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The InMode RF Multi-System with the Non-invasive Applicators employs RF energy for various applications:

•Forma (Plus). Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.

•WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids.

•BodyFX™ (WMBody)/MimiFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.

The InMode RF Multi-System with the Fractional Applicators employs RF energy for various applications:

•Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin.

•Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

•Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

The InMode RF Multi-System supports multiple radiofrequency (RF) applications and accessories. The InMode RF Multi-System is compatible with the Fractional RF Applicators and the Non-Invasive RF Applicators, and employs RF energy for various applications.

The InMode RF Multi-System consists of platform console with an AC/DC power supply unit, two applicator connectors, RF generator, RF measuring circuit, controller, footswitch and user interface including a touch screen. The RF Applicator is connected to the console via a cable and a footswitch activates the energy delivery to the applicator. The applicators are comprised of a handle and electrodes, and some of them are used with a single-use tip.

This 510(k)-file submission includes all the FDA-Cleared applicators under one submission with the RF-supporting console, as cleared in K182325, compatible with all applicators.

The below list comprises the set of applicators to be registered under the subject device:

• . Non-Invasive RF Applicators:
  • Forma (Plus) O
  • Plus (Plus Plus) O
  • Plus90 O
  • WMface O
  • BodyFXTM (WMBody) O
  • MiniFX™ O
• Fractora O
  • 24 pins tip (FRF) -
  • -60 pins tip
• Morpheus8™M O
  • 12 pins tip (Prime Tip) ।
  • 24 pins tip (Fractora 3D) -
  • 40 pins tip (Body Tip) -
  • -T tip

This document describes a 510(k) premarket notification for the InMode RF Multi-System. It aims to demonstrate substantial equivalence to previously cleared predicate devices. The information provided heavily focuses on bench performance data (electrical safety, EMC, software V&V) and comparison to predicate devices, rather than clinical performance data with specific acceptance criteria directly tied to efficacy on patients.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set information is not detailed in this document in the typical format one would expect for a clinical performance study demonstrating direct efficacy on patients for specific indications.

The document states "Clinical Performance Data: Non-Applicable" and "Animal Performance Data / Histology Data: Non-Applicable". This indicates that the substantial equivalence determination for this device largely relies on similarities in design, materials, and compliance with general electrical and safety standards, rather than new clinical trials demonstrating performance against specific clinical efficacy metrics.

However, based on the provided text, I can infer the acceptance criteria and how the device proves it meets those criteria in the context of a 510(k) submission, which focuses on substantial equivalence to existing devices.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence)

The primary acceptance criterion for a 510(k) submission, especially when clinical data is "Non-Applicable," is demonstrating substantial equivalence to existing legally marketed predicate devices. This means that the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable in the context of a clinical test set for efficacy. The "testing" here refers to bench testing for electrical safety, EMC, software V&V, and comparison of technical specifications. There are no explicit "test set" patient sample sizes mentioned for clinical performance, as the document states "Clinical Performance Data: Non-Applicable."
• Data Provenance: The data provenance is primarily from bench testing conducted by the manufacturer (InMode Ltd.) and external labs for standard compliance. The country of origin for the applicant is Israel. This is a premarket notification, indicating retrospective evaluation against regulatory standards and existing predicate devices, rather than prospective clinical data collection for this submission.

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

• Not applicable. Since the study is primarily focused on demonstrating substantial equivalence through bench testing, rather than establishing clinical ground truth for diagnostic or therapeutic accuracy, there is no mention of external experts or their qualifications for establishing ground truth in this context. The "ground truth" here is compliance with recognized safety and performance standards (e.g., IEC standards), which is assessed through defined test procedures.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data or images. This is not a human-reader study or a clinical trial requiring such adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improvement:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical Performance Data: Non-Applicable." This type of study is specifically designed to assess human reader performance, usually in diagnostics, often with AI assistance.

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

• Not applicable. This device is a physical RF energy system used by a human operator, not an AI algorithm. Its "performance" is its ability to deliver RF energy safely and effectively as designed, and to perform its indicated functions.

7. The Type of Ground Truth Used:

• The "ground truth" for this 510(k) submission is based on:
  • Regulatory Standards: Compliance with recognized international standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-2).
  • Bench Test Results: Data from electrical safety, EMC, and software verification and validation testing, which confirmed the device's technical specifications and adherence to design requirements.
  • Comparison to Predicate Devices: The established safety and effectiveness of the legally marketed predicate devices serve as the "ground truth" for substantial equivalence. The new device is compared against the known characteristics and performance of these predicates.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a "training set" of data in the sense of machine learning. The device's functionality is based on established RF technology and engineering principles.

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

• Not applicable, as there is no "training set" in the machine learning sense. The device's design and operational parameters are based on scientific and engineering knowledge, informed by the specifications of previously cleared predicate devices.

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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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used as a supplemental test to verify positive and equivocal results from female endocervical and male urtheral specimens in the VIDAS Chlamydia (CHL) assay and is substantially equivalent to cell culture for the qualitative detection of Chlamydia antigen.

The VIDAS Chlamydia Blocking assay is a fully automated enzyme-linked fluorescent immunoassay (ELFA) and requires only the addition of the blocking and reference reagents to the VIDAS Chlamydia strips.

The provided text is a summary of substantial equivalence for a medical device cleared in 1996. It does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding acceptance criteria, specific study design elements, and statistical analysis metrics. This is typical for older 510(k) summaries, which often focused on substantial equivalence rather than explicit performance targets and detailed study breakdowns as seen in more recent submissions.

However, I can extract the available information and highlight what is missing based on your template.

Acceptance Criteria and Study Information (Based on Available Data)

1. Table of Acceptance Criteria and Reported Device Performance

Missing: Specific quantitative acceptance criteria (e.g., sensitivity, specificity thresholds, PPV/NPV targets) are not provided in this summary. The performance is broadly stated as "substantially equivalent" to cell culture.

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

The summary does not provide the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It refers to "the data comparing the performance... to that of cell culture" in Section 8 of the submittal, which is not provided here.

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

The summary does not provide this information.

4. Adjudication Method for the Test Set

The summary does not provide this information.

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

No, based on the description, this was a standalone device performance study comparing the VIDAS Chlamydia Blocking assay to cell culture as the reference method. MRMC studies are typically for image-based diagnostic aids and involve human interpretation, which is not the case for this automated immunoassay.

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

Yes, this was a standalone performance study of the VIDAS Chlamydia Blocking assay. It is an automated enzyme-linked fluorescent immunoassay (ELFA) and does not involve human interpretation of the assay results in a "human-in-the-loop" manner.

7. The Type of Ground Truth Used

The ground truth used for comparison was cell culture. The text explicitly states: "The data comparing the performance of the VIDAS Chlamydia Blocking assay to that of cell culture..." and that "The VIDAS Chlamydia Blocking assay...is substantially equivalent to cell culture for the qualitative detection of Chlamydia antigen."

8. The Sample Size for the Training Set

The summary does not provide information on a training set size. For an immunoassay like this, the "training" might refer to assay development and optimization, rather than a distinct training set in the machine learning sense. The available text describes the performance study rather than the development process.

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

The summary does not provide this information, as it doesn't describe a traditional "training set" or its ground truth establishment.

In summary: The provided text is a high-level summary from a 1996 510(k) submission focused on demonstrating substantial equivalence. It lacks the quantitative performance metrics, detailed study design parameters (like sample sizes, expert qualifications, adjudication methods), and specific acceptance criteria that are commonly found in more recent regulatory documents or required by your detailed template. The core comparison was against cell culture as the gold standard.

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