(120 days)
The Manipuseal device is indicated for use in all laparoscopic surgical procedures where use of a uterine manipulator is appropriate and the surgeon intends to remove intraperitoneal tissue through the vagina by use of a colpotomy on culdotomy incision.
The Manipuseal device is comprised of an occluding balloon, Manipuseal uterine manipulator and tip, and a CO2 Port. Manipulator consists of a toroidal or doughnut shaped balloon that is manufactured from silicone. The occluding balloon is designed to be inflated using a maximum of 180 ml of room air. The occluding balloon is an integral part of the Manipuseal device and is neither replaceable nor removable. The occluding balloon is filled using a commercially available 50 ml The occluding balloon occludes the vagina, while the Manipuseal syringe. manipulator is positioned in the patient and is used for manipulation. The Manipuseal is a standard uterine manipulator, which consists of a handle, body and tip made from Acrylonitrate-Butadiene-Styrene (ABS). Once the manipulator tip is positioned in the cervix, the surgeon then commences the laparoscopic portion of the procedure. By moving the Manipuseal handle outside of the patient, the tip of the device moves, therefore positioning the cervix/uterus to provide a clearer view of the surgical field. The Manipuseal provides full anteversion, retroversion, and lateral motion for greater visibility and uterine movement. The CO2 port is made up of a standard luer connection and is color coded green for easy identification. The insufflator is connected to the luer lock connector using a standard insufflator tube with an inline filter. The insufflator's maximum deliverable pressure is 14-16 mm Hg. It is also possible to produce pneumoperitoneum by connecting the insufflator to the trocar ports (a standard laparoscopic procedure).
The provided document is a 510(k) summary for the "In Situ Systems Manipuseal," a uterine manipulator/occluder. It details the device, its intended use, predicate devices, and performance testing, among other things. However, it does not explicitly define acceptance criteria in terms of specific quantitative metrics (e.g., accuracy, sensitivity, specificity thresholds) for a device meant to be proven against such criteria.
The "studies" mentioned are limited to:
- Biocompatibility testing: This indicated the device "is biocompatible." No specific acceptance criteria or detailed results are provided.
- Occluder Balloon burst testing: This showed the balloon "can withstand burst testing up to 2.5 times the recommended inflation." No specific acceptance criteria (e.g., minimum burst pressure) or detailed results are provided.
- Clinical study: This study "demonstrated that the Manipuseal was associated with less short term morbidity and a faster recovery rate during either abdominal or vaginal hysterectomy procedures in 358 patients." No explicit acceptance criteria or detailed results beyond this qualitative statement are provided.
Given the nature of the device (a physical surgical instrument) and the context of a 510(k) submission seeking substantial equivalence to predicate devices, the "acceptance criteria" are generally implied to be that the device performs safely and effectively for its intended use, similar to the predicate devices. The studies conducted aim to demonstrate this, rather than meet specific numerical performance thresholds typically associated with AI/software devices.
Therefore, many of the requested elements for AI/software device evaluation (like sample size for test sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission for a physical medical device.
However, based on the provided text, I can extract the relevant information and indicate where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are safe for human contact. | The Manipuseal is biocompatible. |
| Occluder Balloon Burst Strength: Balloon can withstand intended and stressed inflation pressures. | The occluding balloon can withstand burst testing up to 2.5 times the recommended inflation. |
| Clinical Effectiveness/Safety: Device performs its intended function safely and effectively, comparable to predicate devices. | Associated with less short term morbidity and a faster recovery rate during either abdominal or vaginal hysterectomy procedures. |
Note: The acceptance criteria are "implied" as specific quantitative thresholds (e.g., "burst pressure must be > X mmHg") are not explicitly stated in the document.
2. Sample size used for the test set and the data provenance
- Sample Size for the Clinical Study: 358 patients.
- Data Provenance: New Zealand (retrospective or prospective status is not specified, but typically clinical studies are prospective, though the document does not confirm this.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. For a physical device like a uterine manipulator, "ground truth" as conceptualized for AI/diagnostic devices (e.g., expert consensus on image findings) is not relevant. The "ground truth" here is the clinical outcomes and safety observed in patients. Clinical judgments in the study would have been made by the surgeons and medical staff involved, who are implicitly qualified by their roles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. This concept is specific to studies where multiple readers interpret data and reconcile disagreements. For a clinical study observing patient outcomes with a physical device, this type of adjudication is not typically performed or relevant.
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
- No. This is a physical medical device, not an AI or diagnostic imaging device. An MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This question is not applicable to a physical medical device.
7. The type of ground truth used
- Clinical Outcomes/Safety Data: The "ground truth" effectively derived from patient outcomes (morbidity, recovery rate) as observed in the clinical study.
8. The sample size for the training set
- Not Applicable / Not Provided. This question is for AI/machine learning models. For a physical device, there is no "training set." The device is designed, manufactured, and then tested.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As there is no training set for a physical device, this question is not relevant.
§ 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.