(50 days)
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 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.
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 the same version of the previously cleared Hutchinson Technology Inc. (HTI) InSpectra™ Tissue Spectrometer System, Model 325, and represents changes to the indications for use statement.
The InSpectra™ is composed of the following components:
InSpectra™ Tissue Spectrometer: A spectrometer that contains light detection circuitry, a microprocessor, and a display screen.
InSpectra™ Optical Cable: A fiber optic light integration cable that contains one set of optical fibers to integrate wavelengths of light and transmit to the tissue, and a second set of optical fibers that receives light from the tissue and returns it to a photosensitive detector. Light emitting diodes in the optical cable connector are the light source. Optical cable distal tips are available in 12, 15, 20, 25, and 35mm spacing, and are differentiated by color. The 12-25mm cable tips are gray; the 35mm cable tip is blue. The optical cable is supplied with a storage case.
InSpectra™ Calibrator: A disposable module used to normalize the tissue spectrometer and calibrate during startup of the InSpectra tissue spectrometer system. The calibrator is available in two sizes: 12-25mm (labeled in black) and 35mm (labeled in blue).
InSpectra™ Shield: A disposable interface that attaches to the distal tip of the optical cable. The shield protects the measurement from ambient light interference, protects the optical fibers, and has an adhesive surface to attach to the patient for continuous monitoring and a liner to use for intermittent measurements. The shields are available in two sizes to fit the optical cables and are differentiated by color: 12-25mm (gray) and 35mm (blue). The shield is packaged in the calibrator. To ensure accurate Sto2 measurements, use a new InSpectra shield for each patient. Do not reuse.
InSpectra™ System Check: A method to check system measurements.
InSpectra™ OptoLink™ RS232 Optical Converter: A device used to export StO2, date, and time data from the spectrometer.
InSpectra™ Software: Software, which displays data from the tissue spectrometer on a computer during a live session or from an encrypted data file
The provided text is a 510(k) Premarket Notification summary for the InSpectra™ Tissue Spectrometer System, Model 325. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.
Crucially, the document states:
"Test Reports: Published clinical studies are presented showing that StO2 measurements provide valuable medical information in various disease states."
However, the document does NOT contain the specific details required for the acceptance criteria and study information requested in your prompt. It mentions "published clinical studies" generally but does not provide any of the following:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on the regulatory submission and device description, not performance metrics against specific criteria.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- 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 relevant. The InSpectra™ is a tissue spectrometer, not an AI-assisted diagnostic tool that requires human reader interpretation in the context of MRMC studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The InSpectra™ is a standalone device in the sense that it measures StO2; it's not an "algorithm only" that then needs human interpretation in the way AI radiology tools might. However, performance metrics for its standalone accuracy are not detailed here.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned for any studies.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Summary based on the provided text:
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device due to a reworded indication for use. It asserts that "Published clinical studies are presented showing that StO2 measurements provide valuable medical information in various disease states," but it does not include the detailed breakdown of acceptance criteria or the specifics of any studies (sample sizes, ground truth methodology, expert involvement, etc.) that would prove the device meets these criteria. The document is a regulatory submission for a minor change (reworded indications for use) to an already cleared device, not a detailed clinical study report.
§ 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).