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The ViOptix ODISsey Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services.

The ODISsey Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

The ODISsey Tissue Oximeter is an optically based device that noninvasively estimates the percent oxygen saturation (StO2) in a volume of tissue underneath the sensor.

This document describes an animal study used to demonstrate the performance of the ViOptix ODISsey Tissue Oximeter.

1. Table of Acceptance Criteria & Reported Device Performance

Note: The document does not specify quantitative acceptance criteria (e.g., a specific correlation coefficient or accuracy range). The reported performance is qualitative ("excellent correlation").

2. Sample Size & Data Provenance

• Test Set Sample Size: The study used three dog limbs.
• Data Provenance: Animal study, specifically using surgically removed and perfused dog limbs. The country of origin is not specified but is implicitly the location of the ViOptix, Inc. in Fremont, CA, or the testing facility they contracted. This is a prospective study.

3. Number of Experts and Qualifications for Ground Truth

• The ground truth was established by a Radiometer OSM3™ Hemoximeter (CO-Oximeter), which is described as a "gold standard." There is no mention of human experts establishing or adjudicating the ground truth in this specific animal study documentation. The CO-Oximeter itself serves as the reference measurement.

4. Adjudication Method for the Test Set

• None (as ground truth was established by an instrument, not human experts).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not conducted according to this document. The study focuses on comparing the device's readings against a "gold standard" instrument and a predicate device.

6. Standalone (Algorithm Only) Performance Study

• Yes, this constitutes a standalone performance study. The device, the ViOptix ODISsey Tissue Oximeter, directly measured StO2 in tissue, and its output was compared to reference measurements. There is no human intervention in the device's measurement process itself.

7. Type of Ground Truth Used

• Instrumental Gold Standard: The ground truth for tissue oxygen saturation (StO2) was established by a Radiometer OSM3™ Hemoximeter (CO-Oximeter), which is referred to as a "gold standard."

8. Sample Size for the Training Set

• The document does not provide information regarding a training set. This is a performance validation study, not a description of the algorithm development or internal training.

9. How Ground Truth for the Training Set Was Established

• As no information on a training set is provided, the method for establishing its ground truth is not applicable/not available in this document.

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Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2).

The InSpectra™ Tissue Spectrometer with 12 to 25 mm probes is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

The InSpectra™ Tissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity with 12 mm to 25 mm probes.

The value of these measurements in disease states has not been demonstrated.

The InSpectra™ is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). This value is a reflection of localized perfusion of that tissue.

The InSpectra™ is composed of the following components.

• Monitor: The "InSpectra Tissue Spectrometer" houses the user interface, and associated electronics. It serves as the analytical and display instrument.
• Patient Cable: The "Optical Integrator" transmits light to and from the Tissue Spectrometer and the patient;
• Patient Interface: The "OptoShield™" interface is a disposable pad that mechanically attaches to the distal end of the Optical Integrator. Its bottom has an adhesive backing for attachment to the patients skin for continuous monitoring. Until ready for use, the adhesive is covered with a liner to allow intermittent measurements.
• Printer: A "Thermal Printer" may be used to print out the StO2 results for time trending and recording purposes.
• Optical Converter: An "Optolink™" RS232 Optical Converter - Model 300 is a device that converts the optical output of the Spectrometer to an electrical signal.
• Set-up Accessories: A "System Check™" module with both "High" and "Low" "Single Point References" are provided to verify proper system operation.
• Inspectra System Software: Software provided on a compact disk for use on a personal computer that displays data from the tissue spectrometer on a computer during a live session or from an encrypted data file.

The provided document is a Special 510(k) Modified Device summary and an FDA clearance letter for the InSpectra™ Tissue Spectrometer System, Model 325. This specific submission is for a modification to an already cleared device, primarily involving new software that allows viewing, storing, and charting of the output measurement.

Therefore, the document does not contain typical acceptance criteria and a detailed study proving the device meets those criteria, as one would expect for a de novo device submission or a substantial re-evaluation. Instead, it focuses on demonstrating that the modification (new software) does not alter the fundamental safety and effectiveness of the previously cleared predicate device.

Here's an attempt to answer your questions based on the limited information provided in the context of this specific submission:

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

Based on the nature of this 510(k) submission (modification of an existing device with new software), explicit quantitative acceptance criteria for clinical performance are not detailed in this document. The primary acceptance criterion for this specific submission seems to be that the new software does not degrade the performance or introduce new risks compared to the predicate device.

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

The document states: "Hutchinson Technology, Inc. has conducted extensive testing of the new Inspectra™ Software to verify adherence to requirements."

• Sample Size: Not specified.
• Data Provenance: Not specified (country of origin, retrospective/prospective). Given it's a software functionality test, it's likely internal validation on test data.

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 or not specified. For a software update focused on displaying existing data, a panel of clinical experts for ground truth establishment is not typically required in the same way as for a diagnostic algorithm. The "ground truth" here would relate to the correct display and storage of the StO2 values generated by the core spectrometer, which is assumed to be accurate from the predicate device's clearance.

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

Not applicable or not specified. Adjudication methods are typically employed in studies where human interpretation or consensus is needed to establish a ground truth for diagnostic accuracy, which is not the primary focus of this software modification submission.

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, an MRMC study was not done. This submission is for a software modification that allows viewing and storing existing data, not for an AI-assisted diagnostic tool.

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

The software itself is a standalone component for data visualization and storage. Its performance as described is independent of human interpretation for its basic function (displaying and storing data). The core device (the spectrometer) is a standalone algorithm (measuring StO2), and its standalone performance would have been established during the predicate device's clearance (K012759). This submission focuses on the software's functionality related to that existing device's output.

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

For the software modification, the "ground truth" would be the known, expected output values from the InSpectra™ Tissue Spectrometer. The software's performance is validated against whether it accurately receives, displays, and stores these values without alteration. This is a technical (software) validation against the original device's output, not a clinical ground truth like pathology or outcomes.

8. The sample size for the training set

Not applicable. This is a software modification for data display and storage, not a machine learning or AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of software modification.

Ask a specific question about this device

Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2).

The InSpectra™ Tissue Spectrometer with 12 to 25 mm probes is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

The InSpectra™ Tissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity with 12 mm to 25 mm probes.

The value of these measurements in disease states has not been demonstrated.

The InSpectra™ is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO₂). This value is a reflection of localized perfusion of that tissue. The InSpectra™ is a modified version of the previously cleared Hutchinson Technology Inc. (HTI) Biospectrometer NB Oximeter, Model 1111, and represents upgrades in hardware and software, while relying on the same principles of operation.

The InSpectra™ is composed of the following components.

• Monitor: The "InSpectra Tissue Spectrometer" houses the user interface, associated electronics. It serves as the analytical and display instrument.
• Patient Cable: The "Optical Integrator" transmits light to and from the Tissue Spectrometer and the patient;
• Patient Interface: The "OptoShield™" interface is a disposable pad that mechanically attaches to the distal end of the Optical Integrator. Its bottom has an adhesive backing for attachment to the patients skin for continuous monitoring. Until ready for use, the adhesive is covered with a liner to allow intermittent measurements.
• Printer: A "Thermal Printer" may be used to print out the StO2 results for time trending and recording purposes.
• Optical Converter: An "Optolink™" RS232 Optical Converter Model 300 is a device that converts the optical output of the Spectrometer to an electrical signal.
• Set-up Accessories: An "OptoCheck™" module as well as both "High" and "Low" "Single Point References" are provided to verify proper system operation.

The provided 510(k) summary for the InSpectra™ Tissue Spectrometer System, Model 325, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

However, based on the limited information available in the document, here's an attempt to extract and infer what is presented regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or specific thresholds for StO2 measurement. Instead, it relies on demonstrating equivalent clinical performance to its predicate device.

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

• Sample Size: Not explicitly stated. The document only mentions "A human study."
• Data Provenance: Not explicitly stated regarding country of origin. The study was a "human study" and implied to be prospective due to comparing a new device against an existing one, but retrospecive analysis of data from the predicate device might have informed design, though not explicitly stated for the "human study".

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

This information is not provided in the document. The study compared the new device's performance against a predicate device, not against an independently established "ground truth" using expert consensus. The predicate device's readings served as the comparator.

4. Adjudication Method for the Test Set

This information is not provided. The study focused on comparing the new device against the predicate.

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

Not applicable. This device is a tissue spectrometer, not an AI-assisted diagnostic imaging device that involves human readers interpreting cases. The study mentioned is a comparison of two medical devices measuring StO2.

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

Yes, in essence, the "human study comparing device performance between the InSpectra™ and the predicate system" can be considered a standalone performance study. The InSpectra™ system itself, with its enclosed software and hardware, generates the StO2 measurement. The study aimed to show that this standalone measurement from the InSpectra™ was equivalent to the standalone measurement from the predicate device.

7. The Type of Ground Truth Used

The "ground truth" in this context was the measurements provided by the predicate device (Biospectrometer - NB Oximeter, Model 1111). The study aimed to demonstrate that the InSpectra™ measurements were equivalent to those of the predicate. This is a common approach for 510(k) submissions demonstrating substantial equivalence.

8. The Sample Size for the Training Set

Not applicable/Not provided. The document describes a medical device, not a machine learning algorithm that requires a separate "training set" for its core functionality. While the device contains "software" and an "algorithm," the context here is a traditional medical device demonstrating equivalence, not an AI/ML device being developed and trained.

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

Not applicable/Not provided. As stated above, this device is not presented as an AI/ML device with a training set. The "algorithm" mentioned is fundamental to how it calculates StO2, not a learned model from a training set.

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