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The CoralWell™ Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.

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This FDA 510(k) clearance letter for the CoralWell™ Single-use Ureteral Access Sheath does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria.

The letter is a regulatory document confirming that the FDA has reviewed MacroLux Medical Technology Co., Ltd.'s premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It outlines various regulatory requirements the manufacturer must adhere to (e.g., Quality System regulation, UDI Rule, adverse event reporting), but it does not detail performance testing or clinical studies.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document.
2. Sample sized used for the test set and the data provenance: Not available. The document is about regulatory clearance, not performance testing details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available, as no performance study is described.
4. Adjudication method: Not available.
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 device is a physical medical instrument (ureteral access sheath), not an AI/software device. Therefore, an MRMC study with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as it's not an algorithm.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not applicable, as this is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

To obtain information about performance criteria and testing for such a device, one would typically need to review the actual 510(k) submission summary or a separate technical document from the manufacturer, which would contain details of bench testing, biocompatibility studies, and potentially animal or clinical performance data if submitted. The clearance letter itself is a summary of the FDA's regulatory decision, not a detailed technical report.

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The SeleneView® (model: HC29, HC29-G, HC35, HC35-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures.

The SeleneView® (model: HO35, HO35-G, HO42, HO42-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures.

SeleneView® is intended for use in professional healthcare facility environments such as hospitals and clinics. SeleneView® is designed for use in adults.

SeleneView® Single-Use Digital Hysteroscope consists of a handle, insertion and endoscope cable. SeleneView® is provided sterile (sterilized by ethylene oxide [EO]) and intended to be single-use.

The built-in light emitting diode (LED) at the distal tip of SeleneView® Single-Use Digital Hysteroscope provides a light source, the lens module captures the light signal, then the complementary metal-oxide-semiconductor (CMOS) image module converts the light signal into an electrical signal; the endoscope cable connects SeleneView® Video Processor, which provides power and processes video signal from the endoscope.

The SeleneView® is intended to be used combined with ViewHub® Video Processor to perform its intended function and the ViewHub® has been 510(k) cleared in K233779.

SeleneView® Single-Use Digital Hysteroscope has the following physical and performance characteristics:

• Camera and LED light source at the distal tip

• Sterilized by Ethylene Oxide

• For single-use

This FDA 510(k) summary describes the "SeleneView® Single-Use Digital Hysteroscope" and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI-powered diagnostic device.

The document focuses on non-clinical tests demonstrating the device's technical performance, sterility, biocompatibility, and electrical safety, comparing these aspects to a predicate hysteroscope. It explicitly states in section {6} related to non-clinical tests that "It is concluded form the nonclinical tests that the subject devices are as safe, as effective, and perform as well as the legally marketed predicate device identified above to support a substantial equivalence determination." This implies that the device is being cleared based on its equivalence in fundamental operating principles and safety features, not on the performance of a diagnostic algorithm meeting specific acceptance criteria for a clinical outcome.

Therefore, I cannot provide the requested table and information as it is not present in the provided text. The document does not describe an AI component or a study with clinical endpoints that would involve ground truth, expert adjudication, or sample sizes for AI model testing.

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The BubbleView™ Single-Use Digital Flexible Cystoscope is a sterile, single-use, flexible endoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The BubbleView™ is intended to provide visualization via ViewHub® video processor and can be used with endoscopic accessories.

BubbleView™ is intended for use in a hospital environment or medical office environment. BubbleView™ is designed for use in adults.

ViewHub® is designed to display live imaging data from compatible MACROLUX™ endoscopes.

The Single-Use Digital Flexible Cystoscope System consists of BubbleView™ Single-Use Digital Flexible Cystoscope (consists of a handle with control lever, endoscope cable and access port for accessories, and a flexible body portion) and ViewHub® Video Processor with itsaccessories including power cables. The BubbleView™ is provided sterile (sterilized by EQ) and intended to be single-use. The ViewHub® is a reusable multi-patient use device. The built-in LED at the Distal tip of the BubbleView™ Single-Use Digital Flexible Cystoscope provides a light source, the lens module captures the light signal, then the CMOS module converts the light signal into an electrical signal: the endoscope cable connects the BubbleView™ to the ViewHub®, which provides power and processes video signal from the endoscope; the control lever on the handleconnected to the controllable portion by a wire rope controls the bending direction and angle of the controllable portion: the instrument channel delivers water and other instruments. The ViewHub® Video Processor is a video imaging system that receives video signals from the connected endoscope, controls the lightat the endoscope tip and outputs this signal including a graphical user interface to a connected external video monitor.

The provided text is a 510(k) summary for the BubbleView™ Single-Use Digital Flexible Cystoscope and ViewHub® Video Processor. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for an AI/ML-driven device. As such, it does not contain the detailed information requested regarding acceptance criteria, study methodologies for AI/ML performance, ground truth establishment, or multi-reader multi-case studies.

The document primarily describes:

• The device and its intended use.
• A comparison to a legally marketed predicate device (Pusen Single Use Flexible Video Cystoscope System K222602) to establish substantial equivalence based on indications for use and technological characteristics.
• Non-clinical performance tests for mechanical and optical characteristics. These tests are to support the safety and effectiveness of the hardware (the cystoscope and video processor) itself, not an AI component.

Therefore, I cannot extract the information requested about acceptance criteria and study data for an AI/ML device from this specific FDA submission document. The questions you posed are highly relevant for AI/ML medical devices, but this document appears to be for a traditional medical imaging device without an explicitly stated AI/ML component.

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The LoopView® is a sterile, single-use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree.

The endoscope is intended to provide visualization via MACROLUX™ video processor.

The endoscope is intended for use in a hospital environment. It is designed for use in adults. The ViewHub® is designed to display live imaging data from compatible MACROLUX™ endoscopes.

The Single-Use Diaital Flexible Bronchoscope System consists of LoopView® Single Bronchoscope (consists of a handle with control lever, endoscope cable and access port for accessories, and a flexible body portion) and ViewHub® Video Processor with its accessories including power cables. The LoopView® is provided sterile (sterilized by EO) and intended to be single-use. The ViewHub® is a reusable multi-patient use device.

The built-in LED at the Distal tip of the LoopView® Single Bronchoscope provides a light source, the lens module captures the light signal, then the CMOS module converts the light signal; the endoscope cable connects the LoopView® to the ViewHub®, which provides power and processes video signal from the endoscope; the control lever on the handle connected to the controllable portion by a wire rope controls the bending direction and angle of the controllable portion; the instrument channel delivers water and other instruments. Suctioning of saliva and mucus from airway is possible through the suction system.

The ViewHub® Video Processor is a video imaging system that receives video signals from the connected endoscope, controls the light at the endoscope tip and outputs this signal including a graphical user interface to a connected external video monitor.

The LoopView® Single-Use Digital Flexible Bronchoscope has the following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Flexible insertion cord
• Camera and LED light source at the distal tip
• Sterilized by Ethylene Oxide
• For single-use

The ViewHub® Video Processor has the following physical and performance characteristics:

• Snapshot, white balance, zoom and HD video output

• supports HDMI video output formats

• Touch Panel

• Reusable

The provided text describes a 510(k) premarket notification for a medical device, the LoopView® Single-Use Digital Flexible Bronchoscope and ViewHub® Video Processor. It outlines the device's indications for use, technological characteristics, and non-clinical testing performed to establish substantial equivalence to a predicate device.

However, the document does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance, human reader improvement with AI assistance, or related ground truth establishment. The testing described focuses on the device's physical and performance characteristics, biocompatibility, sterilization, electrical safety, and software verification/validation, typical for a Bronchoscope system.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance specific to an AI/ML component.
• Sample size used for the test set and data provenance for an AI/ML study.
• Number of experts and their qualifications for establishing ground truth for an AI/ML study.
• Adjudication method for an AI/ML test set.
• MRMC comparative effectiveness study results, effect size of human readers improving with AI vs. without AI assistance.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data) for AI/ML.
• Sample size for the training set for AI/ML.
• How the ground truth for the training set was established for AI/ML.

The document discusses "software verification and validation testing" but frames it as typically done for medical device software, which ensures functionality and safety, not necessarily AI/ML performance for diagnostic or assistive tasks.

In summary, the provided text details the FDA 510(k) clearance process for a bronchoscope system and its video processor, focusing on non-clinical testing for substantial equivalence. It does not include information on acceptance criteria or a study related to an AI/ML component's performance.

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The device is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The Single-Use Digital Flexible Ureteroscope System consists of CoralView® Single-Use Digital Flexible Ureteroscope (consists of a handle with control lever, endoscope cable and accessories, and a flexible body portion) and ViewHub® Video Processor with its accessories power cable and connector cables. The Coralliew® is provided sterile (sterilized by EO) and intended to be single-use. The ViewHub® is a reusable multi-patient use device. The built-in LED at the Distal tip of the CoralView® Single Ureteroscope provides a light source, the lens module captures the light signal, then the CMOS module converts the light signal; the endoscope cable connects the CoralView® to the ViewHub®, which provides power and processes video signal from the endoscope; the control lever on the handle connected to the controllable portion by a wire rope controls the bending direction and angle of the controllable portion; the instrument channel delivers water and other instruments. The ViewHub® Video Processor is a video imaging system that receives video signals from the light at the endoscope tip and outputs this signal including a graphical user interface to a connected external video monitor.

This document is a 510(k) summary for the CoralView® Single-use Digital Flexible Ureteroscope. It does not describe an AI medical device or software. Therefore, there is no information in the provided text to generate acceptance criteria or a study that proves the device meets acceptance criteria related to AI performance.

The content focuses on the substantial equivalence of this ureteroscope to a predicate device, based on non-clinical tests such as biocompatibility, electrical safety, mechanical performance, photobiological safety, and optical performance.

Specifically, the document states:

• Non-Clinical and/or Clinical Tests Summary & Conclusions: "Nonclinical tests demonstrated that the CoralView® Single-use Digital Flexible Ureteroscope is as safe and effective as the predicate device."
• Optical Performance: "Comparative testing was performed for the subject device to support substantial equivalence, including: Field of view (FOV), Resolution, Depth of field (DOF), Signal-to-noise ratio (SNR), Dynamic range, Image intensity uniformity (IIU), Unit relative distortion, Color performance."

Since the request is about "acceptance criteria and the study that proves the device meets the acceptance criteria" specifically framed for an AI/software device, and this document pertains to a physical medical device (a ureteroscope), I cannot fulfill the request as stated with the provided input.

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