(100 days)
The Polygon Resection Device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception.
The Polygon Resection Device is a handheld manually operated device designed for the hysteroscopic removal of intrauterine tissue. The device is provided sterile. The shaft of the device is design to fit into the working channel of any hysteroscope that includes a 3.0 mm (Fr) straight working channel. The device is activated by the physician by squeezing the trigger. A rotation knob is provided to enable the physician to rotate the cutting bay into an orientation that aligns with the desired specimen. The barb fitting provides an attachment port for a vacuum system. The vacuum system pulls the specimen into the cutting window where it can be resected and aspirated out of the patient. There are no electrical or powered connections necessary for operation of the device.
The provided text describes the Polygon Resection Device, a hysteroscopic tissue removal device, and its supporting studies for FDA 510(k) clearance. Here's an analysis of the acceptance criteria and supporting studies based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly states that a range of tests were conducted and that "All test samples met the acceptance criteria for each test." However, the specific numerical acceptance criteria for most tests are not explicitly detailed. The reported performance is generally qualitative, confirming successful completion or compliance.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Sterilization Efficacy (in accordance with ISO 11135-1: 2014) | -Validated in accordance with ISO 11135-1: 2014. |
| -All test samples met acceptance criteria. | |
| Shelf Life (including package integrity and functional testing) | -Validated. |
| -All test samples met acceptance criteria. | |
| Biocompatibility (in accordance with ISO 10993-1: 2009) | -Evaluated including Cytotoxicity, Guinea Pig Maximization Sensitization, Irritation, and Acute Systemic Toxicity testing. |
| -All test samples met acceptance criteria. | |
| Design Verification - Joint Connection Strength | -Tested. |
| -All test samples met acceptance criteria. | |
| Design Verification - Visual Inspection | -Inspected. |
| -All test samples met acceptance criteria. | |
| Design Verification - Tissue Trap Removal Force | -Tested. |
| -All test samples met acceptance criteria. | |
| Functional Performance - Hysteroscope Compatibility | -Tested in a simulated use model. |
| -All test samples met acceptance criteria. | |
| Functional Performance - Vacuum System Compatibility | -Tested in a simulated use model. |
| -All test samples met acceptance criteria. | |
| Functional Performance - Device Cutting Performance | -Tested in a simulated use model (successful removal of tissue without clogging, cutting rate, and fluid usage). |
| -All test samples met acceptance criteria. | |
| Clinical Usability (Ease of use, successful tissue removal without clogging, number of activations) | -Evaluated through a clinical usability study with 5 physicians and 32 cases. |
| -Demonstrated that the subject device can be used per the Instructions for Use as intended (successful removal of tissue without clogging, ease of use, appropriate number of activations for procedure completion). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Clinical Usability Study: 32 cases.
- Data Provenance: The document does not explicitly state the country of origin or if it was retrospective or prospective. Given it is a "clinical usability study" to evaluate "ease of use" and "successful removal of tissue," it strongly implies a prospective study involving human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: 5 physicians.
- Qualifications: "a range of experience." Specific experience levels (e.g., years as a gynecologist) are not provided. The study indicates these physicians were trained gynecologists.
4. Adjudication Method for the Test Set:
- The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "clinical usability study" setup suggests that the physicians themselves were the evaluators of usability and successful tissue removal in their respective cases. There's no mention of independent reviewers or a consensus process for the 32 cases to establish a 'ground truth' in the typical sense of diagnostic accuracy. The assessment of successful removal "without clogging" and "ease of use" was likely based on the performing physician's assessment during the procedure.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not done. The device is a physical hysteroscopic tissue removal device, not an AI-driven diagnostic or assistive imaging tool that typically undergoes MRMC studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone algorithm performance study was not done. This device is a surgical instrument requiring direct human operation, not an autonomous algorithm.
7. Type of Ground Truth Used:
- For the non-clinical tests (sterilization, shelf life, biocompatibility, design verification, functional performance), the ground truth was established by adherence to standards (ISO 11135-1, ISO 10993-1) and internal design specifications/acceptance criteria for each test.
- For the clinical usability study, the "ground truth" for usability and performance (successful tissue removal without clogging) was implicitly established by the treating physicians' assessment during the procedures against the intended use and expected device performance. This isn't "pathology" or "outcomes data" in the sense of a diagnostic classification, but rather procedural success and ease of operation.
8. Sample Size for the Training Set:
- The document describes a physical medical device, not an AI/ML algorithm. Therefore, there is no concept of a training set in the context of machine learning. The "training" for the device would be the design, manufacturing, and quality control processes.
9. How Ground Truth for the Training Set Was Established:
- As there is no training set for an AI/ML algorithm, this question is not applicable to the Polygon Resection Device.
§ 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.