(340 days)
The Nam illumination probe with chopper is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and manipulation during cataract surgery.
This product transmits light through the optical fiber to the inside of the eye to illuminate the intraoperative field of the eyeball. It consists of tube, handle, optical fiber, fiber cloth, and connector.
Please note that the provided document is a 510(k) summary for the "Nam illumination probe with chopper," a non-powered device used for illumination during cataract surgery. These types of devices typically do not involve the same kind of performance studies (e.g., diagnostic accuracy, reader studies) as AI/ML-driven or image-analyzing software as a medical device (SaMD).
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for a diagnostic/AI performance study with corresponding performance metrics like sensitivity, specificity, or AUC. Instead, the performance data focuses on demonstrating the device's physical and biological safety, and benchtop performance against relevant standards.
| Test Category | Standard/Method | Purpose/Performance |
|---|---|---|
| Sterilization & Shelf-life | ISO 11135 | EO sterilization validation |
| ASTM F1980-16 | Shelf-life testing | |
| USP | Sterility testing | |
| ISO 10993-7 | EO residual testing | |
| USP | Endotoxin testing | |
| Biocompatibility | ISO 10993-5 (Cytotoxicity) | Demonstrated acceptable cytotoxicity |
| ISO 10993-10 (Skin Irritation, Sensitization) | Demonstrated acceptable skin irritation and sensitization | |
| ISO 10993-11 (Acute systemic toxicity) | Demonstrated acceptable acute systemic toxicity | |
| USP (Endotoxin) | Demonstrated acceptable endotoxin levels | |
| USP (Material Mediated Pyrogenicity) | Demonstrated acceptable material-mediated pyrogenicity | |
| Electrical safety/EMC | Not Applicable | Not a powered device |
| Software V&V | Not Applicable | Device does not include software or firmware |
| Mechanical & Acoustic Testing | ISO 15004-1 & ISO 15752 | Performance testing (Specific metrics not detailed, but results supported substantial equivalence) |
| ASTM D4169-16 | Shipping validation | |
| Benchtop Performance | ISO 15752:2010 and ISO 15004-2:2007 | Benchtop performance testing (Specific metrics not detailed, but results supported substantial equivalence in terms of illumination and functionality as an endoilluminator) |
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 applicable or not provided in the document. The studies conducted are primarily benchtop or laboratory-based (sterilization, biocompatibility, mechanical performance) on the device itself, rather than studies involving patient data or a "test set" in the context of diagnostic accuracy.
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 studies are not diagnostic performance studies requiring expert ground truth for patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the studies are not diagnostic performance studies requiring adjudication of ground truth.
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 MRMC study was conducted. This device is an illumination probe, not an AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done as this is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically defined for diagnostic or AI performance studies is not applicable here. The "truth" for the performance data presented (e.g., sterility, biocompatibility, mechanical properties) is established by adherence to recognized international standards (ISO, ASTM, USP) and validated laboratory testing methodologies.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML 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.