(57 days)
P-Scope is intended to be used in diagnostic and therapeutic procedures for endoscopy within the peritoneal cavities including the female reproductive organs.
The device contains two separate functioning components. First is the single-use, sterile P-scope device, which includes camera mounted on a 3 or 5 mm rigid shaft and reusable high-definition video display includes ports such as USB and HDMI, which allow for connections to external high-definition video screens. This feature enables the surger and more detailed view of the surgical field during the procedure.
In summary, the P-scope combines the single-use laparoscope device with a high-definition video camera for imaging, and a reusable video display with an image processor for displaying the video feed, along with connectivity options to external video screens.
The provided text is a 510(k) summary for the medical device P-Scope. This document focuses on demonstrating that the P-Scope is "substantially equivalent" to legally marketed predicate devices, primarily through non-clinical testing. It explicitly states that "The subject devices do not require clinical studies to support the determination of substantial equivalence."
Therefore, based solely on the provided text, there is no information available regarding acceptance criteria related to AI performance, sample sizes for test sets (as no clinical test sets were used for AI evaluation), expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details. The 510(k) summary concerns the physical endoscope device and its safety/performance, not an AI component.
To fulfill your request, I must state what can be extracted from the document concerning the device's validation against its intended use, even if it doesn't involve AI.
Here's an interpretation based on the provided text, highlighting the absence of information related to AI-specific criteria, as the document doesn't pertain to an AI device:
Device: P-Scope (Endoscope)
Regulatory Submission: K241502
Based on the provided K241502 510(k) summary, the P-Scope device's acceptance criteria and proven performance relate to its physical and functional attributes as an endoscope, not to an AI component or its performance. The document explicitly states that "The subject devices do not require clinical studies to support the determination of substantial equivalence." Therefore, no information regarding AI-specific acceptance criteria or human-AI interaction studies is present.
The study that proves the device meets the acceptance criteria is detailed as non-clinical bench testing, EMC, and electrical safety testing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI Related):
| Acceptance Criteria Category | Specific Criteria (Implicitly based on standards) | Reported Device Performance (Summary) |
|---|---|---|
| Physical Design | - Single-use, sterile laparoscope with camera mounted on 3 or 5 mm rigid shaft | - Device has these physical characteristics |
| Imaging System | - High-definition video camera | - Integrated |
| - LED lighting for illumination | - Used for clear visibility | |
| - Resolution of 160K pixels (400x400) | - Achieved, noted as lower than predicate but wider FoV | |
| - 120° Field of View (FoV) | - Achieved | |
| Display Unit | - Reusable high-definition video display | - Integrated |
| - USB and HDMI ports | - Functioning for external connections | |
| Sterility | - Provided sterile (typically via EO gas) | - Achieved |
| Biocompatibility | - Biocompatible as per ISO 10993 standards | - Achieved |
| Safety (Electrical) | - Conformity to IEC 60601-1-2:2014+A1:2020 (EMC) | - Successfully completed |
| - Conformity to IEC/TR 60601-4-2:2016-05 (EMC) | - Successfully completed | |
| - Conformity to ANSI AAM ES 60601-1:2005+A1:2020 (Electrical safety) | - Successfully completed | |
| - Conformity to IEC 60601-2-18:2009 (Electrical safety) | - Successfully completed | |
| Performance (Bench) | - Conformity to ISO 8600-1 "Endoscopes — Medical endotherapy devices — Part 1: General requirements" | - Successfully completed |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set: No patient or image data test sets were used, as the validation was based on non-clinical bench testing of the physical device.
- Data Provenance: Not applicable for a non-clinical, non-AI device validation. The testing was conducted in accordance with international and FDA-recognized standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. Ground truth in the context of AI/diagnostic accuracy was not established, as no clinical test set was used and there is no AI component. The validation focused on engineering specifications and safety standards met through bench testing.
4. Adjudication Method for the Test Set:
- Not applicable. No human-interpreted test sets requiring adjudication were involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not conducted because:
- The device is an endoscope, not an AI image analysis system.
- The submission explicitly states, "The subject devices do not require clinical studies to support the determination of substantial equivalence."
6. Standalone Performance (Algorithm Only without Human-in-the-Loop):
- Not applicable. There is no algorithm or AI component to report standalone performance for.
7. Type of Ground Truth Used:
- Not applicable. For this submission, "ground truth" refers to the engineering specifications and performance benchmarks outlined in the referenced international standards (e.g., ISO 8600-1, IEC 60601 series). The device's performance was measured against these predefined physical and electrical safety parameters.
8. Sample Size for the Training Set:
- Not applicable. There is no AI component, and thus no training set was used.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no AI component or training set.
In summary, the provided FDA 510(k) summary for the P-Scope pertains to a conventional medical device (an endoscope) and not an AI-powered device. Therefore, the questions related to AI-specific acceptance criteria, test sets, ground truth establishment, and human-AI studies are not addressed by this document. The device's acceptance criteria are met through adherence to established engineering, safety, and performance standards via non-clinical bench testing.
§ 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.