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The Schoelly Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with intracorporeal pneumatic, ultrasound, electrohydraulic or laser lithotripters.

The Schoelly Ultra-Mini Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with laser lithotripters.

The proposed Schoelly Nephroscope Family comprises two different application sets: One set for Percutaneous Nephrolithotomy (PCNL) with the trade name "Schoelly Nephroscope Set'' and one set for Mini PCNL with the trade name "Ultra-Mini Nephroscope Set".

Both sets include a rigid, reusable endoscope (nephroscope) that is used in conjunction with a commercially available and approved light guide, light source. video camera, monitor, and printer. Light guide, light source, video camera, monitor, and printer are not included in the scope of delivery and are further not within the scope of this application.

In case of both sets, the nephroscope is accompanied by corresponding accessories to allow for access and passage of the nephroscope and retrieval instruments and for irrigation. Those include compatible endoscopic sheaths, obturators, and bridges.

The Schoelly Nephroscope Set and the Schoelly Ultra-Mini Nephroscope set are delivered in non-sterile conditions and have already obtained CE mark.

The provided document describes the Schoelly Nephroscope Set and Schoelly Ultra-Mini Nephroscope Set and claims substantial equivalence to predicate devices. It does not present a study proving the device meets specific performance acceptance criteria in terms of clinical outcomes or diagnostic accuracy in humans.

Instead, the performance data section focuses on engineering and biocompatibility testing to demonstrate the device's safety and functionality in a technical sense, aligning with established medical device standards.

Here's an analysis based on the information provided:

1. Table of acceptance criteria and reported device performance:

   Performance Metric (Acceptance Criteria Implicitly Met)	Reported Device Performance (as per testing)
   Temperature (specified in IEC 60601-2-18)	Measured surface temperatures at various locations using different light sources reached steady state and met requirements specified in IEC 60601-2-18.
   Optical Parameters (specified in ISO 8600)	Tested for all relevant optical parameters (e.g., field of view and direction of view accuracy) and met requirements specified in ISO 8600.
   Biocompatibility (according to ISO 10993)	A series of biocompatibility tests (cytotoxicity, sensitization, acute systemic toxicity) demonstrated that patient-contacting components are biocompatible.
   Reprocessing - Cleaning (AAMI TIR12:2010, AAMI	Reprocessing validations completed, including manual and automated cleaning. These studies were performed in accordance with AAMI TIR12:2010, AAMI TIR30:2011, and ANSI/AAMI ST15883-1:2009.
   Reprocessing - Sterilization (ISO 14937:2009,	Reprocessing validations completed, including steam sterilization. These studies were performed in accordance with ISO 14937:2009, ANSI/AAMI ST81:2004, ISO 17664:2004, and ANSI/AAMI/ISO 17665-1:2006.
   Electrical Safety (IEC 60601-2-18)	The device is stated to be IEC 60601-2-18 compliant, indicating it meets electrical safety standards.

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

   • Test Set Sample Size: Not applicable in the context of clinical studies. The document describes device testing (temperature, optical, biocompatibility, reprocessing) which involves physical samples of the device components, not a patient test set. No patient data is involved in these reported performance tests.
   • Data Provenance: The tests conducted are laboratory-based engineering and biological compatibility tests. They are not derived from patient data or clinical settings. The document implies these tests were conducted by the manufacturer (Schoelly Fiberoptic, GmbH) as part of their submission to the FDA.

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

   • Not applicable. These are engineering and safety tests against predefined standards (e.g., IEC, ISO, AAMI TIR), not clinical studies requiring expert ground truth for diagnostic accuracy.

4. Adjudication method for the test set:

   • Not applicable. This concept applies to clinical studies where expert consensus might be needed for diagnosis or outcome measurement. The reported tests are objective measurements against specified technical standards.

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:

   • No MRMC or AI-related study was done or is mentioned. The device is a traditional endoscope (nephroscope) and its accessories, not an AI-powered diagnostic tool.

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

   • Not applicable. The device is a surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" for the reported performance evaluations is defined by international and national standards for medical device safety, performance, and reprocessing (e.g., IEC 60601-2-18, ISO 8600, ISO 10993, AAMI TIR, ISO 17664). The device's performance is compared against the technical specifications and requirements outlined in these standards.

8. The sample size for the training set:

   • Not applicable. The device is a physical instrument, not an AI algorithm that requires a training set.

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

   • Not applicable, as there is no training set mentioned or implied for this type of device submission.

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The Schoelly CMOS Video Nasopharyngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhinoflaryngoscopic technique. The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor.

The Schoelly CMOS Video Nasopharyngoscope System consists of a flexible and steerable endoscope and a camera control unit (CCU) for regulation of light intensity and connection to a monitor, PC, medical video recorder or printer for image display or image documentation.

The endoscope has outer surfaces mainly made from plastic. The endoscope handle incorporates a control lever to bend the distal tip and an integrated LED light source. Light is transmitted through fiberoptic bundles illuminating the anatomy under investigation. The video signal is captured by a CMOS imaging sensor located at the tip of the endoscope shaft and transferred to the CCU.

The endoscope further incorporates a ventilation system to protect the shaft. The exhaust valve at the endoscope handle can further be used for leakage testing. For this purpose the system is accompanied by a leakage tester and accessories.

The Schoelly CMOS Video Nasopharyngoscope System is delivered in a non-sterile condition and is already CE marked.

The provided document K132009 for the Schoelly CMOS Video Nasopharyngoscope System is a 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria based on studies involving clinical outcomes or diagnostic performance metrics like sensitivity, specificity, or AUC.

Therefore, the document does not contain the information requested regarding acceptance criteria related to diagnostic performance or image interpretation, nor does it describe a study assessing such performance (like a standalone study or MRMC study).

The "acceptance criteria" mentioned in the document refer to general safety and performance standards for a medical device of its type, confirmed through non-clinical testing, rather than criteria for diagnostic accuracy or human reader improvement.

Here's a breakdown of why each requested point cannot be addressed from the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document states, "Performance data demonstrated that the Schoelly CMOS Video Nasopharyngoscope System has met pre-determined acceptance criteria and is substantially equivalent to the predicate devices." However, these acceptance criteria are related to engineering, safety (IEC standards), biocompatibility (ISO 10993), and reprocessing validation, not image interpretation performance or diagnostic accuracy.

2. Sample size used for the test set and the data provenance: Not applicable. There is no diagnostic "test set" described as the submission is for a device for visualization, not for an AI/CAD system or a diagnostic tool requiring such a test set. The non-clinical tests involved physical device testing, reprocessing validation, and electrical safety, not the analysis of medical images or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment experts are mentioned because there's no diagnostic test set being evaluated.

4. Adjudication method: Not applicable. No adjudication is mentioned for diagnostic results.

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 type of study is for evaluating AI-assisted diagnostic tools. The Schoelly CMOS Video Nasopharyngoscope System is a visualization device, not an AI or CAD system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is not an algorithm that would have standalone performance.

7. The type of ground truth used: Not applicable. No diagnostic ground truth is established or used for performance evaluation in this 510(k). The evaluation is around the physical and functional aspects of the endoscope itself.

8. The sample size for the training set: Not applicable. There is no AI component, and thus no training set.

9. How the ground truth for the training set was established: Not applicable. There is no AI component, and thus no training set or ground truth establishment for it.

In summary, the provided 510(k) document for the Schoelly CMOS Video Nasopharyngoscope System is a regulatory submission for a medical device (endoscope) that emphasizes substantial equivalence to predicate devices based on non-clinical engineering, safety, and reprocessing performance, rather than clinical diagnostic performance metrics and studies involving image interpretation by human experts or AI.

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The Scholly Flexiscope IQ 101 is indicated for video visualization of sites in conjunction with endoscopic devices.

Not Found

This document is a 510(k) clearance letter for the Schoelly Flexiscope IQ 101, an endoscope and accessories. This type of FDA letter does not include detailed studies and acceptance criteria as it's a clearance based on substantial equivalence to a predicate device, not a de novo approval or PMA which would involve extensive clinical trial data.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, and expert qualifications is not available in this document.

The document only states:

• Device Name: Schoelly Flexiscope IQ 101
• Indications for Use: The Schoelly Flexiscope IQ 101 is indicated for video visualization in conjunction with endoscopic devices.

To provide the information requested, a premarket approval (PMA) application or a de novo submission would typically be required, which would contain detailed clinical and non-clinical studies. This 510(k) merely establishes substantial equivalence to a previously cleared device.

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The Flexiscope Optomodul is indicated for use during dental in the country bear when a video image is desired. The Flexiscope Optomodul Is Indreason 2007 - 100 mm a video image is desired.

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I am unable to answer your request. The provided text is a 510(k) premarket notification letter from the FDA to Schoelly Fiberoptic, GmbH regarding their Flexiscope Optomodul device. This letter indicates that the FDA has reviewed the device and determined it to be "substantially equivalent" to predicate devices already on the market.

However, a 510(k) notification does not contain the acceptance criteria or the study that proves the device meets those criteria. Instead, it's a notification seeking to demonstrate that a new device is as safe and effective as a legally marketed predicate device. The detailed performance data and acceptance criteria would be part of the technical documentation submitted by the manufacturer to the FDA, but they are not included in this letter.

Therefore, I cannot extract the information required to populate the table and answer your questions based on the provided text.

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