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510(k) Data Aggregation
(114 days)
The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.
The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The devices are for use in professional Healthcare Facility Environment.
The device consists of a Single-use Flexible Cystoscope and a Digital Video Monitor for endoscopic image processing and displaying. They are used in conjunction with other accessories for the endoscopy and treatment of adult bladder.
The provided document, a 510(k) summary for the Hunan Vathin Medical Instrument Co. Ltd's Single-use Flexible Cystoscope and Digital Video Monitor, describes non-clinical performance testing for device acceptance and claims substantial equivalence to a predicate device. However, it does not contain information related to a study proving the device meets acceptance criteria through clinical performance metrics, multi-reader multi-case (MRMC) studies, or AI-assisted diagnostic improvements. The document focuses on bench testing, biocompatibility, electrical safety, sterilization, software validation, and cybersecurity.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including specifics on sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how training ground truth was established. This information is typically found in clinical validation studies, which are not detailed in this 510(k) summary.
The document primarily addresses the safety and fundamental performance of the device itself (e.g., optical properties, mechanical bending, material biocompatibility) rather than its diagnostic accuracy or impact on human reader performance, especially in relation to AI assistance.
Despite the lack of information to fully address your request, here's what can be extracted from the document regarding acceptance criteria for non-clinical performance:
1. A table of acceptance criteria and the reported device performance (based on non-clinical tests):
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance and Compliance |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1:2018 for "Surface - Mucosal Membrane" (< 24 hrs) for: Cytotoxicity, Irritation, Sensitization, Pyrogenicity, Acute Systemic Toxicity. | "All evaluation acceptance criteria were met." (Implies compliance with ISO 10993-1:2018 and successful completion of all listed tests without adverse findings.) |
| Electrical Safety & EMC | Complies with IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, IEC 60601-4-2. | "Electrical safety and EMC testing were conducted on the device complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2, IEC 60601-4-2 for EMC." (Implies compliance with these standards.) |
| Sterilization Validation | Validated according to ISO 11135 (EO sterilization). | "EO sterilization of the Single-use Flexible Cystoscope has been validated according to ISO 11135." (Implies successful validation meeting the standard.) |
| Shelf Life & Packaging Testing | Packaging integrity and product performance maintained after accelerated aging (ASTM F1980-21) and simulated transport (ASTM D4169-22). | "Shelf Life and Sterile Barrier System of the Single-use Flexible Cystoscope have been validated. Packaging integrity testing and product performance testing were carried out following the accelerated aging of the final devices per ASTM F1980-21 and simulated transportation distribution according to ASTM D4169-22." (Implies successful validation meeting these standards, indicating acceptable shelf life and packaging integrity.) |
| Software V&V | Compliance with FDA Guidance: "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 for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions"." (Implies compliance with FDA guidance regarding software V&V.) |
| Cybersecurity Testing | Compliance with FDA Guidance: "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". | "Cybersecurity testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions"." (Implies compliance with FDA guidance regarding cybersecurity.) |
| Bench Testing - Mechanical Performance | Meets design specifications and comparable to predicate device; in accordance with ISO 8600-1, ISO 8600-4. | "The mechanical performance testing was conducted in accordance with applicable parts of ISO 8600-1, ISO 8600-4." (Implies successful testing meeting these standards and demonstrating design specification compliance and substantial equivalence.) |
| Bench Testing - Optical Performance | Meets design specifications for: Field of view, Direction of view, Depth of field, Geometric distortion, Image intensity uniformity, Color performance, Signal-To-Noise Ratio, Dynamic Range. | "Bench testing - Optical Performance" was conducted for all listed parameters. (Implied successful completion and meeting of specifications, leading to the overall conclusion of substantial equivalence in performance.) |
| Bench Testing - Photobiological Safety | Complies with IEC 62471:2006. | "The subject device was tested according to FDA recognized standards IEC 62471:2006." (Implies successful testing and compliance with the standard.) |
2. Sample size used for the test set and the data provenance: Not applicable/Not provided. The document describes bench testing on the device itself, not a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth for clinical diagnostic performance is not discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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: Not applicable/Not provided. This device is a flexible cystoscope, not an AI-powered diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/Not provided. This device is an endoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. The "ground truth" for the non-clinical tests would be the established engineering and safety standards (e.g., ISO, IEC, ASTM) and the device's design specifications.
8. The sample size for the training set: Not applicable/Not provided. This is a hardware device, not an AI algorithm requiring a training set of data.
9. How the ground truth for the training set was established: Not applicable/Not provided.
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