(28 days)
The Expect™ Slimline (SL) Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope. It can also be used for delivery of injectable materials (fluids) or fiducials into tissue or for passage of accessory devices.
The Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle is and endoscopic ultrasound aspiration needle that can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope with a standard luer connection and delivered into the digestive tract. The needle is used to acquire samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. An aspiration sample is obtained by penetrating the lesion with the needle while applying suction. Per manufacturer's instructions, the Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle can also be used for delivery of injectable materials (fluids) or fiducials into tissue or for passage of accessory devices.
This looks like a 510(k) summary for a medical device (an aspiration needle), not an AI/ML algorithm. Therefore, many of the requested criteria related to AI/ML software validation (like MRMC studies, training/test set ground truth, expert adjudication, etc.) are not applicable and are not present in the provided text.
The document discusses substantial equivalence to a predicate device, focusing on "technological characteristics" and "performance data" that appear to be related to physical device performance rather than software performance.
Based on the provided text, here's what can be extracted:
- Device: Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle
- Purpose: To sample targeted submucosal and extramural gastrointestinal lesions through an echoendoscope, and for delivery of injectable materials (fluids) or fiducials, or passage of accessory devices.
- Key Change: The only change to the device is an increase in the allowable fiducial marker size that is compatible with the Expect Slimline 22ga Needle, from 0.35mm OD to 0.46mm OD. The physical device itself remains unchanged from its predicate.
Here's an attempt to answer your questions based only on the provided text, noting where information is not present or relevant to this type of device:
1. A table of acceptance criteria and the reported device performance
The document states that "additional performance testing was conducted to evaluate the ability of the device design to support the proposed change" (i.e., increased fiducial size). It also mentions "Bench Testing includes simulated use testing."
However, no specific acceptance criteria values or reported performance metrics (e.g., flow rates, force requirements, successful delivery rates, etc.) are detailed in the provided K173184 summary. The summary simply concludes that "Boston Scientific Corporation has demonstrated that the proposed Expect™ Slimline (SL) is substantially equivalent to the Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K163058)." This implies that the performance met the internal criteria used to establish substantial equivalence for the altered fiducial size, but the specifics are not disclosed in this summary.
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only states "Bench testing has been performed on the proposed Expect™ Slimline (SL) device."
- Data Provenance: Not specified. "Bench testing" would typically be conducted in a lab setting, not on patient data from a specific country, and would be prospective in nature (designed and executed tests).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical medical device, not an AI/ML system requiring expert interpretation or ground truth establishment in the manner of medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human reader interpretation or clinical adjudication.
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 algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a physical device, "ground truth" would relate to its physical and functional performance specifications (e.g., successful passage of fiducials of a certain size, structural integrity, ability to aspirate, etc.), which would be verified by engineering tests and measurements, not clinical ground truth in the AI sense.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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.