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suRESubtraction Ortho software is intended to generate subtraction images and improve the visualization of contrast enhancement. The system can load two or more CT images with and without contrast enhancement. When used by a qualified physician, a potential application is to determine the course of treatment.

Device Description

The SURESubtraction Ortho, CSSO-001A is a post-processing software that subtracts image information by comparison of two data sets, one of which is contrast enhanced. Registration software is used to match the two independent studies. This registration software has been used on Toshiba CT systems for a number of years with no adverse events reported.

AI/ML Overview

Here is an analysis of the provided text regarding the acceptance criteria and study for the SURESubtraction Ortho, CSSO-001A device:

This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device after a modification to an accessory software (SURESubtraction Ortho) to extend its anatomical region of use. The provided text does not explicitly state specific quantitative acceptance criteria or detailed performance metrics used in a formal clinical study. Instead, it describes general improvements and performance validation.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria are not presented in the provided document, the table below reflects what can be inferred from the "Testing" section and the claims of improvement.

Acceptance Criteria (Inferred)	Reported Device Performance
Ability to generate subtraction images.	"SURESubtraction Ortho, CSSO-001A, performs in a manner similar to the predicate device in that subtraction images are created which aid in diagnosis."
Successful visualization of calculated enhanced edema in varying positions and rotations.	"Performance studies demonstrated that resultant subtraction images produced by the software can be used to successfully visualize calculated enhanced edema in varying positions and rotations."
Improved visualization of contrast enhancement compared to the predicate software.	"in comparing original CT images processed with SURESubtraction Ortho versus the predicate software, the resultant images demonstrate improved visualization." This is also stated in section 15: "Additionally, this software includes modifications that improve upon the visualization of contrast enhancement as demonstrated in the performance studies included in this submission."
Conformance to Quality System Regulations, ISO 13485, and applicable IEC standards (IEC62304, IEC62366, 21 CFR §1020).	"This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC62304 and IEC62366 standards. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via product report."
Software Documentation for Moderate Level of Concern per FDA guidance.	"Software Documentation for a Moderate Level of Concern, per the FDA guidance document... is also included as part of this submission."

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

The document states "performance studies" were conducted but does not specify the sample size for any test set (number of images, cases, or patients).

The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective). The nature of the testing described ("bench testing" and "resultant subtraction images produced by the software") suggests it could be based on existing or simulated data, rather than a prospective clinical trial.

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 of experts used to establish ground truth, nor does it provide their qualifications. The mention of "qualified physician" in the Indications For Use suggests clinical relevance, but details about expert review for the study are absent.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

The document does not describe an MRMC comparative effectiveness study. The study described focuses on the device's ability to produce subtraction images and improve visualization, not on human reader performance with or without the device. Therefore, no effect size of human improvement with AI assistance is provided.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the testing described appears to be a standalone (algorithm only) performance assessment. The text mentions "resultant subtraction images produced by the software" and an "improved visualization" when comparing software outputs to each other, without involving human interpretation performance as the primary endpoint. "Bench testing" is also mentioned, reinforcing this.

7. The Type of Ground Truth Used

The document implies a form of expert assessment or comparison to a gold standard, but it does not explicitly state the specific type of ground truth used. The claims of "successful visualization of calculated enhanced edema" and "improved visualization" suggest that there was a reference or standard against which the software's output was judged, likely by human observers or against a known expectation. However, it's not explicitly stated if this was pathology, outcomes data, or a formal expert consensus.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This submission is for a modification of existing software, and the discussion focuses on performance studies, not the original development or training of the core algorithm.

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

Since no training set details are provided, there is no information on how its ground truth was established.

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