Search Results
Found 2 results
510(k) Data Aggregation
(247 days)
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter and kidney.
This endoscope is composed from flexible insertion tube, control section, light guide connector and video connector, and equipped CCD for image transfer system.
URF-V2R has identification marking for opposite bending direction on the control section and the bending section of the URF-V2R moves in the direction opposite to the conventional endoscopes, such as the URF-V2.
The Olympus URF-V2/V2R is a uretero-reno videoscope designed for endoscopic diagnosis and treatment within the ureter and kidney. The device was deemed substantially equivalent to its predicate device (Olympus XURF Type V, K072957) based on non-clinical testing.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence through compliance with recognized standards and non-clinical testing, rather than reporting specific performance metrics against pass/fail acceptance criteria. The "acceptance criteria" are generally the successful fulfillment of the requirements in the listed standards.
| Acceptance Criteria (General) | Reported Device Performance Statement |
|---|---|
| Risk Analysis (ISO 14971:2007) | "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment." |
| Biocompatibility (ISO 10993 Series) | "Biocompatibility testing is performed in accordance with the FDA Guidance. Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process' issued on June 16 2016." |
| Performance Testing | "Performance testing was carried out to verify the safety and the effectiveness of the subject device. The results of the above performance testing demonstrated that the subject device has no concerns on safety and effectiveness." (Specific enumerated performance metrics are not provided in this summary, but the general conclusion of satisfactory performance is stated). |
| Reprocessing Validation (FDA Guidance) | "The reprocessing validation test was performed in accordance with the FDA guidance 'Guidance for Industry and FDA Staff - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling issued on March 17, 2015'" |
| Software Validation (FDA Guidance) | "The software validation activities were performed in accordance with the FDA Guidance, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' issued on May 11, 2005." |
| Electromagnetic Compatibility & Electrical Safety (IEC 60601 Series) | "Electromagnetic compatibility and electric safety have been validated in accordance with FDA`s currently recognized standards." (Specifically lists AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012; IEC 60601-1-2 Edition 4.0: 2014-02; IEC 60601-2-18 Edition 3.0: 2009-08). |
| Overall Safety and Effectiveness | "The technological characteristic differences between the predicate device and the subject device have been confirmed that they are substantially equivalent through the following tests and standards... The results of the above performance testing demonstrated that the subject device has no concerns on safety and effectiveness... Therefore, the subject device is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical testing (bench testing, biocompatibility, reprocessing validation, software validation, EMC/electrical safety) to demonstrate substantial equivalence. It does not refer to a "test set" in the context of clinical data or patient samples. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) for such a set is not applicable or provided in this K-submission summary, as the study appears to be entirely non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Since this submission relies on non-clinical testing and engineering validation, there is no mention of experts establishing a "ground truth" in the context of clinical images or patient data. The ground truth for engineering tests would be derived from physical measurements, standard compliance, and established engineering principles.
4. Adjudication Method for the Test Set:
Given that the testing is non-clinical and does not involve human readers evaluating a test set of medical cases, an adjudication method is not applicable and not mentioned.
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 document describes the regulatory submission for an endoscope (a physical device), not an Artificial Intelligence (AI) software. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and not mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
As the device described is a physical endoscope and not an AI algorithm, a standalone algorithm performance study is not applicable and not mentioned.
7. The type of ground truth used:
The "ground truth" in this context refers to the verifiable outcomes of non-clinical tests. This includes:
- Compliance with specific requirements outlined in international standards (e.g., ISO 14971 for risk management, ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and EMC).
- Successful completion of defined performance tests (e.g., mechanical durability, optical parameters).
- Validation against FDA guidance documents for reprocessing and software.
Essentially, the ground truth is established through rigorous engineering and laboratory testing against predetermined specifications and regulatory guidelines rather than clinical outcomes or expert consensus on medical cases.
8. The Sample Size for the Training Set:
The document does not refer to a "training set" as it is not an AI/machine learning device. The "training" in the context of device development refers to manufacturing processes and quality control, not data training. Therefore, information on a training set sample size is not applicable.
9. How the Ground Truth for the Training Set was Established:
As there is no "training set" in the AI/ML context, the method for establishing its ground truth is not applicable.
Ask a specific question about this device
(91 days)
The PolyScope Flexible Endoscope is indicated in flexible endoscopic procedures for diagnostic and therapeutic applications where flexible endoscopes are standard of care including:
- Gastroenterology, including procedure of the Biliary system involving the hepatic and pancreatic ducts.
- Urology, including procedures involving the bladder, ureter, renal pelvis and kidney.
The PolyScope Xenon-Endoscopic light source LS 200 provides white examination light (sunlight spectrum) for all endoscopic applications including:
- During video endoscopy.
- During fiber endoscopy.
- During micro-endoscopy.
- During endoscopy using rigid optics.
- During usage of forehead illumination.
The PolyScope Flexible Endoscope is comprised from two main components: a disposable, flexible, steerable mini-endoscope and a flexible, modular, reusable optical disposable, Holters, etc. to the catheter to allow the visualization of the desired area.
The PolyScope LS 200 XENON-Endoscopic light source provides white examination light (sunlight spectrum) for all endoscopic applications including:
- During video endoscopy.
- During fiber endoscopy.
- During micro-endoscopy.
- During endoscopy using rigid optics.
- During usage of forehead illumination.
The provided text is a 510(k) summary for the PolyScope Flexible Endoscope and PolyScope Xenon Light Source. It focuses on establishing substantial equivalence to predicate devices based on intended use, general design, and fundamental scientific technology. There is no information provided regarding specific acceptance criteria or a study proving the device meets performance metrics in the way a clinical study would for an AI-powered device.
Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving the device meets those criteria, as the document doesn't contain that type of information.
The document discusses:
- Device Description and Intended Use: Clearly outlines what the devices are and what they are used for.
- Predicate Devices: Identifies the legally marketed devices to which the PolyScope devices are compared for substantial equivalence.
- Technological Characteristics Summary & Substantial Equivalence Statement: Asserts that the subject devices share the same intended use, general design, and fundamental scientific technology as their predicates.
- Performance Data Summary: States that "appropriate testing including safety, performance and functional testing" was conducted, but does not provide any specific criteria, results, or study details. This typically refers to bench testing, electrical safety, biocompatibility, and sterilization validations, which are not outlined in the provided text.
Specifically, the following information you requested is not available in the provided text:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed.
- Sample size used for the test set and the data provenance: No test set details are provided.
- 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 or test set with ground truth is described.
- Adjudication method for the test set: Not applicable.
- 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 device is an endoscope and light source, not an AI-powered diagnostic device, so an MRMC study is not relevant here.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
Page 1 of 1