Search Results

Transmission of light energy from the light source to an optical instrument.

The light-guide cable is used to transmit light during endoscopic procedures or for other medical illumination application when the properties and operating instructions are complied with.

The light-guide cable is designed for use with halogen, xenon or LED based light which are utilized in medical applications that involve endoscopes, medical instruments or microscopes.

The Olympus Light-Guide Cables that are subject to this submission are intended to transmit light from the light source to an optical instrument. For that purpose the Light-Guide Cable includes a bundle of optical fibers as transmission medium. The light guide adapters are intended for the mechanical connection of the Light-Guide Cables to light sources or to endoscopes.

There are two variants of Light-Guide Cables which differ according to the shaft diameter of the connected endoscope. Cable WA03300A (2.8 mm, 3 m, CF type) can be combined with endoscopes, which have a diameter ≤ 4.1mm. Endoscopes with a diameter > 4.1mm are combined with WA03310A (4.25 mm, 3 m, CF type). Otherwise the Light-Guide Cables are identical.

This document describes the FDA's 510(k) clearance for Olympus Light-Guide Cables. The core of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to provide full performance study details typical of a de novo device. Therefore, the specific information requested in the prompt, such as detailed acceptance criteria, sample sizes for test/training sets, expert qualifications, and effect sizes for human-in-the-loop studies, is largely not present in this type of regulatory document.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Reported Device Performance

The document states, "The Light-Guide Cables comply with all applicable requirements/standards as listed in Appendix IIIc of this submission." However, Appendix IIIc is not provided, so the specific acceptance criteria and their corresponding reported device performance values are not detailed in this text.

The document also mentions that "the design of the subject device Light-Guide Cables is identical to that of the predicate devices" with "minor design modifications." It asserts that these differences "do not negatively impact safety or effectiveness" and "do not raise different questions of safety or effectiveness."

Based on the provided text, a table of acceptance criteria and reported device performance cannot be fully constructed. The document primarily relies on the substantial equivalence to a predicate device that has been "used safely and effectively for years," and compliance with general safety standards.

The closest we get to "reported performance" is the mention of electrical safety testing and reprocessing validation.

Study Information (Based on provided text)

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

   • Sample Size: Not explicitly stated as a separate "test set" in the context of a new performance study. The document states that because the devices are substantially equivalent and the predicate has been used for years, "it was not considered necessary to re-test the performance of the Light-Guide Cables concerned." However, "complete evidence of the performance test records is included in this submission" (referenced in Appendix 12a-e, which is not provided).
   • Data Provenance: Not specified. Given the reliance on predicate device history and general standards compliance, no specific new clinical data is presented here.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new "ground truth" was established for a new clinical test set as the submission relies on substantial equivalence and existing predicate safety/effectiveness.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no new clinical test set requiring adjudication for ground truth was conducted.

4. 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 passive light-guide cable, not an AI-assisted diagnostic or therapeutic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device. Physical bench testing was likely done for electrical safety and reprocessing validation, but not a "standalone algorithm" performance.

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

   • For the aspects that were tested (Electrical Safety, Reprocessing), the "ground truth" would be the established international and national standards (e.g., ANSI AAMI ES60601-1, IEC 60601-2-18) against which the device's electrical performance was measured, and validated sterilization protocols for reprocessing.
   • For the overall device, the "ground truth" for safety and effectiveness is largely based on the predicate device's established use history and compliance with general device regulations.

7. The sample size for the training set: Not applicable. This is a physical medical device, not an AI model requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Isolux Ilc OptiLux LED Illuminator is indicated for use in transmitting light for illumination purposes from an LED source via a fiber optic cable and attached to either an endoscope, surgical head light or other tools that contain in providing illumination to body cavities during examinations or surgical procedures.

Not Found

The provided documents are a 510(k) clearance letter and an Indications for Use statement for the "OptiLux LED Illuminator." These documents, from the FDA, confirm the device's regulatory clearance and its intended use but do not contain any information regarding acceptance criteria, device performance studies, or data about the device's accuracy or efficacy.

Therefore, I cannot fulfill your request for information on the following:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The OptiLux LED Illuminator is a physical device for illumination, not an algorithm. Therefore, this type of study is not applicable, and no information about it would be found here.
7. The type of ground truth used: Not applicable and not available.
8. The sample size for the training set: Not applicable and not available.
9. How the ground truth for the training set was established: Not applicable and not available.

The documents primarily focus on:

• The FDA's determination of substantial equivalence to a predicate device.
• The regulatory classification of the device (Class II).
• The indications for use: "transmitting light for illumination purposes from an LED source via a fiber optic cable and attached to either an endoscope, surgical head light or other tools that contain in providing illumination to body cavities during examinations or surgical procedures."

Ask a specific question about this device

The Kogent™ Spetzler Lighted Suction Tubes are intended to provide surgical site illumination from a high intensity light source.

This device is a disposable Kogent™ Spetzler Lighted Suction Tubes, designed for single use in surgical procedures. Lighted Suction Tubes require connection with a suitable operating room suction system to deliver suction as well as with a suitable illumination machine. Lighted Suction Tubes are designed to provide illumination while having the ability to aspirate the surgical site. The devices are provided sterile by Ethylene Oxide and in sterile packaging.

The provided document is a 510(k) Pre-market Notification for a medical device called "The Kogent™ Spetzler Lighted Suction Tubes." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials.

Therefore, much of the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, and training set details for AI/software devices cannot be found in this document, as it describes a physical surgical instrument, not an AI or software-based medical device.

However, I can extract the relevant information about the "acceptance criteria" as described in this 510(k) submission, which primarily revolves around demonstrating substantial equivalence through bench testing and comparison to a predicate device.

Here's the information that can be extracted, interpreted within the context of a 510(k) submission for a non-AI surgical device:

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

For a 510(k) submission for a physical device, "acceptance criteria" are generally evaluated by demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance is reported in terms of equivalence or similarity in key characteristics.

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

• Test Set Sample Size: The document mentions "Bench testing was performed on the Kogent™ Spetzler Lighted Suction Tubes to verify the design inputs." However, it does not specify the sample size (e.g., number of units tested). This is typical for engineering bench tests for this type of device, where specific product units are tested to confirm design specifications.
• Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Katalyst Surgical, LLC, which is based in Chesterfield, MO, USA. This is prospective testing conducted specifically for this 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)

This question is not applicable to a 510(k) submission for a non-AI surgical instrument. The "ground truth" for a physical device's performance is established through objective engineering measurements and adherence to recognized standards, not by expert consensus on interpretations as would be the case for an AI diagnostic device.

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

Not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes, typically for AI or diagnostic devices. For this physical surgical device, performance is evaluated against engineering specifications and relevant 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

Not applicable. An MRMC study is relevant for diagnostic or AI-assisted interpretation tasks. This document is for a basic surgical illumination and suction device.

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

Not applicable, as this is not an algorithm or AI device.

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

The "ground truth" (or basis for verification) in this context involves:

• Engineering specifications and measurements: Verifying design dimensions and characteristics.
• Industry Standards: Compliance with IEC 60601-1 (electrical safety) and ISO 10993 (biocompatibility).
• Direct comparison to a legally marketed predicate device: Demonstrating equivalence in performance and characteristics.

8. The sample size for the training set

Not applicable, as there is no "training set" for a physical surgical device in the way there is for an AI algorithm.

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

Not applicable, as there is no "training set" for this type of device.

Ask a specific question about this device

The Schott Light Guide Cable is indicated for use in transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes and endoscopes, providing illumination in body cavities during examinations or surgical procedures.

The Light guide cable consists of glass fibers which are glued or fused into ferrules on both ends. The ends are polished to effectively transmit light and are equipped with standard endoscope connectors to transmit visible light from the light source to the intended instrument. The fibers are covered by Silicone sheathing for ease of handling and protecting the fibers from damage. The device is intended to be Ethylene Oxide (EtO) sterilized by the user. Sterilization information is contained in section 14.

This looks like a 510(k) premarket notification for a Light Guide Cable, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a new, innovative device. Therefore, much of the requested information (like efficacy studies, sample sizes for test and training sets, number of experts for ground truth, MRMC studies, etc.) is not typically included in such a submission.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

This document does not provide a table with specific quantitative acceptance criteria (e.g., minimum light transmission efficiency, specific durability metrics) and corresponding reported performance values. The performance testing is described at a high level.

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

• Sample Size: Not specified. The document states "performance testing includes electrical safety testing and sterilization validation." This typically involves a defined number of units for testing, but the specific sample size, especially for comparing performance metrics against a predicate, is not detailed.
• Data Provenance: Not applicable in the context of device performance data for a 510(k) of this type. Performance testing is done in a lab setting by the manufacturer, not from clinical patient data.

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

Not applicable. This device is a light guide cable, not a diagnostic or AI-driven device requiring expert-established ground truth for its performance assessment in a clinical context. Its performance is evaluated through engineering and sterilization tests.

4. Adjudication method for the test set:

Not applicable. There's no adjudication needed as it's not a diagnostic or classification task.

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 is not an AI-assisted diagnostic device.

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

Not applicable. This is a physical medical device (a cable), not an algorithm.

7. The type of ground truth used:

• Technical Specifications/Standards: The "ground truth" for electrical safety and sterilization validation would be the relevant FDA Recognized Consensus Standards (e.g., IEC standards for electrical safety, ISO standards for sterilization).
• Predicate Device Characteristics: For substantial equivalence, the characteristics of the Isolux America K991208 Endoscopic Fiber Optic Cable serve as the de facto "ground truth" for comparison.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Ask a specific question about this device

Ask a specific question about this device

The Endoscopic Fiberoptic Cable is used to conduct visible light from a light source to an endoscope during a surgical procedure.

Endoscopic Fiberoptic Cable

The provided text is a letter from the FDA regarding a 510(k) premarket notification for an "Endoscopic Fiberoptic Cable." This document is a regulatory approval letter, not a study report or technical documentation that describes acceptance criteria, device performance, and study details.

Therefore, the information requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) cannot be extracted from the provided text.

The document primarily states that the FDA has reviewed the device and determined it is substantially equivalent to legally marketed predicate devices for the stated indications for use, thereby allowing it to be marketed. It does not contain the detailed technical performance data or study specifics you are looking for.

Ask a specific question about this device

The ISOLUX America's fiber optic cable is indicated for use in transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes and endoscopes, providing illumination in body cavities during examinations or surgical procedures.

Fiberoptic Cable

The provided document does not contain information about acceptance criteria, device performance, or any studies conducted. It is an FDA 510(k) clearance letter for a fiber optic cable, indicating it is substantially equivalent to previously marketed devices. Therefore, I cannot answer your request based on the provided text.

Ask a specific question about this device

To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource attaches to fiberoptic cable which is then attached to a headlight or microscope or video camera. The lightsource supplies light for the headlight or microscope or video camera.

Lightsource or illuminator I-100

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Lightsource Model or Illuminator I-100". It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

None of the requested details regarding acceptance criteria, device performance, study designs (sample size, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance), or training set information are present in the provided text.

Ask a specific question about this device