(9 days)
The SpyScope Access and Delivery Catheter is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the biliary system including the hepatic ducts.
The SpyScope Access and Delivery Catheter is a sterile, single-use device comprised of two main components: a flexible delivery catheter and a handle. The device is intended to be used to guide both the SpyGlass Direct Visualization Probe (K050403) or other visualization devices and accessory devices, (such as biopsy forceps, cytology brushes, stone retrieval baskets, etc.) during endoscopic retrograde cholangiopancreatography (ERCP) procedures. The SpyScope Access and Delivery Catheter is introduced to the desired anatomical location through a duodenoscope with a minimum working channel diameter of 4.2mm. The distal tip of the SpyScope Access and Delivery Catheter is designed to articulate in four directions.
The provided text is a 510(k) summary for the Boston Scientific SpyScope Access and Delivery Catheter and generally contains information for regulatory clearance. It describes the device, its intended use, and substantial equivalence to predicate devices based on technological characteristics and performance data.
However, the document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving device performance against those criteria in the way you've outlined for typical AI/ML device studies. This document predates the widespread use of AI/ML in medical devices and therefore doesn't address metrics like sensitivity, specificity, or reader studies.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- The document implies that "bench testing was conducted to evaluate the design features... and establish specifications of the descriptive characteristics." However, it does not explicitly list these specifications (acceptance criteria) or the precise performance values measured against them.
- The "performance data" section is very general, stating that these specifications "were used to demonstrate substantial equivalence."
| Acceptance Criteria (Implied from text) | Reported Device Performance (Implied from text) |
|---|---|
| Design features and descriptive characteristics (e.g., articulation, working channel, control knobs, locking mechanism) | Met all established specifications, demonstrating substantial equivalence to predicate devices (Olympus SwingTip Cannula, Olympus CHF Type BP30 Choledochofiberscope). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. The document states "bench testing was conducted," but provides no details on sample size for the test set or data provenance (e.g., simulated scenarios, actual device samples, number of cycles tested for durability, etc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not present. This type of information is relevant for studies involving human interpretation (e.g., radiology images) or clinical outcomes where expert consensus or adjudication defines the "ground truth." For a mechanical device like a catheter, "ground truth" performance is typically established through engineering specifications and physical testing, not expert consensus on medical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not present. Adjudication methods are used in reader studies or clinical trials to resolve discrepancies in expert opinions, which is not relevant for this type of bench testing.
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 a catheter, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is purely mechanical and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance would be derived from engineering specifications and physical measurements obtained during bench testing. For example, testing the articulation range, working channel diameter, material strength, and durability against predefined engineering standards. The document only generally states that "specifications of the descriptive characteristics" were established.
8. The sample size for the training set
- Not applicable/Not present. Since this device does not involve AI or machine learning, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
In summary:
The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the SpyScope Access and Delivery Catheter to predicate devices based on design and functional characteristics, supported by general bench testing. It does not provide the detailed performance metrics, study designs, expert involvement, or AI/ML-specific information that your request implies. This is typical for a 510(k) from 2005 for a mechanical 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.