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STARRYSHINE Gauze Sponges are intended for use to control bleeding, absorb body fluid, and protect wounds from contamination

STARRYSHINE GAUZE SPONGE Are composed of USP type VII gauze, available in the thickness of 8 ply (2" x 2") 4 ply (2" x 2"), it's non-sterile and made with 100% cotton.use in control bleeding, absorb body fluids and protect wounds from contamination.

The provided text is a 510(k) summary for a medical device (STARRYSHINE Gauze Sponges). It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information about a study proving the device meets specific acceptance criteria using performance data.

This type of submission (510(k)) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific study with performance metrics. For devices like gauze sponges, substantial equivalence is typically demonstrated by showing similar or identical composition, function, and intended use as an existing device.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not available in the provided document.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Not available. The document does not specify quantitative acceptance criteria or provide performance data.

2. Sample sized used for the test set and the data provenance

• Not applicable/Not available. No test set or associated data provenance is mentioned as part of a performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not available. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method for the test set

• Not applicable/Not available. 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 a gauze sponge, not an AI-powered diagnostic tool, so an MRMC study with AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used

• Not applicable/Not available. No ground truth is mentioned. The equivalence is based on the characteristics of the device itself and comparison to a predicate.

8. The sample size for the training set

• Not applicable/Not available. No training set is mentioned.

9. How the ground truth for the training set was established

• Not applicable/Not available. No ground truth for a training set is mentioned.

Summary of what the document implies about "meeting acceptance criteria":

The "acceptance criteria" here are implicitly centered around demonstrating substantial equivalence to an existing, legally marketed predicate device. The study that "proves" the device meets these criteria is the submission of information detailing the device's characteristics and directly comparing them to the predicate.

• Acceptance Criteria (Implicit for Substantial Equivalence):

  • Similar or identical composition (USP type VII gauze, 100% cotton).
  • Similar or identical function (control bleeding, absorb body fluids, protect wounds from contamination).
  • Similar or identical intended use (dental office or hospital setting).
  • Similar or identical physical characteristics (e.g., thickness: 8 ply, 4 ply; size: 2" x 2").
  • Safety and effectiveness comparable to the predicate device.

• Reported Device Performance (as presented for substantial equivalence):

  • The device is composed of USP type VII gauze, 100% cotton.
  • Available in 8 ply (2" x 2") and 4 ply (2" x 2").
  • Intended for use in controlling bleeding, absorbing body fluids, and protecting wounds from contamination.
  • The manufacturer states: "TC DENTAL PRODUCTS INC. has concluded that the STARRYSHINE Gauze sponges are effective and safe for their intended use and perform as well as legally marketed predicate device, Such as Surgicade Non-sterile gauze sponges."

In essence, the "study" described is the comparison to the predicate device, Surgicade TM Non-Sterile Gauze Sponges, which serves as the benchmark for establishing safety and effectiveness. No specific quantitative performance data of STARRYSHINE Gauze Sponges itself is provided beyond its descriptive attributes and intended use.

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