Search Results

The Disposable Endometrial Suction Curette is indicated for obtaining endometrial tissue samples by vacuum suction for endometrial histopathology examination. The specimens obtained are then used for the following: Endometrial cancer detection, Determine response to estrogen replacement therapy, Detection of pathology resulting in: Infertility, menstrual disorders, abnormal or dysfunctional uterine bleeding, postmenopausal bleeding, endometrial dating.

The proposed device is single-use, sterile disposable endometrial suction curette, which is intended to obtain endometrial tissue samples by vacuum suction mainly for endometrial histopathology examination and cytological examination or clinical examination in Gynaecological examination. Disposable Endometrial Suction Curette, including Type A and Type B, consists of a rod, barrel ' and sealing ring. The rod is used to generate negative pressure to draw the sample (fluid or mucous) into the barrel. The barrel is used to contain the drawn samples. The sealing ring ensures that the handle can be assembled closed with the barrel for keeping certain negative pressure.

The provided text describes a 510(k) summary for a Disposable Endometrial Suction Curette (K102847). This submission is for a medical device that obtains tissue samples, and the regulatory review focuses on substantial equivalence to a predicate device rather than novel performance claims. As such, the information you're requesting regarding acceptance criteria from clinical studies as typically understood for AI/diagnostic algorithms is largely not applicable in this context.

Here's an explanation based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Important Note: The provided text does not include any acceptance criteria related to diagnostic accuracy, sensitivity, or specificity by comparing device output to a ground truth, which would typically be present for an AI-powered diagnostic device. This is because the device itself is a sampling tool, not a diagnostic algorithm. Its "performance" is about its ability to obtain a sample, not to interpret it.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not applicable. The "tests" mentioned are primarily engineering and functional tests of the physical device, not clinical studies involving a patient test set in the way an AI diagnostic would have. No patient data or clinical samples are described as being used for the purpose of determining performance for this 510(k) submission.
• Data Provenance: Not applicable.

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):

• Number of Experts/Qualifications: Not applicable. There was no clinical ground truth established for a test set in the context of this device's performance evaluation for the 510(k) submission. The "ground truth" for the device's function would be its ability to physically collect a sample, which is assessed through engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Adjudication Method: Not applicable. No clinical test set or subjective interpretations requiring adjudication were involved.

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:

• MRMC Study: No. This device is a physical sampling tool, not an AI or diagnostic algorithm that would assist human readers in interpretation. Therefore, an MRMC study is not relevant.

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

• Standalone Performance: No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Type of Ground Truth: Not applicable in the context of diagnostic performance. The "ground truth" for this device's function would be the successful collection of endometrial tissue, which is assessed through its mechanical and functional tests. The subsequent diagnostic examination of the collected specimen (e.g., for cancer) would use pathology as ground truth, but that is a downstream process performed by a lab, not part of this device's performance evaluation.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.

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

• Ground Truth for Training Set: Not applicable.

Summary of the Study (as described for this device):

The "study" described for the Disposable Endometrial Suction Curette (K102847) is a non-clinical performance evaluation focused on engineering and functional testing, rather than a clinical trial measuring diagnostic accuracy.

• Purpose: To demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device (SelectCells™Mini, K974819).
• Methodology:
  • "Tests have been developed which are considered sufficient to ensure the efficacy and safety of the device for its intended use."
  • These tests included:
    • Visual inspection: To confirm the device's physical appearance and integrity.
    • Dimensional checks: To ensure the device conforms to design specifications.
    • Functional tests: To verify that the device can perform its intended mechanical action (e.g., generating negative pressure to aspirate samples).
• Key Finding: Based on these tests, the device was determined to be "substantially equivalent" to the predicate device. This means the FDA found that the new device is as safe and effective as the predicate device already on the market, despite not explicitly detailing all test results. The 510(k) process primarily relies on demonstrating equivalence rather than proving novel efficacy.

In essence, this submission is for a physical instrument, and its "performance" means it works as intended mechanically to collect a sample, not that it interprets diagnostic information. Therefore, the types of detailed acceptance criteria, ground truth, and studies typically associated with AI/diagnostic algorithms are not documented in this 510(k) summary.

Ask a specific question about this device