(46 days)
The EndoCure Model EUR078A has been designed for endoscopic observation and diagnosis within both the urinary tract (ureter, renal pelvis, and renal calyx) and biliary tract (common bile duct and hepatic duct). Therapeutic endoscopic procedures using various kinds of accessories are also possible, and include the ability to extract or fragment stones within these organs.
EndoCure Model EUR078A is used during the examination / procedure as an ureteroscope. The ureteroscope is an instrument for examining the inside of the urinary tract. The ureteroscope is used to see beyond the bladder into the ureters, the tubes that carry urine from the kidneys to the bladder. Through the ureteroscope, the doctor can see a stone in the ureter and then remove it with a small basket at the end of a wire inserted through an extra channel in the ureteroscope. Another way to treat a stone through an ureteroscope is to extend a flexible fiber through the scope up to the stone and then, with a laser beam projected through the fiber, break the stone into smaller pieces that can then pass out of the body in the urine. The EndoCure Model EUR078A ureteroscope is not designed for or intended to be used with electro-surgical (cautery) devices due to the metal distal tip.
The provided text is a 510(k) summary for the EndoCure Model EUR078A endoscope, aiming to demonstrate its substantial equivalence to a predicate device, the Olympus URF-P2 Ureterorenofiberscope/Choledochofiberscope.
The document does not contain information about a study proving the device meets acceptance criteria in the context of AI-powered performance or a comparative effectiveness study with human readers. Instead, it focuses on non-clinical testing to demonstrate safety and performance of the physical medical device (endoscope).
Therefore, I cannot fulfill most of your request related to AI device performance, sample sizes for test sets, expert adjudication, MRMC studies, or standalone algorithm performance.
However, I can extract the non-clinical testing performed for this medical device related to its safety and general performance.
Here's what can be extracted from the document regarding the acceptance criteria and tests for the physical endoscope device:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical targets in a table format for performance metrics. Instead, it lists the types of non-clinical tests performed, implying that successfully passing these tests demonstrates the device's acceptable safety and performance. The performance metrics of the device are compared directly to the predicate device in a table format.
| Parameter | Acceptance Criteria (Implied: Substantial Equivalence / Compliance with Standards) | Reported Device Performance (EndoCure Model EUR078A) | Predicate Device Performance (Olympus URF-P2) | Similarities and Differences |
|---|---|---|---|---|
| Intended Use | Substantially equivalent to predicate | For endoscopic observation and diagnosis within urinary tract (ureter, renal pelvis, renal calyx) and biliary tract (common bile duct, hepatic duct). Therapeutic procedures (extract/fragment stones) also possible. | Same as EndoCure Model EUR078A | Substantially equivalent indications for use |
| Field of View | Identical to predicate (90 degrees) | 90 degree | 90 degree | Identical |
| Depth of View | Identical to predicate (1-50mm) | 1-50mm | 1-50mm | Identical |
| Optical System | Identical to predicate (Fiberoptic Bundle) | Fiberoptic Bundle | Fiberoptic Bundle | Identical |
| Distal End Outer Diameter | Compared to predicate | 7.3 French (2.43mm) | 9.3 French (3.1mm) | Difference in distal end outer diameter |
| Insertion Tube O.D. | Compared to predicate | 8.4 French (2.8mm) | 9.9 French (3.3mm) | Difference in insertion tube O.D. |
| Bending Angulation | Compared to predicate | Up:270/Down:270 | Up:180/Down:180 | Difference in bending angulation |
| Channel Inner Diameter | Identical to predicate (1.2mm) | 1.2mm | 1.2mm | Identical |
| Working Length | Identical to predicate (700mm) | 700mm | 700mm | Identical |
| Biocompatibility | Compliance with ISO 10993 Standards | Performed tests (listed below) | Not specified in summary, but assumed for predicate | Demonstrated compliance through specific tests (e.g., cytotoxicity, irritation, sensitization, systemic toxicity) |
| Electrical Safety/EMC | Compliance with IEC 60601-1 and IEC 60601-1-2 | Performed tests (listed below) | Not specified in summary, but assumed for predicate | Demonstrated compliance through specific tests |
| Endoscopic Equipment Safety | Compliance with IEC 60601-2-18 | Performed tests (listed below) | Not specified in summary, but assumed for predicate | Demonstrated compliance through specific tests |
| Material Analysis | Not explicitly defined, but implies characterization (FTIR, SEM) | Performed tests (FTIR, SEM Analysis) | Not specified in summary | Material characterization performed |
| Angulation Flex | Not explicitly defined, but implies functional testing | Performed test | Not specified in summary | Functional test performed |
| Optical Metrics | Compliance with ISO 8600-3 (field of view, direction of view) | Performed test | Not specified in summary, but assumed for predicate | Test performed according to standard |
| Physical Dimensions | Compliance with ISO 8600-4 (maximum width of insertion portion) | Performed test | Not specified in summary, but assumed for predicate | Test performed according to standard |
2. Sample size used for the test set and the data provenance:
- This information is not provided in the document. The non-clinical tests typically involve testing of device prototypes or representative samples, but the specific number of units tested for each test is not detailed.
- Data provenance (country of origin, retrospective/prospective) is also not applicable to this type of non-clinical device testing, which usually takes place in a laboratory or test facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information is not applicable as the document describes non-clinical engineering and biological safety testing, not AI performance evaluation that requires expert human ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for non-clinical device testing. Expert adjudication methods are used in clinical studies or AI performance evaluations to establish ground truth from human interpretations.
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:
- No, an MRMC comparative effectiveness study was not done as this document pertains to the 510(k) clearance of a physical medical device (endoscope), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance test was not done as this document relates to a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground truth in this context refers to the objective measurements and established standards against which the device's physical and biological performance is measured. For example, for biocompatibility, the ground truth is the absence of cytotoxicity, irritation, sensitization, or systemic toxicity as defined by ISO 10993 standards and observed in the biological test models. For optical parameters, the ground truth is the measurement according to ISO 8600 series standards.
8. The sample size for the training set:
- Not applicable. This relates to manufacturing and testing of a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.