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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 Tru-MR TM laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

The Truphatek Tru-MRTM MR conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.

Here's a breakdown of the acceptance criteria and the study details for the Truphatek Tru-MR™ Laryngoscope set, based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes physical testing of the device for MR compatibility, not a study involving human or clinical data. Therefore, the concept of "sample size used for the test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" as it refers to patient data is not applicable.

The "test set" for this device was the Truphatek Tru-MR™ Laryngoscope set itself (handle, battery, and blades). The testing was performed on the device to verify its MR Conditional properties.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of information is not applicable to this submission. The "ground truth" for MR compatibility of a medical device is established by standardized testing protocols (e.g., ASTM F2052-02), not through expert consensus or interpretation of clinical data in the same way an AI algorithm's output might be evaluated. The result (e.g., < 45 degree string deflection) is a direct, measurable physical outcome.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert opinions on clinical data are resolved. For physical device testing, the results are objectively measured according to the specified standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI systems in a clinical setting, often comparing human readers with and without AI assistance. The Truphatek Tru-MR™ is a physical medical device (laryngoscope) and not an AI system.

6. Standalone Performance Study (Algorithm Only)

No, a standalone (algorithm only) performance study was not done. This is not an AI-powered device. The "performance" described is the physical device's MR compatibility.

7. Type of Ground Truth Used

The "ground truth" used for this device was based on physical measurements and adherence to an industry standard: ASTM F2052-02. The acceptance criterion of "< 45 degree string deflection" in a 3.0 Tesla environment serves as the objective measure of its MR compatibility, which is the key performance aspect for this device's intended use.

8. Sample Size for the Training Set

This is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated above.

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