Search Results

The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.

The V10 vital signs monitor non-invasive blood pressure, pulse rate, non-invasive functional oxygen saturation of arterial hemoglobin for adult, pediatric and neonate patients and body temperature for adult and pediatric patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.

The Mediana V10 vital signs monitor is a lightweight and compact device (249 x 211 x 154 (mm) (WxHxD) and 3.0 kg) powered by AC mains (100-240VAC, 50Hz/60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 7-segment LED displays.

The provided text describes the Mediana V10 vital signs monitor, which measures non-invasive blood pressure (NIBP), pulse rate (PR), functional arterial oxygen saturation (SpO2), and temperature (Temp). The document is a 510(k) summary for FDA clearance.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to the device's ability to demonstrate substantial equivalence to its predicate device (Mediana V10, K152659) and compliance with relevant international standards. The performance is reported in terms of equivalence to the predicate and compliance with these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• NIBP Clinical Evaluation: The text states, "To verify the accuracy of measuring, the clinical evaluation was performed on adult, pediatric and neonate." It does not specify the exact sample size (number of patients) within each age group.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether the studies were retrospective or prospective. Given the submitter's location (Republic of Korea), it's plausible the studies were conducted there. The nature of clinical evaluations for device clearance typically implies prospective data collection, but this is not explicitly stated.

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

The document does not provide details on the number of experts or their qualifications for establishing ground truth in the clinical evaluations (NIBP and Temperature).

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical test sets.

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

No, an MRMC comparative effectiveness study was not done. The device is a vital signs monitor, and the performance evaluation is based on the accuracy of its measurements against established standards and predicate device performance, not on a human-in-the-loop diagnostic task that would typically involve MRMC studies.

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

Yes, the primary clinical evaluation for NIBP and Temperature accuracy is a standalone performance assessment of the device's measurement capabilities. The device directly measures these parameters; it is not an AI algorithm assisting human interpretation of images, for instance.

7. The Type of Ground Truth Used

The ground truth for NIBP and Temperature measurements would typically be established using a reference standard method for blood pressure (e.g., intra-arterial measurement or an established oscillometric reference device for NIBP accuracy, and a high-accuracy reference thermometer for temperature) in a clinical setting. While not explicitly stated, compliance with ISO 81060-2 for NIBP implies a rigorous clinical validation against an accepted reference.

8. The Sample Size for the Training Set

The document describes performance testing for a finished device, not a machine learning model that would require a separate "training set." Therefore, there is no mention of a training set or its size.

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

As there is no mention of a machine learning model or a training set, this question is not applicable. The device's performance is based on its underlying hardware and signal processing, validated through the clinical and performance tests described.

Ask a specific question about this device

The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.

The V10 vital signs monitor is to monitor non-invasive blood pressure, pulse rate, non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) for adult, pediatric and neonate patients and body temperature for adult and pediatric patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.

The Mediana V10 vital signs monitor is a lightweight and compact device (298 × 218 × 172 (mm) (W×H×D) and 3.4 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 7-segment and LED displays.

The Mediana V10 device is a vital signs monitor designed to measure non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), and temperature (Temp) in adult, pediatric, and neonatal patients across various healthcare settings.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria with specific thresholds for each vital sign measurement or detailed performance data for the V10 device itself. Instead, it states that the V10's specifications and performance are equivalent to predicate devices that comply with specific standards.

Therefore, the table below will reflect this equivalence statement. The "Acceptance Criteria" are implied by the standards and performance of the predicate devices, and "Reported Device Performance" is stated as being equivalent.

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

The document states: "The Mediana vital signs monitor, Model V10 substantially has been tested in accordance with the system V & V plan #MDR-EG140718-01 included with the submission using production equivalent units prior to release to market."

• Sample Size for Test Set: Not specified. The document mentions "production equivalent units" but does not provide a number or range for the test set sample size.
• Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the study was retrospective or prospective.

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

There is no information provided regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set within the provided text. The assessment relies on equivalence to devices that already comply with established standards.

4. Adjudication Method for the Test Set

There is no information provided regarding an adjudication method for the test set.

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

• No evidence of a MRMC comparative effectiveness study. The document focuses on the technical equivalence of the V10 to predicate devices, not on the improvement of human readers with or without AI assistance. The V10 is a standalone vital signs monitor, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance assessment was conducted, but it's framed as equivalence testing. The document states: "The Mediana vital signs monitor, Model V10 substantially has been tested in accordance with the system V & V plan #MDR-EG140718-01 included with the submission using production equivalent units prior to release to market." This indicates that the device itself underwent testing to demonstrate its performance, which was then compared to that of predicate devices to establish substantial equivalence. However, the exact performance metrics or detailed results of this standalone testing are not provided, only the conclusion of equivalence.

7. Type of Ground Truth Used

• The "ground truth" for the V10's performance is implicitly tied to the performance established by the predicate devices and their adherence to recognized standards (e.g., AAMI SP10 for NIBP). For example, if the predicate device's NIBP measurements were validated against an invasive arterial line (a common ground truth for NIBP), then the V10's "equivalence" implies it meets similar accuracy standards. However, the document does not directly state the specific ground truth used for the V10's own testing.

8. Sample Size for the Training Set

• Not applicable / Not specified. The V10 is described as a vital signs monitor, which typically relies on established measurement principles and calibrated sensors, not a machine learning algorithm requiring a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not relevant to this device as described.

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

• Not applicable / Not specified. As the device does not appear to be an AI/ML-based system requiring a training set, this question is not relevant.

Ask a specific question about this device

The Viora V10 system is intended for dermatological procedures.

The V-ST Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The V-Form Handpiece (with BC and FC applicators) is indicated for delivering non thermal RF combined with massage:

• · relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and
• . temporary reduction in the appearance of cellulite.

The Viora V10 system is a RF multi application platform with two available treatment Handpieces:

• V-ST Handpiece Bi-polar radiofrequency (RF) Handpiece.
• · V-Form Handpiece (with BC and FC applicators) mechanical vacuum massage and Bi-polar radiofrequency (RF) Handpiece.

The Main Unit (console) provides the operational and safety function of the system. The operator can modify the treatment parameters to achieve specific tissue effects depending on individual patient's skin condition and anatomical structure.

This document describes the Viora V10 system, an RF multi-application platform intended for dermatological procedures. It leverages existing predicate devices (Viora V20 system K142093 and Viora Reaction™ system K090221) to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a specific test set with a sample size for evaluating the V10 system through human subject data. Instead, it relies on predicate device data and bench testing.

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

Not applicable, as no dedicated human subject test set is described with ground truth established by experts.

4. Adjudication method for the test set

Not applicable, as no dedicated human subject test set is described.

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 MRMC comparative effectiveness study is mentioned. This device is an RF multi-application platform, not an AI-assisted diagnostic tool typically assessed with MRMC studies.

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

This is not applicable as the device is not an algorithm performing a diagnostic function. The "standalone" performance here refers to the device's functional and safety performance through bench testing, which was done.

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

For the V10 system itself, the "ground truth" for demonstrating safety and effectiveness relies on:

• Compliance with recognized international standards (IEC 60601 series).
• Bench testing results comparing its performance to predicate devices.
• Demonstrated equivalence of technological characteristics and intended use to previously cleared predicate devices.

8. The sample size for the training set

Not applicable. This document describes a medical device seeking 510(k) clearance based on substantial equivalence to predicate devices, not an AI/ML algorithm that requires a training set.

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

Not applicable, as no training set for an AI/ML algorithm is mentioned.

Ask a specific question about this device

The intended use of the Pride Mobility Products Corporation V Series Scooters is to provide mobility to disabled persons having limited walking capabilities.

The V Series Scooters are three and four wheeled battery-operated scooters. Features include a programmable controller, removable seat, a foldable tiller, two piece frame, and an off board charger; specific models include a Power Seat actuator. Additional safety features include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Scooters can be disassembled into four parts: the rear section, the front section, batteries, and the seat; this allows for ease of use when traveling or storing the unit.

The V Series Scooters are designed with ultimate safety, stability, and performance in mind and are designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.

This document describes a 510(k) premarket notification for Pride Mobility Products Corporation's V Series Scooters. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, specific device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not available within this document. This submission relies on non-clinical testing and comparison to predicate devices to establish safety and effectiveness.

Here's a breakdown of what can be extracted from the provided text, and where your requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable for this type of submission. A 510(k) generally does not present a table of specific acceptance criteria with corresponding performance statistics in the way a clinical trial might. The "performance" is implicitly demonstrated through compliance with standards and comparison to a predicate device.

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

• Not applicable. This submission does not describe a clinical "test set" with human or AI performance data. The "testing" mentioned is non-clinical.

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

• Not applicable. There is no "test set" with expert-established ground truth described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No such adjudication method is mentioned for this type of non-clinical testing.

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, an MRMC study was not done. This device is a mobility scooter, not a diagnostic AI system, therefore such a study is irrelevant.

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

• Not applicable. This device is a mobility scooter, not a standalone algorithm.

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

• Not applicable. There is no "ground truth" established in the context of clinical data for performance evaluation in this submission. Safety and effectiveness are demonstrated through compliance with engineering standards and substantial equivalence to existing devices.

8. The sample size for the training set:

• Not applicable. This is a hardware device (scooter), not an AI algorithm requiring a training set.

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

• Not applicable. (See point 8).

What is available regarding testing and performance:

The document states:

• Non-Clinical Testing: Compliance to applicable Testing Standards is as follows:

  • RESNA WC Vol.1 2008 DRAFT - Requirements and Test Methods for Wheelchairs (Including Scooters)
  • RESNA WC Vol. 2 2008 DRAFT - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems
  • ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.
  • IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety
  • CAL 117 - Flammability Testing

• Discussion of Clinical Testing Performed: N/A (Not Applicable)

• Comparison to Predicate Devices: "The V Series Scooters are substantially equivalent to the Pride Mobility, Victory Three Wheel Scooter (K072165) and the Victory Four Wheel Scooter (K071949) when comparing, performance, maneuverability, stability, and structure."

Conclusion:

The V Series Scooters demonstrated substantial equivalence to predicate devices (Pride Mobility, Victory Three Wheel Scooter K072165 and Victory Four Wheel Scooter K071949) based on non-clinical testing and comparison of performance, maneuverability, stability, and structure. The non-clinical testing indicated compliance with several RESNA, ANSI/RESNA, IEC, and CAL flammability standards. No clinical testing or AI-specific performance evaluation with acceptance criteria, ground truth, or expert review was performed or reported in this 510(k) submission.

Ask a specific question about this device