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The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The maximum use time of the infusion sets shall not exceed 24 hours. The intravenous infusion needle should be used for only single dose administration and not to be left in place for more than 2 hours.

The proposed devices are indicated for the delivery of fluids from a container to a patient's vascular system through an infusion needle under the action of gravity. The proposed devices have 8 different configurations with 4 different filter sizes, and they are provided sterile and single use. The proposed devices include 32 models.

This document describes a 510(k) premarket notification for "Infusion Sets for Single Use." This is a medical device application that demonstrates "Substantial Equivalence" to a predicate device. This type of submission relies on non-clinical testing to support its claims, rather than clinical studies with human participants. Therefore, several of the requested categories are not applicable (N/A) to this document.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a tabulated format with specific numerical targets. Instead, it refers to conformity with established international and US standards for medical devices. The "reported device performance" is implicitly that the device conforms to these standards, making it "substantially equivalent" to the predicate device and safe for its intended use.

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: The document does not specify the exact sample sizes used for each individual non-clinical performance and biocompatibility test. It simply states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." For in-vitro tests, typical sample sizes are relatively small and determined by the specific ISO/ASTM standard.
• Data Provenance: The testing was conducted as part of the submission by Jiangsu Suyun Medical Materials Co., Ltd. from China. The types of tests (Performance Testing, Biocompatibility Testing, Sterility, Shipping and Shelf-life) are generally performed prospectively in a lab setting rather than being retrospective analyses of existing data. The specific country of origin for the data acquisition (i.e., where the labs are located) is not explicitly stated beyond the sponsor's location.

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)

This is N/A. For non-clinical device testing, "ground truth" is established by adhering to widely accepted international and national standards (e.g., ISO, ASTM, USP). The "experts" are the qualified laboratory personnel performing the standardized tests, and their qualifications are in conducting these specific test methods, not in clinical interpretation.

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

This is N/A. Adjudication methods are typically relevant for clinical studies or studies involving subjective human assessment (like image interpretation). Non-clinical performance and biocompatibility tests are objective measurements against predefined criteria in standards, not subject to individual interpretation requiring adjudication.

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

This is N/A. This submission is for a physical medical device (infusion sets), not an AI/software device that involves human readers or image interpretation. No MRMC study was performed.

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

This is N/A. This submission is for a physical medical device, not an algorithm or AI device.

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

The "ground truth" for this device's performance and safety is based on established international and national standards and test methods. For example, the ISO 8536 series for infusion equipment, ISO 10993 series for biocompatibility, and various USP and ASTM standards define the accepted methods and criteria for assessing device attributes like flow rate, mechanical integrity, material safety, and sterility.

8. The sample size for the training set

This is N/A. This is a 510(k) submission for a physical medical device, not a machine learning or AI model that requires a training set.

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

This is N/A. As mentioned above, there is no training set for a physical medical device.

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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.

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