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B.O.L.T model (VA01) Base unit with it`s accessory devices attachment (VA01-0, VA01-1 and VA01-2) and the B.O.L.T application is a patient vitals measuring and monitoring system used for spot-checking and measuring the physiological parameters of adult patients / users of age or older). The physiological parameters measured and monitored are: · Non-Invasive Blood Pressure (NIBP), Pulse Rate (PR) · Oxygen saturation (SpO2), Pulse Rate (PR) · Body Temperature (TEMP) B.O.L.T application is downloaded and installed in a Bluetooth enabled smart devices/ computer. The operations of the base unit and the attached devices like start and stop are controlled by the B.O.L.T application and the results are displayed by the B.O.L.T application on the screen of the smart devices/ computer. This device is applicable for use by an adult and it can be used in a clinical setting like a physician office and also in a home environment for patients to keep track of the physiological parameters mentioned above. Home users are advised to contact their physician if any abnormal values are indicated. B.O.L.T. NIBP model Base unit (VA01) along with an inflatable cuff (VA01-0) that is wrapped around the upper arm, is a fully automatic, non-invasive, wireless blood pressurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual. B.O.L.T, IRT model Base unit (VA01) along with a thermometer probe (VA01-1) using infrared sensor detects body temperature from the ear canal in the adult population. B.O.L.T, Pulse Oximeter model Base unit (VA01) along with a pulse oximeter probe (VA01-2) is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) from the fingertip of adult users.

The B.O.L.T patient monitor system base unit VA01 is elegantly designed with small form factor. The devices NIBP, IRT thermometer and Pulse Oximeter connects to the base unit. The device has two LED indicators that display power status and Bluetooth connectivity status. The device has an on/off slide switch on the side and USB power socket. The device has one accessories port with Lemo connector to connect IRT Thermometer and Pulse Oximeter, one at a time. There are two other ports to connect the twin tubes of the NIBP Cuff. The base unit has a rechargeable lithium polymer battery and device should be used only in battery mode and it should not be used while charging. The power adapter is given only for charging the device. The B.O.L.T. NIBP device model VA01-0 connects to the VA01 Base unit's twin port and measures both systolic and diastolic blood pressure and pulse rate via a standard oscillometric method. The oscillometric method senses the vibrating signal via the closed air pipe system and utilizes a microcontroller in the base unit to automatically sense the characteristics of the pulse signal. Unlike with the traditional measuring method, based o6i the Korotkov sound, with the oscillometric method the use of a stethoscope is not required. Through simple calculations, this method provides accurate blood pressure readings: the systolic pressure is defined as the blood pressure when the cuff pressure oscillating amplitude begins to increase, while the diastolic blood pressure is defined as the pressure when the cuff pressure oscillating amplitude stops decreasing. The device includes a plastic enclosure and external wraparound cuff, and it requires an external device (e.g. a smartphone) to display results and perform user interaction. The IRT Thermometer module of B.O.LT., model VA01-1, patient monitoring system is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the ear canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces. The unit measures the infrared energy emitting from the middle ear and the surrounding tissue. This energy is absorbed by lenses and converted into temperature values. The IRT electronic thermometer accessory (VA01-1) connects to the accessory connector of the B.O.L.T Base unit (VA01) patient monitoring system and readout value is displayed on the connected Bluetooth device like a Smart Phone, tablet or personal computer. The Infrared Ear thermometer module of B.O.L.T, model VA01-1 patient monitoring system consists of the following parts: - Thermopile Sensor . - Application-Specific Integrated Circuit . - . Lens - Probe cover (Single use and probe cover to be disposed after each measurement) ● The B.O.L.T model VA01-2 fingertip pulse oximeter accessory device features a small form factor. low power consumption, a convenient operation, and portability. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement. The fingertip pulse oximeter accessory device connects to the accessory connector of the B.O.L.T VA01 base unit. The readout value Spo2(%) and Pulse rate values are displayed on the connected Bluetooth device like a Smart Phone, tablet or personal computer. The user manual which is provided with the device provides the detailed specifications. The system is controlled and operated via the B.O.L.T application which is downloaded and installed in a Bluetooth enabled smartphone/tablet/computer. The B.O.L.T application is supported for the following versions of Android/IOS and Windows operating system. - . The Android OS version 4.0 or higher. - . The iOS version 7 or higher. - . The Windows OS version 8 or higher The software communicates with the base unit (VA01) through Bluetooth communication to the connected smartphone/tablet/computer. The user has to pair the base unit with handheld mobile devices or computers through Bluetooth and use the Software application to operate and control the devices attached to the base unit. Functions like activating and stopping the device and display of the test value are all performed by the B.O.L.T application residing in the Bluetooth connected smartphone/tablet/computer. The device/s is connected to the accessory port of the base unit. The base unit takes signals from the connected device like NIBP Cuff, Pulse oximeter, IRT Thermometer. The software and firmware of the B.O.L.T patient monitoring system, process the data from the accessory devices, then display the parameters/measured data on the screen of a wirelessly connected Bluetooth device like a smartphone/ tablet/ personal computer. B.O.L.T application can hold any number of records and recognized by user ID. The number of records is limited by the data storage capacity of the secured cloud infrastructure. FCC grant is obtained under FCC ID: 2AFV6-AMI-BU-2. The data collected from devices can be securely uploaded/stored in a secured cloud. The secured cloud is HIPAA compliant and hosted in a HIPAA compliant data Centre. All the protected health information and the physiological data of a user/patient is encrypted at rest. The communication over the internet to the cloud utilizes the HTTPS/TLS protocol. The B.O.L.T is also packaged with a SDK (Software Development Kit) to integrate the reading from the devices to an external system like a Care Portal/Electronic Medical Record software system

The provided document details the 510(k) summary for the B.O.L.T (Body Life Tracker) device, which includes modules for Non-Invasive Blood Pressure (NIBP), Infrared Radiation Energy Technology (IRT) Thermometer, and Pulse Oximeter (SpO2). The acceptance criteria and study designs are described for each module to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

1.1. B.O.L.T NIBP (Non-Invasive Blood Pressure)

1.2. B.O.L.T IRT Thermometer

1.3. B.O.L.T Pulse Oximeter

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

• B.O.L.T NIBP:

  • Sample Size: 106 subjects (adult males and females between 18 and 65 years).
  • Readings for NIBP: 318 readings for statistical analysis.
  • Readings for Pulse Rate: 89 readings for statistical analysis.
  • Data Provenance: Clinical study, likely prospective, country of origin not specified but the standards are international (EN ISO).

• B.O.L.T IRT Thermometer:

  • Sample Size (EN ISO 80601-2-56:2012): 105 subjects (adult males and females between 18 and 65 years). 37 febrile, 68 non-febrile.
  • Readings for Statistical Analysis: 105 readings.
  • Sample Size (ASTM E1965-98): 120 subjects (adult males and females between 18 and 65 years). 35 febrile, 83 afebrile.
  • Readings for Statistical Analysis: 118 readings.
  • Data Provenance: Controlled human clinical studies, likely prospective, country of origin not specified.

• B.O.L.T Pulse Oximeter:

  • Sample Size: 12 subjects recruited, 10 subjects used for the clinical study (adult males and females between 18 and 65 years). 2 dark pigmented, 8 light pigmented.
  • Readings for SpO2: 250 readings for statistical analysis.
  • Readings for Pulse Rate: 225 pulse rate readings obtained.
  • Data Provenance: Clinical study (invasive controlled de-saturation study), likely prospective, country of origin not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• The document does not explicitly state the number of experts used or their qualifications for establishing ground truth for the clinical studies. Ground truth was established by comparison against reference devices that are cleared under existing K numbers:
  • NIBP: Omron model HEM 907 (K032305)
  • IRT Thermometer: Braun PRO 4000 (K031928), and DT-K11E (K172861) as a contact reference thermometer.
  • Pulse Oximeter: Contec Medical Systems model CMS-50D (K082641) (as a reference device) and Radiometer model ABL 800 Basic with Co-oximeter (for measuring SaO2 from arterial blood sample).

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test sets. The accuracy of the B.O.L.T devices was evaluated by comparing their measurements directly to those obtained from the established reference devices and standards.

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

• No MRMC comparative effectiveness study was done. The studies described are device-to-reference device comparisons, not human reader performance studies with or without AI assistance. The B.O.L.T is a vital signs monitor, not an AI-assisted diagnostic imaging tool that would typically involve MRMC studies.

6. Standalone Performance

• Yes, standalone performance (algorithm only without human-in-the-loop performance) was effectively done for each module. The studies evaluate the accuracy of the B.O.L.T device's measurements (NIBP, SpO2, Temperature) against established reference devices, without the direct involvement of human interpretation of the device's output for diagnostic purposes beyond reading the measurements themselves. The device's operation is controlled by an application, but the core measurement accuracy is assessed as a standalone system.

7. Type of Ground Truth Used

• The ground truth used was established by comparison with measurements from predicate/reference medical devices and in the case of SpO2, also with outcomes data (SaO2 values from arterial blood samples) measured by a Co-oximeter which is considered a gold standard for blood oxygen saturation. This is a form of empirical validation against established clinical standards and reference instruments.

8. Sample Size for the Training Set

• The document describes clinical validation studies (test sets) but does not provide any information regarding the sample size used for the training set for the device's development or algorithms. The device's technological characteristics are based on established methods (e.g., oscillometric method for NIBP, infrared for temperature, photoelectric for pulse oximetry), rather than deep learning algorithms requiring large training datasets.

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

• Since no specific training set for an AI/ML algorithm is described, the ground truth establishment for a training set is not applicable here. The device's underlying principles are based on known physiological measurement techniques and are validated against established medical device standards and reference instruments.

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The HEM-9000AI is intended to measure systolic and diastolic blood pressure, and pulse rate in adults with an arm circumference of 17-50 cm (7-20 inches) and to measure/calculate radial augmentation index (AI). The HEM-9000AI is intended for use in physician's offices, hospitals, clinics and other medical facilities where non-invasive blood pressure and radial augmentation index measurements/calculations are performed on patients and invasive measurement is contraindicated.

The augmentation index (AI) function of the HEM-9000AI has not been evaluated on patients who have inter-ventricular conduction delays (IVCD).

The HEM-9000AI is an oscillometric NIBP measurement and applanation tonometry augmentation index (AI) measurement/calculation device. The HEM-9000AI utilizes both an oscillometric blood pressure detection technology via a cuff wrap at upper arm as well as a tonometry measurement at the radial artery at the HEM-9000AI measures the oscillometric signal for NIBP measurement and processes the data through its CPU and algorithm within the device. It provides measurements of systolic and diastolic blood pressures, as well as pulse rate for adult patients with upper arm circumference in the range of 7 - 20 inches (17 -- 50 cm). AI information is collected via tonometry by the placement of a set of sensors over the radial artery at the wrist. The tonometer applies pressure and compresses the radial artery until sensors detect the pulse wave (PW). The signal is sent back to the central processor, which separates the superimposed waveform into the eiected wave and the reflected wave components. AI is derived from the pulse wave by calculating the amplitude-ratio of "reflected wave" to "ejected wave" at the radial artery. All information appears on the device display and can be printed. The device is self-contained, single unit with both oscillsometric and tonometry signal detection built in.

Here's a breakdown of the acceptance criteria and study information for the HEM-9000AI, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The provided document specifically mentions two key performance aspects: Non-Invasive Blood Pressure (NIBP) measurement and Augmentation Index (AI) measurement/calculation.

Study Details

Here's a summary of the study details based on the provided text:

1. Sample Size used for the test set and the data provenance:

   • Augmentation Index (AI) Comparison: 162 patients.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "sequential order" measurements on patients, suggesting a prospective design for this particular comparison.
   • NIBP Testing: The document mentions "Clinical testing for the NIBP aspect was performed in accordance with the specific requirements established within ANSI/AAMI SP-10:2002." ANSI/AAMI SP-10 typically requires a certain number of subjects (e.g., 85 adult subjects) for clinical validation, but the exact count isn't specified here for the HEM-9000AI's NIBP component.

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

   • Not applicable/Not specified in the provided summary. For NIBP validation against AAMI SP-10, the "ground truth" would typically be invasive arterial pressure measurements, not expert consensus. For AI, the "ground truth" was essentially the measurement from the predicate device (SphygmoCor Px).

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

   • Not applicable/Not specified. The clinical testing described does not involve subjective interpretations requiring adjudication.

4. 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. This device is a measurement device, not an AI-assisted diagnostic imaging or interpretation system that would typically involve human readers.

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

   • Yes, implicitly. The performance evaluation for both NIBP and AI describes the device's measurements/calculations as standalone outputs, without human interpretation of the algorithm's direct output being part of the primary evaluation. The comparison to the predicate device is a standalone performance metric.

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

   • NIBP: Conformance to ANSI/AAMI SP-10:2002 typically implies comparison against invasive arterial blood pressure measurements as the reference standard (ground truth). This is not explicitly stated but is the common practice for such standards.
   • Augmentation Index (AI): The "ground truth" for the AI comparison was the measurement obtained from the predicate device, SphygmoCor Px, on the left radial artery. The study aimed to show "similar results" to this established device.

7. The sample size for the training set:

   • Not specified. The document primarily discusses performance testing (validation) rather than explicit details about the development or training of the AI algorithms. The NIBP algorithm is stated to be the "same" as the HEM-907XL, suggesting it was already established. The AI calculation is mentioned, but its development process or training data size is not detailed.

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

   • Not specified. As noted above, details about algorithm development or training ground truth are not provided in this summary.

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