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The Accutech Family of PowerFlex laser delivery devices (bare fibers, sidefire fibers, ENT fibers, and Endoprobes) are indicated for incision/ excision, ablation, and coagulation (hemostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode and Ho:YAG wavelengths (488 - 2100 nm) for the indications for which the lasers have been cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.

The Accutech Family of PowerFlex Laser Delivery Devices is comprised of the following main components (by fiber optic configuration type): Bare Fibers - No Sheaths - Glass fiber optic with jacket - SMA connector Bare Fibers - With Sheaths - Glass fiber optic with jacket - Sheath - SMA connector SideFire Fibers - Glass fiber optic with jacket with distal (patient contact) fiber tip encased in glass capillary tube - SMA connector - Adjustable handle (tightens on fiber to allow user to direct laser energy to desired target site) Endoprobes/ ENT Fibers - A glass fiber optic protected by a medical grade stainless steel needle/ cannula (patient contact) and handle at the distal end and by a plastic jacket from the proximal to distal end - SMA connector Additional Accessory(ies) - Optional Radiofrequency identification (RF ID) connector for use with INTERmedic Diode Laser Family of lasers (as specified to Accutech Medical by INTERmedic for use with their laser systems)

The provided text is a 510(k) summary for the Accutech Family of PowerFlex Laser Delivery Devices. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance studies against specific acceptance criteria. Therefore, most of the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training data, and ground truth establishment) is not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified. This document is a 510(k) summary, which typically summarizes the results of various tests (e.g., biocompatibility, sterilization, performance testing) but does not usually include details like geographical origin of test data or whether it was retrospective or prospective, especially for a device like a laser delivery fiber.

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

• Not applicable/Not specified. The device is a laser delivery fiber. "Ground truth" in the context of expert consensus is typically associated with diagnostic devices, where human experts interpret medical images or data. For a surgical accessory like this, performance is usually assessed through engineering tests, ex-vivo or in-vivo animal studies, and potentially human clinical use (though often not required to establish substantial equivalence for accessory devices).

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

• Not applicable/Not specified. See point 3.

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 laser delivery system, not an AI-assisted diagnostic or therapeutic system involving human readers.

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

• Not applicable. This device is a physical medical instrument, not a software algorithm. Its "performance" is inherently tied to its physical interaction with a laser system and a user.

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

• Not applicable/Not specified. Performance for this type of device is usually validated through engineering bench testing (e.g., power transmission, durability, sterility) and potentially preclinical (animal) or limited clinical studies demonstrating safe and effective use when paired with cleared laser systems. The document states that the device is for "incision/ excision, ablation, and coagulation (hemostasis)" but does not detail how the ground truth for these actions would be established for the delivery fiber itself, beyond functional verification.

8. The sample size for the training set:

• Not applicable. As a physical accessory, there is no "training set" in the context of machine learning or AI.

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

• Not applicable. See point 8.

In summary, the provided 510(k) summary for the Accutech Family of PowerFlex Laser Delivery Devices focuses on demonstrating substantial equivalence based on similar indications for use, device operation, and technical/functional capabilities to predicate devices. It does not contain the detailed performance testing, acceptance criteria, sample sizes, expert evaluations, or ground truth methodologies typically associated with studies for diagnostic AI devices, as it is a different class of medical device.

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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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