(85 days)
The Schoelly Cystoscopes/Hysteroscopes and Accessories with additional Optical Grasping Forceps (51-0575a) and Optical Scissor (51-0576a) are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The Schoelly Cystoscopes/Hysteroscopes and Accessories with additional Optical Grasping Forceps (51-0575a) and Optical Scissor (51-0576a) are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.
The Schoelly Cystoscope/Hysteroscope and Accessories comprise several models of rigid endoscopes as well as rigid endoscopic sheaths, obturators, and instrument bridges; the currently marketed system also includes a flexible grasping forceps. This Premarket Notification adds two rigid cystoscope/hysteroscope accessories (optical scissors and optical grasping forceps), both of which have been designed and are intended for use with the currently marketed Schoelly 4mm rigid cystoscope/hysteroscope and 20Fr sheath cleared in K150158. There are no changes to any of the other system components or accessories, nor are there any changes to the Schoelly Cystoscope/Hysteroscope and Accessories indications for use. The optical scissors and optical grasping forceps accessories both consist of a rigid shaft with an inner lumen that accommodates the 4mm Schoelly Cystoscope/Hysteroscope. The outer diameter and the working length of both accessories are 4.6mm and 266mm, respectively. During application, the scissor or the forceps can be attached to the cystoscope via a simple mechanical locking located at the very proximal portion of the devices. The scissor or grasper is then inserted through a 20Fr Schoelly Cystoscope/Hysteroscope Sheath while being connected to the Schoelly Cystoscope/Hysteroscope. Another mechanical locking mechanism allows the user to lock all three coaxial components (scope, scissor/grasper accessory, and sheath) together. The scissor and grasper accessories incorporate a control handle. Operation of the control handle actuates the distal tip double action jaws via a pull wire mechanism. The optical scissor and grasper accessories are made entirely of stainless steel. The accessories are reusable instruments that are supplied nonsterile.
The provided text is a 510(k) premarket notification for a medical device. It describes the acceptance criteria for a new device and its accessories (optical grasping forceps and optical scissors) and states that testing was performed to confirm substantial equivalence to a predicate device. However, it does not provide the detailed results of a study to prove the device meets those acceptance criteria in the format requested, particularly for AI/machine learning aspects.
The document discusses non-clinical performance testing. It indicates that the device has met "pre-determined acceptance criteria" but does not define these criteria numerically or provide the raw or summarized performance data against them. There is no mention of AI or machine learning in this submission.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions that "Design verification and validation activities included the following: Physical/functional/bench testing (cutting performance, gripping performance, ease of movement, visibility in the endoscope image)..." and later concludes that the device "meet all the pre-determined acceptance criteria of the testing performed to confirm substantial equivalence." However, the specific acceptance criteria (e.g., "cutting performance must be >= X cycles," or "grip strength must be >= Y N") and the actual measured device performance against these criteria are not provided in this document.
2. Sample sized 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 document refers to "testing performed" but does not elaborate on the sample sizes for physical/functional/bench testing, biocompatibility, or reprocessing validation.
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 is not applicable as the document describes a physical medical device (cystoscopes/hysteroscopes and accessories) and refers to non-clinical performance testing, not studies involving human interpretation or AI using ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document describes a physical medical device and non-clinical performance testing, not studies involving human interpretation or AI.
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 is not applicable. The document describes a physical medical device; there is no mention of AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The document describes a physical medical device; there is no mention of an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. The document describes non-clinical performance testing of a physical medical device. The "ground truth" would be the engineering specifications and test standards for physical attributes like cutting force, grip strength, material properties, and reprocessing efficacy.
8. The sample size for the training set
This is not applicable. The document describes a physical medical device and non-clinical testing, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. See point 8.
Summary of available information from the document:
Here's a table based on the limited information that can be inferred regarding performance criteria and the claim of meeting them, acknowledging the absence of specific numerical acceptance criteria and performance data:
| Criterion Type | General Acceptance Criteria Mentioned (Not Specific Numerical) | Claimed Device Performance |
|---|---|---|
| Physical/Functional Performance | - Cutting performance | "Meet all the pre-determined acceptance criteria" (specifics not provided) |
| - Gripping performance | "Meet all the pre-determined acceptance criteria" (specifics not provided) | |
| - Ease of movement | "Meet all the pre-determined acceptance criteria" (specifics not provided) | |
| - Visibility in the endoscope image (for optical accessories) | "Meet all the pre-determined acceptance criteria" (specifics not provided) | |
| Biocompatibility | - Cytotoxicity | "Testing as per 10993-1:2018" (implies met relevant standards) |
| - Irritation | "Testing as per 10993-1:2018" (implies met relevant standards) | |
| - Sensitization | "Testing as per 10993-1:2018" (implies met relevant standards) | |
| - Acute systemic toxicity | "Testing as per 10993-1:2018" (implies met relevant standards) | |
| - Material mediated pyrogenicity | "Testing as per 10993-1:2018" (implies met relevant standards) | |
| Reprocessing Validation | - Cleaning validation (AAMI TIR12:2010, AAMI TIR30:2011, FDA Guidance) | "Reprocessing validations for new accessories" (implies met relevant standards) |
| - High level disinfection validation (ASTM E 1837:96, FDA Guidance) | "Reprocessing validations for new accessories" (implies met relevant standards) | |
| - Sterilization validation (ISO 17664:2017, ANSI/AAMI/ISO 17665-1:2006, FDA Guidance) | "Reprocessing validations for new accessories" (implies met relevant standards) | |
| - Performance testing (visual inspection, ease of movement, cutting performance) after reprocessing | "Reprocessing validations for new accessories" (implies met relevant standards) |
Conclusion: The provided document is a 510(k) summary for a traditional medical device (cystoscopes/hysteroscopes and accessories) and details the types of non-clinical tests performed to demonstrate substantial equivalence to a predicate device. It explicitly states that the device "meet all the pre-determined acceptance criteria" but does not provide the specific numerical acceptance criteria or the study results/data that would allow for a detailed fulfillment of your request regarding device performance against acceptance criteria. Crucially, it does not involve AI/machine learning, human readers, or structured ground truth beyond standard engineering/biocompatibility testing.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.