstrate substantial equivalence.
| Characteristics | TheriRidge™ | ProOsteon 200™ |
|---|---|---|
| Median Pore Diameter | 12 microns | 80 microns |
| Bulk Density | 1.7 g/cc | 1.3 g/cc |
| True/Skeletal Density | 3.0 g/cc | 3.0 g/cc |
| Porosity | 43 % * | 57 % |
| Crystallinity | > 95% HA | > 90% HA |
| Compressive Strength | 4.3 MPa (3 to 6 MPa) | 5.8 MPa (4 to 10 MPa) |
| *Excluding channels |
The study proves the device meets the "acceptance criteria" of substantial equivalence to the predicate device, Pro Osteon® 200, based on these physical and chemical characteristics and similar performance in a pre-clinical animal model.
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: The text mentions "Pre-clinical performance testing conducted on TheriRidge™ and Pro Osteon® 200 in a canine animal model." However, the number of animals (sample size) used in this test is not specified.
- Data Provenance: "Canine animal model" implies the data is from an animal study, not human patients. The country of origin is not specified. The study is pre-clinical.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable as the study is pre-clinical performance testing on an animal model, not a diagnostic device requiring expert interpretation of results to establish ground truth for a test set. The evaluation seems to be based on physical observations and measurements within the animal model, as described in the next point.
4. Adjudication Method for the Test Set
- Given the nature of the pre-clinical animal study, an adjudication method in the context of human expert review (e.g., 2+1, 3+1) is not applicable. The assessment was likely made by researchers or veterinary pathologists involved in the animal study based on "handling characteristics, wound healing, implant stability, and the presence of healthy tissue in or adjacent to the devices." No details about specific adjudication protocols are provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance can potentially improve their performance. This submission is for a bone graft substitute, not a diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical bone graft substitute, not an algorithm, and therefore does not have "standalone" algorithm performance.
7. The Type of Ground Truth Used
- For the pre-clinical animal study, the "ground truth" was established through direct observation and measurement in the canine animal model regarding "handling characteristics, wound healing, implant stability, and the presence of healthy tissue in or adjacent to the devices." This is essentially a form of outcomes data or histopathological assessment within the animal model.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a physical bone graft substitute.
§ 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.