(7 days)
The Expect™ EUS-FNA device is intended for sampling targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
The Expect™ Endoscopic Ultrasound Aspiration Needle (EUS-FNA) is an endoscopic ultrasound aspiration needle that can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope with a standard luer connection and adjacent to the digestive tract. The needle is used to acquire aspirate samples from within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope and acquired on suction.
The provided document describes a Special 510(k) Premarket Notification for the Expect™ Endoscopic Aspiration Needle, which focuses on demonstrating substantial equivalence to a predicate device through a modified handle design. It primarily relies on bench testing as evidence of performance.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet required specifications for the modified handle design. | Bench Testing has been performed on the Expect™ EUS-FNA device to demonstrate that the modified handle design met the required specifications for the completed tests. |
Explanation: The document does not explicitly list distinct, quantifiable acceptance criteria with numerical targets. Instead, it states that bench testing was performed to ensure the modified handle design met the required specifications for the completed tests. This implies that the 'acceptance criteria' were integrated into the specifications for each bench test performed, and the device passed these tests. Without further information about the specific "required specifications," it's impossible to provide a more detailed table.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "bench testing," but does not provide details on the number of samples or trials conducted.
- Data Provenance: Not specified, but generally, bench testing is conducted in a laboratory setting by the manufacturer (Boston Scientific Corporation). The document doesn't provide information on country of origin for data or whether it's retrospective or prospective, as these terms are typically applied to clinical studies, not bench tests for mechanical modifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Bench testing for a modified handle design does not typically involve human experts to establish "ground truth" in the way clinical studies do. The "ground truth" would be the engineering specifications and performance metrics established by the manufacturer.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used in studies where multiple human readers or interpreters assess data to establish a definitive diagnosis or finding. This is not relevant for bench testing of a mechanical device modification. The "adjudication" in this context would be the pass/fail result against established engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. The document does not mention any MRMC comparative effectiveness study. The study presented here is limited to bench testing of a modified handle design.
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No. This section is not applicable as the device is a mechanical endoscopic aspiration needle, not an algorithm or AI system. Its performance is directly tied to a human operator's use. The "standalone" performance, in a purely mechanical sense, would refer to the device's physical properties and function as demonstrated in bench testing.
7. The Type of Ground Truth Used
- Type of Ground Truth: Engineering specifications and performance metrics established by the manufacturer. For a mechanical device, "ground truth" during bench testing refers to the objective, measurable standards and requirements that the device must meet (e.g., tensile strength, flexibility, fluid flow rates, usability of handle), which are set based on design requirements and safety standards.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document describes a Special 510(k) based on bench testing of a modified handle design for a medical device. There is no mention of a "training set" as would be used for machine learning algorithms. The development and refinement of the handle design would involve iterative engineering and testing, but not in the context of a "training set" as understood in AI studies.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set in the context of this device and study type.
§ 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.