(115 days)
The “candidate device” is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures.
The "candidate device" is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage.
The MultApump™ System is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures.
The “candidate device” consists of a Disposable Pump Head, pump motor, clamp & bracket, power supply and power cord(s) for use in laparoscopy. The Disposable Pump Head is a sterile, single-use device, composed of Stainless Steel, glass filled Polypropylene, Medical Grade EPDM, ABS plastic, plastic and flexible PVC tubing. It has an interface dock for attachments of the reusable pump motor. The pump motor, clamp, power supply and power cord are reusable components.
This 510(k) summary does not contain the detailed information required to describe the acceptance criteria and a study proving the device meets those criteria, as typically expected for AI/ML-enabled devices.
The document discusses a traditional medical device (an irrigation pump) and focuses on substantial equivalence to a predicate device based on its intended use and technological characteristics rather than performance metrics from a specific study.
Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study details, sample sizes, expert ground truth, or MRMC studies, as this information is not present in the provided text.
Based on the provided text, here's what can be inferred (and what cannot):
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The document states that the "candidate device has the same technological characteristics as a legally marketed predicate device." It claims comparability based on features, specifications, materials, and mode of action. However, it does not define specific performance metrics or acceptance criteria (e.g., flow rate accuracy, pressure limits, sterile barrier integrity) that would typically be evaluated in a study for this type of device. There are no performance results reported.
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable/Not specified. This document describes a traditional device notification, not a study involving a test set of data.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/ML device, and no ground truth establishment by experts for a test set is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication method is described.
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/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth is mentioned in the context of a performance study.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
Summary of available information from the text provided:
The provided text is a 510(k) summary for a traditional medical device, the MultApump™ System, an irrigation pump used in laparoscopic surgical procedures. The submission focuses on demonstrating substantial equivalence to a predicate device (Davol (Bard) - K961492) based on its intended use and technological characteristics.
The document states:
- The candidate device provides "controlled powered irrigation during laparoscopic surgical procedures."
- It is explicitly stated that "The candidate device has the same technological characteristics as a legally marketed predicate device. Specifically, the features, specifications, materials, and mode of action are equivalent."
The notification includes an "MANUFACTURER'S STATEMENT OF SUBSTANTIAL EQUIVALENCE" which reiterates the intended use and states that "The candidate device has the same technological characteristics as a legally marketed predicate device."
Crucially, the document does not describe any specific performance study with acceptance criteria, test sets, or data analysis typically associated with evaluating the performance of AI/ML-enabled devices. The clearance (K981940) was granted based on the determination of substantial equivalence to an existing device rather than a detailed performance study with quantifiable metrics.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.