(260 days)
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:
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Clinical Efficacy (TBS) | TBS is an independent clinical risk factor for fracture. | "TBS is an independent clinical risk factor for fracture" was "demonstrated using 3 published studies and a report provided by the Frax group to Medimaps." |
| Clinical Efficacy (FRAX Adjustment) | TBS can be used in association with WHO's FRAX® to adjust and improve the FRAX® probability of hip fracture and of major osteoporotic fracture in postmenopausal women and in men. | "demonstrated using 3 published studies and a report provided by the Frax group to Medimaps." |
| Applicability of TBS Categories to US Population | The fracture risk associated with TBS categories (derived from a Canadian cohort) is applicable to the US population. | "Two studies have been used to demonstrate that the TBS categories of fracture risk computed from the Canadian study are applicable to the US population." Additionally, another study demonstrated that "the TBS values of the population included in the Canadian study are similar to the normal TBS values of the US population." |
| Normative Data for US Population | Establishment of normative TBS data for different demographics within the US. | A US clinical study was conducted "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 referenced against the NHANES IV database. The study confirmed that "TBS values obtained for all lumbar vertebral combinations (L1, L2, L3, L4) decreased significantly with age." |
| Substantial Equivalence | Device is substantially equivalent to predicate devices in intended use, technological characteristics, input data, and measurements. | The filing states: "Based on the comparison given above and the discussion of the intended use, technological characteristics, input data and measurements provided by the subject and predicate devices, the subject device is substantially equivalent to the cited predicate devices." (Predicate devices: Med-Imaps TBS iNsight (K121716) and GE Lunar FRAX™ 10-year Fracture Risk software option (K082317)). |
| Software Standards & Risk Management | Conformance to recognized standards for medical device software, risk management, and cybersecurity. | Adherence to IEC 62304, ISO 14971, and FDA guidances for software validation, Off-the-Shelf software, and cybersecurity. |
Study Details:
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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.
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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. -
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. -
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. -
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. -
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.
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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. -
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.
§ 892.1170 Bone densitometer.
(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.