(60 days)
ab medica Irrigation/Suction Gravity System is indicated for use in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
ab medica Irrigation/Suction Gravity System is intended for irrigation and suctioning of the surgical field during laparoscopic surgery. This device is intended to be used in the operating room and by surgeons only. The system consists of control handpiece pre-connected to a tubing set and removable cannula. The tubing set and the 5 mm and 10 mm cannulae are single-use devices and provided in sterile condition. Only the 3 mm reusable cannula is provided non sterile. The system is used during laparoscopic surgery to deliver sterile irrigation fluids and/or to produce suction to evacuate blood and small tissue debris, and t o maintain a clear view of the surgical site. Irrigation and suctioning functions are provided through the cannula, which is inserted to the surgical site by means of a trocar, and are manually controlled by surgeon through the control valves on the handpiece.
The provided text describes a medical device called the "ab medica irrigation/suction gravity system" and its 510(k) premarket notification to the FDA. The information primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of AI/ML performance.
However, based on the non-clinical simulated use testing mentioned, we can infer the acceptance criteria and the study that was likely performed to demonstrate performance. The document explicitly states:
"Non-clinical simulated use testing was performed to verify safety and effectiveness as compared to the predicate. Performance testing, including irrigation and suction flow rate, verified that the abmedica irrigation/suction gravity system is substantially equivalent to the predicate Core Dynamics devices and raises no new issues of safety and effectiveness."
Given this, the acceptance criteria would be that the device's performance (specifically irrigation and suction flow rates) is substantially equivalent to the predicate device.
Here's an attempt to structure the answer based on the provided text, recognizing that some information is not directly available because the document focuses on regulatory approval rather than a detailed scientific study publication:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Irrigation flow rate is substantially equivalent to the predicate (Core Dynamics, Inc. Laparoscopic/suction/irrigation probe). | "Performance testing, including irrigation and suction flow rate, verified that the abmedica irrigation/suction gravity system is substantially equivalent to the predicate Core Dynamics devices and raises no new issues of safety and effectiveness." (Specific numerical values for flow rates are not provided in this summary document). |
| Suction flow rate is substantially equivalent to the predicate (Core Dynamics, Inc. Laparoscopic/suction/irrigation probe). | "Performance testing, including irrigation and suction flow rate, verified that the abmedica irrigation/suction gravity system is substantially equivalent to the predicate Core Dynamics devices and raises no new issues of safety and effectiveness." (Specific numerical values for flow rates are not provided in this summary document). |
| No new issues of safety and effectiveness compared to the predicate device. | "Performance testing...raises no new issues of safety and effectiveness." This implies the device performed similarly to the predicate without introducing new risks or underperforming. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not explicitly stated. The study involved "non-clinical simulated use testing." This typically refers to bench testing rather than patient data.
- Data provenance: "Non-clinical simulated use testing." This indicates lab-based testing rather than patient data from a specific country. It is not retrospective or prospective in the sense of clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical device performance study (irrigation/suction flow rates) rather than an AI/ML diagnostic or prognostic study requiring expert ground truth for interpretation. The ground truth would be the measurement standards for flow rates.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for performance testing of physical device characteristics. Measurements of flow rates would presumably be adjudicated by comparing against predetermined engineering specifications or predicate device performance.
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 device is an irrigation/suction system, not an AI/ML diagnostic tool, so MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm, but a physical medical device. The "standalone" performance testing refers to the device's functional characteristics (flow rates) in a simulated environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For "irrigation and suction flow rate" performance testing, the ground truth would be established by:
- Validated measurement instruments: Devices used to measure fluid flow and suction pressure, calibrated against known standards.
- Predicate device performance: The performance of the legally marketed predicate device (Core Dynamics, Inc. probe and tubing set) as a benchmark for "substantial equivalence."
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. This device does not involve a machine learning training set.
§ 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.