Search Results

Single-Use Digital Flexible Ureteroscope (F-URS)(ZSR-URS-02, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) : This product is used in medical institutions, in conjunction with our electronic endoscope image processor. for imaging in examination, diagnosis or treatment of urinary system diseases.

Endoscope Imaging Processor (ZSR-EOS10) : Applicable to medical institutions, which are connected with electronic endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors.

Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) Single-Use Digital Flexible Ureteroscope (F-URS) is used in medical institutions, in conjunction with our electronic endoscope image processor, for imaging in examination, diagnosis or treatment of urinary system diseases. This device uses ethylene oxide (EO) sterilization process. This product consists of two main parts: an operating handle with directional control and connecting wires, as well as a flexible insertion tube.

Electronic Endoscope Imaging Processor (ZSR-EOS10) Applicable to medical institutions, which are connected with electronic endoscopes during endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors. The device is composed of aluminum alloy chassis and motherboard and power supply components.

The Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) and Electronic Endoscope Imaging Processor make up the video ureteroscope system.

The provided text is for a 510(k) premarket notification for a Single-Use Digital Flexible Ureteroscope (F-URS) and an Electronic Endoscope Imaging Processor. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive clinical trials. Therefore, the information regarding acceptance criteria and performance studies will differ significantly from what would be found in a submission for a new AI/software device that requires proving clinical benefit.

Based on the provided text, here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance for this device is based on substantial equivalence to existing predicate devices, not on specific performance metrics established as acceptance criteria for clinical efficacy. The "acceptance criteria" here refer to meeting recognized standards for medical devices of this type, ensuring safety, and demonstrating that any differences from the predicate do not raise new questions of safety or effectiveness.

Discussion of Differences (from Comparison Table, if differences existed):
The document states for "Maximum insertion portion width(mm)" and "Field of view (degree)" that these are "Similar" or "Same" after analysis, concluding that "Only differences in specifications and dimensions. All the performance was tested and the results met the standard requirements, this difference will not raise any issues in safety and effectiveness." This indicates that any numerical differences in these parameters were evaluated against the relevant standards and found to be acceptable.

2. Sample size used for the test set and the data provenance

The document explicitly states: "No clinical study is included in this submission."

Therefore, there is no "test set" in the context of clinical data. The testing performed was non-clinical bench testing to demonstrate compliance with recognized industry standards and evaluate engineering performance, biocompatibility, and sterilization effectiveness.

• Sample Size for Bench Testing: The document does not specify the exact number of units or samples used for each non-clinical test (e.g., how many ureteroscopes were tested for bending angle, how many samples for biocompatibility). This level of detail is typically found in the full test reports, not the 510(k) summary.
• Data Provenance: The data provenance is from non-clinical laboratory and bench testing, likely conducted by the manufacturer or accredited testing facilities. There is no mention of country of origin for this testing, but it can be inferred the testing supports a device manufactured by Dongguan ZSR Biomedical technology Company Limited in the PEOPLE'S REPUBLIC OF CHINA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical study was conducted, there was no clinical "test set" requiring expert ground truth establishment. The "ground truth" for the non-clinical tests is defined by the objective metrics and thresholds established in the referenced international standards (e.g., ISO, IEC, ASTM).

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring an adjudication method.

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. This device is a physical medical instrument (ureteroscope and imaging processor), not an AI/software device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical instrument, not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for this 510(k) submission is derived from:

• International Standards and Recognized Test Methods: For performance, biocompatibility, and sterility, the ground truth is compliance with the specifications and thresholds defined in the referenced standards (e.g., ISO, IEC, ASTM).
• Predicate Device Characteristics: For determining substantial equivalence, the technological characteristics and performance of the legally marketed predicate device (K230200) serve as a baseline for comparison.

8. The sample size for the training set

Not applicable. This device is a physical medical instrument, and no machine learning algorithm development (which would require a training set) is mentioned or implied.

9. How the ground truth for the training set was established

Not applicable. There was no training set.

Ask a specific question about this device

The Disposable Ureteral Guide Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract

The propose device, Disposable Ureteral Guide Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. This device is divided into 4 types: Straight type (ZSR-UA), Y type (ZSR-UAY), W type (ZSR-UAW), Cross type (ZSR-UAC). The device is composed of guide sheath and dilator.The guide sheath consists of guide sheath tube and connector (straight, Y-shaped, W-shaped and cross-shaped). The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

The provided text describes the 510(k) premarket notification for a medical device called the "Disposable Ureteral Guide Sheath." It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing. The document does not detail a study proving the device meets acceptance criteria related to AI/algorithm performance or human reader improvement.

Therefore, I cannot provide information on acceptance criteria for AI performance, sample sizes for AI test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI. These sections are not relevant to the provided text.

However, I can extract information regarding the non-clinical performance testing acceptance criteria and results as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

For non-clinical performance testing, the document refers to compliance with standards. The 'Discussion' section under 'Comparison of technological characteristics with the predicate devices' (Table 1) provides some insight into the performance aspects considered, although explicit numerical acceptance criteria are not always stated, rather the outcome of testing.

2. Sample Size Used for the Test Set and Data Provenance

This document describes non-clinical engineering and bench testing, not a clinical study involving a "test set" of patient data in the way an AI/ML device would.

• Sample Size: Not explicitly stated as a grand total for testing. For specific tests like "Coefficient of Friction," it mentions "25 repeated tests." For "Bending Resistance," it mentions "20 times of repetition."
• Data Provenance: This is bench test data, not patient data. The country of origin for the manufacturing company is Dongguan ZSR Biomedical technology Company Limited, China. The testing would have been conducted as part of their device development and validation process. It is neither retrospective nor prospective in the context of patient data studies; it's product validation testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study involving expert readers establishing ground truth for diagnostic accuracy, but rather bench testing against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or clinical adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not pertain to an AI-assisted diagnostic device, nor does it describe an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This document does not pertain to an algorithm, AI, or software device. It is for a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing described would be the engineering specifications and industry standards (e.g., specific force values for tensile strength, visual inspection for defects after bending, a defined Sterility Assurance Level). For biocompatibility, the 'ground truth' is compliance with the ISO 10993 series of standards.

8. The Sample Size for the Training Set

Not applicable. This is for a physical device, not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this type of device.

Ask a specific question about this device