(17 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 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.
| Acceptance Criteria (Inferred from modification nature) | Reported Device Performance (as stated) |
|---|---|
| Software Functionality: New software must accurately view, store, and chart the StO2 output. | "All test results verify that the software meets or exceeds all predetermined specifications." |
| Data Integrity: The software does not alter the StO2 information already displayed on the predicate device. | "The software does not alter the information already displayed on the predicate device. There is a one-way communication from the monitor to the user PC." |
| Safety: The modification does not introduce new safety concerns. | (Implicit in 510(k) clearance for a software modification) |
| Substantial Equivalence: The modified device is as safe and effective as the predicate device. | "HTI believes that the modified device is substantially equivalent to the unmodified predicate device." (Accepted by FDA) |
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.
§ 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).