(29 days)
Hutchinson Technology Incorporated's InSpectra™ StO2 Tissue Oxygenation Monitor 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™ StO2 Tissue Oxygenation Monitor 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" StO2 Tissue Oxygenation Monitor ("Model 650"), is a lightweight and transportable system that is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). The Model 650 is composed of the following components:
InSpectra™ StO2 Tissue Oxygenation Monitor. The InSpectra™ StO2 Monitor contains an LCD screen, a microcontroller, cooling fan, back-up battery, and internal software. The monitor has an internal lithium ion battery and two external data ports. It is equipped with an adjustable C-clamp for attachment to an IV pole.
InSpectra™ StO2 Cable, which can be removed from the monitor and replaced, contains light detection circuitry, a microcontroller, one set of optical fibers to transmit light to the tissue, and a second set of optical fibers that receive light from the tissue and return it to a photosensitive detector and internal software.
The InSpectraTM StO2 Sensor. The single-use InSpectra™ StO2 Sensor, when connected to the InSpectra™ StO2 Cable, conducts the optical signal to the patient and back to the monitor. The sensor has a shield to protect the measurement from ambient light interference, a reinforced cable to protect the optical fibers, and an adhesive surface to facilitate attachment of the sensor to the patient for continuous monitoring.
The provided text does not contain detailed acceptance criteria for the InSpectra™ StO₂ Tissue Oxygenation Monitor, Model 650, nor does it describe a specific study proving the device meets particular numerical criteria.
Instead, the document is a 510(k) premarket notification for a labeling clarification for an existing device (Model 650). The key takeaway from the provided text is that no new testing was required or conducted because the change was only a labeling clarification, and the manufacturer concluded no new technological issues were raised.
Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this document.
Here's what can be inferred or explicitly stated based on the provided text, along with what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not detailed. The document states that the device is "substantially equivalent" to predicate devices, implying that its performance meets the level established by those devices. However, no specific numerical acceptance criteria (e.g., accuracy, precision ranges, sensitivity, specificity) are provided for this submission.
- Reported Device Performance: Not reported for this submission. The submission is for a labeling clarification, not new performance data.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable/not provided. No new performance testing was conducted for this 510(k) submission.
- Data Provenance: Not applicable/not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable/not provided. No new performance testing was conducted to establish ground truth.
- Qualifications of Experts: Not applicable/not provided.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC study was not done as part of this submission. The document explicitly states "no new testing was required."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: Not applicable to this submission. The device is a monitor that measures physiological parameters. Performance evaluation would typically be against a gold standard measurement, not human interpretation of an algorithm's output in the same way as an imaging AI. However, no new performance studies of any kind were conducted for this submission.
7. The Type of Ground Truth Used:
- Ground Truth Type: Not applicable/not provided for this submission. Any original ground truth for the predicate device would have been established, but it's not detailed here.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable/not provided. This device is a measurement monitor, not an AI model requiring a training set in the typical sense.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: Not applicable/not provided.
Summary of Device Rationale for Substantial Equivalence (from the text):
The manufacturer (HTI) claims substantial equivalence for the "Model 650 with labeling clarifications" to predicate devices (K061619 and K053618) based on:
- Design
- Technological characteristics
- Intended use
- Equivalence in terms of design, functionality, principles of operation, performance specifications
- The conclusion that the labeling clarifications raise "no new technological issues."
- A risk analysis was conducted, which supported the conclusion that no new testing was required.
§ 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).