(361 days)
Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.
The Bindex Bl-2 system consists of handheld ultrasound transducer and software. Bindex Bl-2 is connected to the USB port of a computer and controlled with computer software. Bindex Bl-2 is used for measurement of cortical bone thickness and it provides Density Index (DI), a parameter which estimates bone mineral density at the hip as measured with DXA. For measurements, gel is applied on skin and ultrasound transducer is manually placed on the measurement location. Standardized measurement location is at proximal tibia (1/3 length of tibia). Transducer is manually oriented perpendicularly to the surface of the cortical bone to achieve accepted measurement. Measurement is repeated five times at each measurement location. Finally, transducer is disinfected by wiping gel off with isopropyl alcohol moistened cloth.
The associated accessories include:
- . Measurement stick
- Ultrasound gel (optional)
The Bindex BI-2 device underwent performance testing to demonstrate its safety and effectiveness, especially concerning its use in a home healthcare environment and its applicability to Hispanic individuals.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Type/Context |
|---|---|---|
| Electromagnetic Interference: Essential performance and Basic Safety maintained according to IEC 60601-1-2 Edition 4.0. | Test samples passed the tests with intact Essential Performance and Basic Safety. | EMC Testing for home healthcare environment (Table 2). |
| Environmental Hazards: Essential performance and Basic Safety maintained according to IEC 60601-1:2005 +Am1:2012 (Clause 5.7, 8.8.3, 8.7) and IEC 60601-1-11:2015 (Clause 4.2.2, 4.2.3.1, 8.3.1, 10.1.2). | Test samples passed the tests with intact Essential Performance and Basic Safety. | Environmental Testing for home healthcare environment (Table 2). |
| Biocompatibility: Device in skin contact for -2.5 similar in Caucasians and Hispanics. | Sensitivity 80%, Specificity 91% for Hispanics. Sensitivity 80%, Specificity 86% for Caucasians. | Clinical trial in Albuquerque, New Mexico, USA. |
| Overall Clinical Performance (Predicate): Statistically at least 80% sensitivity and specificity for hip osteoporosis with 95% confidence. | 90% sensitivity (patients in yellow/red area). 90% specificity (patients in green/yellow area). | Established in previous predicate device study (K161971) and published study (Karjalainen et al., Osteoporosis International 2016). |
2. Sample Size Used for the Test Set and Data Provenance
- EMC/Environmental/Biocompatibility/Electrical/Software/Mechanical/Acoustic Testing: The specific sample sizes for these engineering tests are not explicitly stated in the provided text. They typically involve a small number of devices or components representing the product. The data provenance is from internal testing conducted by the manufacturer or certified labs.
- Clinical Performance (Hispanic Population Study):
- Sample Size: 293 postmenopausal women (153 Caucasian, 140 Hispanic).
- Data Provenance: Prospective clinical trial conducted in Albuquerque, New Mexico, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not specify the number or qualifications of experts used to establish ground truth for the engineering tests (EMC, environmental, etc.).
For the clinical performance study aiming to validate DI thresholds in Hispanic populations:
- The ground truth for osteoporosis diagnosis was established using DXA (Dual-energy X-ray Absorptiometry) measurements of total hip or femoral neck T-score
§ 892.1180 Bone sonometer.
(a)
Identification. A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers.” See § 892.1(e) for the availability of this guidance document.