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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.

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

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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.

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The FMwand Ferromagnetic Surgical System is indicated for cutting and coagulation of soft tissue during surgical procedures, including Gynecologic procedures (open, transabdominal only).

The FMwand Ferromagnetic Surgical System is a soft tissue cutting and coagulation device that consists of the FMwand Generator that is electrically connected to the sterile, single-use FMwand Handpiece by the FMwand Power Module (a resterilizable, reusable accessory cable) and a single-use, sterile air line. Like the predicate device, the handpiece includes actuation buttons that can be used to activate the handpiece tip. Also like the predicate device, an optional footpedal can be used to activate the handpiece. The connectors at both ends of the FMwand Power Module are designed to fit only the FMwand Generator and FMwand sterile, disposable accessories. The FMwand Power Module is provided non-sterile. It is intended to be cleaned and sterilized prior to the initial use and before each subsequent reuse.

The provided 510(k) summary for the FMwand Ferromagnetic Surgical System (K130606) does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This submission is for a traditional medical device (an electrosurgical system) and focuses on demonstrating substantial equivalence to a predicate device through bench testing and compliance with existing standards.

Therefore, many of the requested criteria related to AI/ML device testing (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this document.

The document primarily discusses that the new device is "substantially equivalent" to an existing predicate device (Domain Surgical System, K121881) by demonstrating that differences do not raise new questions of safety and effectiveness, and that the device functions as intended based on bench testing.

Here's an analysis based on the information available, noting where specific AI/ML related criteria are not met:

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for clinical performance. Instead, it relies on demonstrating that the new device performs identically or equivalently to the predicate device through bench testing and compliance with standards. The "performance" is implicitly deemed acceptable if it matches the predicate and meets relevant safety standards.

Study Proving Device Meets Acceptance Criteria:

The document refers to "bench testing" as the primary study type to demonstrate safety and effectiveness and substantial equivalence.

• "All applicable bench testing was performed with the FMwand Ferromagnetic Surgical System to assure that it functions as intended. Bench tests verified that the generator output was within specification and that the thermal output of the handpiece and tip corresponded to the target values."
• "The FMwand Ferromagnetic Surgical System passed all bench tests performed. Details are found in Section 15: of this submission."
• Biocompatibility testing was performed according to ISO 10993-1 and 510(k) Memorandum G95-1.
• Compliance with electrical safety standards included IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-2.

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

• Sample Size: Not specified in the provided text. Bench testing typically involves a number of units or measurements, but specific quantities are not given here.
• Data Provenance: Not specified. Bench tests are usually conducted in laboratories by the manufacturer or third-party testing facilities. The country of origin of testing data is not mentioned, and the testing is inherent to the device's design and manufacturing rather than involving patient data. This is a retrospective analysis of the device's physical and electrical properties, not clinical data.

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

• Not Applicable. This is a traditional medical device (electrosurgical system), not an AI/ML device requiring expert ground truth for interpretation of outputs like images. Bench testing involves objective measurements against predefined specifications and standards.

4. Adjudication method for the test set:

• Not Applicable. See point 3. Testing involves objective measurements, not subjective expert reviews that would require 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:

• No. This is not an AI/ML device. No MRMC study was conducted or is relevant for this type of device.

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

• Not Applicable. This is not an AI/ML device. Standalone performance for an algorithm is not relevant. The device's "standalone" performance refers to its ability to meet specifications when operated.

7. The type of ground truth used:

• For the technical performance of the device (generator output, thermal output, electrical safety): Predefined specifications and recognized international or national safety and performance standards (e.g., IEC 60601 series). These are objective criteria.
• For biocompatibility: ISO 10993 series standards define the "ground truth" for material safety.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device. There is no "training set" in the context of machine learning.

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

• Not Applicable. See point 8.

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The Domain Surgical System is indicated for cutting and coagulation of soft tissue during surgical procedures, including Gynecologic procedures (open transabdominal only).

An electrosurgical cutting and coagulation device (and accessories) is a device intended to remove tissue and control bleeding by use of high-frequency electrical current (21 CFR §878.4400). It is classified as a Class II (510(k)) device.

The Domain Surgical System is a soft tissue cutting and coagulation device that consists of a generator that is electrically connected to a sterile, single-use handpiece and an optional footswitch. Like the predicate devices, the handpiece includes an actuation button that can be used to activate heating in the handpiece tip. Also like the predicate devices, an optional footswitch can be used to activate the system.

The provided text is a 510(k) summary for the Domain Surgical System, which is an electrosurgical cutting and coagulation device. This submission is intended to modify the Indications for Use statement to add specificity, consistent with its intended use and the indications for use for the legally marketed Peak Surgery System. The device itself was previously cleared by FDA through 510(k) #K110439.

Based on the provided document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note: This submission is an amendment to specify the indications for use, not a new device clearance. All the performance data described above was previously reported and accepted as part of 510(k) #K110439.

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

The document primarily discusses bench testing and compliance with standards. It does not mention a "test set" in the context of a clinical study with human or animal subjects for this specific submission (K121881). The tests described are engineering and laboratory tests.

• Sample Size for Test Set: Not applicable to this type of regulatory submission and the tests described.
• Data Provenance: Not applicable. The data is from laboratory and engineering bench tests rather than clinical data from specific countries or retrospective/prospective studies.

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

This section is not applicable. The ground truth for the "test set" (bench testing) is based on engineering specifications and international standards, not expert human assessment.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to clinical studies where multiple experts evaluate cases and a consensus or tie-breaking mechanism is used. The tests described are objective engineering and laboratory tests.

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 section is not applicable. This device is an electrosurgical cutting and coagulation device, not an imaging or diagnostic device that would typically involve "human readers" or AI assistance in the way described for an MRMC study.

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

This section is not applicable. This device is a surgical tool, not an algorithm. Its operation inherently involves a "human-in-the-loop" (the surgeon). The "software" mentioned controls the generator, which is part of the overall surgical system, not a standalone diagnostic or interpretive algorithm.

7. The type of ground truth used

The "ground truth" for the tests described are:

• Engineering Specifications: For generator output and thermal output.
• International Standards: For electrical safety (IEC 60601 series) and biocompatibility (ISO 10993-1).
• Design Requirements: For software functionality and performance.

8. The sample size for the training set

This section is not applicable. The device is not an AI/ML algorithm that requires a "training set" in the context of machine learning. The "software" mentioned in the document is a control system software, not a learning algorithm trained on data.

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

This section is not applicable for the same reasons as #8.

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Endocervical Hysterectomy Electrode is indicated for treatment of following Condition

1. Excision of inner cervix during supracervical hysterectomy.

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Here's an analysis of the provided text regarding the acceptance criteria and study for the Gyn LLETZ Electrode (Endocervical Hysterectomy Electrode):

Based on the provided document, the device did not undergo a study to prove its performance against specific clinical acceptance criteria in the manner typically seen for novel medical devices or AI-powered devices. This submission is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than proving de novo safety and effectiveness through extensive clinical trials.

The provided document (K070877) is a 510(k) submission for the Gyn LLETZ Electrode.

Here's a breakdown based on your requested information:

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

There are no specific clinical performance acceptance criteria listed in this 510(k) submission, nor is there reported clinical device performance that would traditionally be presented in a table for a study.

The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device.

Acceptance Criteria for 510(k) Submission (implied):

• Meet electrical and mechanical requirements.
• Be substantially equivalent to the predicate device in terms of intended use, technological characteristics, and safety and effectiveness.

Reported Device Performance:

• "Meet the electrical and mechanical requirements of ANSI/AAMI HF-18 Standard for Electrosurgical Devices."
• "The subject device is substantially equivalent to the predicate device." (This is a conclusion, not a performance metric.)

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

• Sample size: Not applicable. There was no clinical "test set" in the context of proving device performance described in this 510(k) submission. The submission relies on a comparison to a predicate device.
• Data provenance: Not applicable. Clinical data for device performance was not provided or referenced 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)

• Number of experts: Not applicable. No clinical ground truth was established from a test set for this 510(k) submission.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable. No clinical test set or adjudication method was 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

• MRMC study: No. This is not an AI-powered device, and no MRMC study was conducted or reported.
• Effect size: Not applicable.

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

• Standalone performance: No. This is an electrosurgical electrode, not an algorithm, so standalone algorithm performance is not relevant.

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

• Type of ground truth: Not applicable in the context of clinical performance data. The "ground truth" for this 510(k) submission is the regulatory acceptance of the predicate device.

8. The sample size for the training set

• Sample size for training set: Not applicable. This is not a machine learning or AI device, so there is no "training set."

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

• Ground truth for training set: Not applicable.

Summary for this specific device and submission:

The document describes a 510(k) premarket notification for an electrosurgical device (Gyn LLETZ Electrode). The primary mechanism for clearance is demonstrating substantial equivalence to a previously cleared predicate device (Apple Medical Fisher Cone Biopsy Electrode, K061651). The submission does not include data from a clinical study with specific performance acceptance criteria, test sets, or ground truth establishment as would be expected for a novel device or an AI/ML product. Instead, it relies on meeting recognized electrical and mechanical standards (ANSI/AAMI HF-18) and a comparison to the predicate device.

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The Fischer Cone Biopsy device is indicated for Large Loop Excision Of The Transformation Zone (LLETZ) in the diagnosis and treatment of some cervical intraepithelial neoplasias (CIN) and dysplasias.

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I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "Fischer Cone Biopsy Excisor." This type of document primarily confirms that the device is "substantially equivalent" to a legally marketed predicate device and grants permission to market it.

The document does NOT contain the following information that you requested:

• A table of acceptance criteria and reported device performance. The FDA clearance letter does not detail the specific performance metrics or acceptance criteria used in the substantial equivalence determination. It focuses on regulatory compliance rather than detailed device efficacy or safety study results in this letter.
• Sample size used for the test set and data provenance. This information would typically be found in the device's 510(k) submission, not the clearance letter.
• Number of experts used to establish the ground truth and their qualifications. Again, this level of detail about study design is not in this document.
• Adjudication method.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs. without AI assistance. This device is a surgical excisor, not an AI-assisted diagnostic tool, so such a study would not be applicable.
• If a standalone performance (algorithm only) was done. Not applicable as it's not an algorithm.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

Therefore, I cannot fulfill your request for a description of the acceptance criteria and the study that proves the device meets them based on the provided text. The FDA letter only states that the device is "substantially equivalent" for its indicated uses to previously marketed devices.

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To be used for soft tissue cutting of the uterine cervix and coagulation, intraepithelial neoplasia, condylomata acuminata, and miscellaneous lesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc.

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This document is a 510(k) premarket notification letter from the FDA regarding the Thomas Medical Electrodes. It is a regulatory document and does not contain the kind of information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth information, etc.) because these types of studies are not typically required for a 510(k) clearance, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the given text. The prompt asks for details about a study that proves the device meets acceptance criteria, but this document only states that the device is substantially equivalent to a predicate device and can proceed to market.

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Indication for the LLETZ procedure include: A cytological and coposcopic suspicion of CIN; A transformation zone which is fully visible and fully confined to the cervix; LLETZ in indicated for those patients who have had abnormal pap smear report with cytologic evidence of CIN, colposcopic examination of the cervix unsatisfactory finding and who, in the physician's opinion are suitable candidates for the procedure.

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The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance, or any studies conducted as described in your request.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements... and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions."

This indicates that the clearance is based on substantial equivalence to a predicate device, not on new performance studies proving the device meets specific acceptance criteria. Therefore, I cannot provide the requested information.

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