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The Livia is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. The Livia is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.

The LIVIA is a TENS device. TENS is an acronym for Transcutaneous Electrical Nerve Stimulator, and it works as a pain treatment system through electrotherapy. The unit sends light electrical pulses into the body through the skin by the use of electrodes, which are placed over peripheral nerves. The TENS unit works by sending high frequency electrical signals that are both continuous and mild to block out those pain signals that are being delivered to the brain. The Livia device was designed with specific pulse frequency and pulse length that are suitable for its intended use. When these pain signals are halted, pain isn't felt by the reactive area and the patient get relief. Low frequency bursts of mild electrotherapy also help the natural pain control response to activate, and these beta endorphins ease the pain that are being felt by the patient.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for the "new" indication (dysmenorrhea) are derived from the fact that a clinical trial was specifically conducted to demonstrate effectiveness and safety for this indication. For the other indications (general chronic pain, muscle pain), the device is considered substantially equivalent to the predicate, implying they meet the general TENS efficacy and safety criteria.

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

• Sample Size for Test Set: 65 participants
• Data Provenance: Not explicitly stated, but the submitter (LifeCare Ltd.) is based in Tiberias, Israel. The clinical study was a "multi-center" study conducted at "four study sites." This suggests the data could be from Israel or other international locations where these study sites were located. The study design was prospective (a "randomized, controlled, multi-center, crossover, prospective, double-blind clinical study").

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

This type of device (TENS for pain relief) relies on patient-reported outcomes (e.g., pain scales, quality of life surveys) rather than expert interpretation of medical images or pathology. Therefore, there were no experts used to establish a ground truth in the typical sense of diagnostic accuracy studies. The "ground truth" for pain relief was the subjective experience reported by the participants themselves, measured using standardized scales like VAS.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense. The primary outcome measure (VAS score for pain) is a direct patient report. There's no mention of an external adjudication panel for the primary endpoint. The study design was double-blind, meaning neither the participants nor the researchers administering the device knew whether it was the active Livia device or the sham device.

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

No, an MRMC comparative effectiveness study was not conducted. MRMC studies are typically used for diagnostic devices where multiple readers interpret clinical cases. This study was a clinical trial evaluating pain relief, which uses patient-reported outcomes.

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

Isolated standalone performance of a software algorithm was not performed as this device is a hardware TENS unit. The clinical trial directly evaluated the device's efficacy when used by humans.

7. The Type of Ground Truth Used

The ground truth for the effectiveness of pain relief was patient-reported outcomes, specifically:

• Visual Analogue Scale (VAS) for pain intensity.
• Quality of Life (QoL) scores.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI development. This study is an effectiveness trial for a physical medical device. The closest concept related to establishing the device's parameters would be the R&D and engineering phases that determined the specific pulse frequency and length, but this information is not detailed here and wouldn't be referred to as a "training set" in this context.

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

As there's no mention of a "training set" for an algorithm, this question is not applicable based on the provided text. The device's design (e.g., specific pulse frequency and length) was likely established through engineering design, pre-clinical testing, and potentially prior clinical experience with similar TENS devices, rather than an algorithmic training process.

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The Livia is designed for symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

The LIVIA is a TENS device. TENS is an acronym for Transcutaneous Electrical Nerve Stimulator, and it works as a pain treatment system through electrotherapy. The unit sends light electrical pulses into the body through the skin by the use of electrodes. which are placed over peripheral nerves. The TENS unit works by sending high frequency electrical signals that are both continuous and mild to block out those pain signals that are being delivered to the brain. The Livia device was designed with specific pulse frequency and pulse length that are suitable for its intended use. When these pain signals are halted, pain isn't felt by the reactive area and the patiernt get relief. Low frequency bursts of mild electrotherapy also help the natural pain control response to activate, and these beta endorphins ease the pain that are being felt by the patient.

The provided text is a 510(k) summary for the device "Livia." It outlines the device's indications for use, its comparison to predicate devices, and the non-clinical tests performed to demonstrate substantial equivalence. However, it explicitly states in Section 9: "Discussion of Clinical Tests Performed: Livia Inc. determined that bench and non clinical testing were sufficient to demonstrate that the LIVIA device is as safe and effective as the predicate devices."

This directly indicates that no clinical study was performed or required for the Livia device to obtain 510(k) clearance based on substantial equivalence to existing predicate devices. Therefore, I cannot provide details on acceptance criteria or a study that proves the device meets those criteria, as such a study was not conducted or submitted for this specific 510(k) clearance.

The document primarily focuses on demonstrating that the Livia device has similar technological characteristics and performs comparably to the predicate devices (Philips Consumer Lifestyle PulseRelief (K151035) and NeuroMetrix ASCEND (K10433)), and that non-clinical testing was deemed sufficient by the manufacturer and accepted by the FDA for this substantial equivalence determination.

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