(25 days)
Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
The device is suitable for professional healthcare facility environments such as hospitals and clinics.
The subject device, Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
The device is suitable for professional healthcare facility environments such as hospitals and clinics.
The subject device consists of an endoscope (a hysteroscope) which includes an insertion portion and handle, and the following accessories: 2 pieces of two-way valves and 1 piece of silicone cap.
The provided document, K241987, describes a 510(k) premarket notification for a medical device and does not contain information about acceptance criteria and a study that proves the device meets those criteria from an AI/algorithm performance perspective.
The document is a K241987 submission for a Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101). This device is a traditional medical instrument used for viewing the cervical canal and uterine cavity. It is not an AI/algorithm-based device.
Therefore, many of the requested fields related to AI/algorithm performance, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this submission.
The "Performance" section within the document refers to non-clinical performance testing of the physical device, such as mechanical, optical, and biocompatibility tests, not an algorithm's performance.
Here's a breakdown of the information that is available in the document, framed against your request:
Acceptance Criteria and Device Performance for Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
As this is a physical medical device (a hysteroscope) and not an AI or algorithm, the acceptance criteria and performance data relate to its physical and functional attributes. The document states that "Verification testing including performance testing using previously submitted methods and acceptance criteria cleared under K232003... were conducted to evaluate the modifications. The subject device passed all the testing in accordance with internal requirements and applicable standards."
Due to the nature of the device, many of the requested fields are not relevant.
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted but does not explicitly detail the quantitative acceptance criteria or the specific reported device performance values beyond stating that the "subject device passed all the testing." The acceptance criteria are implicitly those established for the predicate device (K232003) and internal requirements/applicable standards.
| Test category | Test Item | Acceptance Criteria (from K232003 / applicable standards) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Surface and Edges Visual Assessment | Passed | Passed |
| Water Delivery System (Flow Rate and Leakage Testing) | Passed | Passed | |
| Basic Size (Dimensional Analysis and Compatibility Testing of the Two-way Valve) | Passed | Passed | |
| Comprehensive Performance of Luer Taper per ISO 80369-7:2021 and ISO 80369-20:2015 | Passed | Passed | |
| Pullout Force of Silicone Cap | Passed | Passed | |
| Compatibility with Accessories When Installing Silicone Cap | Passed | Passed | |
| Sealing Test after Installing the Two-way Valve (Leakage Testing under Pressure) | Passed | Passed | |
| Optical Performance | Depth of field (Note: RP-G-C0101 changed from 5 mm | 3 mm ~ 50 mm (for RP-G-C0101) | Met |
| Biocompatibility | Cytotoxicity test per ISO 10993-5:2009 | Passed | Passed |
| Sensitization test per ISO 10993-10:2011 | Passed | Passed | |
| Intracutaneous Reactivity test per ISO 10993-23:2021 | Passed | Passed | |
| Acute Systemic Toxicity test per ISO 10993-11:2017 | Passed | Passed | |
| Material-Mediated Pyrogenicity test per USP | Passed | Passed | |
| Sterilization | EO/ethylene chlorohydrin (ECH) residual testing per ISO 10993-7:2008 | Below stated residual limits | Met |
| Shelf Life & Packaging | ASTM F1980-21, ISO 11607-1:2019, ISO 11607-2:2019, ASTM F 1929-15, ASTM F88/F88M-23, ASTM F1886/F1886M-16, ASTM D4169-23 | Passed | Passed |
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: Not specified for individual performance tests. The testing refers to "subject device" and implies a representative number of units were tested.
- Data Provenance: Not specified. Testing was conducted internally by Guangzhou Red Pine Medical Instrument Co., Ltd.
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)
- Not applicable. This relates to human expert review for AI/algorithm performance. The device is a physical hysteroscope. The "truth" for physical performance tests (e.g., leakage, dimensions, biocompatibility) is determined by objective measurements against established standards, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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 is a physical medical device, not an AI system. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For Biocompatibility: "Ground truth" is established by adherence to recognized international standards (e.g., ISO 10993 series, USP ) and observable biological responses in tests.
- For Mechanical/Optical Performance: "Ground truth" is based on engineer specifications, physical measurements, and conformity to applicable industry standards (e.g., ISO 80369-7:2021).
- For Sterilization/Shelf Life: "Ground truth" is based on validated methods (e.g., ISO 11135:2014) demonstrating sterility assurance levels and packaging integrity per standards (e.g., ISO 11607).
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it's not an AI/algorithm-based device.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.