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

The InSpectra™ Tissue Spectrometer 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™ 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, Patient Cable, Patient Interface, Printer, Optical Converter, Set-up Accessories, and Inspectra System Software.

The provided text outlines the submission of a Special 510(k) for a modified device, the InSpectra™ Tissue Spectrometer System, Model 325. However, it does not contain the detailed acceptance criteria or the specific study results that prove the device meets these criteria. The document states that "All test results verify that the device meets or exceeds all predetermined specifications," but does not list these specifications or the performance metrics.

Therefore, for the requested information, many fields will be marked as "Not provided in the input text."

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not provided in the input text.
• Data Provenance: Not provided in the input text (e.g., country of origin, retrospective or prospective). The submission is from Hutchinson, MN, USA.

The document indicates "extensive testing" was conducted to verify adherence to requirements, but does not detail the nature or scale of this testing for the test set.

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 in the input text.
• Qualifications of experts: Not provided in the input text.

4. Adjudication method for the test set:

• Not provided in the input text.

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:

• No, an MRMC comparative effectiveness study was not done. The device described is a non-invasive monitoring system for measuring tissue oxygen saturation (StO2), not an AI-assisted diagnostic imaging device that human readers would interpret. Therefore, the concept of human readers improving with AI assistance is not applicable to this device.

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

• Yes, implicitly. The InSpectra™ Tissue Spectrometer System, Model 325, measures an "approximated value of percent hemoglobin oxygen saturation in tissue (StO2)." It is a standalone monitoring device. While clinicians interpret the StO2 readings, the device itself provides the measurement without human input into the measurement process. The "Test Conclusions" state that "All test results verify that the device meets or exceeds all predetermined specifications," which implies testing of the device's performance in isolation.

7. The type of ground truth used:

• Not explicitly stated, but for a device measuring "percent hemoglobin oxygen saturation in tissue (StO2)," the ground truth would typically be established by:
  • Direct, invasive measurements (e.g., blood gas analysis of tissue samples): This is a common method for validating non-invasive oximetry devices.
  • Other established gold-standard non-invasive methods: If such a method exists for tissue oxygen saturation.
  • Physiological models or controlled experiments: Where tissue oxygenation levels can be precisely manipulated and known.

8. The sample size for the training set:

• Not applicable as this seems to be a hardware device with an algorithm for calculating StO2, rather than a machine learning model that requires a distinct training set. The text refers to "predetermined specifications" and "extensive testing" for the modified device itself.

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

• Not applicable (as per point 8).

Summary of what the document does provide:

• Device Name: InSpectra™ Tissue Spectrometer System, Model 325
• Intended Use: Noninvasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2). Indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
• Predicate Device: InSpectra™ Tissue Spectrometer System, Model 325, (K042020)
• Rationale for Equivalence: Based on design, technological characteristics, intended use, and extensive testing, the modified device is substantially equivalent to the unmodified predicate device and raises no new issues of safety or effectiveness.
• Conclusion: "All test results verify that the device meets or exceeds all predetermined specifications."

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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.

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