(28 days)
The CooperSurgical Advincula Delineator™ Uterine Manipulator is indicated to provide delineation of the vaginal fornices and maintain pneumoperitoneum as a uterine manipulator during Total Laparoscopic Hysterectomy, Laparoscopic Assisted Vaginal Hysterectomy and/or Laparoscopic Supra-Cervical Hysterectomy.
The Advincula Delineator Uterine Manipulator is intended for use during total laparoscopic hysterectomy (TLH), laparoscopic assisted vaginal hysterectomy (LAVH), and/or laparoscopic supracervical hysterectomy (LSH) procedures. It is single-use, disposable, and provided sterile. The device has a distal balloon built into the arched shaft, and a sliding colpotomy cup, called a Koh-Cup, that locks into place with a position lock. The handle at the proximal end allows the user to hold the device and to manipulate the uterus. When properly positioned, the outer rim of the Koh-Cup delineates the vaginal fornices and provides an anatomical landmark to facilitate uterine resection. An occluder balloon is used to maintain pneumoperitoneum during the procedure.
The Advincula Delineator Uterine Manipulator is available with Koh-Cups sized 2.5cm or 4.0cm in diameter. The Koh-Cup is made of Hytrel and the manipulator is made of stainless steel, silicone, various plastics, adhesives and inks. The subject device is intended to be used in hospitals.
This document describes the premarket notification (510(k)) for the Advincula Delineator™ Uterine Manipulator, which is a medical device and not an AI/ML powered device. As such, it does not involve the type of acceptance criteria and study designs typically associated with AI/ML device performance (e.g., sensitivity, specificity, MRMC studies, ground truth established by experts).
The acceptance criteria presented here are for the substantial equivalence of a modified medical device to a predicate device, focusing on material changes and packaging, rather than an AI algorithm's diagnostic or predictive performance.
Therefore, the requested information, specifically regarding AI/ML device performance, acceptance criteria, test set details, expert involvement, and ground truth methodologies, cannot be extracted from this document as it is not relevant to the described device and its review process.
Instead, the document focuses on:
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Acceptance Criteria (for device modification equivalence): The "acceptance criteria" here refer to demonstrating that changes made to the device (specifically, the Koh-Cup material and packaging) do not raise new questions of safety or effectiveness compared to the predicate device.
- The criteria are met by passing a series of non-clinical performance tests.
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Study Proving Acceptance Criteria Met: The study undertaken was a series of non-clinical performance tests on the modified device.
Here's a breakdown of the relevant information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance and Acceptance |
|---|---|---|
| Sterilization | ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Not explicitly stated "passed," but implied by "The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence." |
| ISO 11135:2014 (Ethylene Oxide Sterilization Process Requirements) | Not explicitly stated "passed," but implied as above. | |
| Shelf Life & Shipping | Shelf life demonstration up to 1 year | Demonstrated up to 1 year. |
| ISO 11607-1:2006 (Packaging for Terminally Sterilized Medical Devices) | Not explicitly stated "passed," but implied as above. | |
| ISTA 3A:2008 (Packaged-Products for Parcel Delivery System Shipment) | Not explicitly stated "passed," but implied as above. | |
| ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems) | Design verification testing was performed after accelerated aging (equivalent to one year real-time aging). Devices met predetermined acceptance criteria. | |
| Design Verification | Compression test (for Koh-Cup) | The test results show that the subject Koh-Cup met the predetermined acceptance criterion. (To verify it can withstand adequate compression force). |
| Pull Off test (for Koh-Cup) | The test results show that the subject Koh-Cup met the predetermined acceptance criterion. (To verify it does not disassemble from the device when used as intended). | |
| Distortion test (for Koh-Cup) | The test results show that the subject Koh-Cup met the predetermined acceptance criterion. (To verify it can withstand adequate force). | |
| Temperature Testing (for Koh-Cup) | The test results show that the subject Koh-Cup met the predetermined acceptance criterion. (To verify it can withstand adequate temperature). | |
| Biocompatibility | Cytotoxicity (per ISO 10993-5:2009) | Results demonstrated the new Koh-Cup was non-cytotoxic. |
| Sensitization (per ISO 10993-10:2010) | Results demonstrated the new Koh-Cup was non-sensitizing. | |
| Irritation (per ISO 10993-10:2010) | Results demonstrated the new Koh-Cup was non-irritating. |
Regarding the AI/ML specific questions (2-9), this document does not contain that information as the device is not an AI/ML product.
- 2. Sample size used for the test set and the data provenance: Not applicable. Testing was performed on physical device samples, not data sets.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not relevant here. Device performance was assessed against engineering and biocompatibility standards.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI-assisted device.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" here refers to the pre-established engineering and biocompatibility specifications and standards the physical device needed to meet.
- 8. The sample size for the training set: Not applicable. There is no training data set for this physical medical device.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the document details the testing performed to demonstrate that a physical medical device with material and packaging changes is substantially equivalent to a previously cleared predicate device, rather than the performance of an AI/ML algorithm.
§ 884.1640 Culdoscope and accessories.
(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope 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 culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. 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.