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The Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath are intended for use during cystoscopic, nephroscopic, laparoscopic and ureteroscopic procedures. The Cook® Fiber Optic Bundle is intended for direct visualization of body cavities or organs. The Flexor® Deflecting Access Sheath is used to provide access as well as protection for the Cook® Fiber Optic Bundle and has a second working channel for passage of additional instrumentation.

The Cook® Fiber Optic Bundle is a small diameter fiber optic consisting of inner illuminating fibers and an outer imaging fiber bundle contained in a plastic sleeve. At one end of the imaging bundle is a distal lens and at the other end a fixed eyepiece. The distal lens system focuses an image of the target area under observation onto the tip of the optical imaging fiber bundle. The image is then transmitted to an adjustable focus eyepiece or video adapter at the proximal end of the fiber optic. The eyepiece or video adapter may be connected to a standard video camera to allow the image to be viewed on a video monitor. The light transmitting optical fibers used for illumination have a separate adapter which couples to the external light source. The Fiber Optic Bundle is 2.8 French and available in lengths ranging of 115 and 150cm. The fiber optics are supplied sterile and are intended for up to 10 uses and may be sterilized or disinfected by liquid immersion.

The Flexor® Deflecting Access Sheath is a single use sterile dual lumen access sheath that is used to provide access as well as protection of the Cook® Fiber Optic Bundle and has a second working channel for passage of additional instrumentation. The Flexor® Deflecting Access Sheath consists of a tapered dilator and a dual lumen sheath. The sheath is hydrophilically coated, which is activated when wetted. The sheath is attached to a handle assembly which when manipulated allows the tip of the sheath to deflect. When assembled, the Fiber Optic Bundle and sheath act in a manner similar to a flexible endoscope. Because the sheath is deflectable and the Fiber Optic Bundle is flexible, the user is able to position the Fiber Optic Bundle to the desired site in the appropriate body cavity or organ. The sheath has two lumens which allows one lumen to be an access channel for Endoscopic instrumentation and the second lumen to be used as an access port for the fiber optic bundle. The Flexor Deflecting Ureteral Access Sheaths will be available in 45 and 75 centimeter lengths. The Flexor® Deflecting Ureteral Access Sheath will be available in 45 and 75cm lengths. The outside diameter is 15 French. The large lumen's inside diameter is 8.85 French and the inside diameter of the smaller lumen is 3.15 French. When assembled with the Cook® Fiber Optic, the Flexor® Deflecting Access Sheath provides protection for the Cook® Fiber Optic Bundle and deflects up to 180°.

The Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath will be sold sterile as sets as well as sterile single order items.

The provided document is a 510(k) summary for the Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and the specifics of a study proving device performance in the context of AI/machine learning.

The document states: "Biocompatibility and bench performance testing was performed to demonstrate the safety and performance of the Cook® Fiber Optic bundle and the Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath when used together. Testing was performed by Cook Urological, Incorporated and an independent laboratory in accordance with recognized standards. All test results were acceptable."

This indicates that some testing was done, and it met acceptance criteria, but the criteria themselves and the specific numerical results are not provided in this summary. Furthermore, this device is a traditional medical device (fiber optic bundle and access sheath), not an AI/ML-driven device. Therefore, questions related to AI performance, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies for AI improvement are not applicable to the information contained in this document.

Given the information provided, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

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

• Sample Size: Not specified.
• Data Provenance: Testing performed by Cook Urological, Incorporated and an independent laboratory. No specific country of origin or whether it was retrospective/prospective is mentioned. Given the nature of bench testing for a physical medical device, it would likely be laboratory-based rather than clinical data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable as this is not an AI/ML device requiring expert ground truth for diagnostic accuracy. Testing was for device safety and performance (e.g., physical characteristics, biocompatibility).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable for the type of bench and biocompatibility testing described for this traditional medical device.

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, this is not an AI/ML device. Therefore, no MRMC study comparing human readers with/without AI assistance was performed or described.

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

• Not applicable, as this is a physical medical device, not an algorithm.

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

• Not applicable in the context of diagnostic AI. For physical device performance, "ground truth" would be established by validated test methods, adherence to engineering specifications, and recognized standards for biocompatibility.

8. The sample size for the training set:

• Not applicable, as this is a physical medical device, not an AI/ML system requiring a training set.

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

• Not applicable, as this is a physical medical device, not an AI/ML system requiring a training set.

In summary, the provided 510(k) summary (K072521) for the Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath describes a traditional medical device. The document confirms that "Biocompatibility and bench performance testing was performed" and "All test results were acceptable," but it does not provide the specific numerical acceptance criteria or the detailed results of these tests. Many of the questions posed are relevant to AI/machine learning devices and therefore do not apply to the information available in this 510(k) submission.

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The device is used to provide light for endoscopic devices. Those devices can be connected directly to the light source or by fiber bundles or single fibers. The device is intended for prescription use only.

The cold light sources of the PS series consist of short arc metal-halide or xenon lamps, driven by electronic ballasts. Optical components such as mirrors, lenses, filters and coatings focus the light to a small diameter of typically 1.5-4mm. Fiber light guides (single or bundles) transmit the light to the application such as endoscopes.

The provided text is a 510(k) summary for a medical device called the "PS series" light source with fiber. This submission focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance through a clinical study with acceptance criteria.

Therefore, the document explicitly states: "No performance data is required for this Class II device nor requested by FDA (ODE)."

This means most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this particular 510(k) submission.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. No test set performance data was provided or required for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No ground truth establishment was performed as no test set data was provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set data was provided for adjudication.

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 light source, not an AI-powered diagnostic device. No MRMC study was performed.

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

• Not applicable. This device is a light source, not an algorithm. No standalone performance study was conducted.

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

• Not applicable. No ground truth was established as no performance study was conducted.

8. The sample size for the training set

• Not applicable. No training set was used as this device is a light source, not a machine learning algorithm.

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

• Not applicable. No training set or associated ground truth was used for this device.

Summary of Device Safety and Effectiveness Demonstration:

Instead of performance criteria, the submission focuses on demonstrating safety and effectiveness through:

• Substantial Equivalence: Comparing the PS series to legally marketed predicate devices (Isolux and Cogent/WelchAllyn light sources and cables) in terms of use, design, and function.
• Safety Standards Compliance: The device is designed to and fully meets several international safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, UL2601-1, CAN/CSA-C22.2 No. 601-1-M90, 47 CFR Ch.1 Part 15 (FCC), IEC 60601-2-41).
• Technological Characteristics: Describing the components (short arc metal-halide or xenon lamps, electronic ballasts, optical components) and how they function to focus white light into fiber light guides for endoscopic applications. The short arc lamp is cited as improving effectiveness of focusing, similar to the predicate device.

The conclusion states that the technological differences to the predicate devices do not affect the safety or efficacy of the submitted devices, leading to the determination of substantial equivalence.

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The Tru-Cable™ endoscopic fiber optic cable is designed to transmit light for illumination purposes from a remote source to an endoscope or similar surgical instrument. It can be adapted to be compatible with a variety of illuminators.

The Truphatek Tru-Cable™ endoscopic fiber optic cables are:

• . Lengths of 10 feet (3.5m)
• Diameters 3.5mm and 5.0mm .
• The fiber optic cable is hermetically sealed in a closed system so that it can be . sterilized or high level disinfected using most common methods.
• The cables are sold non-sterile. .
  The fiber optic cables are designed for use with all the most popular light source illuminators and surgical instruments that are equipped with standard endoscopic adapters. They are designed for user high level disinfection and / or sterilization by autoclave or high level disinfection may be done via Steris® or Liquid Chemicals, i.e. Cidex OPA®. The cable is rated for 100 uses when processed via autoclave.

This document is a 510(k) Pre-Market Notification for the Tru-Cable™ endoscopic fiber optic cables. It focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs. without AI assistance
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This device is a physical medical instrument (fiber optic cable), not an AI/software device. The 510(k) summary provided is for a traditional medical device submission, which typically focuses on bench testing, biocompatibility, sterilization validation, and comparison to legally marketed predicate devices, rather than performance metrics typically associated with AI/ML diagnostic or prognostic tools.

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The Accutech EndoLite Probe is intended for use in the treatment of ocular pathology.

The Accutech EndoLite Probe is indicated for use in ocular photocoagulation of the anterior and posterior segment for the indications for use cleared for the 532-659 nm laser system(s) with which it is compatible for use.

The Accutech EndoLite Probe is comprised of the following main components:

• A glass fiber optic protected by a medical grade stainless steel needle and handle at . the distal (patient contact) end and by a plastic jacket at the proximal (laser connection) end; and
• . A universal SMA laser connector.

The Accutech EndoLite Probe is provided as a sterile, single use 532-659 nm laser energy delivery system device (accessory). The universal SMA connector at the proximal end of the optical fiber delivery device is designed to be attached to the optical fiber Laser Port of the compatible 532-659 nm laser system with universal SMA compatibility that has been qualified by Accutech Medical Technologies, Inc. for use with the Accutech EndoLite Probe.

This document is a 510(k) summary for the Accutech EndoLite Probe. It does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes, or expert adjudication as it is a submission for substantial equivalence to predicates rather than a performance study report.

The document indicates that the device is "substantially equivalent" to predicate devices, meaning it has similar indications for use, device operation, and technical/functional capabilities. This type of submission relies on the safety and effectiveness profile of existing, legally marketed devices.

Therefore, I cannot provide the requested information based on the given text.

The document does not describe a study that proves the device meets specific acceptance criteria. Instead, it asserts substantial equivalence to predicate devices based on similarities in indications for use, design features, and functional features.

Here's a breakdown of why the requested information cannot be extracted:

• Acceptance Criteria and Reported Device Performance: This document does not specify any quantitative acceptance criteria or report specific performance metrics from a study. The basis for clearance is "substantial equivalence" rather than direct numerical performance outcomes.
• Sample Size and Data Provenance (Test Set): No specific test set or study data is presented. The submission relies on comparison to predicate devices, not an independent performance study.
• Number of Experts and Qualifications (Ground Truth): No ground truth establishment is described because there is no independent performance study.
• Adjudication Method: Not applicable, as there's no independent performance study requiring adjudication.
• MRMC Comparative Effectiveness Study: Not applicable. This is a claim of substantial equivalence for a medical device accessory, not a comparative effectiveness study involving AI or human readers.
• Standalone Performance Study: No standalone performance study (algorithm only) is described.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable, as this is not an AI/algorithm-based device requiring a training set in the conventional sense.
• How Ground Truth for Training Set Was Established: Not applicable.

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Sovis Optique's endoscopic light cable is designed to transmit light for illumination purposes from a remote source to an endoscope or similar surgical instrument. It can be adjusted to be compatible with major manufacturers' equipment.

Sovis Optique's endoscopic light cable consists of two metal end fittings connected by a glass fiber bundle and a silicone sheath covering. The sheath is reinforced with a stainless steel spring. The protruding optical end is made from an independent piece of glass bonded to a stainless steel support for ease of replacement.

The provided text is a 510(k) summary for a medical device (endoscopic light cable). It asserts substantial equivalence to a predicate device based on similar intended use, target population, environment of use, design, and materials.

However, the provided document does not contain information about:

• Specific acceptance criteria, performance metrics, or a formal study proving the device meets those criteria.
• Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for a study.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• The type of ground truth used in such studies.
• Sample size for training sets or how ground truth for training sets was established.

The summary discusses two minor differences between the proposed and predicate device:

1. Reinforced sheath: The summary claims the reinforcement is molded into the silicone and does not contact human tissues. It also states that "biocompatibility tests performed on the material, the silicone that may potentially contact patients poses no additional safety issues."
2. Independent glass rod at the source end: The summary states "The rod is made from the same components as CUDA or UFR product (i.e., glass, epoxy glue and stainless steel). There is thus no significant adverse effect on safety."

These statements suggest that some form of testing or evaluation was performed for biocompatibility, but details of these tests, their acceptance criteria, or their results are not explicitly provided in the text you've given.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving their fulfillment as the necessary information is not present in the provided 510(k) summary. This document focuses on demonstrating substantial equivalence, not on detailed performance study results against specific acceptance criteria.

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Smith & Nephew Light Sources, light guides and accessories are indicated for use with the Subcutaneous Illuminator for the purpose of providing transillumination during endoscopic resection of superficial varicosities of the lower extremities.

Smith & Nephew Light Sources, Light Guides and accessories are designed to transmit light to the surgical site via fiberoptic bundles in the light guide. The light guides mate to the Subcutaneous Illuminator and Light Source with instrument specific adapters.

This 510(k) summary does not contain the information required to answer your request. It is a submission for a medical device (Smith & Nephew Light Sources and Accessories) that relies on substantial equivalence to existing predicate devices.

Here's why the requested information is not available in these documents:

• Acceptance Criteria and Device Performance: The document states, "The basic design and function of the Smith & Nephew Light Sources and Accessories are unchanged compared to information provided in previous submissions." This indicates that no new performance studies were conducted, and therefore, no new acceptance criteria or reported device performance metrics are provided in this submission. The FDA's letter also confirms substantial equivalence rather than a new approval based on performance data.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no new performance study was performed for this 510(k) submission, there are no details about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information. These details are typically found in documents describing the validation of a new or significantly modified device, especially AI/ML-driven devices.

In essence, this document is a regulatory filing asserting that the new version of the light sources and accessories is essentially the same as previous, cleared versions, and thus does not require new performance testing.

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The Subcutaneous Illuminator is indicated for transillumination and irrigation during endoscopic resection of superficial varicosities of the lower extremities.

The Smith & Nephew Subcutaneous Illuminator transfers light to the surgical site via glass fiber optics and includes irrigation via an irrigation channel. The Subcutaneous Illuminator allows it to gain access to the surgical site.

The provided K99/323 510(k) summary for the Smith & Nephew Subcutaneous Illuminator does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, this 510(k) submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, function, and intended use. The FDA letter confirms the substantial equivalence primarily based on these comparisons.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader studies, as this information is not present in the provided text.

The primary "proof" of the device's acceptability in this context is its substantial equivalence to already legally marketed devices, rather than a specific performance study with measured acceptance criteria.

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The SolarTec™ Source 270 System is intended for use:

1. To provide visible light for with various rigid or flexible endoscopes, other lighted tools, and surgical headlamps that contain fiber bundles or single fibers for illumination
2. In providing illumination for the purposes of allowing observation and manipulation of body cavities and tissues, hollow organs, and canals.
3. With applications that include, but are not limited to, headlights and/or externally illuminated endoscopes used in arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhyno-laryngoscopy, urology, and vascular endoscopy as well as surgical headlights used in various open surgical procedures.

The Subject Device is designed with a safety interlock on the lamp replacement door. If the cover is opened, the power to the device will be interrupted. The Subject Device is cooled with a forced air fan to prevent the temperature of the unit from exceeding a safe level. If in the event that the fan malfunctions and/or fails to operate properly and the internal temperature of the device exceeds the engineered specifications, the device is designed with an internal thermal protection mechanism that automatically shuts off the power to the lamp. The Subject Device contains a user replaceable lamp fixture. The Subject Device has incorporated several safety features into the product design. These safety features include: a) The lamp is never operated beyond its specified power range, b) The lamp life is limited to approximately 1000 hours by analog circuitry. This limit is significantly below the safe rated life expectancy of the lamp (approximately 4000 hours) as stated by the lamp manufacturer, c) The enclosure has interlor structures (baffles), which will dampen the sound level and confine any debris which might result from the non-passive lamp failure. The Subject Device used with a Cogent Light single fiberoptic cable typically produces a uniform output image.

The provided document is a 510(k) Premarket Notification for the SolarTec™ Source 270. It primarily focuses on the safety and effectiveness of the device, rather than diagnostic performance metrics typically associated with AI/ML devices. Therefore, much of the requested information regarding sample sizes, expert evaluations, ground truth, and comparative effectiveness studies is not applicable to this type of device and submission.

Here's an breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This device is a light source, not a diagnostic tool with performance metrics like sensitivity or specificity. The "acceptance criteria" presented are primarily safety standards and effectiveness claims related to light production and delivery.

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

This information is not applicable as this is a medical device for illumination, not a diagnostic AI/ML system requiring a test set of data. The submission focuses on engineering specifications and compliance with safety standards rather than performance on a clinical dataset.

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

This information is not applicable. The "ground truth" for this device would be its adherence to safety standards and its ability to produce light as described, not clinical diagnoses by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. No test set requiring adjudication of findings is described for this device.

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 information is not applicable. This device is a light source, not an AI/ML diagnostic tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

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

This information is not applicable. This is a physical device, not an algorithm.

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

The "ground truth" for this device's safety is its compliance with specified international and national safety standards (IEC601-1-2.1993, IEC601-2-18:1996, UL2601-1). For its effectiveness claims, the "ground truth" would be physical measurements of light output, spectral characteristics, and image uniformity, as demonstrated through engineering testing and design specifications. No clinical "ground truth" in the diagnostic sense (e.g., pathology) is relevant.

8. The sample size for the training set

This information is not applicable. This is a physical light source, not a machine learning model.

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

This information is not applicable.

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The Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.

The Fiber Optic Endoillumination Probe is provides intraocular illumination. The light is transmitted from the source to the inside of the eye through a flexible optical fiber, which has been threaded through an illumination probe.

The provided text is a 510(k) summary for the MicroVision, Inc. Fiber Optic Endoillumination Probe. It does not describe an "acceptance criteria and the study that proves the device meets the acceptance criteria" in the typical sense of a clinical or performance study with defined metrics. Instead, this document focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested elements for a study that "proves the device meets acceptance criteria" are not applicable or cannot be extracted from this document, as it's not a report of such a study.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document doesn't define quantitative acceptance criteria for performance; instead, it establishes equivalence based on descriptive characteristics.

Study Details (Not Applicable/Cannot be Extracted from a 510(k) Summary for Substantial Equivalence):

The 510(k) summary is a premarket notification to demonstrate substantial equivalence, not a detailed report of a performance study with specific acceptance criteria in the sense of clinical trial outcomes or detailed engineering specifications. It relies on comparing descriptive and technological characteristics to a legally marketed predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This document describes the device itself and its comparison to a predicate, not a performance study on a test set. There is no mention of a "test set" of patients or data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth establishment for a test set is not relevant to a 510(k) substantial equivalence submission for this type of device. The "ground truth" here is essentially the characteristics of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set or adjudication process is described.

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 fiber optic endoillumination probe, a physical medical device for illumination during surgery, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

• Not applicable. This device is a physical surgical tool, not an algorithm.

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

• For the purpose of substantial equivalence: The "ground truth" is the established characteristics and performance of the predicate device (Infinitech, Inc. Fiber Optic Probe, K870942). The claim is that the new device is functionally identical or very similar.

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.

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

• Not applicable. No training set is involved.

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