(280 days)
The Endoscopic Water Pump is a peristaltic pump intended to supply fluid to compatible endoscopes or endotherapy devices for irrigation of the gastric and colonic mucosa during endoscopic or endotherapeutic procedures, allowing to aid in visualisation, diagnosis and treatment.
AGS's Endoscopic Water Pump comprises:
- A host machine (including drive system, peristaltic pump head, housing, etc.); -
- Operating component (Rotatable Knob and Footswitch); -
- -Hanger assembly(optional);
- -An irrigation tube (optional)
The Endoscopic Water Pump is a motorized pump designed to transfer water from a bottle, via a tube, to an endoscope or EndoTherapy devices, and the pump is operated by a footswitch. It uses a peristaltic pump head to move the water through the tube. The speed of the rotation of the pump head is adjustable by the user, using flow control knob on the front of the pump.
The provided text is a 510(k) summary for the Endoscopic Water Pump. It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence. However, it does not contain information about acceptance criteria, a study that proves the device meets acceptance criteria, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.
The document explicitly states:
- "No Clinical test is included in this submission." (CH2.03.9)
- And for Performance Data: "The Endoscopic Water Pump meets all design specifications and medical device standards for electrical safety and EMC (IEC 60601), and the Irrigation tube meet the standard for sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." (CH2.03.8)
This indicates that the submission relies on adherence to design specifications and recognized standards, along with non-clinical performance (which is not detailed as a specific study with acceptance criteria in the requested format), rather than a clinical study or a study directly comparing algorithm performance against specific acceptance criteria.
Therefore, most of the requested information cannot be extracted from this document.
Here's a summary of what can be inferred or directly stated from the provided text, along with the information that is not present:
1. A table of acceptance criteria and the reported device performance
- Not present in the requested format. The document states the device "meets all design specifications and medical device standards" and "non-clinical performance meets the design specification." It also provides a comparison of technical characteristics and performance with the predicate device (Table CH2.03.6), primarily focusing on maximum output flow for different endoscope types. However, explicit acceptance criteria with corresponding performance metrics are not presented in a table.
2. Sample sized used for the test set and the data provenance
- Not present. No test set or data provenance is mentioned as a clinical study was not performed. The performance evaluation seems to be based on engineering tests and adherence to standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not present. Since no clinical test or test set requiring ground truth was conducted, this information is not available.
4. Adjudication method for the test set
- Not applicable / Not present. Since no clinical test or test set requiring ground truth was conducted, this information is not available.
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 / Not present. This device is an Endoscopic Water Pump, a hardware device, not an AI or software device that assists human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not present. This is a hardware device; the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not present. As no clinical study or test set requiring ground truth was performed, this information is not relevant.
8. The sample size for the training set
- Not applicable / Not present. This is a hardware device, not a machine learning model, so there is no training set in the typical sense.
9. How the ground truth for the training set was established
- Not applicable / Not present. This is a hardware device, not a machine learning model, so there is no training set or ground truth for it.
Information provided in the document related to performance:
-
Performance Comparison (from Table CH2.03.6, "Performance" row):
- Proposed device (AGS):
- Maximum output flow is generally higher than the predicate device.
- For endoscopes with an auxiliary water channel and using irrigation tube AG-5247-3.2: approx. 240~248ml/min at flow setting 10 (maximum) with a new pump head. Recommended flow settings: 1-10.
- For instrument channel flushing (GIF-Q260, 2.8mm diameter channel): approx. 240~258ml/min at flow setting 10 (maximum) with a new pump head. Recommended flow settings: 1-10.
- Predicate device (Olympus OFP-2):
- Water feed controlled by footswitch. Flow rate variable, controlled from front panel.
- For endoscopes with an auxiliary water channel and using tube MAJ-1608/MAJ-1651 (CF-Q180AL): approx. 230ml/min at flow setting 9 (maximum) with a new pump head. Recommended flow settings: 1-6.
- For instrument channel flushing (1) (CF-Q260AL/DL, 3.2mm diameter channel): approx. 785ml/min at flow setting 9 (maximum) with a new pump head. Recommended flow settings: 5-9.
- For instrument channel flushing (2) (GIF-Q260, 2.8mm diameter channel with 2.5mm ultrasound probe): approx. 100ml/min at flow setting 9 (maximum) with a new pump head. Recommended flow settings: 5-9.
- Comparison Note: The proposed device's maximum output flow is higher than the predicate. The submission states that "we confirmed that the proposed device can meet the clinical requirements through simulate the clinical use of proposed device," and that "the simulation test in Section 12 demonstrates the substantial equivalence of the Endoscopic Water Pump." (Section 12 is not provided in the excerpt).
- Proposed device (AGS):
-
Shelf Life:
- Proposed device: 5 years for host machine, 3 years for irrigation tubes.
- Predicate device: Unknown.
- Comparison Note: "we conducted the shelf life validation in Section 14 which can prove that the difference of shelf life doesn't raise different questions regarding its safety and effectiveness." (Section 14 is not provided in the excerpt).
-
Sterility/Single Use:
- Proposed device irrigation tube: Sterile supplied, Single use.
- Predicate device irrigation tube: MAJ-1608, MAJ-1651 is single day use item; MAJ-1607, MAJ-1681, MAJ-1682 is single use. MAJ-1651, MAJ-1681 and MAJ-1682 supplied sterile.
-
Biocompatibility:
- Proposed device materials contacting human body: ABS, PVC, PC. Biocompatibility tested to ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021.
- Predicate device: Biological information unknown.
- Comparison Note: "biological risks are acceptable, please refer to Section 15." (Section 15 is not provided in the excerpt).
In conclusion, the document emphasizes compliance with standards and non-clinical performance assessments rather than a detailed study with specific acceptance criteria and ground truth in the context of diagnostic accuracy, which would be typical for an AI/CADe device.
§ 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.