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    K Number
    K150112
    Device Name
    HS AMICA DEVICES FAMILY
    Manufacturer
    HS HOSPITAL SERVICE SPA
    Date Cleared
    2015-09-10

    (233 days)

    Product Code
    GEI,DEV
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K053290,K083157
    Why did this record match?
    Reference Devices :

    K053290, K083157

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Coagulation (thermoablation) of soft tissue. Not for use in cardiac procedures.

    Device Description

    HS AMICA devices family is an integrated system for thermoablation of tissues through controlled emission of non-ionizing electromagnetic radiations in the microwave and radiofrequency ranges. Especially the HS AMICA family consists of 3 devices and relative accessories emitting: 1. Only microwaves (MW) or 2. Only radiofrequency waves (RF) or 3. Either microwaves or radiofrequency waves (not simultaneously). The three devices emit the specific wavelength through their applicators (probes) that are inserted into the human body and deliver electromagnetic energy through their emitting tip, causing the thermoablation. Briefly, the HS AMICA devices family consists of two main components: 1) the generator; 2} the applicator (probe). The generator of the electromagnetic energy is available in the following variants, depending on the specific electromagnetic emission: 1. AMICA GEN AGN-H. This variant is characterized by both the MW and RF modules that must be selected by the physician. When the MW function is selected, the RF emission is disabled and viceversa and thus the modules operate in mutually exclusive fashion 2. AMICA GEN AGN. This variant has only the MW module. 3. AMICA GEN AGN-R This variant has only the RF module. In all cases, the AMICA GEN is provided with an electronic control unit (EC), for data exchange with the patient applied parts, the interpretation of user's commands through front panel controls or external peripherals (such as the footswitch for remote energy start/stop), the continuous update of the machine indicators, and the control of the energy generation modules MW and/or RF. The applicator (probe) is disposable and consists of the following variants, to be used for the MW or RF thermoablation: 1. AMICA PROBE. This variant is a microwave coaxial antenna of asymmetric dipole type allowing the emission of the MW energy 2. RF AMICA-PROBE. This variant is used for radiofrequency energy delivery through monopolar interstitial electrode.

    AI/ML Overview

    The provided text is a 510(k) Summary for the HS AMICA devices family, an electrosurgical cutting and coagulation device. It primarily focuses on demonstrating substantial equivalence to predicate devices (K083157 and K053290) through a comparison of technological characteristics and performance data.

    However, the document does not contain the level of detail typically required to fully answer a request for acceptance criteria and a study proving a software/AI-based device meets those criteria, especially regarding clinical study design elements like sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies for AI performance.

    The "Performance Data" section discusses:

    • Electrical safety
    • Electromagnetic compatibility
    • Software verification and validation (developed and validated according to FDA guidance and IEC 62304:2006, but no specific performance criteria or results are given beyond "compliance")
    • Biocompatibility
    • Performance test-bench: This is the closest to device performance, focusing on physical ablation size on ex-vivo tissues for both microwave and radiofrequency components, compared to predicate devices.

    Therefore, many parts of your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully answered as the document describes a traditional electrosurgical device, not an AI/software-driven diagnostic or assistive system with the types of performance metrics you've outlined.

    However, I can extract the information that is present and indicate where information is missing based on the context of the document.

    Acceptance Criteria and Device Performance (Based on available information for a physical device, not AI)

    Acceptance Criteria (Implicit from equivalence claim)Reported Device Performance
    Electrical Safety: Compliance with AAMI ANSI ES60601-1:2005 (19-5) and IEC 60601-2-2 (6-228)"The subject device was tested for the electrical safety demonstrating that it complies with AAMI ANSI ES60601-1:2005 (19-5) and IEC 60601-2-2 (6-228)."
    Electromagnetic Compatibility: Compliance with AAMI ANSI IEC 60601-1-2 (19-2)"The subject device was tested according to AAMI ANSI IEC 60601-1-2 (19-2). The results demonstrate the compliance with the standard."
    Software Verification and Validation: Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices requirements FDA - May 2005" and IEC 62304:2006 (13-8)"The HS AMICA medical devices family has been developed and validated according to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices requirements FDA - May 2005 and according to IEC 62304:2006 (13-8)." (Note: No specific performance metrics for software, just compliance with development/validation standards).
    Biocompatibility: Evaluation according to Blue Book Memo, G95-1 and ISO 10993-1 (2-156)"The biocompatibility evaluation for the subject device was conducted in accordance with Blue Book Memo, G95-1 'Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing and the International standard ISO 10993-1 (2-156)." (Specific materials mentioned as biocompatible).
    Performance (Ex-vivo Ablation Size): Ablation dimensions (depth, width, length) on different tissues should be equivalent to predicate devices K053290 (RF) and K083157 (MW)."The results demonstrate that the ablations obtained with HS AMICA have equivalent dimensions compared to the predicate devices K053290 (RF ablation) and K083157 (MW ablation) proving that the performance of the HS AMICA device is at least as good as the performance of the predicate devices."

    Detailed Study Information (Based on a typical AI/Software Device Request vs. Provided Document)

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

      • Provided: For the "Performance test-bench" (ablation size), the data provenance is "ex-vivo tissues (muscle, liver, lung and kidney)". No specific number or type of "samples" (e.g., number of tissue blocks, number of ablation procedures) is given, nor is the origin country. This is not a clinical test set in the context of AI.
      • Missing for AI: No information on test set size (e.g., number of images, cases) or data provenance (e.g., retrospective/prospective, number of sites/patients, country of origin) for AI performance evaluation.

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

      • Provided: Not applicable. The "ground truth" for the performance test was the physical measurement of ablation size on ex-vivo tissues. This was a physical measurement, not an expert-derived truth.
      • Missing for AI: No information on expert involvement or their qualifications.

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

      • Provided: Not applicable. Ground truth was direct measurement for the physical performance test.
      • Missing for AI: No information.

    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:

      • Provided: No. This study was not an MRMC comparative effectiveness study involving human readers. It was a comparative performance test of a physical device against its predicates on ex-vivo tissue concerning ablation size and general safety/EMC standards.
      • Missing for AI: No information.

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

      • Provided: Not applicable. This device is an electrosurgical unit, not an algorithm performing a standalone diagnostic or assistive function on its own data inputs (like images). The "software verification and validation" mentioned refers to the embedded software that controls the hardware, not an AI algorithm for autonomous decision-making or analysis.
      • Missing for AI: No information.

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

      • Provided: For the "Performance test-bench," the ground truth was the physical measurement of the size (depth, width, length) of the ablation zone created on ex-vivo tissues.
      • Missing for AI: Not applicable in the context of this device.

    7. The sample size for the training set:

      • Provided: Not applicable. This device is not an AI model that undergoes a "training set" in the machine learning sense. The "training" relates to the design and testing process of the engineering.
      • Missing for AI: No information.

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

      • Provided: Not applicable. See point 7.
      • Missing for AI: No information.

    In summary, the provided document from the FDA is a 510(k) summary for a traditional electrosurgical device, not an AI-powered diagnostic or assistive medical device. As such, it details engineering and safety performance (electrical safety, EMC, biocompatibility, and physical ablation size) relative to predicate devices, rather than the complex clinical validation and ground truth establishment methods typical for AI/ML-based software products.

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