(163 days)
The InMode System with the Morpheus8 90 Applicator is intended for use in dermatological procedures where coaqulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 90 Applicator is limited to Skin Types I-IV.
The InMode System with the Morpheus8 90 Applicator 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 Fractora3D 90 Applicator (K180189), inclusive of minor software modifications. The InMode System with the Morpheus8 90 Applicator employs fractional RF multi-electrode technology for procedures requiring electrocoaqulation and hemostasis. The Morpheus8 90 Applicator is 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 90 Applicator consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 90 Applicator is connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The Morpheus a handle and a detachable, sterilized, disposable, singleuse 24 pin tip head accessory.
The provided text is a 510(k) summary for the InMode System with the Morpheus8 90 Applicator. It describes a device that is substantially equivalent to a previously cleared device. Therefore, the information provided focuses on demonstrating this substantial equivalence rather than presenting an independent acceptance criteria study for a novel device or AI algorithm.
Here's a breakdown based on your request, filling in where possible from the provided text and noting when the information is not available due to the nature of a 510(k) submission for an already cleared device's modification:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a modification (clearing the Fractora 3D 90 for a treatment depth of up to 7mm via software change) and claiming substantial equivalence to predicate devices, explicit "acceptance criteria" and "reported device performance" in the sense of a new clinical study with specific metrics are not detailed for the subject device in the provided document. Instead, the document relies on previously established performance of predicate devices and comparative testing.
The "acceptance criteria" can be inferred as meeting the safety and performance characteristics of the predicate devices. The "reported device performance" is implicitly that the subject device performs equivalently.
| Acceptance Criteria (Inferred) | Reported Device Performance (Implied) |
|---|---|
| Safety and effectiveness equivalent to predicate devices (K180189, K200947). | Demonstrated through non-clinical testing, including: |
| Compliance with electrical and mechanical safety standards (IEC 60601-1). | Full compliance with IEC 60601-1 demonstrated (inherited from predicate and confirmed for modifications). |
| Compliance with electromagnetic compatibility standards (IEC 60601-1-2 and IEC 60601-2-2). | Full compliance with IEC 60601-1-2 and IEC 60601-2-2 demonstrated (inherited from predicate and confirmed for modifications). |
| Generation of fractional coagulation necrosis pattern in target tissues via thermal effect. | Ex-vivo tissue testing demonstrated equivalent fractional coagulation necrosis patterns to predicate devices, even at the expanded treatment depth of 7 mm. Bench testing confirms device specifications are met. This includes comparing the thermal effect of the subject device to the primary predicate up to a treatment depth of 7 mm. |
| Software functions correctly for the extended treatment depth. | Software validation testing performed (for minor software modifications to implement the 7mm depth). |
| Maintains patient contact material inertness and safety. | Patient contact materials are identical to the predicate device. |
| Device specifications (RF max output power, frequency, dimensions, weight, input voltage) are met. | Specifications are provided and implicitly met: RF Max Output Power: 65 Watt, RF Output Frequency: 1 MHz, Dimension: 46cm W x 46cm D x 100cm H, Weight: 30 Kg, Main Line Frequency: 50-60 Hz, Input Voltage (nominal): 100-240 VAC. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a numerical sample size for patients or clinical cases. The testing was primarily ex-vivo tissue testing and bench testing.
- Data Provenance: The testing for the current submission was conducted to compare the subject device to the predicate devices. The original predicate device (K180189) performance testing is referenced, and further ex-vivo testing was performed with the secondary predicate device (K200947). The exact location or nature (retrospective/prospective) of these non-clinical tests is not specified beyond "ex-vivo tissue testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. Given that the testing detailed is primarily ex-vivo and bench testing, rather than a clinical trial requiring human interpretation of results against a gold standard, this type of expert review is typically not part of these types of 510(k) submissions.
4. Adjudication Method for the Test Set
- This information is not provided. As above, for non-clinical, ex-vivo, and bench testing, a formal adjudication process using multiple experts is generally not applicable in the same way it would be for clinical image interpretation or diagnosis.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a MRMC comparative effectiveness study was not done. The document states, "No clinical data was submitted." The submission relies on non-clinical performance data and substantial equivalence to legally marketed predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- This device is not an AI algorithm. It is a physical medical device (radiofrequency technology for dermatological applications). Therefore, the concept of "standalone algorithm performance" is not applicable here. The "performance" refers to the device's physical and functional capabilities.
7. The Type of Ground Truth Used
- For the ex-vivo tissue testing, the "ground truth" would be the physical measurement and visual assessment of the fractional coagulation necrosis pattern in the tissue. This is a direct physical effect, not an expert consensus or pathology report in the traditional sense for diagnostic AI. For electrical, mechanical, and EMC testing, the "ground truth" would be the defined standards (e.g., IEC 60601 series).
8. The Sample Size for the Training Set
- Not applicable. This document describes a medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no training set for this device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. 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.(b)
Classification. Class II.