(28 days)
This device is intended to regulate flow through the working channel of a ureteroscope, cystoscope, or other endoscope.
The San Antonio Stopcock is a one-way stopcock with a male luer lock adapter (MLLA) and a barbed fitting. The device is comprised of a polycarbonate body, a nylon barbed adapter, and a polyethylene valve stem. The polycarbonate stopcock body has a MLLA and a female luer adapter (FMLA). The nylon barbed fitting has a MLLA that is attached to the FMLA of the stopcock body. The polyethylene valve stem assembly is seated within the polycarbonate stopcock body and controls the flow of liquids. The San Antonio Stopcock is operated by fitting the male luer end to the female connection of the endoscope and the barbed end to an irrigation set or other tubing. The device is sold sterile and is intended for one-time use.
The provided document is a 510(k) Premarket Notification for the "San Antonio Stopcock" device. It outlines the regulatory submission, device description, indications for use, and a comparison to a predicate device. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, this document is a regulatory approval letter and summary, not a clinical study report. It states that performance and biocompatibility testing was conducted and met "pre-determined acceptance criteria," but it does not specify what those criteria were, nor does it describe the study design, sample sizes, ground truth establishment, or expert involvement.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
Cannot be fully provided. The document states:
- "Compatibility and Leakage Testing – Testing demonstrated that the San Antonio Stopcock met the compatibility requirements with supporting devices and that the device does not leak under a gravity flow test setup."
- "Biocompatibility Testing Per ISO 10993-1 and FDA guidance, testing for Cytotoxicity, Sensitization, and Intracutaneous Reactivity demonstrated that the devices are biocompatible."
- "For these tests, all pre-determined acceptance criteria were met."
However, the specific acceptance criteria (e.g., "leakage rate must be less than X mL/hr") and quantitative reported performance (e.g., "leakage rate was Y mL/hr") are not detailed in this document.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific compatibility requirements (not detailed) | Met compatibility requirements with supporting devices. |
| No leakage under gravity flow test setup (specific leakage limit not detailed) | Device does not leak under a gravity flow test setup. |
| Biocompatibility standards per ISO 10993-1 and FDA guidance for Cytotoxicity, Sensitization, and Intracutaneous Reactivity (specific thresholds not detailed) | Demonstrated biocompatibility. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Cannot be provided. The document mentions "testing" but does not specify sample sizes for any test sets, nor does it provide information on data provenance (country of origin, retrospective/prospective). While "Cook Incorporated" is based in Bloomington, IN, USA, this doesn't tell us about the test data origin.
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/Cannot be provided. These types of details are relevant for studies involving subjective interpretation or diagnostic accuracy assessments (e.g., image-based AI tools). The "San Antonio Stopcock" is a physical medical device (a valve) intended to regulate fluid flow. Its performance is assessed through objective engineering and biological tests (leakage, compatibility, biocompatibility), not through expert interpretation of data points that establish a "ground truth" in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Cannot be provided. As above, this concept typically applies to studies where multiple experts evaluate ambiguous cases and an adjudication method is used to resolve discrepancies for ground truth establishment. This is not relevant for the objective performance testing described for a physical device like a stopcock.
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 type of study (MRMC for AI assistance) is completely irrelevant for a mechanical device like a stopcock. No such study would have been performed or would be necessary for this kind of product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This question pertains to AI/algorithm performance. The San Antonio Stopcock is a physical medical device, not an algorithm. Therefore, no standalone algorithmic performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not clearly defined within the document. For the types of tests described (compatibility, leakage, biocompatibility), "ground truth" would be established by predefined engineering specifications, industry standards (e.g., ISO for biocompatibility), or direct physical measurements. For instance, a "no leakage" acceptance criterion inherently defines its own ground truth through the objective measurement of fluid escape.
8. The sample size for the training set
Not applicable/Cannot be provided. This question is relevant for machine learning or AI models which require training sets. The San Antonio Stopcock is a physically manufactured device, not an AI model. Therefore, there is no "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As stated above, there is no training set for this device.
Summary of what's provided for the San Antonio Stopcock:
- Device Type: Mechanical medical device (stopcock) for regulating fluid flow.
- Purpose of Tests: To ensure reliable design, performance, and biocompatibility in comparison to a predicate device.
- Tests Performed: Compatibility and Leakage Testing, Biocompatibility Testing (Cytotoxicity, Sensitization, Intracutaneous Reactivity).
- Outcome: All pre-determined acceptance criteria were met, supporting substantial equivalence to the predicate device.
The provided document is a regulatory piece stating that the device passed certain tests, but it does not delve into the granular details of those tests, which would typically be found in an internal design verification report or a full test protocol, not a 510(k) summary.
§ 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.