(233 days)
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No
The document describes a device using A-mode ultrasound and software for calculations, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is indicated for measurement and estimation of body composition, not for treating any medical condition or disease.
No
The "Intended Use / Indications for Use" section explicitly states "The BX2000 is only intended to be used on generally healthy adults and children (6 or older) and is not for diagnosis of disease or condition."
No
The device description clearly states that the BodyMetrix BX2000 is a portable, hand-held device that uses A-mode ultrasound and includes hardware components like a piezoelectric transducer and a USB interface. While the BodyView Software is mentioned, it is used in conjunction with the hardware device.
Based on the provided information, the BodyMetrix BX2000 and BodyView Software are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility of potential recipients, or to monitor therapeutic measures.
- BodyMetrix BX2000/BodyView Function: The BodyMetrix BX2000 uses ultrasound to measure tissue thickness in vivo (on the living body). The BodyView Software processes this in vivo data to estimate body composition metrics.
- No Specimen Examination: The device does not examine specimens (blood, tissue samples, etc.) in vitro. It directly interacts with the body.
- Intended Use: The intended use is for measuring localized fat and muscle thickness and estimating total body fat percentage, not for diagnosing diseases or conditions based on the analysis of bodily specimens.
Therefore, the BodyMetrix BX2000 and BodyView Software fall under the category of in vivo diagnostic or measurement devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
(1) BodyMetrix BX2000 is indicated for the measurement of localized fat layer thickness and localized muscle thickness. When used with the BodyView Software it can be used to estimate total body fat percentage (%BF). The BX2000 is only intended to be used on generally healthy adults and children (6 or older) and is not for diagnosis of disease or condition.
(2) The BodyView Software is indicated for the calculation of the estimated total body fat percentage (%BF), localized fat layer thickness, and localized muscle thickness. The BodyView Software is indicated for calculating Waist-to-Hip Ratio (WHR), and Body Mass Index (BMI). The Body View Software is indicated for estimating Basal Metabolic Rate (BMR). The Body View software can track changes in the measurements, and generate body composition reports.
Product codes
OMV
Device Description
BodyMetrix BX2000™ is a portable, hand-held device that uses A-mode ultrasound to measure tissue thickness. The device is powered and communicates with a portable or desktop computer through a USB interface. A piezoelectric transducer is used to generate and transmit ultrasound. sound waves into tissue. The reflected sound waves are detected by a second and separate piezoelectric transducer and digitized before the data is transferred through a USB cable to the computer.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasound
Anatomical Site
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Indicated Patient Age Range
adults and children (6 or older)
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical Testing:
BX-2000 acoustic output limits are: ISPPA.3 60 mW/cm² (Maximum)
ISPTA.3 0.02 mW/cm² (Maximum)
MI · 0.02 (Maximum)
Clinical Testing:
Clinical testing was conducted and submitted as part of the 510(k) application to confirm that BodyMetrix BX2000™ is as safe and effective device for measuring tissue thickness and estimating percentage body fat.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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