(30 days)
Geistlich Mucograft® and Geistlich Mucograft® Seal are indicated for:
- · covering of implants placed in immediate or delayed extraction sockets;
- · localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants;
- · alveolar ridge reconstruction for prosthetic treatment; and
- · recession defects for root coverage.
Geistlich Mucograft® and Geistlich Mucograft® Seal are surgically implanted, fully resorbable devices intended for oral tissue regeneration. The matrices are made of collagen without further cross-linking. All configurations of the product are sterilized in a double package by gamma irradiation. Geistlich Mucograft® and Geistlich Mucograft® Seal are composed of two structures: one smooth structure and one porous structure. The device allows tissue adherence as a prerequisite for favorable wound healing. The "outer" side (i.e., turned towards the soft tissue) with a smooth surface consists of compact collagen and has a smooth texture with the appropriate elastic properties to accommodate suturing. The "inner" porous structure consists of collagen fibers in a loose, porous arrangement to allow cell invasion for soft tissue ingrowth. This roughened surface is placed next to the host tissue to facilitate tissue integration.
The products are provided as follows:
- Geistlich Mucograft®: 15 x 20 mm, 20 x 30 mm, and 30 x 40 mm ●
- . Geistlich Mucograft® Seal: 8 mm and 12 mm diameter
This document is a 510(k) Premarket Notification from the FDA regarding Geistlich Mucograft® and Geistlich Mucograft® Seal. It concludes that the device is substantially equivalent to legally marketed predicate devices. However, the provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically expected for medical device performance evaluation (e.g., accuracy, sensitivity, specificity, or clinical outcomes with defined thresholds).
Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Identical Indications for Use.
- Similar technological characteristics (material, shape, single-use, sterilization method).
- Leveraging performance data from the applicant's own predicate device (mechanical testing, biocompatibility, sterilization, shelf-life, and clinical performance testing).
- Risk assessment to demonstrate that minor changes (new size configuration and slight manufacturing changes) do not raise new questions of safety or effectiveness.
Therefore, many of your requested details, such as a table of acceptance criteria, device performance, sample sizes for test sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of FDA submission for substantial equivalence.
Here's an analysis based on the information available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical metrics (e.g., success rates, healing times) for the subject device. The primary "performance" reported is its substantial equivalence to predicate devices, which implies that it performs similarly to devices already on the market.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on "performance data... from the applicant's own predicate device" and a "risk assessment" rather than specific new clinical or performance test sets for the current iteration of the device. Therefore, details about test set sample size or data provenance for a new study are not provided.
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. Ground truth establishment by experts for a specific test set is not described, as the submission focuses on substantial equivalence to predicate devices based on a comparison of characteristics and leveraging existing predicate data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No new test set or adjudication method is described.
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 device is a collagen matrix (bone grafting material), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document states "clinical performance testing from the applicant's own predicate device was leveraged." This implies that outcomes data from previous clinical studies on the predicate device were considered, rather than a new "ground truth" being established for the current submission.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a "training set" or establishing ground truth for machine learning.
Summary regarding acceptance criteria and study data:
The provided text for K210280 (Geistlich Mucograft® and Geistlich Mucograft® Seal) is an FDA 510(k) summary for a "substantial equivalence" determination. It does not describe a new clinical study with specific acceptance criteria and performance metrics for the subject device. Instead, it demonstrates substantial equivalence by:
- Highlighting identical Indications for Use with predicate devices.
- Confirming identical materials, manufacturing, sterilization methods, and packaging to predicate devices (with minor exceptions for size and slight manufacturing process changes).
- Leveraging performance data (mechanical testing, biocompatibility, sterilization, shelf-life, and clinical performance) from the applicant's own predicate device.
- Performing a risk assessment to conclude that minor changes do not raise new questions of safety or effectiveness.
Therefore, the "proof" that the device meets "acceptance criteria" here is the FDA's determination of substantial equivalence, based on the documented comparison to predicate devices and the existing performance data of those predicates. There are no new, specific quantitative acceptance criteria or a dedicated study described for this submission in the way you might find for novel device performance claims.
§ 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.