(481 days)
For the management of hypertrophic and keloid scars
The NewGel Plus introduced by NewMedical Technology, Inc., is a device which substantially equivalent to other marketed silicone gel sheets. Indications for use are substantially the same, that is, topical treatment of scars. The advantages over other marketed devices from other vendors include the size of the strips in the package to enhance ease of use. In summary, the features incorporated into the NewMedical NewGel Plus have specific advantages over other substantially equivalent products to enhance ease of placement/ application along with the care and comfort of the patient. Neither one of the above features will raise any safety concern because they don't change any of the basic design concepts compared to other similar approved devices.
The provided text describes a 510(k) summary for the NewGel Plus device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria.
Therefore, many of the requested categories for a study proving device performance against acceptance criteria cannot be extracted from this document, as such a study was not conducted or reported in this format.
Here's an breakdown of what can be determined:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or performance metrics are reported in this 510(k) summary. The document solely focuses on establishing substantial equivalence based on:
- Intended Use: Topical treatment of scars (hypertrophic and/or keloid). (Met by claiming similarity to predicate)
- Materials: Medical grade silicone gel and natural alpha-tocopherol (Vitamin E). (Met by claiming similarity to predicate and listing materials)
- Design: Adhesive methods of scar management, similar reinforcement materials, similar non-stick backings, similar transparent trays. (Met by claiming similarity to predicate)
- Operational Principles: Similar site preparation, method of application, ease of use and replacement, precautions, indications, and components. (Met by claiming similarity to predicate)
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. No formal "test set" or clinical study with data provenance is described as the basis for this 510(k) submission.
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. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned.
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 not an AI-assisted diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product (silicone gel sheet), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The basis of this submission is substantial equivalence to legally marketed predicate devices, not direct performance against a "ground truth" derived from patient outcomes or pathology for this specific device. The implicit "ground truth" is that the predicate devices are considered safe and effective for their intended use.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device and submission.
9. How the ground truth for the training set was established
Not applicable.
§ 878.4025 Silicone sheeting.
(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.