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The Optasia Medical SpineAnalyzer™ is intended for the visualization or quantitative assessment of vertebral body deformities between levels T4 and L4 of the thoracic and lumbar spine in adult patients at risk of osteoporotic fracture. The qualified medical practitioner uses the device to calculate vertebral deformity ratios derived from the interactive placement of morphometry markers. Deformity grades are then calculated using criteria published by Genant . Additionally, the qualified medical practitioner can record a manual Genant Semi-Quantitative score based on visual assessment.

The qualified medical practitioner may use the deformity ratios and deformity grades to assist in the diagnosis of vertebral fracture and may, along with knowledge of patient history, apply medical expertise and best practice clinical judgment to determine if therapeutic intervention is indicated.

The Optasia Medical SpineAnalyzer is a stand-alone software package which can be installed and used on any "personal computer" meeting the minimum specification requirements defined in Tab 16, section 16.6. SpineAnalyzer is designed with context sensitive menus to guide the qualified medical practitioner through the vertebral assessment workflow of lateral spine xpractionel images from patients at risk of, or suffering from, osteoporosis.

The SpineAnalyzer allows visualization of the spine from lateral spine x-ray or DXA images, and hence identification of vertebral deformities. The SpineAnalyzer can then suggest points that represent the vertebral bodies in the image using a "6-point morphometry" protocol, for the vertebrae the image asing a - These points are then reviewed by a suitably qualified beedical practitioner who can adjust them using his/her clinical expertise to medical practicity. The spine in the spine in the region of interest.

A set of "tools" are provided within the SpineAnalyzer software to allow the A set of "tools" and peasure features on the digital image of cimical Specialist to announce es" which are derived from heights or ratios of spiric us "derormism" (1) in ther tools are provided to allow the neights of the vertebral boxed; allowing the physician to compare these measurements to be reported)
measurements against those made on previous occasions and hence infer improvement or deterioration in the condition of the area of interest of the spine.

The Optasia Medical SpineAnalyzer guides the qualified medical practitioner's workflow in the objective assessment of the vertebrae T4 through L4 captured in the image. In osteoporosis, a vertebral deformity may indicate an osteoporotic fracture. A qualified medical practitioner can use the information provided by SpineAnalyzer, together with other clinical information, to make a diagnosis.

In patients who have been diagnosed with osteoporosis, a change in vertebral deformity over time may indicate an incident vertebral fracture. SpineAnalyzer facilitates the comparison of baseline and follow-up spine xray or DXA images which the qualified medical practitioner, together with other clinical information, can use to diagnose incident vertebral fracture.

The intended use of SpineAnalyzer™ is to facilitate the visual or quantitative assessment of vertebral body deformities in lateral DXA or digital/digitized X-ray images.

Here's a breakdown of the acceptance criteria and study information for the Optasia Medical SpineAnalyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary explicitly states: "No performance data (laboratory, animal or clinical) is included." Therefore, there are no acceptance criteria or reported device performance metrics within this document. The submission relies on substantial equivalence to a predicate device.

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

Since no performance study was included, there is no test set sample size mentioned. Consequently, data provenance is also not applicable as no data was used in a performance study.

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

As there was no performance study, no experts were used to establish ground truth for a test set.

4. Adjudication Method for the Test Set

With no test set or performance data, no adjudication method was employed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done and therefore no effect size of human readers improving with AI vs. without AI assistance is reported.

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

No standalone performance study was done. The device's description emphasizes a human-in-the-loop workflow where a "suitably qualified medical practitioner" reviews and adjusts the software's suggestions.

7. The Type of Ground Truth Used

Since no performance studies were conducted, no ground truth was used for evaluation.

8. The Sample Size for the Training Set

The document does not mention any training set or its sample size. This suggests that the device's development likely did not involve a supervised machine learning approach requiring a labeled training set in the context of this 510(k) submission.

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

As no training set is mentioned, there is no information on how its ground truth would have been established.

Summary of the K163475 P. Submission:

The Optasia Medical SpineAnalyzer 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (GE LUNAR Dual-energy Vertebral Assessment View Software, K023554) based on intended use and technological characteristics, rather than through a performance study with acceptance criteria and measured device performance. The submission explicitly states: "No performance data (laboratory, animal or clinical) is included." This means that for this particular submission, the FDA did not require or receive clinical performance data to support the device's function as described. The marketing authorization was granted based on the comparison of features and intended use to a previously cleared device.

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