Search Results

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

• Livia: Average 28.1 points reduction
• Sham: Average 17.6 points reduction
• Statistically significant difference (P

Ask a specific question about this device

The Patient Status Engine is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, heart rate variability (R-R interval), ECG derived respiration rate data (EDR), skin temperature, activity, posture and optional SpO2 and non-invasive Blood Pressure (BP). Data is transmitted wirelessly from the sensors to the Patient Gateways and from the Patient Gateways to a central Server where it is stored for analysis. The Patient Status Engine can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.

The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information.

The data from the Patient Status Engine is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients nor replace standard monitoring and/or routine care.

The Patient Status Engine (PSE2) is a wireless data collection system that monitors physiological data and consists of the following components / subsystems and optional third party devices as listed below:

Components and Subsystems:
Patient Gateway (Samsung Tablet) – Manufactured by Samsung
Patient Gateway Software – Manufactured by Isansys Lifecare Ltd
Lifetouch Blue Sensor – Manufactured by Isansys Lifecare Ltd
Lifetemp Sensor– Manufactured by Isansys Lifecare Ltd
Lifeguard Server Software – Manufactured by Isansys Lifecare Ltd

Additional third party Accessories:
Pulse Oximeter 3150– Manufactured by Nonin
Blood Pressure Monitor UA767– Manufactured by A&D Medical
Skintact ECG Electrodes – Manufactured by Leonhard Lang
Ambu White Sensors – Manufactured by Ambu Inc.

At the subsystem level the Patient Gateway, Lifetouch Blue Sensor and Lifetemp Sensor are collectively identified as the Patient Digitisation Engine (PDE2). The inclusion of the Lifeguard Server completes the Patient Status Engine (PSE2).

The provided text is a 510(k) summary for the Isansys Lifecare Ltd Patient Status Engine. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it does not contain a specific study that proves the device meets explicit acceptance criteria in the format requested.

The document states that no human clinical testing was required to support the medical device, as its indications for use are equivalent to the predicate device. It relies instead on non-clinical performance tests against applicable standards. Therefore, an analysis of acceptance criteria and proven device performance as typically found in clinical studies (e.g., sensitivity, specificity, AUC) is not present.

Below is an attempt to structure the available information regarding "acceptance criteria" based on the non-clinical performance data provided.

1. Table of Acceptance Criteria and Reported Device Performance

Given that no clinical study with specific performance metrics (like accuracy, sensitivity, specificity) against a ground truth is provided, the "acceptance criteria" here refer to compliance with various electrical, electromagnetic, biocompatibility, risk management, and software standards.

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

Not applicable. The "tests" were non-clinical performance and engineering validation tests, not tests on a dataset of patient data.

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

Not applicable. Ground truth as typically defined for clinical performance studies (e.g., diagnoses by experts, pathology reports) was not established for patient data in this submission. The "ground truth" for the non-clinical tests was compliance with international standards, which is evaluated by test engineers and accredited laboratories.

4. Adjudication method for the test set

Not applicable, as no external test set requiring expert adjudication was used.

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

Not applicable. This device is a remote monitoring system, not an AI-assisted diagnostic tool that would typically involve human readers. No MRMC study was conducted or mentioned.

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

Not applicable. The evaluation was for the entire system's compliance with safety and performance standards for a monitoring device, not a standalone AI algorithm.

7. The type of ground truth used

The "ground truth" for this submission was the compliance with established international and national standards for medical device safety, electromagnetic compatibility, biocompatibility, software development, usability, and risk management.

8. The sample size for the training set

Not applicable. No machine learning model or "training set" is mentioned in the context of this 510(k) submission.

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

Not applicable, as there was no training set.

Ask a specific question about this device

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.

Ask a specific question about this device

The Precision One Lifecare and Detecto Body Fat scales measure weight and use bioelectrical impedance analysis (BIA) technology to estimate and keep a record of body fat percent, total body water percent, bone mass percent, and muscle mass percent. The scales also provide a daily calorie intake recommendation and a fitness assessment. The scales are intended for use in the home/domestic setting only.

Estimated body fat percent is intended for use on individuals 7-17 years old (Healthy Children) and 18-80 years old (Healthy Adults).

Estimated body water percent, estimated muscle mass percent, estimated bone mass percent, and calorie intake are intended for use on individuals 18-80 years old.

Children under 7 years old and adults over 80 years old can use the scales for normal weighing mode only.

The scales are not intended for diagnosis.

The Body Fat scales use BIA (Bio Impedance Analysis) technology which passes an electrical current through the body to estimate body fat percent, muscle percent, body water percent, and bone percent. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer.

The devices are single frequency electrical bio-impedance analyzer. All models measure current, voltage and phase angle, calculate impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition of: body fat percent, body water percent, muscle mass percent, bone mass percent, daily calories intake recommendation, and provides a fitness assessment. All models have a bi-polar set of contact electrodes which are attached to stainless steel pads on the platform of the analyzer.

The scales can store the personal data of up to 12 users. As well as being an analyzer, these devices can be used as a conventional scale. The models have one operating mode: Algorithm Mode.

Algorithm Mode; Displays estimates of body fat percent and body water percent. The devices compute these values using accepted reviewed published algorithms tailored to the candidate types: general population of the accepted age ranges of adult or children.

The devices consist of a main unit having a glass or stainless steel platform for the user to step on. On the platform, 2 stainless steel electrodes are mounted which are connected to the electronics circuitry with the analyzing MCU. When the user steps on the electrodes (1 for each foot) a small current of about 90μA will pass through the user body through the 2 feet to complete the close circuitry in order for the analyzer to measure and capture the electrical data change in terms of Bio electrical impedance, resistance, reactance, taking into account other parameters as to personal data of Age, Height, Gender, and Weight.

Here's an analysis of the acceptance criteria and the study that demonstrates the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not list specific, quantifiable acceptance criteria for the performance of the body fat scales (e.g., a specific delta or correlation coefficient for body fat percentage). Instead, the acceptance is based on a determination of substantial equivalence to a predicate device.

The reported device performance is that the "two scales provide substantially equivalent results."

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

• Sample Size for Test Set: 70 participants (50 adults and 20 children).
• Data Provenance: Not explicitly stated regarding country of origin. The study was conducted by the "sponsor," suggesting it was an internal study or sponsored by the manufacturer. It was a prospective study, as participants "standing on both the predicate scale and a Body Fat scale to obtain measureable parameters."

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

This information is not provided in the document. The study compares the performance of the subject device to a predicate device, not to an independent "ground truth" established by experts in the context of diagnostic accuracy. The "ground truth" in this performance study is the measurements obtained from the predicate device itself.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in scenarios where multiple experts are evaluating cases and their agreement or disagreement needs to be resolved to establish a definitive ground truth. In this study, the comparison is directly between two devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is a direct comparison between a new device and a predicate device, not an evaluation of human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone (algorithm only) performance assessment was done in the sense that the device's algorithms were compared to those of the predicate device. The text states:

• "The performance of Body Fat Scales was compared to the performance of the predicate device through testing conducted by the sponsor."
• "This testing consisted of 70 participants... standing on both the predicate scale and a Body Fat scale to obtain measureable parameters which are also used for algorithm calculations. This testing showed the two scales provide substantially equivalent results."

This indicates an evaluation of the device's algorithmic output (body composition estimations) in comparison to the predicate, without human intervention in the interpretation of the output for the purpose of the substantial equivalence claim.

7. Type of Ground Truth Used

The "ground truth" for the performance comparison was the measurements obtained from the predicate device (Tanita Model: SC331). The study aimed to show that the subject device produced results "substantially equivalent" to the predicate, making the predicate's output the de facto reference for this comparison. It was not pathology, outcomes data, or expert consensus in an absolute sense, but rather a comparative reference.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The device uses "accepted reviewed published algorithms," which suggests these algorithms were developed based on prior research and data, but the specific training data for these algorithms as applied to this device is not provided. The 70 participants were part of a comparative performance test to demonstrate equivalence.

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

Since a dedicated training set for the subject device is not described, the method for establishing its ground truth is also not provided. The algorithms are stated to be "accepted reviewed published algorithms tailored to the candidate types: general population of the accepted age ranges of adult or children." This implies the underlying algorithms were developed and validated using standard, often clinically derived, methods for BIA calculation in the scientific literature. However, the specifics of this particular device's training data and its ground truth establishment are absent.

Ask a specific question about this device

Ask a specific question about this device