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The device has the same intended use and technological characteristics as the legally premarketed devices. Its usage, mode of action are equivalent to the legally premarketed devices.

se indicate devices that premarketed world widely, the devices also called by people among medical fields , like, doctors, nurses, medical traders purchasers of the medical products, etc., they are commonly used in the nospitals for Pap.s.,

And our this device is the same purpose used for Pap.s.as the premarketed devices which we mentioned as followings;

The device-EosSmear is the Ayer's spatula type with screw round top for easily scraping and removing the cytological material from the surface of the cervix or vagina; and the back of the design is for scraping also of the cervical area and SCJ part of the body.

The device is not a special or very new device, but a common and same type , traditional device that used for Pap. s.. As in the world the spatula is not a special one, people supply the same-premarketed devices as Ayer's spatula in wooden or plastic materials, or Cyto-brush types but with their own brand name , so as the EosSmear is the same usage, intended use, same safety and effectiveness for which is the substantial equivalence to the premarketed devices disposable,low cost and light weight.

The cervical spatula, some doctors used with sterilized, or non-sterilized. As it touches the body surface at very short time, so we made tests of material test which shows non-heavy metal contents of our device,; and the sterility test proves the device is safe and hygiene , no harm to patients due to the sterilization by GAMMA Radiation is approved.

This document is a 510(k) summary for a medical device called "EosSmear," which is described as a disposable cyto/cervical sampler. The summary argues for the device's substantial equivalence to legally premarketed devices.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance beyond general safety and equivalence.

The document focuses on establishing substantial equivalence based on having the "same intended use and technological characteristics" as existing devices, and that its "usage, mode of action are equivalent" to those premarketed devices. It highlights that the device is a common, traditional type (Ayer's spatula) used for Pap smears.

Here's a breakdown of why the requested information cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: This document does not establish specific performance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) as a predicate device might for a software algorithm. It asserts equivalence in function.

2. Sample sized used for the test set and the data provenance: Not applicable. There's no performance study described for the EosSmear's diagnostic capability.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic ground truth is being established for this device's performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 manual sampling tool, not an AI or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for diagnostic performance. The "ground truth" for this submission is the existence and established use of similar manual sampling spatulas.

8. The sample size for the training set: Not applicable. No algorithm is being trained.

9. How the ground truth for the training set was established: Not applicable.

What the document does mention regarding "tests":

The document mentions two types of tests, but these are related to material safety and sterility, not diagnostic performance:

• Material test: "material test which shows non-heavy metal contents of our device"
• Sterility test: "sterility test proves the device is safe and hygiene, no harm to patients due to the sterilization by GAMMA Radiation is approved."

These tests demonstrate general safety and biocompatibility, which are important for any medical device, but they are not performance studies in the sense of demonstrating diagnostic accuracy or efficacy. The core argument for this 510(k) is that the EosSmear is fundamentally the "same type" as existing products and therefore has the "same safety and effectiveness."

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