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ACUTRON is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis

ACUTRON is High Frequency(=Radio Frequency, RF) includes the system main body, a handpieces with single-use micro-needle type electrodes, footswitch and an LCD touch screen control panel. The RF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the ACUTRON creates heat within the target dermal tissue via micro-needles inserted from the tip. The ACUTRON is consists of ; 1) Main unit 2) Smartcure handpiece(FDA cleared K182355) 3) Monopolar type micro-needle electrodes(FDA cleared K182355)

The provided text is a 510(k) summary for the ACUTRON device, an electrosurgical cutting and coagulation device. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing details of new clinical or standalone performance studies with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone performance studies are not available in the provided text.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) summary asserts substantial equivalence based on technical specifications and leveraging performance data from predicate devices, rather than presenting new acceptance criteria and a study demonstrating performance against those criteria.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. No new "test set" in the context of a clinical performance study (e.g., diagnostic accuracy) is described. The performance data is primarily "leveraged" from predicate devices and non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. As no new clinical performance study with a test set requiring expert ground truth establishment is detailed, this information is absent.

4. Adjudication method for the test set

Not applicable/Not provided.

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

No. The device is an electrosurgical unit, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

No. The ACUTRON is a medical device (electrosurgical unit), not a software algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The document describes non-clinical testing of the device itself (electrical and mechanical safety, EMC).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided for a new clinical study. For the animal testing and biocompatibility, the assumption is that established scientific methods and reference standards would be used, but specific "ground truth" for a performance endpoint is not detailed. The document mentions "Ex-vivo histology testing for ACUTRON handpieces is being leveraged from the Smartcure Applicator handpieces, the predicate device." This implies histology was used as a reference for the predicate, but specific details for ACUTRON are not given beyond leveraging.

8. The sample size for the training set

Not applicable/Not provided. This device is hardware for electrosurgery, not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable/Not provided.

Summary of available information related to performance/testing:

The document focuses on demonstrating substantial equivalence to existing predicate devices (Secret RF Smartcure applicator K182355 and Secret RF K170325). The performance data cited is primarily in the form of non-clinical testing and leveraging existing data from the predicate devices.

Non-clinical testing performed for ACUTRON:

• Biocompatibility testing: Leveraged from the predicate device as patient contact components and materials are identical.
• IEC 60601-1: 2005, AMD 1: 2012: General Requirements for basic safety and essential performance of Medical Electrical Equipment. (The requirements were fulfilled).
• IEC 60601-1-2: 2014: General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility). (The requirements were fulfilled).
• IEC 60601-2-2: 2017: Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories. (The requirements were fulfilled).
• Animal testing: Ex-vivo histology testing for ACUTRON handpieces is being leveraged from the Smartcure Applicator handpieces (predicate device).

Conclusion from the document:

The manufacturer concludes that "There are no significant differences between ACUTRON and the predicate device and the reference device. The proposed device does not raise any additional questions regarding safety and effectiveness. ACUTRON has the same indication of use and shares the same technological characteristics as the predicate devices." This substantial equivalence argument is based on the shared technical specifications and leveraging the performance and safety data of the predicate devices.

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The intended use of the Acutron Mentor is for relief of chronic intractable pain, some types of acute pain, and postoperative pain. It is applicable for a wide range of patients with pain, except those for which its use if contraindications for use are reproduced in the 510K submission K981976 in Section 11.0, preface pages 1 - 2. These include contraindications or cautions for patients with cardiac pacemakers, who are pregnant, are using electronic monitoring equipment, or with sensitive skin. It is also vital to obtain an accurate diagnosis of the cause of a patient's pain concurrent with TENS device use so that the overall condition can be addressed.

Symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.

The Acutron Mentor is an electromedical device of advanced design that is capable of delivering precisely modulated currents of variable intensity, frequency, polarity, modulation and waveform configuration to the soft tissues and peripheral nerves of the body via transcutaneous stimulation. The Acutron uses a large, easy to read LCD screen for all treatment set-up and monitoring, which greatly speeds and simplifies usage. The Acutron has four independently controlled and electrically isolated output channels. The multiple outputs and variations of current configuration allow the user many invaluable options of affording comfortable and effective treatment to his or her patients. These are: Conventional pulsed milliamp stimulator, Advanced microcurrent stimulator, Interferential stimulator with classic milliamp and microcurrent options, Russian current stimulator with fixed 2500 Hz carrier frequency with 50 Hz bursts.

This document is a 510(k) premarket notification for the Acutron Mentor TENS device. It primarily focuses on demonstrating substantial equivalence to predicate devices and outlining the device's technical characteristics and intended use. It does not contain a detailed study proving the device meets specific acceptance criteria in terms of performance metrics.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth, their qualifications, or adjudication method for a test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance.
• Type of ground truth used for performance evaluation.
• Sample size for the training set or how ground truth was established for the training set.

The document does provide:

1. Device Description and Intended Use:

• Commercial name: Acutron Mentor
• Device Classification: TENS device (transcutaneous electric nerve stimulator)
• Intended Use: For relief of chronic intractable pain, some types of acute pain, and postoperative pain.
• Key Features: Delivers precisely modulated currents of variable intensity, frequency, polarity, modulation, and waveform configuration. Has four independently controlled and electrically isolated output channels, LCD screen, two current ranges (milliamp and microamp), treatment timer per channel, conductivity test mode. Offers probe and pad electrodes.

2. Legal Marketing and Predicate Devices:

• Acutron Multiwave 911E (K880042B)
• Theratouch 4.7 (K932868)
• Dynatron 550 (K941577)

3. Comparison of Technological Characteristics (Similarities and Differences to Old Acutron Model):

• Similarities: Combination of digital and analog design, double-sided PC boards, four isolated output channels, ability to switch between milliamp and microamp outputs, conductivity monitoring, user modification of waveform/polarity/intensity/modulation/time, rechargeable battery, similar output circuit components, two types of electrodes.
• Differences (New vs. Old):
  • Chassis: New- molded ABS plastic vs. Old- Metal.
  • User Interface: New- buttons around LCD and Command Knob vs. Old- manual knobs and switches.
  • Power Supply: New- External AC/DC adapter powers PCB and trickle charges backup battery vs. Old- external charger for two rechargeable batteries, unit ran only off batteries. (New unit is claimed to be at least as safe, probably more so, due to double fusing, transformer isolation, double sense resistors, and current limiting surge protection).
  • Output Currents: New unit offers additional waveforms and modulations, notably sine wave milliamperage in 2500 Hz (Russian stimulation) and 4000 Hz (interferential currents) ranges.
  • Programmability: New- user can preprogram up to 40 sets of treatment parameters vs. Old- one "basic" set.
  • Output Channels: New- Probe output on channel D, all four channels can be used for pad output vs. Old- three channels for pad, one for probe only.

Conclusion:

This document serves as a regulatory submission (510(k)) to demonstrate the substantial equivalence of the Acutron Mentor to previously cleared devices, primarily based on technological characteristics and intended use. It does not detail specific performance studies with acceptance criteria, test sets, or expert evaluations that would typically be associated with proving clinical efficacy or diagnostic accuracy. Such studies are generally not required for 510(k) submissions where substantial equivalence can be demonstrated through other means, like technological comparison to predicate devices.

Ask a specific question about this device