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The InMode System with the Morpheus8 (Fractora) Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis.

At higher energy levels greater than 62 ml/pin, use of the Morpheus8 (Fractora) Applicators is limited to Skin Types I-V.

The InMode System with the Morpheus8 (Fractora) Applicators is a computerized, programmed, RF technology-based device intended for dermatological applications which requires skin electrocoagulation and hemostasis.

The device platform is basically constituted on the same system platform as FDA cleared for the proposed predicate device; The InMode System with the Fractora3D/3D-90 Applicators (K180189). The device applicators employ fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Morphues8 (Fractora) Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multielectrode pins.

The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Morpheus8 (Fractora) Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 (Fractora) Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The subject device applicator comprises a disposable, single use, fractional RF electrode pins tip head.

The InMode System with the Morpheus8 (Fractora) Applicators comprises the following applicator tip heads:

• Morpheus8 24 Pin Applicator (Fractora3D) tip (FDA Cleared in K180189)
• Morpheus8 40 Pin treatment tip (New tip) .
• . Morpheus8 12 Pin treatment tip (New tip)
• . Morpheus8 T Pin treatment tip (New tip)

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "InMode System with the Morpheus8 (Fractora) Applicators." It establishes the substantial equivalence of this new device to a previously cleared predicate device.

Crucially, this document is for an electrosurgical cutting and coagulation device, not an AI/ML-based medical device. Therefore, the questions related to AI/ML device performance, such as ground truth, multi-reader multi-case studies, training sets, and expert consensus, are not applicable to the information contained in this document.

The primary acceptance criteria for this type of device, as per the document, revolve around substantial equivalence to a predicate device in terms of:

1. Intended Use/Indications for Use
2. Technological Characteristics
3. Safety and Effectiveness (demonstrated through performance testing and compliance with recognized standards).

Here's a breakdown of the relevant information provided in the document concerning the device's acceptance criteria and the study proving it meets those criteria:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device (InMode System with the Fractora3D/3D-90 Applicators, 510(k) No. K180189). The 'studies' are non-clinical bench performance tests.

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

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical or image-based AI/ML test set. The 'test set' here consists of the subject device (InMode System with new Morpheus8 applicators) comparing its performance and characteristics against the predicate device.
• Data Provenance: The tests are non-clinical bench performance tests. Data is proprietary to the manufacturer (InMode MD Ltd.) and was collected as part of their device development and regulatory submission process. There is no mention of country of origin for data related to patients or clinical studies, as none were required or performed. The tests are "retrospective" in the sense that they were performed after the device was manufactured to verify its specifications.

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

• This is not applicable as there is no "ground truth" established by experts in the context of an AI/ML device for diagnostic purposes. The ground truth for performance here is the physical output of the device and its compliance with engineering specifications and recognized safety standards, measured by calibrated equipment.

4. Adjudication Method for the Test Set

• Not applicable for this type of device. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers or labelers, typically in image interpretation for AI/ML ground truth generation. Here, the "test" is largely a comparison of engineering specifications and performance with those of a predicate device and relevant standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. This type of study is for evaluating human performance, often with and without AI assistance, especially in diagnostic imaging. It is not relevant for an electrosurgical device like the InMode System.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) was Done

• Not applicable. There is no "algorithm" in the sense of an AI/ML model being assessed independently. The performance assessed is the device's physical output and adherence to safety standards.

7. The Type of Ground Truth Used

• The "ground truth" implicitly used for this device's performance evaluation comprises:
  • Engineering Specifications: The design parameters and operational capabilities of the device as per its intended function (e.g., RF output power, frequency, energy per pin, dimensions).
  • Recognized Consensus Standards: Compliance with international standards for medical electrical equipment (IEC 60601 series, AAMI/ANSI standards) and sterilization (ISO 11137-1).
  • Predicate Device Performance: The established performance and safety characteristics of the legally marketed predicate device (K180189) serve as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. As no training set is involved, no ground truth needed to be established for it.

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The InMode System with the Fractora3D/3D-90 Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis.

At higher energy levels greater than 62 m./pin, use of the FRF applicator is limited to Skin Types I-IV.

The InMode System with the Fractora3D/3D-90 Applicators is a computerized, programmed, RF technology based device intended for dermatological applications which requires skin electrocoagulation and hemostasis. The device platform is basically constituted on the same system platform as FDA cleared for InMode FRF Applicator (K151273). The InMode System with the Fractora3D/3D-90 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Fractora3D/3D-90 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multielectrode pins. The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Fractora3D/3D-90 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Fractora3D/3D-90 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises a disposable, single use, 24 electrode pins tip.

Based on the provided text, the device in question is the "InMode System with Fractora3D/3D-90 Applicators," which is an electrosurgical cutting and coagulation device. The document is a 510(k) summary, which aims to demonstrate substantial equivalence to a predicate device rather than proving efficacy through clinical trials with specific acceptance criteria as one might see for novel AI/software devices. Therefore, much of the requested information regarding "acceptance criteria" for performance, "ground truth establishment," "expert adjudication," and "multi-reader multi-case studies" is not applicable or explicitly stated in the context of this traditional medical device submission.

Here's a breakdown of the information that is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

• AAMI/ANSI 60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
• IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
• IEC 60601-2-2 Edition 5.0 2009-02, Medical Electrical Equipment Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories. |
  | Accuracy and Consistency of RF Output Parameters (Bench Test) | Performance bench tests were performed to measure the accuracy and consistency of the RF output parameters. Results demonstrated that the InMode System complies with design requirements and consists of similar RF output specifications as the predicate device. |
  | Safety and Efficacy for Indicated Use (Animal Study) | A preclinical study on a porcine model evaluated thermal effects and tissue healing. "The animal study results show that the InMode System with the Fractora3D/3D-90 Applicators are safe for use and effective in achieving the specified indications of dermatological and general electrocoagulation and hemostasis." |
  | Biocompatibility of Patient Contact Materials | All device materials which come in direct contact with the patient skin are biocompatible. Reference made to predicate devices: K102461, K082451, K142438, K151019 and K081365 for biocompatibility determination. |
  | Substantial Equivalence to Predicate Device (Performance Specs)| The performance specifications (including RF frequency, pulse duration, and RF energy per pin) of the InMode System were shown to be similar and yielded similar RF energy per pin values to those of the predicate EndyMed Intensif Applicator (K130501). |

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

• Test Set Sample Size:
  • Bench Test: Not explicitly stated how many tests were run, but it refers to "performance bench tests."
  • Animal Study: The study was conducted on a "porcine model." The exact number of animals is not specified, but it refers to a "single RF treatment" per animal at various follow-up times (immediately, 7, 14, and 21 days post-treatment).
  • Clinical Data: "Not Applicable" for this 510(k) submission.
• Data Provenance: The device manufacturer (InMode MD Ltd.) is located in Israel. The studies are described as pre-clinical (animal model) and bench tests. The location where these specific tests were performed is not detailed. The data is retrospective in the sense that it's reported for a 510(k) submission, but the tests themselves would have been performed prospectively as part of validation.

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

• This concept of "ground truth established by experts" is not explicitly applicable or discussed in the context of this traditional device submission for electrocoagulation and hemostasis. The "ground truth" for the animal study would be the histological findings and clinical observations of tissue effect and healing. The expert interpreting these would likely be a veterinary pathologist, but their number and qualifications are not specified in this summary.

4. Adjudication method for the test set

• Not applicable/mentioned. This is typically relevant for diagnostic AI studies where multiple readers might review cases.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study was not done. The document states "Clinical Performance Data: Not Applicable."

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

• This is not an AI/algorithm-driven device. It is a physical electrosurgical device. Therefore, the concept of "standalone performance" of an algorithm is not applicable. The device's performance stands alone in its ability to deliver RF energy as specified.

7. The type of ground truth used

• For the non-clinical studies:
  • Bench Tests: The ground truth is the designed specifications and physical measurements of RF output parameters.
  • Animal Study: The ground truth is histological analysis (tissue changes and healing process) and observation of the gross thermal effects in the porcine model.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a "training set."

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

• Not applicable. As this is not an AI/machine learning device, there is no "training set" or ground truth establishment method for one.

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The Fractora is intended for dermatological procedures requiring ablation and resurfacing of the skin.

The Fractora is composed of a console, hand held applicator, and disposable tip, designed to deliver bipolar radiofrequency electrical current to the skin surface, via an array of multi-electrode pins.

The provided 510(k) summary for the Invasix Ltd. Fractora device does not contain the detailed information requested regarding specific acceptance criteria, a study proving the device meets those criteria, or most of the other parameters you've asked for.

The document is a typical 510(k) submission which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance study results against pre-defined acceptance criteria.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative metrics (e.g., specific thresholds for ablation depth, resurfacing percentage, or safety outcomes). The acceptance criterion implicitly seems to be "similar output and intended use as the predicate device" and raising "no new issues of safety or effectiveness."
• Reported Device Performance:
  • Bench Testing Performance Data: The submission states "bench testing performance data" was presented, but the specifics and their outcomes are not included in the summary.
  • Histology Data: The submission states "histology data" was presented, but the specifics and their outcomes are not included in the summary.
  • Substantial Equivalence Claims:
    • Intended use is identical to the predicate device (Matrix RF applicator).
    • Technological characteristics are similar (delivers bipolar RF energy through multi-electrode pins).
    • Main output parameter (energy per pin) is identical to the predicate.
    • Minor differences in number of pins and array dimensions may slightly affect the number of pulses required.

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

• Not provided. The document refers to "bench testing performance data" and "histology data" but does not specify the sample sizes used for these tests or whether they were conducted on humans, animals, or ex-vivo tissue, nor their provenance (country of origin, retrospective/prospective).

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

• Not provided. The summary does not describe any study involving expert ground truth establishment.

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

• Not provided.

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/Not done (based on provided text). This device is a medical device for dermatological procedures, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its function and was not conducted.

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

• Not applicable/Not done (based on provided text). This device is not an algorithm, but a physical device (console, hand-held applicator, disposable tip). Standalone algorithm performance is not relevant.

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

• Partially inferred: The document mentions "histology data," which implies some form of pathological or microscopic examination was used as a basis for evaluating the device's effects on tissue. However, the specific type of ground truth (e.g., expert interpretation of histology, specific measurements) is not detailed.

8. The sample size for the training set:

• Not applicable/Not provided. This is not an AI/machine learning device, so a "training set" in that context does not apply. If "training set" refers to data used for device design and optimization, it's not specified.

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

• Not applicable/Not provided. As above, no training set for an AI model is mentioned.

In summary, the provided 510(k) summary primarily focuses on demonstrating substantial equivalence based on intended use and technological characteristics, along with a general statement about bench testing and histology data. It does not provide the detailed performance study information, acceptance criteria, or ground truth establishment methods typically associated with clinical trials or AI/diagnostic device evaluations.

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