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510(k) Data Aggregation
(93 days)
The Ureterorenoscope System has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopic surgery within urinary tract and interior of the kidney.
The Ureterorenoscope System consists of a single-use Ureterorenoscope(HU30S) to provide illumination and intuitive images in endoscopy and endoscopic surgery within urinary tract and interior of the kidney and serves as a guide to diagnosis and management with accessories and an image processor, previous clearly by K231118, for clinical image processing.
The single-use Ureterorenoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image processor processes the images from the Ureterorenoscope and outputs video signals to a display.
The provided text is a 510(k) summary for the Ureterorenoscope System. It primarily focuses on demonstrating substantial equivalence to a predicate device based on bench performance, biocompatibility, sterilization, and electrical safety.
Crucially, the document explicitly states "Clinical study: Not applicable." This means that the submission did not include a study that proves the device meets specific acceptance criteria based on clinical performance with human subjects, especially concerning AI-driven functionalities for diagnosis or assistance.
Therefore, I cannot provide details regarding acceptance criteria for a study related to AI performance, sample size for a test set, ground truth experts, adjudication methods, MRMC studies, or standalone algorithm performance, as such a study was not part of this 510(k) submission.
The "performance data" section (Section 8 of the 510(k) summary) details various engineering and safety tests, not clinical efficacy or AI performance.
Below is a breakdown of what can be extracted from the provided text regarding device performance, categorized to best fit your request, while acknowledging the absence of AI-specific clinical study data.
Table of Acceptance Criteria and Reported Device Performance (Based on Bench Testing and Safety Standards)
Since no clinical study data for AI performance is present, the "acceptance criteria" here refer to compliance with various engineering, safety, and manufacturing standards. The "reported device performance" indicates that the device met these standards.
| Acceptance Criteria Category | Specific Criteria/Standard (Implicitly Met) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Assessed in accordance with FDA guidance "Use of International Standard ISO 10993-1" and International Standard ISO 10993-1. (Implies meeting cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogens criteria). | "Biocompatibility of the single-use Ureterorenoscope was evaluated in accordance with the FDA guidance... and International Standard ISO 10993-1... as recognized by FDA." (Implies compliance and passing of tests). |
| Sterilization & Shelf Life | Sterilization Process validated according to ISO 11135:2014. EO/ECH residual test performed according to ISO 10993-7:2008. Shelf-life determined based on optical/performance testing after accelerated aging (ASTM F1980-16). Package validation according to ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1886/F1886M-16, ASTM F88/F88M-15, ASTM F1929-15. (3-year shelf life). | "Sterilization Process has been validated accordance with ISO 11135:2014. EO/ECH residual test was performed according to ISO 10993 - 7:2008. The shelf life is determined based on optical testing and product performance testing affer accelerated aging test according to ASTM F1980 - 16... Package validation was conducted according to ISO 11607..." (Implies compliance and validated 3-year shelf life). |
| Electrical Safety & EMC | Compliance with IEC 60601-1 (general medical electrical equipment safety), IEC 60601-2-18 (endoscopic equipment safety), and IEC 60601-1-2 (EMC). | "The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC." |
| Software Verification & Validation | Compliance with FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions." | "Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance..." (Implies compliance). |
| Bench Performance (Optical) | Optical performance testing according to ISO 8600 series. Color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, SNR, dynamic range, image frame frequency, system delay. (Compared with predicate device). | "Optical performance testing according to ISO 8600 series. Color performance (color reproduction), geometric distortion, optical performance (resolution, depth of field and image intensity uniformity). SNR and dynamic range, image frame frequency and system delay test compared with the predicate device." (Implies satisfactory performance comparable to predicate). |
| Bench Performance (Mechanical/Physical) | Water resistance, deflection, leakage, and flow rate. | "Mechanical testing including water resistance, deflection, leakage and flow rate." (Implies satisfactory performance). |
| General Equivalence Characteristics (Non-Test) | Same sterilization method, energy source, principle of operation, and similar design with same parameters (FOV, DOV, deflection angle). | "The device has the same sterilization method, energy source, principle of operation and similar design with same parameters such as FOV, DOV, deflection angle etc." (Stated as characteristic for substantial equivalence). |
Regarding AI-Specific Questions (Not Applicable Based on Provided Text):
- Sample size used for the test set and the data provenance: Not applicable. No clinical test set data from an AI study is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth data from an AI study is provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set data from an AI study is provided.
- 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: Not applicable. The document explicitly states "Clinical study: Not applicable."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical ureterorenoscope system, not a standalone AI algorithm for diagnostic interpretation in this submission.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for AI performance. The ground truth for bench testing is defined by engineering specifications and measurements against the predicate device.
- The sample size for the training set: Not applicable. There is no mention of an AI training set.
- How the ground truth for the training set was established: Not applicable. There is no mention of an AI training set or its ground truth establishment.
In summary, this 510(k) submission for the Ureterorenoscope System focuses on the physical and functional aspects of the endoscope and image processor, along with compliance to relevant safety and performance standards, rather than clinical performance from an AI perspective.
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