FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The D-ACTOR® handpiece uses pressurized air pulses to accelerate a projectile within a guiding tube. The accelerated projectile hits a skin-contacting steel activator which is dampened by elastic O-rings that affix it to the distal end of the handpiece and a vibration absorber at proximal end of the handpiece. When the projectile impacts the activator, slow-rising, low-amplitude pressure pulses are generated. Standard coupling gel is typically used to reduce the loss of pulse amplitude to surrounding air. The D-ACTOR 200 System consists of a Control Unit, Handpiece, Mains Cable, Commercially available coupling gel, Foot switch (optional), and Tablet PC (optional). The password protected GUI interface software allows the operator to create, save and edit treatment programs for application to various muscle groups, and permits the operator to create, edit and save individual patient treatment program routines and progress notes. Various software features permit the operator to: (1) adjust energy level, number of pulses, frequency and total pulses delivered, (2) display and adjust skin contact intensity of the applicator, (3) save treatment images/videos to track progress, and (4) utilize Visible Body® interactive 3D musculature to allow the operator to "mark" and save treatment regions to patient records.

AI/ML Overview

The Storz Medical AG D-ACTOR® 200 Vibration Massage System, as described in K173692, is a Class I medical device intended for the relief of minor muscle aches and pains, temporary increase in local blood circulation, and activation of connective tissue. The provided documents detail its substantial equivalence to predicate devices based on technological characteristics and performance testing rather than acceptance criteria for clinical efficacy.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the traditional sense of performance metrics (like sensitivity, specificity, accuracy) for a diagnostic AI device, nor does it define specific clinical performance endpoints with associated thresholds for a therapeutic device. Instead, the "performance testing" section and the "Substantial Equivalence Comparison" table demonstrate that the D-ACTOR® 200 meets design specifications and is functionally equivalent to its predicate devices.

The acceptance criteria here appear to be primarily focused on meeting design specifications, safety standards, and demonstrating technological equivalence to legally marketed predicate devices.

Acceptance Criteria (Implied from Performance Testing)	Reported Device Performance and Equivalence
Device Design Specifications: The D-ACTOR® 200 must meet its own design specifications and demonstrate equivalence in key technological characteristics to predicate devices. This includes aspects like intensity settings, applicator head properties, vibration frequency, penetration depth, energy flow density, and acoustic wave generation parameters.	"Verification and validation testing was performed and demonstrated that the D-ACTOR® 200 meets the design specifications and is safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed."

The "Substantial Equivalence Comparison" table (page 6) directly compares the D-ACTOR® 200 to the predicate AW Modules, showing largely equivalent or comparable characteristics across 20 parameters, including:

Indications for Use: Same
Modes/Mechanisms of Action: Same
Max/Min Intensity Settings: 1-5bar (compared to 1-5bar and 1-3bar for predicates)
Number/Size of Applicator Heads: 4 (6mmOD, 15mmOD, 20mmOD, 35mmOD) (compared to 3/2 for predicates with slightly different sizes)
Max/Min Displacements: 0.6 – 2.0mm (compared to 0.6 – 2.0mm and 2.0mm for predicates)
Max/Min Vibration Frequency: 1-21Hz (compared to 0.5-21Hz and 0.5-3Hz for predicates)
Maximum Penetration Depth: 32.3mm (compared to 17mm and 32.3mm for predicates)
Energy Flow Density: 5bar/0.284mJ/mm², 3bar/0.176mJ/mm² (compared to 3bar/0.176mJ/mm² for predicates). Note: At 5bar, the D-ACTOR® 200 has a higher energy flow density than the predicate, but this is reported as part of the substantially equivalent comparison.
Operating Mode, Projectile Mass, Type of Acoustic Wave Generation: Same |
| Software Validation: The device software must be validated to an appropriate level of concern. | "The D-ACTOR® 200 software was validated and demonstrated to be of a Moderate level of concern..." It also complies with IEC 62304:2006: Medical Device Software Software Life Cycle Process. |
| Hazard Analysis/Risk Management: All identified risks must be mitigated to an acceptable level. | "...hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an acceptable level." It complies with ISO 14971:2000/A1:2003: Medical devices: Application of risk management to medical devices. |
| Biocompatibility: Skin-contacting components must be biocompatible. | "The skin contacting component was tested for biocompatibility and found to conform to elements of ISO 10993-1:2003." |
| Electrical Safety and Electromagnetic Compatibility (EMC): The device must conform to relevant international safety and EMC standards. | "The D-ACTOR® 200 was tested and demonstrated to conform to the general safety requirements of IEC 60601-1:2012 (Ed. 3.1); as well as the electromagnetic compatibility requirements of IEC 60601-1-2:2007 (3rd Ed.)." It also complies with IEC 61000-3-2:2000 and IEC 61000-3-3:2000 for EMC. |
| In-vitro Performance: In-vitro measurements of applicator displacement, force, and penetration depth should be equivalent to the predicate devices. Ultrasonic energy parameters should also be evaluated and comparable. | "In-vitro testing was performed to determine applicator displacement, force and penetration depth and was demonstrated to be equivalent to the AW module (i.e., D-ACTOR provided as OEM) of the predicate devices. Ultrasonic energy comprises approximately 5% of D-ACTOR® 200 total output and this parameter was evaluated by employing modified protocols from IEC 61846. Those tests demonstrated energy flow densities (ED) of 0.176mJ/mm2 at 3 bar pressure (same ED as the predicates) and 0.284mJ/mm2 at 5 bar pressure." |

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

The provided document describes performance testing related to device characteristics (e.g., electrical safety, EMC, biocompatibility, in-vitro physical parameters) and comparisons to predicate devices, but not a clinical study with a "test set" of patients or data. Therefore, typical sample size and data provenance (country of origin, retrospective/prospective) for a study evaluating diagnostic or treatment efficacy in a patient population are not applicable here.

The "testing" mentioned is for engineering verification and validation, involving laboratory measurements and comparisons to established standards and predicate device specifications.

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

This information is not applicable as there is no clinical "test set" requiring expert ground truth establishment for patient outcomes or conditions. The "ground truth" in this context would be the measured physical properties of the device and compliance with engineering standards.

4. Adjudication Method for the Test Set

This information is not applicable as there is no clinical "test set" requiring adjudication.

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

This information is not applicable. The D-ACTOR® 200 Vibration Massage System is a therapeutic device, not an AI-powered diagnostic tool used by human readers for interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

This information is not applicable. The D-ACTOR® 200 is a physical therapeutic device, not an algorithm, and its performance inherently involves human operation and interaction with a patient.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is based on:

Engineering Specifications and Design Requirements: The device's internal design parameters and intended operational characteristics.
International Consensus Standards: Compliance with recognized standards like IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 14971, and IEC 62304.
Predicate Device Characteristics: Direct comparison of physical and operational parameters (e.g., intensity, frequency, penetration depth) with the legally marketed predicate devices (AW module of Dermablate Effect and TattooStar Effect Y).
In-vitro Measurements: Laboratory measurements of physical properties such as applicator displacement, force, and penetration depth.

8. The Sample Size for the Training Set

This information is not applicable. The D-ACTOR® 200 is a physical therapeutic device, not an AI/machine learning algorithm, and thus does not have a "training set" in the context of data-driven model development. Its development and testing follow traditional engineering verification and validation processes.

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

This information is not applicable for the same reasons as point 8.

Summary

Regulation Number and Section

§ 890.5660 Therapeutic massager.

(a)
Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.