(163 days)
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord are for the temporary retraction of the gingival margin. The Retraction Cord is placed in the sulcus to displace gum tissue for a small period of time in dental procedures.
GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord are dental retraction materials used to aid accurate impressions of sub-gingival margins by temporary gingival displacement, control sulcular seepage and control hemorrhage. Non-impregnated retraction materials are to be used in combination with an astringent/hemostatic solution of choice. The usage is inherently of transient nature. Typical exposure time is less than five minutes. The non-impregnated retraction materials consists only of braided or knitted cotton yarn soaked with an aqueous surfactant solution and then dried to facilitate absorption of medicament containing retraction solution of dentist's choice into the cotton cord. The braided and knitted cord configurations are available in different sizes to fit the sulcus.
This document describes the premarket notification (510(k)) for GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.
The document focuses on demonstrating substantial equivalence to a predicate device (Quicknit Cord, K131799) based on shared technological characteristics, intended use, and indications for use, rather than presenting a performance study against specific acceptance criteria for a new clinical claim or diagnostic capability.
Therefore, many of the requested elements for a study demonstrating acceptance criteria cannot be extracted from this document, as it is a 510(k) submission for a medical device regulatory clearance, not a clinical performance study with acceptance criteria.
However, I can extract information related to the non-clinical performance data provided, which serves as evidence for safety and substantial equivalence.
Here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria with corresponding performance metrics for a clinical study in the typical sense (e.g., sensitivity, specificity, accuracy). Instead, it presents non-clinical performance data and states that Biocompatibility meets requirements of ISO 10993.
| Test/Characteristic | Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets requirements of ISO 10993 | Meets requirements of ISO 10993 |
| Cutting Test | (Not explicitly stated) | (Not explicitly stated, but performed) |
| Water Contact Test | (Not explicitly stated) | (Not explicitly stated, but performed) |
| In Vitro Cytotoxicity | Meets requirements of ISO 10993-5:2009 | (Implied by Biocompatibility statement) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. No clinical test set is described as this is a non-clinical evaluation for substantial equivalence.
- Data Provenance: Not applicable for a clinical test set. The non-clinical tests (Cutting Test, Water Contact Test, Biocompatibility) would have been conducted in a laboratory setting, likely by the manufacturer or a contract research organization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set with ground truth established by experts is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set 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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a dental retraction cord, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for a clinical ground truth. For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the referenced ISO standards.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning or AI device.
Summary of what the document does provide regarding "proof" of meeting criteria:
The document asserts that the device meets safety and effectiveness requirements by demonstrating substantial equivalence to a legally marketed predicate device (Quicknit Cord, K131799). This demonstration relies on:
- Non-clinical performance data: "Cutting Test, Water Contact Test and Biocompatibility testing" were performed.
- Compliance with standards: The non-clinical performance testing utilized ISO 10993-1:2009 (Biological evaluation of medical devices) and ISO 10993-5:2009 (Tests for in Vitro Cytotoxicity). The document explicitly states that the "Biocompatibility meets requirements of ISO 10993".
- Comparison to Predicate: A comparison table (Table 8.1) highlights the similarities between the proposed device and the predicate in terms of intended use, indications for use, material composition (both primarily cotton, non-impregnated), product code, classification, and material compatibility. The key differences noted (e.g., configurations, presence of a surfactant in the proposed device) are argued to "not raise new questions of safety and effectiveness."
- No Clinical Performance Data: The document explicitly states, "Clinical performance testing has not been performed for GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord." This is common for 510(k) submissions where substantial equivalence can be established through non-clinical data.
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