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As a Transcutaneous Electronic Nerve Stimulation (TENS) device for:

the symptomatic relief of chronic intractable pain, and

as an adjunctive treatment in the management of post-surgical or post-traumatic pain.

As a Neuromuscular Electrostimulation (NMES) device for:

the relaxation of muscle spasms,

prevention or retardation of disuse atrophy,

increasing local blood circulation,

muscle re-education,

immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis

and

to maintain or increase the range of motion.

Acticare HFT/HFI is a hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves or muscles. It may be used as a TENS device to aid the blocking of pain signals traveling to the brain or as a NMES device for muscle stimulation.

The provided text describes a 510(k) summary for the Bioinduction Acticare HFT/HFI device, a Transcutaneous Electronic Nerve Stimulator (TENS) and Neuromuscular Electrostimulation (NMES) device. However, it does not contain a study that establishes acceptance criteria or proves the device meets specific performance metrics in terms of clinical effectiveness or accuracy.

The document focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and safety testing, rather than a clinical performance study with defined acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

• 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 and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Information that can be extracted related to testing:

The device was tested in accordance with the following non-clinical standards:

• IEC 60601-2-10:2001 (Specific requirements for nerve and muscle stimulators)
• IEC 60601-1:1988 (General requirements for safety of medical electrical equipment), Amendment 1, 1991-11, Amendment 2, 1995
• IEC 60601-1-1:2000 (Safety requirements for medical electrical systems)
• IEC 60601-1-2:2005 (EMC compatibility and additional FCC requirements)
• IEC 60601-1-4:2000 (Software for use in Medical Devices)

The conclusion states that the device has "similar technical characteristics, performances and applications" to predicate devices, and that the "information supplied in the full 510(k) application illustrates that the device does not pose any new questions of safety or effectiveness." This implies that the performance aspects assessed were primarily technical specifications as compared to the predicate devices and adherence to relevant safety standards. There is no mention of a clinical or analytical performance study that would typically define acceptance criteria based on diagnostic accuracy or efficacy.

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The Aptiva™ v2.13U is a multifunctional transcutaneous electrical nerve stimulator (TENS) equipped with a surface electromyography and electroneurography.

Aptiva™ is indicated for symptomatic relief and management of chronic pain, intractable pain and/or as an adjunctive treatment for the management of post-traumatic pain.

The dynamic surface electromyography and electroneurography system is used for biofeedback, relaxation training, and muscle re-education as well as monitoring and display of bioelectric signals produced by muscles, stimulate peripheral nerves, and monitor and display the electrical activity produced by nerves.

The Aptiva™ v2.13U consists of a console on a mobile floor stand, power cord, battery charger, patient remote control, cables, and Manuals (User and Application). The Aptiva™ v2.13U is provided in four functional models (Ballet, Flamenco, Hip-Hop, and Jazz). EMG features are provided in the Ballet and Hip Hop models. One version of the Ballet model (Option Etoile) includes electroneurography (ENG) functions and a printer. Aptiva™ v2.13U uses commercially available electrodes. Models designated "Light" versions do not include the full treatment databases.

The provided text describes a 510(k) summary for the Lorenz Biotech Aptiva™ v2.13U device. This document focuses on demonstrating substantial equivalence to predicate devices and detailing the device's intended use and technological characteristics.

Regarding your request for acceptance criteria and a study proving the device meets them, the provided text does NOT contain information about specific performance acceptance criteria for diagnostic accuracy, sensitivity, specificity, or other clinical performance metrics, nor does it detail a study that evaluates these metrics in a clinical context.

Instead, the "PERFORMANCE TESTING" section states: "Testing included in this premarket notification includes electrical safety, electromagnetic compatibility, and design verification and validation testing. No materials of the Aptiva™ v2.13U are in direct contact with treatment sites and therefore no biocompatibility testing was provided. Test results demonstrate that the Aptiva™ v2.13U fulfills the prospectively defined performance specifications."

This indicates that the performance testing focused on engineering and safety specifications, not clinical efficacy or diagnostic accuracy as would be assessed in a study with a test set, ground truth, and expert readers. The 510(k) process for this type of device often relies on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics and intended use, rather than conducting new clinical effectiveness studies for each submission.

Therefore, I cannot fulfill most of your request based on the provided text.

Here's what I can provide based on the information given, and where most of your requested points cannot be answered:

1. A table of acceptance criteria and the reported device performance

The following information cannot be provided as it is not present in the given text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

The Aptiva™ v2.13U is a Transcutaneous Electrical Nerve Stimulator (TENS) and EMG/ENG device, which are typically cleared through 510(k) based on established safety and performance standards for electrical devices and substantial equivalence, rather than extensive clinical studies for diagnostic accuracy that would involve a "test set" and "ground truth" in the way described for, for example, an AI imaging device.

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