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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).

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

The document does not describe a separate "test set" in the context of a de novo clinical study with human subjects for the Bindex BI-2. Its performance demonstration relies on showing equivalence to the predicate device.

• Clinical Studies: The document states, "The same clinical and pre-clinical data supports the safe and effective use of Bindex Bl-100, to which substantial equivalence is shown." This implies that the clinical data for the predicate device (Bindex BI-100) serves as the basis for clinical effectiveness.
• Engineering Tests (Biocompatibility, Electrical, EMC, Mechanical, Acoustic): These tests were conducted on the Bindex BI-2 itself, but sample sizes for these specific engineering tests are not provided (e.g., number of devices dropped, number of units tested for EMC). The provenance is implied to be internal testing by Bone Index Finland, Ltd.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this submission. The submission is a 510(k) for substantial equivalence to a predicate device, not a de novo clinical study establishing new clinical ground truth for a novel device. The document references "other clinical risk factors or patient characteristics" as aids to diagnosis for the physician, suggesting the device provides data to be used in conjunction with a physician's expert judgment, rather than replacing it or having its output directly adjudicated by a panel.

4. Adjudication Method for the Test Set

Not applicable. No new clinical test set requiring adjudication is described for the Bindex BI-2 device in this submission.

5. 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

Not applicable. The Bindex BI-2 is described as a medical device (bone sonometer) that measures "apparent cortical bone thickness" and provides a "Density Index (DI)." It is not an AI-based diagnostic image interpretation system with a "human-in-the-loop" component in the way that an MRMC study would typically evaluate. The device provides quantitative measurements to aid a physician, not AI-assisted readings of complex medical images.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The Bindex BI-2 operates as a standalone measurement device. It directly measures cortical bone thickness using ultrasound. The output (thickness, Density Index) is a quantitative measurement, not an "algorithm-only" interpretation in the sense of a machine learning model. The device itself is the "standalone" entity that performs the measurement. However, its output is intended to be used by a physician "in conjunction with other clinical risk factors or patient characteristics."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the Bindex BI-2 itself, the ground truth for its technical performance (e.g., accuracy of thickness measurement) is not explicitly detailed in this summary. Instead, the submission relies on the established "safe and effective use" of the predicate device (Bindex BI-100). The predicate device's indications for use mention "diagnosis of osteoporosis" and "determination of fracture risk," implying that its effectiveness was likely demonstrated against clinical endpoints such as bone mineral density (often measured by DXA, as suggested by the BI-2 providing a parameter estimating density at the hip as measured with DXA), or potentially fracture outcomes data, for which ultrasound measurements serve as a surrogate.

The Bindex BI-2's output (Density Index) "estimates density at the hip as measured with DXA," suggesting DXA as a clinical ground truth for the predicate's or implied target value.

8. The Sample Size for the Training Set

Not applicable for a training set in the context of machine learning. The device is a measurement instrument, not an AI model that requires a training set. If "training set" refers to the data used to develop the algorithms for the predicate device, that information is not provided in this summary.

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

Not applicable, as there is no mention of an algorithm training set in the context of machine learning.

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