(129 days)
As a space-making barrier in the treatment of periodontal defects and guided tissue regeneration procedures; As a grafting material containment membrane.
Cytoplast™ Resorb is a bioresorbable material. Specifically, the device is designed to be biocompatible, cell occlusive, spacemaking, and clinically manageable. The product is supplied sterile and packaged individually in various sizes.
The provided 510(k) summary for Cytoplast™ Resorb (K993610) does not contain detailed information about acceptance criteria or a specific study that proves the device meets such criteria in terms of performance metrics.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than proving performance against predefined acceptance criteria for a novel device. Substantial equivalence relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Here's an analysis of the provided text based on your request:
1. Table of acceptance criteria and the reported device performance:
This information is not present in the provided document. The 510(k) summary asserts that "Osteogenics Biomedical, Inc. has concluded that the Cytoplast Resorb Barrier Membrane is safe and effective for its intended use and performs at least as well as the legally marketed predicate device." This is a conclusion of equivalence rather than a report of specific performance metrics against pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not present in the provided document. The submission does not describe a clinical study or a specific test set of data with associated sample sizes or data provenance.
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):
This information is not present in the provided document. Since there is no mention of a test set and ground truth establishment, these details are absent.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present in the provided document.
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 information is not present in the provided document. This device is a bioresorbable material, not an AI-powered diagnostic or assistive tool, so an MRMC study would not be applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not present in the provided document. The device is a physical barrier membrane, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not present in the provided document.
8. The sample size for the training set:
This information is not present in the provided document.
9. How the ground truth for the training set was established:
This information is not present in the provided document.
Summary of Device Acceptance Approach in K993610:
The acceptance of Cytoplast™ Resorb, as detailed in this 510(k) submission, is based entirely on the demonstration of substantial equivalence to an already legally marketed predicate device, the Gore Resolut XT Regenerative Material (K973594).
The core argument for acceptance is presented in Section VI. COMPARISON TO PREDICATE DEVICES:
- "The Cytoplast Resorb Barrier Membrane is similar in composition, and identical in function and intended use to legally marketed devices such as the Gore Resolut XT Regenerative Material."
- "Accordingly, Osteogenics Biomedical, Inc. has concluded that the Cytoplast Resorb Barrier Membrane is safe and effective for its intended use and performs at least as well as the legally marketed predicate device."
This means that instead of defining specific performance acceptance criteria and conducting studies to meet them, the manufacturer concluded that their device is equivalent in fundamental characteristics (composition, function, intended use) to an existing device already deemed safe and effective by the FDA. The FDA's letter confirms this finding of substantial equivalence, allowing the device to be marketed.
Therefore, the "study that proves the device meets the acceptance criteria" in this context is the comparison to the predicate device as outlined by the FDA's 510(k) process for substantial equivalence, rather than a performance study against novel acceptance criteria. No specific clinical trial or human subject data related to the Cytoplast™ Resorb itself is described in this excerpt to establish its performance.
§ 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.