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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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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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