Search Results

The IRIS Thermocoagulator and Digital Colposcope is intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe, and to provide magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in selecting areas for biopsy and diagnosing as needed for a colposcopy exam.

The Liger Medical IRIS Thermocoagulator and Digital Colposcope is a portable thermal coagulator with integral colposcope that provides assistance for clinician examination of the cervix as well as utilizes a heated probe to ablate human tissue. It is specifically designed for use in resource-limited settings. The colposcope and thermal ablation modes can be used separately from each other. The device is a handheld, portable, battery-operated, ablator with an LCD display and optical camera to assist diagnosis and treatment, in a safe, effective, easy to use package with sufficient battery life to sustain work for 4 hours. Thermal coagulation can be used in hospital and non-hospital professional healthcare locations.

The IRIS colposcope/thermal ablation device is not intended on into the vaginal canal during colposcopic examination. The camera remains outside the vaginal cavity and functions comparably to a standard non-invasive colposcope in terms of providing magnified visual assistance to the clinician. There is no patient contact during the colposcopic examination. Contact between the clinician and the device is mitigated through good clinical practice of wearing protective gloves, limiting contact to intact skin protected by operating gloves.

The thermal ablation probe, which is reusable and provided non-sterile, is designed to perform low-power destruction of human tissue with high temperatures by tissue contact with an electrically heated probe tip. The biocompatibility of the probe materials conforms to all recommended endpoints per FDA's guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" for limited duration mucosal membrane contact.

The provided text is a 510(k) Summary for the Liger Medical IRIS Thermocoagulator and Digital Colposcope. It details the device's intended use, comparison to predicate devices, and non-clinical performance testing. However, it explicitly states "Not Applicable" under "9. Clinical Performance Data."

Therefore, based solely on the provided text, a detailed response to points 1-7, 8, and 9 for a study proving the device meets acceptance criteria cannot be fully constructed, as the document states no clinical performance data was used for this submission. The device's substantial equivalence was demonstrated through non-clinical performance testing and comparison to predicate devices.

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

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

The document describes various non-clinical tests performed, implying these tests have acceptance criteria, but the specific numerical acceptance criteria and the precise quantified performance results are not detailed in a comparative table format. We only get a list of tests performed.

Table of Acceptance Criteria (Implied) and Reported Device Performance (General):

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

• Sample size: Not specified as no clinical performance data was provided. The non-clinical tests would have involved specific test units, but the "sample size" in terms of patient data is not applicable here.
• Data provenance: Not applicable.

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

• Not applicable as no clinical performance data/test set with human expert ground truth was mentioned.

4. Adjudication method for the test set:

• Not applicable as no clinical performance data/test set requiring adjudication was mentioned.

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, a MRMC comparative effectiveness study was not done according to this document. The device includes a digital colposcope for magnified visualization to aid in selecting areas for biopsy and diagnosis, but the submission explicitly states "Not Applicable" for clinical performance data, meaning no study assessing human reader improvement with or without AI assistance was presented here.

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

• Not applicable. The device is a physical instrument (thermocoagulator and digital colposcope), not an AI algorithm in isolation. While it has a "Digital Colposcope" component capable of camera-assisted visualization, the document does not describe any standalone algorithm performance.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" would be the established engineering and safety standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 8600-1, ISO 8600-3, ISO 10993-1) against which the device's technical performance was measured. No clinical ground truth (e.g., pathology, outcomes data) was used or presented in this 510(k) summary.

8. The sample size for the training set:

• Not applicable. This document is for a physical medical device, not an AI/ML algorithm that requires a training set of data.

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

• Not applicable.

Ask a specific question about this device

The Liger Medical HTU-110 is intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe.

Not Found

The provided document is limited to a 510(k) clearance letter for a medical device called the "Liger Medical HTU-110," which is a gynecologic electrocautery device. This type of document typically focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or comprehensive clinical study data in the way one would find for a significantly novel or AI-powered device.

Therefore, the document does not contain information to address the posed questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The 510(k) clearance letter confirms that the device is "intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe." The clearance is based on the device being substantially equivalent to legally marketed predicate devices, meaning its performance characteristics are deemed similar enough to existing devices that it does not raise new questions of safety and effectiveness. The specifics of how that equivalence was demonstrated (e.g., through bench testing confirming electrical output, temperature control, etc.) are usually in the full 510(k) submission, which is not provided here.

Ask a specific question about this device

The Liger Medical ESU-110 is intended to deliver high frequency electrical current for surgical procedures that can be performed with monopolar cutting and/or coagulation of tissue. One intended use of the Liger Medical ESU-110 Electrosurgical Unit is Loop Electrosurgical Excision Procedure (LEEP).

The Liger Medical ESU-110 combines a high-quality, class I type BF electrosurgical generator and a smoke evacuation system into a single, compact unit. This integrated system is designed to perform low-power excision procedures of short duration. The ESU-110 is designed to be portable, single-purpose, and is intended for non-hospital locations where A/C power may be unreliable or unavailable.

The prompt asks for details about the acceptance criteria and the study that proves the device meets them. However, the provided text describes an Electrosurgical and Suction Unit (ESU-110), which is a hardware device, not a software-based AI/ML device.

Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance (e.g., sample size for test set, data provenance, expert consensus, MRMC study, standalone performance, training set details) is not applicable to this document.

The document focuses on demonstrating substantial equivalence of the ESU-110 to predicate devices (Finesse 3rd Generation and Aaron 950) based on:

• Device Description and Functionality Comparison: Highlighting similarities in operation, though simpler due to single-purpose design (low power, fixed output).
• Safety and Performance Standards Conformance: Stating that the ESU-110 conforms to IEC 60601-1-2:2007 (electrical and electromagnetic safety) and IEC 60601-2-2:2009 (patient protection, neuromuscular stimulation, excessive temperatures, spillage, output indication, short circuits).
• In-house Testing: Claiming that these safety concerns were tested in-house by Liger Medical and found to meet or exceed all applicable requirements. This in-house testing constitutes the "study" for this device, proving its safety and performance aspects relevant to electrical and physical standards.

Therefore, I cannot provide the requested table and details because the input document does not pertain to an AI/ML device and thus does not contain the specified categories of information.

Ask a specific question about this device