The addition of reference values does not change the intended use of the EXPERT Spine Morphometry Software. The reference value comparison results are used at the discretion of the physician.

Device Description

Reference values of spine morphometry have been added to the EXPERT Spine Morphometry Software.

AI/ML Overview

The provided text describes a 510(k) pre-market notification for "EXPERT® Spine Morphometry Reference Values". However, the document does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, it focuses on the addition of reference values to existing software and claims this addition does not raise new questions of safety or effectiveness.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based only on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., accuracy, sensitivity, specificity). The document's closest statement to an "acceptance criteria" is that the addition of reference values "does not raise any new questions of safety or effectiveness." This is a regulatory statement rather than a performance metric.
Reported Device Performance: No quantitative performance metrics (e.g., sensitivity, specificity, agreement rates) are reported for the device itself or the new reference values.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: "Data from seven studies and over 3500 subjects have been used to provide normalized reference data for spine morphometry." This refers to the data used to create the reference values, not a distinct 'test set' for evaluating the device's performance against specific acceptance criteria.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as there is no described 'test set' or ground truth establishment relevant to specific performance criteria for the device itself. The "reference data" is the output, not something to be judged against a ground truth in a performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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 MRMC study is described. The device provides "reference values" to physicians, not necessarily an AI-assisted diagnostic tool that would typically be evaluated in an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone performance study for the algorithm itself is described in terms of specific performance metrics. The document states "The reference value comparison results are used at the discretion of the physician," indicating a human-in-the-loop scenario, but no study of its performance is provided.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable, as no ground truth is described for evaluating the performance of the "EXPERT® Spine Morphometry Reference Values" device. The reference values themselves are derived from studies.

8. The sample size for the training set

The "reference data" was derived from "seven studies and over 3500 subjects." This dataset served as the basis for the reference values, akin to a training set for a model that generates these values, though it's more about population statistics than machine learning training in the modern sense.

9. How the ground truth for the training set was established

The document states "Data from seven studies and over 3500 subjects have been used to provide normalized reference data for spine morphometry." It does not detail how the measurements (which would form the "ground truth" for the reference values) were performed or established within those 3500+ subjects. It only indicates they are "normalized reference data."

In summary: The provided 510(k) summary focuses on the regulatory aspect of adding reference values to existing software, asserting that this addition does not raise new safety or effectiveness concerns. It does not contain the detailed performance study information typically found when evaluating the diagnostic accuracy or efficacy of a new medical device component.

Summary

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Image /page/0/Picture/0 description: The image shows the word "LUNAR" in large, bold, black letters. The font is sans-serif and appears to be slightly condensed. The letters are closely spaced, creating a solid block of text. The background is plain white, providing a strong contrast with the black letters.

K 961007

313 W. BELTLINE HIGHWAY

MADISON, WI 53713

(608) 274-2663

JUL 2 5 1996

8.0 510(K) SUMMARY

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(C).

Re:	510(k) Pre-market Notification
Contact Person:	Gary SyringLUNAR Corporation313 West Beltline HighwayMadison, WI 53713
Phone:	(608) 274-2663
Fax:	(608) 274-0853
Date:	March 8, 1996
Device Name:	EXPERT® Spine Morphometry Reference Values
Common Name:	Spine Morphometry Reference Values
Trade Name:	EXPERT® Spine Morphometry Reference Values
Classification Name:	21 CFR 892.1170, Bone Densitometer
Predicate Device:	EXPERT Spine Morphometry, 510(k) K950611DPX Bone Densitometer, Reference Values510(k) K890121

8.1 DESCRIPTION OF THE DEVICE:

Reference values of spine morphometry have been added to the EXPERT Spine Morphometry Software. The addition of reference values does not change the intended use of the EXPERT Spine Morphometry Software. The reference value comparison results are used at the discretion of the physician.

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DISCUSSION OF PERFORMANCE DATA SUBMITTED IN SUPPORT OF 8.2 THE SAFETY AND EFFICACY CLAIMS FOR THE DEVICE:

Data from seven studies and over 3500 subjects have been used to provide normalized reference data for spine morphometry.

CONCLUSIONS DRAWN FROM DATA: 8.3

The addition of spine morphometry reference values does not raise any new questions of safety or effectiveness. The reference data is used at the discretion of the physician.

Tory Ayring
Signed

Gary Syring Printed Name

Director, Regulatory Affairs

Title

Summary of Safety and Effectiveness, Page 2 of 2

Regulation Number and Section

§ 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.