(48 days)
Accell Connexus™ DBM Putty is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:
- Filling of defects after root resection, apicoectomy and cystectomy -
- Filling of extraction sockets to enhance preservation of the alveolar ridge -
- Elevation of maxillary sinus floor -
- Treatment of periodontal defects -
Accell Connexus™ DBM Putty is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier and formulated to a paste or putty-like consistency.
Accell Connexus DBM Putty is osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.
The provided text is a 510(k) Premarket Notification for a medical device, Accell Connexus DBM Putty. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a diagnostic AI/ML device would.
This document describes a medical device (bone graft material) and seeks clearance based on "substantial equivalence" to a predicate device. For such devices, performance is typically demonstrated through material data, animal studies, and comparison to existing products, rather than the kind of AI/ML performance metrics (like sensitivity, specificity, F1-score, or ROC AUC) that would have acceptance criteria and be proven through a clinical study with detailed ground truth, expert adjudication, and statistical analysis as implied by your questions.
Therefore, I cannot provide the requested information in the format of your questions, as the input document does not contain it.
Here's a breakdown of why each of your requested points cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: No such criteria or performance metrics (like sensitivity, specificity, accuracy) are mentioned. The document relies on substantial equivalence.
- Sample size used for the test set and the data provenance: No test set in the diagnostic sense is mentioned. Clinical studies with sample sizes are not discussed for performance evaluation in this context.
- Number of experts used to establish the ground truth... and their qualifications: Ground truth in the context of diagnostic performance (e.g., image interpretation) is not applicable here.
- Adjudication method... for the test set: Not applicable as there is no test set for diagnostic performance evaluation.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: No MRMC study or comparison of human readers with/without AI assistance is mentioned. The device is a bone putty, not an AI or diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; the device is a physical bone graft material, not an algorithm.
- The type of ground truth used: For a device based on substantial equivalence, the "ground truth" revolves around its material properties, biocompatibility, and intended use matching those of the predicate device, often supported by animal studies for osteoinductivity. The text states "The osteoinductive potential is demonstrated in athymic mouse model," which is a form of pre-clinical "ground truth" for one property.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires training data.
- How the ground truth for the training set was established: Not applicable.
What the document does state about performance:
- "Accell Connexus DBM Putty is osteoconductive and osteoinductive bone filling material."
- "The osteoinductive potential is demonstrated in athymic mouse model." (This is the closest to a performance study mentioned).
- "Product safety and effectiveness is adequately supported by the substantial equivalence information, materials data, and animal test results provided in this Premarket Notification."
In summary, this document is for a traditional medical device submitting a 510(k) for substantial equivalence, not for an AI/ML diagnostic device with performance characterized by detailed statistical metrics against a ground truth established by experts.
§ 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.