(42 days)
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:
| Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy) | Reported Device Performance |
|---|---|
| Not provided in the input text | "meets or exceeds all predetermined specifications" (specific numbers are not provided) |
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."
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).