(63 days)
The locking device is an accessory used with endoscopic devices to lock the wire guide(s) in place during endoscopic procedures (e.g. ERCP). The integrated biopsy cap is designed to prevent reflux of body fluids.
The CleverLock Guidewire Locking Device and Biopsy Cap is an accessory used with compatible endoscopic devices to lock the wire guide(s) in place during endoscopic procedures. The two components of the device are the guidewire locking device and the biopsy cap. The skirt portion of the locking device is designed to attach to the biopsy port located on the endoscope barrel. The rigid skirt is matched to fit the scope handle to prevent its rotating during a wire engagement or disengagement. The lock arm has three (3) locking mechanisms (wire slots): inner slot, outer slot and lower slot to accommodate up to three (3) guidewires. The locking feature has a geometry which results in an "audible" click with tactile feedback when the wire has been fully engaged. The biopsy cap is comprised of a cap seal and inner seal. The cap seal sits on top of the locking device skirt. The cap seal is designed with a self-closing slit to minimize fluid passage when all devices are removed from the biopsy channel. The inner seal attaches to the snap fit portion of the locking device; and is designed with a round opening to minimize fluid passage when there is a device inserted into the biopsy channel. The CleverLock Locking Device and Biopsy Cap is available in one model only (MAJ-2455). The proposed CleverLock Locking Device and Biopsy Cap will be sold sterile and is intended for single patient use only.
The provided text describes the "CleverLock Guidewire Locking Device and Biopsy Cap" and its substantial equivalence to a predicate device. It includes information on non-clinical testing, but it does not contain the specific details required to fully address your request, particularly regarding clinical studies, acceptance criteria for performance metrics, sample sizes for test and training sets for an AI/algorithm, expert qualifications, or multi-reader multi-case studies.
The device described is a physical medical device, not an AI/algorithm. Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set," are not applicable.
Below is an attempt to answer the relevant parts based on the provided text, and I will explicitly state when the information is unavailable.
Acceptance Criteria and Study for CleverLock Guidewire Locking Device and Biopsy Cap
The provided 510(k) summary focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device. It does not describe an AI/algorithm, therefore, many of the typical acceptance criteria and study details for AI-powered devices are not present.
1. A table of acceptance criteria and the reported device performance
The document details various bench tests performed, but it does not explicitly state specific numerical acceptance criteria or reported performance values for each test. The "Conclusion" section only broadly states that the device is "substantially equivalent" and "presents no new questions of safety or effectiveness," implying that the device met internal performance specifications without providing the quantitative details.
| Test Name | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|---|
| Scope Engagement Test | Implicitly, device must properly engage with scope. | Implied successful performance as per conclusion. |
| Wire Locking Force Test | Implicitly, sufficient force to lock guidewire. | Implied successful performance as per conclusion. |
| Wire Retention and Lock Removal | Implicitly, secure retention and easy removal. | Implied successful performance as per conclusion. |
| Insertion Force Test | Implicitly, acceptable insertion force. | Implied successful performance as per conclusion. |
| Leak Test | Implicitly, minimal fluid passage/no excessive leakage. | Implied successful performance as per conclusion. |
| Brush, Unlocking Test | Implicitly, proper function during brushing. | Implied successful performance as per conclusion. |
| Angle Test | Implicitly, function across relevant angles. | Implied successful performance as per conclusion. |
| Decay Test | Implicitly, maintain function over time. | Implied successful performance as per conclusion. |
| Biocompatibility | Compliance with ISO-10993 standards. | "Biocompatibility Tests passed" |
| Sterilization | Compliance with specified ANSI/AAMI/ISO standards. | "Sterilization Validation passed" |
| Packaging Integrity | Compliance with ANSI/AAMI/ISO 11607-1. | "support a labeled three-year shelf life" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is primarily non-clinical bench testing. Details on the number of samples tested for each bench test, or any "data provenance" in the sense of patient data, are not disclosed.
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)
This information is not applicable as the device is a physical medical device, not an AI/algorithm that requires expert-established ground truth for a test set. The validation relies on engineering and biological testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the described testing does not involve human interpretation or adjudication in the context of an AI/algorithm's output.
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
This information is not applicable as the device is a physical medical device, not an AI system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical medical device, not an AI algorithm. Its performance is inherent in its design and manufacturing, validated through bench testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biological aspects (biocompatibility, sterilization), the "ground truth" is defined by compliance with established international standards (ISO, USP, ANSI/AAMI/ISO). For the mechanical/performance tests, the "ground truth" would be the device meeting pre-defined engineering specifications and functional requirements as determined by the manufacturer's design verification process. No "expert consensus," "pathology," or "outcomes data" in the clinical sense is mentioned for the evaluation of this specific device's performance.
8. The sample size for the training set
This information is not applicable as the device is a physical medical device, not an AI/algorithm that undergoes training.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical medical device, not an AI/algorithm that undergoes training.
§ 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.