(202 days)
OES CYSTONEPHROFIBERSCOPEs OLYMPUS CYF-5 and CYF-5R have been designed to be used with an Olympus light source, documentation equipment, display monitor. EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra and kidney.
The subject device consists of three parts: the control section, the insertion section, the eyepiece section. The basic principle including user interface and operation for the procedure of the subject device are identical to that of the predicate device.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device: OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5 and CYF-5R. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on its performance in diagnosing or treating a condition.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria for diagnostic/treatment performance. This is because the device is an endoscope used for diagnosis and treatment within the bladder, urethra, and kidney, and the 510(k) submission primarily addresses the safety and performance of the device itself (e.g., sterilization, biocompatibility, electrical safety, optical performance) compared to a predicate device, not its clinical efficacy in a specific diagnostic task like an AI model would for detecting a disease.
Specifically:
- No acceptance criteria or device performance for diagnostic accuracy/effectiveness are mentioned. The performance data section focuses on physical and technical aspects of the endoscope.
- No clinical study for demonstrating substantial equivalence was performed. The document explicitly states: "No clinical study was performed to demonstrate substantial equivalence." This means there was no study involving human patients to show the device's diagnostic or therapeutic effectiveness in a real-world setting, and thus no related acceptance criteria for such a study.
- No information on ground truth establishment, expert consensus, or MRMC studies is provided. These are typically associated with AI/diagnostic software applications.
Here's what is provided regarding acceptance criteria and performance data for the device's physical and technical aspects:
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the document's structure):
The document reports bench testing results to ensure the device performs as intended and meets design specifications. While explicit "acceptance criteria" are not listed in a table, the types of performance tests conducted imply that certain thresholds or standards were met. The "Reported Device Performance" is stated implicitly as having "met design specifications."
| Test Category | Specific Tests Conducted | Implied Acceptance Criteria (not explicitly stated as numerical values) | Reported Device Performance (implicit) |
|---|---|---|---|
| Reprocessing | Reprocessing instruction and method validation testing | Compliance with FDA guidance "Reprocessing Medical Devices in Health Care Setting" (e.g., efficacy of cleaning, disinfection, sterilization) | Compliant, documented |
| Biocompatibility | Cytotoxicity, Intracutaneous, Sensitization, Pyrogen, Acute Systemic Toxicity | Compliance with ISO 10993-1 and specific test standards (e.g., non-toxic, non-irritating, non-pyrogenic) | Compliant |
| Electrical Safety & EMC | Electrical safety (ANSI/AAMI ES 60601-1, IEC 60601-2-18) | Compliance with standards for patient and user safety | Compliant |
| Performance (Bench) | Thermal Safety, Composite Durability, Color Performance, Photobiological Safety, Image Intensity Uniformity, Resolution, Field of View / Direction of View | Device performs as intended and meets design specifications (e.g., images are clear, resolution is adequate, components are durable, colors are accurate, no thermal hazards) | Met design specifications |
| Risk Management | Not a test, but a process followed in accordance with ISO 14971:2007 | Identified and mitigated risks; acceptance criteria identified and performed for design verification tests | Performed, led to verification tests |
2. Sample Size for Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of diagnostic performance measured by patient cases. The "test set" here refers to the device prototypes or production units that underwent bench, reprocessing, and biocompatibility testing. The exact number of units tested is not specified but is implicitly sufficient for the tests performed.
- Data Provenance: The tests are performed on the device itself. Manufacturing sites are in Japan (Shirakawa Olympus Co., Ltd., Aizu Olympus Co., Ltd.). The tests are likely conducted in controlled laboratory environments. No patient data (retrospective or prospective) is involved for this type of submission.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable as this is a device clearance for an endoscope, not an AI or diagnostic software where ground truth based on expert review of clinical data would be established. The "ground truth" for the device's technical performance is established by standardized engineering and medical device testing protocols and their respective acceptance limits.
4. Adjudication Method for Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are for establishing ground truth in clinical datasets, usually for diagnostic AI.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was done. The document explicitly states "No clinical study was performed to demonstrate substantial equivalence." An MRMC study would be relevant for demonstrating the effect of an AI device on human reader performance, which doesn't apply here.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This is a physical medical device (an endoscope), not a software algorithm with standalone performance metrics.
7. Type of Ground Truth Used:
- The "ground truth" for this submission is based on engineering specifications, regulatory standards (e.g., ISO, IEC, FDA guidances), and pre-defined test parameters. For example, a "resolution" test would have a defined target resolution, which serves as the ground truth.
8. Sample Size for Training Set:
- Not applicable. This device is not an AI model that requires a training set.
9. How Ground Truth for Training Set was Established:
- Not applicable for the same reason as above.
§ 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.