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TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture.

TBS iNsight provides as an option an assessment of 10-year fracture risk. It provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO's FRAX® Fracture Risk Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old.

TBS provides information independent of BMD value: it is used as a complement to the data obtained from the DXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers...).

The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk.

The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time. Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not disease or recommend treatment regimens. Only the health care professional can make these judgments.

TBS iNsight is a software application provided for use as a complement to bone mineral density (BMD) acquired from dual energy X-ray absorptiometry (DXA) and other clinical risk factors for osteoporosis and fragility fracture. It calculates a score (Trabecular Bone Score - TBS) derived from the texture of the DXA image of the anterior-posterior (AP) lumbar spine and has been shown to be related to bone microarchitecture. The method analyzes X-ray based images acquired by DXA imaging systems and produces the TBS based on the computation of an Adapted Experimental Variogram (modified fractal-like approach). This variogram is used to measure the degree of spatial variation between pairs of data points in a spatial dimension of a region of a digital image.

The absolute TBS values for the same equivalent tissue thickness vary slightly between GE and Hologic systems. Additionally, within each system, variability in TBS values can be observed across different scan modes. To address these differences, corrections are applied that are both device-specific and mode-specific. For instance, TBS is corrected differently for GE and Hologic systems to account for inherent differences in tissue thickness assessment. Furthermore, corrections are also tailored separately for each scan mode within the same system, ensuring that TBS measurements remain consistent and reliable regardless of the scan mode used. These device-specific and mode-specific corrections are necessitated by differences in the dynamic range of tissue thickness measurements between GE and Hologic devices. The variations arise due to differences in the methodologies used to assess tissue thickness. To harmonize these discrepancies and ensure measurement accuracy, correction fits derived from ex-vivo data are applied individually to each device and scan mode. This approach ensures the accuracy and consistency of TBS measurements across all configurations.

The device is intended to be used for bone health assessment in medical facilities employing one or more DXA system(s) to which the subject device is connected. These facilities are usually hospitals, clinics, healthcare centers, radiology practices and medical imaging centers. The software is designed to be used by qualified clinical professionals (including physicians, radiologists and DXA technicians) and the physicians are solely responsible for making all final patient management decisions.

The provided text does not contain a discrete table of acceptance criteria nor explicit reported device performance metrics against such criteria in a tabular format. However, based on the Performance Testing Summary & Conclusions section (pages 9-10), the acceptance criteria can be inferred from the studies described. The reported performance is woven into the narrative of the study results.

Here's an attempt to derive the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Clinical Association Study 1 (Correlation with microCT):
  • Sample Size: 30 human cadaver lumbar vertebrae.
  • Data Provenance: Not explicitly stated, but "human cadaver lumbar vertebrae" implies a laboratory-based, retrospective study.
• Clinical Association Study 2 (Agreement between V4 and Predicate):
  • Sample Size: 15 human cadaver vertebrae.
  • Data Provenance: Not explicitly stated, but "human cadaver vertebrae" implies a laboratory-based, retrospective study. Measurements were performed on "multiple DXA systems."
• Analytical Reproducibility (Ex Vivo Study):
  • Sample Size: Not explicitly stated, but "dried human lumbar vertebrae," likely similar to the cadaver studies.
  • Data Provenance: Retrospective, laboratory-based.
• Analytical Reproducibility (In Vivo Study):
  • Sample Size: 132 participants.
  • Data Provenance: Not explicitly stated, but "scanned on four different DXA systems" with "repositioning between scans" indicates a prospective, controlled clinical study.
• Performance and Utility (Fracture Risk Assessment):
  • Sample Size: Over 17,000 individuals across 14 international cohorts.
  • Data Provenance: International cohorts, implying retrospective data from multiple countries.
• Performance and Utility (Treatment Monitoring):
  • Sample Size: A "large cohort" of postmenopausal women with osteoporosis. Specific number not provided.
  • Data Provenance: Not explicitly stated, but likely retrospective clinical data.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the various test sets.

• For microCT correlation: Micro-computed tomography (microCT) is an objective imaging technique, so human expert interpretation for ground truth might not be directly applicable in the same way as, for example, image interpretation by radiologists.
• For in vivo studies: The ground truth for bone microarchitecture or fracture risk assessment, as implied by the use of ISCD standards and FRAX, are typically established by clinical diagnosis and follow-up, rather than a panel of experts explicitly reviewing the test set images for ground truth.

4. Adjudication Method for the Test Set

The document does not describe any adjudication methods (e.g., 2+1, 3+1) for establishing ground truth from expert readers for the test sets.

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

• No, an MRMC comparative effectiveness study was not explicitly described in the provided text. The studies focus on the device's standalone performance, its agreement with the predicate device, and its correlation with bone microarchitecture ground truth (microCT), as well as its utility for fracture risk assessment and treatment monitoring.
• The text describes the device as a "complement to both DXA analysis and clinical examination" and states that "The results can be used by a physician in conjunction with other clinical risk factors." While it aids physicians, the document does not include a comparative study evaluating how human reader performance (e.g., diagnosis or risk assessment accuracy) improves with TBS iNsight V4 assistance versus without it.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance assessment was conducted. The "Standalone Performance Testing Summary" section (page 9) explicitly states that "Software Verification and Validation demonstrate specified requirements are met and the software functions as intended."
• Furthermore, the "Clinical Association" and "Analytical Reproducibility" studies directly evaluate the performance of TBS version 4.0 in calculating TBS values and their correlation with microCT independently, and their agreement/reproducibility compared to the predicate, without human intervention in the calculation process.

7. The Type of Ground Truth Used

• Pathology/Objective Measurement: For establishing the relationship between TBS and bone microarchitecture, micro-computed tomography (microCT) measurements were used as the ground truth (e.g., for trabecular number and separation). This is an objective measurement of bone structure.
• Clinical Diagnosis/Outcomes Data: For "fracture risk assessment" and "treatment monitoring," the ground truth implicitly refers to the clinically established reference values (e.g., those used in FRAX) and potentially actual fracture outcomes data from the cohorts. The studies confirm that TBS V4 provides "similar TBS-adjusted FRAX and BMD T-scores" and is effective for monitoring, suggesting that it aligns with known clinical indicators and outcomes.
• Predicate Device Performance: For demonstrating "agreement" and "substantial equivalence," the performance of the predicate device (TBS iNsight V3) serves as a comparative ground truth or benchmark.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set for the TBS iNsight V4 algorithm.

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

The document does not provide information on how the ground truth for any training set was established, as the details of algorithm development and training are not included. The focus is on the performance testing of the final device version.

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TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture.

TBS iNsight provides as an option an assessment of 10-year fracture risk. It provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO's FRAX® Fracture Risk Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old.

TBS provides information independent of BMD value: it is used as a complement to the data obtained from the DXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers . . . ).

The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk.

The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time.

Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not disease, or recommend treatment regimens. Only the health care professional can make these judgments.

TBS iNsight is a software provided for use as a complement to to both DXA analysis and clinical examination. It computes the AP spine DXA examination file and calculates the Trabecular Bone Score (TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture.

It provides as an option an assessment of 10-year fracture risk, based on the WHO's FRAX® Tool, after adjustment for the TBS.

The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk.

The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time.

Here's an analysis of the acceptance criteria and study information for the TBS iNsight device, based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the format requested. However, it describes that the device's performance was evaluated through clinical studies against the predicate devices and known clinical associations. The core acceptance criteria appear to be substantial equivalence to the predicate devices and the demonstration that TBS is a valid clinical risk factor for fracture and can improve FRAX probability estimates.

Implied Acceptance Criteria and Reported Device Performance:

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Clinical Aspects FRAX adjusted for TBS: "3 published studies and a report provided by the Frax group to Medimaps." The specific sample sizes for these studies are not provided in this document. The provenance of these studies is implied to be international given the reference to WHO's FRAX® and the Frax group. The nature (retrospective/prospective) of these studies is not specified.
   • Clinical Aspects TBS iNstats:
     • Canadian cohort: "29,000 Canadian women" (retrospective, likely).
     • Studies for US applicability: "Two studies" but their sample sizes are not provided. The provenance is implied to be US for the applicability demonstration.
   • Normative Data: A "US clinical study" including "Non-Hispanic white US women and men. Non-Hispanic black US women and men and Mexican women and men, aged 20 to 85 years." The data was "provided from the Nhanes IV database." The specific sample size for this US clinical study is not provided within this summary. NHANES IV data is retrospective/cross-sectional.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
   The document does not specify the number or qualifications of experts used to establish ground truth for the clinical studies mentioned. It refers to "published studies" and the "Frax group," implying established methodologies and expert involvement, but direct details are missing.

3. Adjudication Method for the Test Set:
   The document does not specify any adjudication methods (e.g., 2+1, 3+1) used for the clinical studies or for establishing ground truth.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
   The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers improving with AI vs. without AI assistance. The device is described as a "complement" to DXA analysis and clinical examination, implying assistance but not a direct comparison of human performance with and without the tool.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
   The document does not explicitly state if a standalone algorithm performance study was done. The focus is on its role as a "complement" to clinical examination and DXA analysis, and its ability to adjust FRAX scores, which inherently involve human interpretation and clinical data.

6. Type of Ground Truth Used:
   The ground truth implicitly used in the clinical studies relates to:

   • Fracture events: The studies evaluated the device's ability to predict fracture risk, so actual fracture outcomes (e.g., hip fracture, major osteoporotic fracture) served as ground truth.
   • Bone microarchitecture: TBS is described as "related to bone microarchitecture," suggesting that underlying microarchitectural properties (likely measured through other means in the mentioned "published studies") were part of the ground truth for validating the TBS score itself.
   • Normative population data: For the normative data study, the "Nhanes IV database" served as the reference for US population TBS values.

7. Sample Size for the Training Set:
   The document does not disclose the sample size used for training the TBS iNsight algorithm. It details evaluation studies, not algorithm development or training specifics.

8. How the Ground Truth for the Training Set Was Established:
   The document does not provide information on how the ground truth for the training set was established, as it does not discuss the training phase of the algorithm.

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The Med-Imaps TBS iNsight is a software provided for use as a complement to a DEXA analysis. It computes the antero-posterior spine DEXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DEXA image and has been shown to be related to bone microarchitecture and fracture risk. This data provides information independent of BMD value; it is used as a complement to the data obtained from the DEXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers ... ).

The TBS score can assist the health care professional in assessment of fracture risk and in monitoring the effect of treatments on patients across time.

Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not diagnose disease, or recommend treatment regimens. Only the health care professional can make these judgments.

TBS iNsight is a software package that provides an estimate of the trabecular bone quality based on analysis of data derived from DEXA examination. The program utilizes a quantitative bone structural algorithm that analyzes the texture of AP spine projection scans from which the Trabecular Bone Score (TBS) is mathematically derived.

The results (TBS) can be used for comparison to a reference database of age-matched controls.

Here's an analysis of the acceptance criteria and study findings for the Medimaps Group TBS iNsight software, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of quantitative acceptance criteria for each validation study. Instead, it describes general objectives and qualitative outcomes for each performance bench test and clinical study. However, the conclusion states that the device "met all acceptance criteria." Based on the descriptions, we can infer the objectives that served as de-facto acceptance criteria.

2. Sample Sizes and Data Provenance

• Bench Test - µCT and Simulated Projections:
  • Sample Size: Thirty human cadaveric vertebrae.
  • Data Provenance: Ex-vivo (cadaveric tissue). Country of origin not specified, but the company is Swiss.
• Bench Test - µCT and DEXA Scans:
  • Sample Size: Thirty human cadaveric vertebrae.
  • Data Provenance: Ex-vivo (cadaveric tissue). Country of origin not specified.
• Bench Test - Ex-vivo Reproducibility:
  • Sample Size: Not explicitly stated, but likely the same thirty human cadaveric vertebrae from the other bench tests, as it builds on them.
  • Data Provenance: Ex-vivo (cadaveric tissue). Country of origin not specified.
• Clinical Studies - Diagnostic Value:
  • Sample Size: Evaluated through "five cross-sectional studies." Specific sample sizes for each study are not provided.
  • Data Provenance: Clinical (patient data). Retrospective/Prospective not specified for each study, but typical for cross-sectional analysis in published literature. Country of origin not specified.
• Clinical Studies - Prognostic Value:
  • Sample Size: Evaluated through "three longitudinal studies." Specific sample sizes for each study are not provided.
  • Data Provenance: Clinical (patient data). Longitudinal indicates prospective follow-up. Country of origin not specified.
• Clinical Studies - In-vivo Reproducibility:
  • Sample Size: "Two in-vivo reproducibility studies." Specific sample sizes not provided.
  • Data Provenance: Clinical (patient data). In-vivo implies prospective. Country of origin not specified.
• Clinical Studies - Treatment Follow-up:
  • Sample Size: "All six studies" mentioned. Specific sample sizes not provided.
  • Data Provenance: Clinical (patient data). Longitudinal and prospective (clinical trials). Country of origin not specified but likely international across multiple trials.
• Clinical Studies - Age-related US Reference Data:
  • Sample Size: Non-Hispanic white US women aged 30 to 90 years. Specific number of women is not provided.
  • Data Provenance: Clinical (patient data). Likely retrospective collection from a US cohort.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not provide details on the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., radiologist with X years of experience). The ground truth for the bench tests relied on µCT measurements, which is an objective physical measurement rather than expert consensus on images. For the clinical studies, ground truth related to fracture diagnosis/prognosis and treatment effects would typically be established by clinical diagnoses, imaging reports (potentially read by radiologists, but not explicitly stated for this purpose), and follow-up data.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth within the test sets. For the bench tests, the ground truth was objective µCT measurements, precluding the need for human adjudication of image interpretations. For clinical outcomes, fracture events, and treatment responses, these are typically clinical endpoints.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The studies focus on the performance of TBS itself (correlations, reproducibility, diagnostic/prognostic value) rather than comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, the studies described are primarily standalone performance investigations of the TBS iNsight algorithm.

• The bench tests directly assess the algorithm's ability to derive TBS values that correlate with 3D microarchitecture parameters or demonstrate ex-vivo reproducibility.
• The clinical studies evaluate the direct diagnostic, prognostic, and monitoring capabilities of the calculated TBS values.
  While the intended use is "as a complement to a DEXA analysis," the performance evaluation focuses on the algorithm's output (TBS) rather than its impact on a human reader's interpretation flow.

7. Type of Ground Truth Used

• Bench Tests: The primary ground truth for comparing TBS to actual bone structure was 3D microarchitecture parameters derived from µCT (micro-computed tomography) datasets. This is an objective and highly detailed measure of bone structure, often considered the gold standard for microarchitectural assessment.
• Clinical Studies (Diagnostic/Prognostic/Treatment/Reference Data): The ground truth for clinical studies implicitly relies on clinical outcomes data (e.g., confirmed fracture events, patient diagnoses of fracture status, observed response to treatment regimens). For the age-related reference data, the "ground truth" is the observed TBS values within that specific population.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set used to develop the TBS iNsight algorithm. The provided information relates to validation studies, not algorithm development.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established, as it focuses on the validation of the already developed device.

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