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The DEFINE System with the non-invasive applicators employs RF energy for various applications:

The DEFINE System with the Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The DEFINE System with the FORMA Applicator is intended for the relief of minor muscle aches and pain. relief of muscle spasm. and for the temporary improvement of local blood circulation.

The DEFINE System with the MiniFX Applicator is intended for the relief of minor muscle aches and pain, relief of muscle spasm, for the temporary improvement of local blood circulation and for the temporary reduction in the appearance of cellulite.

The DEFINE System with the Morpheus8 Applicator is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed.

At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

The DEFINE device is designed to deliver non-thermal RF energy to the skin and subdermal fat. The RF energy is transmitted to the Applicators and delivered to the treatment area throughout the set of RF electrodes positioned on the treatment units. The invested RF energy is transformed into local heating of the treatment area. Local heating of the skin and underlying tissue layers temporarily ease the symptoms of muscle aches, pain & spasm. It also contributes to the temporary improvement of local blood circulation.

The DEFINE device platform comprises a AC/DC power supply unit, main controller, two RF generators, distributor card and user interface including a touch screen. The system platform contains four designated connectors for the following applicators:

• Cheek Applicator (hands-free) ●
• Chin Applicator (hands-free) ●
• FORMA Applicator ●
• MiniFX ●
• MORPHEUS8 Applicator with the resurfacing, 12 and 24 pin tip heads ●

The DEFINE device RF Applicators are connected to the console via a cable. The delivery of the RF Energy is controlled by a "Start"/"Stop" button on the LCD screen or by a foot pedal. The DEFINE device incorporates a treatment deactivation button. Pressing the deactivation button by either the patient or caregiver would immediately halt the treatment and switch the device into a Pause mode until the operator re-enables it.

The provided text is a 510(k) summary for the InMode Ltd. DEFINE System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment for a study proving the device meets acceptance criteria is not present in this type of regulatory submission.

The 510(k) process primarily relies on showing that a new device is as safe and effective as a legally marketed predicate device. This is often achieved through:

• Comparison of technological characteristics: Demonstrating that the new device has the same fundamental technology, intended use, and similar design as the predicate.
• Non-clinical performance data (bench testing): Verifying that the device meets safety and performance standards (e.g., electrical safety, electromagnetic compatibility, RF energy output).
• Absence of clinical performance data for substantial equivalence: In many cases, if technological characteristics are sufficiently similar and non-clinical testing confirms equivalence, new clinical data is not required.

Based on the provided text, here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of specific "acceptance criteria" and "reported device performance" as typically seen in a clinical trial or performance study (e.g., sensitivity, specificity, accuracy for a diagnostic device) is not applicable or stated in this 510(k) summary for the DEFINE System.

Instead, the submission demonstrates compliance with:

• Safety standards: IEC 60601-1-2, ANSI AAMI ES60601-1, IEC 60601-2-2 (for RF surgical equipment), IEC 60601-1-6 (usability), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), IEC 62304 (software life cycle), ISO 14971 (risk management).
• Equivalence in intended use and technological characteristics to predicate devices.

The "performance" is primarily demonstrated through bench testing for electrical safety, EMD safety, RF output (IEC 60601-2-2), and software validation. These are conformity assessments to established standards rather than performance against a clinical acceptance threshold for diagnostic or therapeutic efficacy outcomes.

Note: The submission explicitly states "Clinical Performance Data: Not Applicable" (page 7 of 14). This signifies that the decision for substantial equivalence was based solely on non-clinical (bench) testing and comparison to predicate devices, without new human clinical studies for performance metrics.

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

• Sample Size for Test Set: Not applicable. No clinical test set data is provided or referenced, as the submission states "Clinical Performance Data: Not Applicable." The "test set" for non-clinical performance refers to the device and its components undergoing bench testing according to various standards. The document does not specify the number of units tested.
• Data Provenance: Not applicable for clinical data. For non-clinical data, it's typically performed by the manufacturer or a certified testing lab. The country of origin of the data is implied to be within controlled engineering/testing environments, likely at the manufacturer's location (Israel) or a contracted lab. The data is implicitly "prospective" in the sense that the tests were conducted specifically for this submission.

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

• Not applicable. There was no clinical test set for which ground truth needed to be established by experts.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. No clinical studies were conducted or referenced for this 510(k) submission. Therefore, no MRMC study, human reader improvement effect size, or AI assistance claims are present.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is an electrosurgical cutting and coagulation device, not an AI or algorithm-only device in the context of diagnostic or interpretive performance. Its performance is tied to its physical mechanisms and safety parameters validated through bench testing, not an algorithm's standalone accuracy. Software validation (IEC 62304) ensures the software functions as intended and is safe, not that it performs a diagnostic or prescriptive task independently.

7. Type of Ground Truth Used

• For non-clinical testing: The "ground truth" is adherence to established engineering standards (e.g., IEC, ANSI, ISO). For example, electrical safety is "ground true" if the device passes the specified tests in IEC 60601-1.
• For clinical performance claims: Not applicable, as no clinical performance data was provided.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set in the typical sense (e.g., for image classification). The "software validation" mentioned relates to the software controlling the device's operation, not to a learned model.

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

• Not applicable, for the same reasons as point 8.

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The InMode System with the Morpheus8 Applicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-V.

The InMode System with the Morpheus8 Applicators is a RF technology based device intended for dermatological applications which require coagulation/contraction of soft tissue or hemostasis. The device platform is identical to the one in FDA-Cleared InMode System with the Morpheus8 Applicators (K200947), inclusive of minor software modifications, cleared in K210492 and K221571. The InMode System with the Morpheus8 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Morpheus8 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Morpheus8 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The device has two Applicators which can be connected to the platform, one at the time. The Morpheus8 Applicator comprises a handle and detachable, sterilized, disposable, single-use 12, 24, and T tip head accessories. The Morpheus8 Body Applicator is identical except that the compatible tip head is a 40 pin tip head.

The provided text is a 510(k) summary for the InMode System with Morpheus8 Applicators. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K200947), rather than conducting a new study to prove a device meets specific acceptance criteria for performance metrics like accuracy, sensitivity, or specificity, which would typically be found in an AI/Software as a Medical Device (SaMD) submission.

Therefore, the requested information about acceptance criteria, study details (sample size, ground truth, expert adjudication, MRMC studies, standalone performance), and training set details for a new device's performance study cannot be extracted from this document. This submission leverages prior testing of the predicate device and argues that no new performance data or clinical data is needed because the current device is substantially equivalent and the changes are minor (e.g., expansion of indications based on energy levels).

Here's what can be inferred and a clear statement of what is missing:

What can be extracted/inferred:

• Device Type: The device is an electrosurgical cutting and coagulation device, specifically using Radiofrequency (RF) technology. It's intended for dermatologic procedures requiring coagulation/contraction of soft tissue or hemostasis. This is a hardware device, not an AI/SaMD.
• Purpose of current submission: This is a "Special 510(k) notice" for an expansion of indications for use based on higher energy levels (greater than 62 mJ/pin) and limiting use to Skin Types I-V for the Morpheus8 Applicator.
• Performance Data Submitted (Leveraged from Predicate):
  • Bench Testing: An ex-vivo tissue study was conducted on two different harvested porcine tissues (muscle and fat) to evaluate the performance and safety of the Morpheus8 Applicators. The study involved biopsy sampling and staining to visualize the tissue coagulation necrosis pattern.
  • Standards Compliance: The device complies with several voluntary recognized standards related to medical electrical equipment (e.g., ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-2).
  • Prior Testing (from K200947): Software validation testing, electrical and mechanical safety testing, comparative bench testing, and ex-vivo tissue testing to evaluate the fractional coagulation necrosis pattern.
• Ground Truth (for the ex-vivo study): The ground truth appears to be based on visualizing the "tissue coagulation necrosis pattern" through biopsy sampling and staining. This would be a direct physical observation of the tissue's response to the device.
• Clinical Performance Data: Explicitly stated as "Not Applicable" for this submission.
• Animal Performance Data / Histology Data: Explicitly stated as "No new animal performance data is submitted to support this submission."
• Training Set/Test Set (as it relates to AI/ML): Not applicable, as this is a hardware device submission, not an AI/ML algorithm.

Information NOT present in the document (and why):

1. Table of acceptance criteria and reported device performance: This document does not describe acceptance criteria for metrics like accuracy, sensitivity, specificity, or similar quantitative performance outcomes typical for diagnostic or AI/ML devices. Instead, the "acceptance" is demonstrated by substantial equivalence to a predicate device and compliance with safety and performance standards for an electrosurgical device. The ex-vivo study concludes that the applicators "perform as intended for the specified indications," but no specific numerical performance metrics are given.
2. Sample size used for the test set and data provenance: The ex-vivo study mentions "two different harvested porcine tissues," but does not specify the sample size (e.g., number of tissue samples, number of treatment applications). Data provenance is "ex-vivo tissue study" (animal tissue, not human patient data), origin not specified beyond "harvested."
3. Number of experts used to establish ground truth & qualifications: Not applicable to ex-vivo studies of this nature using physical staining and observation, unless a subjective assessment by experts was performed (not indicated here).
4. Adjudication method: Not applicable/not described.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted, as this is a hardware device, not an AI/assisted reading device. Therefore, no effect size of human readers improving with AI assistance is reported.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable, as this is a device that requires human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the ex-vivo study, the ground truth was directly observed and visualized "tissue coagulation necrosis pattern" through biopsy and staining. This is akin to a pathological or direct physical outcome.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, this 510(k) submission is for a physical medical device (an RF electrosurgical system) and therefore does not contain the information typically required for an AI/Software as a Medical Device (SaMD) submission regarding AI model performance, training sets, and expert consensus-based ground truth for diagnostic accuracy. The "study" referenced is an ex-vivo tissue study to demonstrate the physical effect of the device on tissue, supporting its intended use.

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