(44 days)
Hip Morphometry Software option is used on a typical dual-energy x-ray absorptiometry (DEXA) image of a femur from a Prodigy bone densitometer. This software provides a measurement of the hip axis length (HAL) and a mean value of HAL for Caucasian females.
The Hip Morphometry Software, to be marketed as Advanced Hip Assessment Software, analyzes previously acquired dual-energy x-ray absorptiometry (DEXA) images of the proximal femur from the Prodigy bone densitometer for measurement of the hip axis length (HAL). The patient is scanned for bone density of the proximal femur with the currently distributed product, and puterit is bounded for official ware measures the HAL. A mean value of HAL for Caucasian females is included for comparison at the sole discretion of a physician.
The provided text unfortunately does not contain the detailed study information required to fill out the table and answer all the questions. The 510(k) summary focuses on establishing substantial equivalence to predicate devices for the "Advanced Hip Assessment Software Option" (Hip Morphometry Software) which measures Hip Axis Length (HAL) from DEXA images.
It states: "The Hip Morphometry Software is substantially equivalent to currently marketed software. No new safety and effectiveness questions are raised with the Hip Morphometry Software application." This implies that extensive new studies proving performance against acceptance criteria beyond what was established for the predicate devices might not have been required for this specific filing.
Here's what can be inferred or stated as "not provided" based on the given text:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Hip Axis Length (HAL) Measurement Accuracy | Not provided | Not provided. The text only states the software "measures the HAL." |
| Reproducibility/Precision of HAL Measurement | Not provided | Not provided |
| Comparison to Gold Standard (if applicable for HAL) | Not provided | Not provided |
| Clinical Efficacy (e.g., impact on fracture risk prediction) | Not provided | Not provided |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not provided.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication method for the test set
- Adjudication Method: Not provided.
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
- MRMC Study: Not provided. Given the nature of the device (automated measurement of HAL), it is unlikely an MRMC study comparing human readers with and without AI assistance would be the primary validation method. The device automates a measurement, rather than assisting human interpretation of complex images.
- Effect Size of Improvement: Not applicable, as no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: The text describes the software as analyzing images for measurement of HAL. This implies a standalone algorithm's performance in generating the HAL value. However, the details of such a study (sample size, metrics, ground truth comparison) are not provided. The "conclusion" states substantial equivalence, suggesting direct performance metrics for this specific device might have been linked to those of the predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not provided. For HAL, a physical measurement on a phantom or cadaver, or established manual measurements by experts on DEXA images, would typically be used as ground truth, but this is not mentioned.
8. The sample size for the training set
- Sample Size (Training Set): Not provided.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not provided.
Summary of what is known from the document:
- Device: Advanced Hip Assessment Software Option (Hip Morphometry Software) for Prodigy bone densitometers.
- Function: Analyzes DEXA images of the proximal femur to measure Hip Axis Length (HAL).
- Comparison: Includes a mean HAL value for Caucasian females for physician comparison.
- Regulatory Context: 510(k) submission, granted substantial equivalence, indicating it is similar in safety and effectiveness to predicate devices (LUNAR EXPERT Morphometry Software K950611 and LUNAR EXPERT Spine Morphometry Reference Values K961007).
- Intended Use: Prescription use only.
§ 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.