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The MAGNETOLITH Muscle Stimulator is indicated for:

-Relaxation of muscle spasms,

-Prevention or retardation of disuse atrophy,

-Increase local blood circulation.

-Muscle re-education,

-Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,

-Maintaining or increasing range of motion.

The MAGNETOLITH delivers electromagnetic pulses to stimulate muscle tissues by applying the Magnetic Induction Field Principle (high-energy magnetic pulses) directly over (but not in direct contact with) the patient in order to achieve the same powered muscle stimulation without having to place adhesive electrode pads directly onto the patient's body. Key components of the device are the Control Unit, Handpiece Applicator, Applicator holder, a Mains cable, and a Trolley. These device components are provided non-sterile and are intended to be reusable.

The principle of operation of the MAGNETOLITHis by the application of a treatment coil to generate electromagnetic induction. i.e., the production of voltage across an electrical conductor in a changing magnetic field. The duration of the individual pulses is short and therefore the system does not increase temperature within the tissues. In addition, the MAGNETOLITH Applicator is cooled by circulating water.

It seems there are no specific acceptance criteria or details of a study proving the device meets those criteria provided in the document. The document is a 510(k) summary for the Storz Medical MAGNETOLITH Muscle Stimulator, demonstrating substantial equivalence to predicate devices, rather than a report on specific performance acceptance criteria.

The "PERFORMANCE TESTING" section (Page 4-5) states that: "Verification and validation testing was performed and demonstrated that the MAGNETOLITH 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." However, it does not explicitly list the acceptance criteria or refer to a specific clinical study with patient data and ground truth establishment.

Instead, the performance testing focuses on:

• Software Validation: The MAGNETOLITH software was validated and demonstrated to be of a moderate level of concern.
• Risk Management: Hazard analysis/risk management was performed, and all risks were mitigated to an acceptable level.
• Biocompatibility: Not performed as there are no body-contacting components.
• Conformity to Standards: The device was tested and demonstrated to conform to general safety requirements of IEC 60601-1:2012, IEC 60601-6:2013, electromagnetic compatibility requirements of IEC 60601-1-2:2014, ISO 14971:2000/A1:2007, IEC 62304:2015, and ISO 13485:2016.

The document then provides a comparison table of the MAGNETOLITH with its predicate devices (HPM-6000 and Bemer Classic & Pro) to establish substantial equivalence based on technological characteristics and safety standards. This comparison is not a study proving specific performance criteria with clinical outcomes.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets those criteria based on the provided text. The document focuses on demonstrating substantial equivalence through technical comparisons and adherence to regulatory standards, not on a clinical performance study with specific acceptance criteria, sample sizes, expert ground truth, or MRMC studies.

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The DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The DUOLITH SD1 with C-ACTOR is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The DUOLITH SD1 with the C-ACTOR Sepia Handpiece uses an electromagnetically generated shock wave produced within the hand-held applicator. The shock wave is generated by discharging a high voltage capacitor located in the Control Unit into a cylindrically shaped coil system in the C-ACTOR Handpiece which is surrounded by a cylindrical metallic membrane. The transient magnetic field produced by the coil induces eddy currents in the metal membrane, causing it to repel from the coil, producing a pressure wave. The membrane is immersed in water and the pressure wave produced by the membrane propagates through the water to a concentric parabolic reflector, where it is reflected to a focal point outside of the Handpiece in front of the reflector. The DUOLITH SD1 with C-ACTOR incorporates micro-processor control of the operating parameters.

Here's an analysis of the provided text regarding the DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly list "acceptance criteria" in a quantitative, measurable format for performance, as might be found in a clinical trial protocol. Instead, it describes compliance with design specifications, safety standards, and then reviews clinical literature to demonstrate effectiveness.

Here's an interpretation of the performance claims based on the clinical literature review:

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document refers to a "review of published literature" that included "89 chronic soft tissue wounds having a range of etiologies including diabetes mellitus." This suggests that the clinical evidence is based on data from 89 patients (cases), at least, with a focus on chronic diabetic foot ulcers within that group. It's unclear if all 89 specifically had diabetic foot ulcers, but the indications for use focus on this specific condition.
• Data Provenance: The document states "The reports from five independent studies." This implies the data were collected from multiple sources, likely different medical institutions or research groups. The country of origin is not specified, nor is whether the studies were retrospective or prospective, though typical clinical studies used for such purposes are prospective.

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

This information is not provided in the document. As this relies on a literature review of previously published studies, the methodology for establishing ground truth within those original studies is not detailed here.

4. Adjudication Method for the Test Set

This information is not provided. As this relies on a literature review, the adjudication methods of the individual studies are not described.

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

No, an MRMC comparative effectiveness study was not done, or at least not described in this 510(k) summary. The document focuses on the device's standalone performance based on existing clinical literature, not on how human readers would improve with AI assistance. The DUOLITH SD1 is a therapeutic device, not a diagnostic AI tool, so an MRMC study comparing human reader performance with and without AI assistance would not be applicable here.

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

Yes, in essence. The entire clinical performance section describes the standalone effectiveness of the DUOLITH SD1 device in treating diabetic foot ulcers. The device itself is a therapeutic modality, and its "performance" is its ability to heal wounds or reduce wound area, independent of any human interpretive intervention like with an AI diagnostic algorithm. The results presented (wound healing rates, wound area reduction) represent the direct outcomes of using the device.

7. The Type of Ground Truth Used

The "ground truth" used in the clinical studies reviewed would be clinical outcomes data. Specifically:

• Complete wound healing (defined clinically, likely by visual inspection and measurement).
• Reduction of wound area (measured clinically).

8. The Sample Size for the Training Set

This information is not applicable/not provided because the DUOLITH SD1 is a medical device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves iterative design, engineering, and nonclinical testing to meet specifications, not data-driven machine learning.

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

This information is not applicable. As explained above, the device does not employ a machine learning model that would need a "training set" with established ground truth. Its development relies on engineering principles and nonclinical testing to ensure it meets performance specifications and safety standards.

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The D-ACTOR® 200 Vibration Massage System is intended for:

• · Relief of minor muscle aches and pains
• Temporary increase in local blood circulation
• · Activation of connective tissue

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.

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.

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.

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