(224 days)
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.
| Acceptance Criteria Category (Implied/General) | Reported Device Performance (Summary from document) |
|---|---|
| Bench Testing | |
| Dimensional Analysis Performance | Performed according to product specifications (passed) |
| Suction Force Performance | Performed according to product specifications (passed) |
| Marker Readability after Bending Performance | Performed according to product specifications (passed) |
| Bending Force Performance | Performed according to product specifications (passed) |
| Biocompatibility Testing | |
| Cytotoxicity | Non-cytotoxic (Passed ISO 10993-5:2009) |
| Sensitization | Non-sensitizer (Passed ISO 10993-10:2021) |
| Irritation | Non-irritant (Passed ISO 10993-23:2021) |
| Packaging and Shipping Validation | |
| Withstand distribution environment | Withstood distribution environment (Passed ASTM D4332-22 & ASTM D4169-22) |
| Seal Peel Test | Passing results (per ASTM F88/F88M-23) |
| Dye Penetration | Passing results (per ASTM F1929-15) |
| Visual Inspection | Passing results (per ASTM F1886/F1886M-16) |
| Sterilization Validation | |
| Sterility Assurance | Sterilization process validated per ISO 11135:2014; sterility testing and documentation provided. |
| Shelf Life | |
| 3-year Shelf Life Claim | Supported by accelerated aging (ASTM F1980-21) and package integrity/bench testing on aged devices. |
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.
§ 884.1175 Endometrial suction curette and accessories.
(a)
Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.(b)
Classification. Class II (performance standards).