(30 days)
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):
- 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.
- 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."
- 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).
- Adjudication method: Not applicable/not described.
- 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.
- Standalone performance (algorithm only without human-in-the-loop performance): Not applicable, as this is a device that requires human operation.
- 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.
- Sample size for the training set: Not applicable, as this is not an AI/ML device.
- 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.
§ 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.