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Use of the RELIEEV Uterine Manipulator Injector is indicated in Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty procedures where manipulation of the uterus is required.

The "RELIEEV" Uterine Manipulator Injector is intended to be used during medical procedures where manipulation of the uterus or injection of fluids into the uterine lumen are needed. This device is a sterile, single use product consisting of a plastic (PVC) insertion tube that includes two lumens, one for inflation of a 10 mL intrauterine balloon (cuff) at the distal end of the insertion tube via the inflation valve using the provided 10 mL syringe and the other for injection of fluid through a distal end-port using a user-provided syringe via the Leur fitting. The device also includes a movable/removable rigid handle that allows alteration of the device insertion depth and includes a cervical stop, laser etched depth markings to aid in setting the insertion depth, and a pilot balloon to assess maintenance of cuff inflation. The device is curved to facilitate forward uterine manipulation. The device has an overall length of 36 cm and an outer diameter of the catheter component of 5.0 mm. When inflated with 10 mL of air, the balloon has a diameter of 23.0-24.9 mm.

This document is an FDA 510(k) summary for the "RELIEEV" Uterine Manipulator Injector. It describes the device and claims substantial equivalence to a predicate device, the Panpac Uterine Manipulator Injector, Model Umi 4.5 (K092980).

Based on the provided text, the device in question is a medical instrument, not an AI/software device. Therefore, the questions related to AI/software performance, ground truth, human readers, and training/test sets are not applicable to this document.

The acceptance criteria and study proving the device meets them are related to the physical and biological safety and performance of the Uterine Manipulator Injector, rather than an AI algorithm.

Here's the information extracted from the document, tailored to the type of device described:

Acceptance Criteria and Device Performance for "RELIEEV" Uterine Manipulator Injector

This device is a physical medical instrument, and its performance evaluation focuses on its physical characteristics, sterility, biocompatibility, and mechanical integrity, comparing it to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document details various tests performed to ensure the device meets safety and performance standards for a physical medical device. The "acceptance criteria" are implied by the successful completion of these tests per the referenced standards and the statement that "all predetermined acceptance criteria were met."

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample sizes for the various tests. It refers to established testing standards (e.g., ISO, ASTM, USP), which would specify appropriate sample sizes for each test type. The data provenance is from bench testing and laboratory evaluations conducted by the manufacturer (LI Medical Corporation LTD.) to support regulatory submission. This is a prospective assessment of newly manufactured devices under controlled conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This concept is not applicable to the assessment of a physical medical device like a uterine manipulator. "Ground truth" in this context refers to the defined acceptable parameters for physical and biological performance, which are established by international standards and regulatory guidelines, not by individual experts evaluating images or clinical data.

4. Adjudication Method for the Test Set

Not applicable for a physical medical device. Performance is judged against specified engineering, material, and biological safety standards, not through adjudication of expert opinions.

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, as this is not an AI/software device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is not an AI/software device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established industry standards and regulatory requirements for medical device safety and efficacy. This includes:

• Physical and mechanical properties (e.g., dimensions, tensile strength, inflation capabilities).
• Sterility assurance (e.g., EtO residuals).
• Biocompatibility (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity).
• Packaging integrity.

These are quantitative metrics or pass/fail criteria derived from validated test methods.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/software device. There is no "training set" in the context of a physical medical device's performance validation; rather, there are samples tested according to predefined standards.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/software device.

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The "RELIEEV" Suction Curette (Flexible 3.0/ Standard 3.6) is used to remove samples of materials from the uterus and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain tissue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.

The "RELIEEV" Suction Curette is a sterile, disposable, single-use device used to obtain a sample from the uterine mucosal lining. It is available in two models – Flexible 3.0 and Standard 3.6 with outer diameters of 3.0 mm and 3.6 mm respectively. The device consists of a tube and piston made of polypropylene (PP) with a silicone O-ring. The subject device is packaged in medical paper grade pouch (60g).

This document describes the premarket notification (510(k)) for the "RELIEEV" Suction Curette. The information provided in the document does not contain details about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered device, as the device is a physical medical instrument, not a software or AI-based product.

The document discusses performance data related to physical bench testing, biocompatibility, packaging and shipping validation, sterilization validation, and shelf life to demonstrate substantial equivalence to a predicate device.

To address your request, I will categorize the information presented in the document as it pertains to the performance and validation of this physical device.

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

Based on the provided document, specific numerical acceptance criteria values are generally not explicitly stated for each test, but rather the conclusion that the device "passed" or "performed according to product specifications" is given. The "Reported Device Performance" here reflects these summarized outcomes.

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

The document does not specify the exact sample sizes for the individual tests (e.g., number of devices tested for suction force, biocompatibility, etc.). It only states that "Physical bench testing was performed" and "The subject device test results were compared with the predicate device".

Data Provenance: The manufacturing company is LI Medical Corporation LTD. in New Taipei City, Taiwan. The studies were likely conducted either internally by the manufacturer or by contract testing laboratories performing the specified ISO and ASTM standards. The data is retrospective in the sense that the tests were performed on finished devices to support the 510(k) submission.

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

This question is not applicable to the "RELIEEV" Suction Curette as described in the document. This is a physical medical device, not a diagnostic device involving expert interpretation of data or images to establish a "ground truth" for a test set. The validation relies on objective physical, chemical, and biological testing standards.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving human interpretation or subjective assessments, which are not detailed in this document for the provided device. The device validation relies on standardized tests with defined pass/fail criteria.

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 question is not applicable. An MRMC study is relevant for diagnostic devices that involve human readers interacting with images or data, often in the context of AI assistance. The "RELIEEV" Suction Curette is a physical instrument for tissue sampling.

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

This question is not applicable. This device is not an algorithm or software. It is a physical suction curette.

7. The type of ground truth used

This question is not directly applicable in the terms usually associated with AI/ML devices. For this physical device, "ground truth" is established through:

• Physical measurements and functional performance standards: Defined by product specifications and comparing against the predicate device.
• Standardized testing methods: Such as ISO and ASTM standards for biocompatibility, sterility, packaging, and shelf-life, which provide objective criteria for success or failure.
• Analytical chemistry and microbiology results: For biocompatibility and sterility.

8. The sample size for the training set

This question is not applicable. There is no AI/ML component described for this device, therefore no "training set" in that context. The device is validated through traditional engineering, biological, and sterility testing.

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

This question is not applicable, as there is no training set for an AI/ML algorithm for this physical device.

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