(153 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 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.
| Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance (Inferred from "equivalent clinical performance") |
|---|---|
| Functional Equivalence: Ability to estimate percent oxygen saturation of hemoglobin in a volume of tissue (StO2) non-invasively and continuously. | The InSpectra™ (new device) shares the intended use of, and measures the same approximated value of percent oxygen saturation of hemoglobin in a volume of tissue as, the Biospectrometer - NB Oximeter, Model 1111 (predicate device). |
| Clinical Performance Equivalence: Provide comparable StO2 measurements to the predicate device in a clinical setting. | "A human study comparing device performance between the InSpectra™ and the predicate system demonstrated equivalent clinical performance." (No specific quantitative metrics for "equivalent" are provided). |
| Hardware and Software Functionality: Proper operation of new electronic components and software platforms. | "Hutchinson Technology, Inc. has conducted extensive testing of the new electronic components to verify adherence to requirements. The new electronic [components that] comprise the system have been tested individually to verify operation per design intent. Software has been evaluated at the unit, integration, and system-level to document proper performance." (No specific quantitative results are provided). |
| Safety: Device operates without introducing new or increased risks. | (Implicit in 510(k) clearance process by demonstrating substantial equivalence to a legally marketed 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.
§ 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).