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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

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

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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 bensity 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 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 provided document is a 510(k) summary for the Bindex BI-2 device, which measures apparent cortical bone thickness. The device received substantial equivalence based on its similarity to a predicate device (Bindex BI-100). The document focuses on demonstrating substantial equivalence rather than presenting an exhaustive de novo clinical study with specific acceptance criteria and detailed device performance metrics against a clinical ground truth.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for clinical accuracy in the traditional sense of a de novo study. Instead, it relies on demonstrating that the Bindex BI-2 (subject device) is substantially equivalent to the Bindex BI-100 (predicate device), for which previous clinical and pre-clinical data supports its safe and effective use.

The "acceptance criteria" here are implicitly related to the predicate device's established performance and the subject device's ability to demonstrate equivalence in technical and functional aspects. The performance data presented are primarily related to engineering and safety testing, not direct clinical diagnostic performance metrics (like sensitivity, specificity, accuracy against a gold standard for bone strength or fracture risk).

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