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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 <-2.5. DXA is considered the gold standard for bone mineral density measurement and osteoporosis diagnosis, and its interpretation is typically done by trained radiologists or other certified medical professionals. The document mentions the method and protocol were "well-established (several publications, suggested by International society for clinical densitometry)," indicating reliance on widely accepted medical standards rather than a specific number of new experts adjudicating data in this particular 510(k) submission.

4. Adjudication Method for the Test Set

• For the engineering tests (EMC, environmental, mechanical, etc.), the adjudication method is typically through comparison against pre-defined limits/standards (e.g., IEC standards). If the device meets these limits, it passes. No human adjudication is explicitly mentioned or generally required for these types of tests.
• For the clinical study, the ground truth was objective DXA measurements, making explicit human adjudication of the ground truth (like 2+1 or 3+1 consensus) unnecessary once the DXA scans were acquired and analyzed according to standard clinical practice. The study compared the device's DI thresholds against these established DXA-based diagnoses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC comparative effectiveness study involving human readers improving with AI vs. without AI assistance was mentioned or appears to have been conducted for this 510(k) submission. The Bindex BI-2 device is a standalone measurement device that provides a Density Index (DI) to aid diagnosis; it does not involve an AI assisting human readers in interpreting images or data to improve their performance compared to unassisted reading. The device provides information, it doesn't assist interpretation of other modalities.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, the core performance of the Bindex BI-2 device is essentially "standalone" in its measurement of cortical bone thickness and calculation of Density Index. The clinical study (Lewiecki, J Clin Densitom 2020) evaluated the standalone diagnostic performance of the DI thresholds (algorithm output) by comparing them directly against DXA-based osteoporosis diagnoses, demonstrating its utility in identifying women likely to have osteoporosis. The "human-in-the-loop" aspect here is the physician's use of the DI as an aid in diagnosis, not an interpretive assistance for another modality.

7. The Type of Ground Truth Used

• Clinical Performance: The ground truth used for the clinical study validating the DI thresholds was DXA Bone Mineral Density (BMD) measurements, specifically total hip or femoral neck T-scores <-2.5, which is the established clinical standard for diagnosing osteoporosis. This can be categorized as outcomes data in the context of diagnostic accuracy, as it reflects the established clinical diagnosis.

8. The Sample Size for the Training Set

• The document describes modifications to an already cleared device (K161971) and discusses a clinical study to expand the intended use population to include Hispanic individuals and validate existing thresholds. It does not describe a new training set for an algorithm. The "thresholds for osteoporosis for DI have been determined in comparison to DXA" based on previous work (Karjalainen et al. 2016). Therefore, the concept of a training set for a new algorithm is not directly applicable to this specific submission, which focuses on validating the existing device's performance in new contexts rather than developing a new algorithm.

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

• As mentioned above, a new training set for an algorithm is not explicitly detailed in this submission. The established DI thresholds, which form the basis for the device's diagnostic output, were determined in comparison to DXA, the "gold standard Axial DXA." The foundational study (Karjalainen et al., Osteoporosis International 2016) would have established its ground truth using DXA measurements as well.

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