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Hutchinson Technology Incorporated's InSpectra™ StO2 Spot Check is intended for use as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in thenar skeletal muscle tissue (StO2).

The InSpectra™ StO2 Spot Check is indicated for use in monitoring patients during circulatory or perfusion examinations or when there is a suspicion of compromised circulation of thenar skeletal muscle.

The InSpectra™ StO2 Spot Check System and its predicate device are designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). The InSpectra"M StO2 Spot Check System is composed of the following components:

The InSpectra™ StO2 Spot Check Monitor (model 300) contains an LCD screen, light source/detection circuitry, microcontrollers, internal software, one set of optical fibers to transmit light to the Cable, a second set of optical fibers that receive light from the Cable and return it to a photosensitive detector and internal software.

The InSpectra™ StO2 Cable (model 3003) is a replaceable component of the InSpectra™ StO2 Spot Check System that transmits light between the Spot Check and the clip.

The InSpectra™ StO2 Thenar Clip (model 1315) has a shield to protect the measurement from ambient light interference and a clip to facilitate the attachment to the patient's thenar for integre the first in a clip to laciniale the attaching thenar eminones (the flock thenar eminence (the fleshy mass on the palmar surface the hand at the base of the thumb) and connects to the InSpectra™ StO2 Cable, model 3003.

• The Charging Station contains circuitry to simultaneously charge the InSpectra™ StO2 Spot Check Monitor and a spare battery. LED indicators display the status of the charging batteries.
  The Spot Check System also includes a replaceable/rechargeable lithium ion battery and a wall/IV pole mounting system

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative results that would allow for a complete description of the device's performance against predefined criteria. The document is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed efficacy study results with acceptance criteria.

However, based on the available text, here's what can be extracted and inferred regarding acceptance criteria and general study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "All test results verify that the device meets or exceeds all predetermined specifications." This is a general statement and does not provide specific acceptance criteria values or the corresponding reported device performance metrics. Without these specifics, a table cannot be constructed.

General Device Description and Intended Use:

• Device Name: InSpectra™ StO2 Spot Check System (Model 300 and accessories)
• Intended Use: Non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in thenar skeletal muscle tissue (StO2). Indicated for use in monitoring patients during circulatory or perfusion examinations or when there is a suspicion of compromised circulation of thenar skeletal muscle.
• Technological Characteristics: Based on near-infrared technology, same basic technological characteristics as the predicate device (InSpectra™ StO2 Tissue Oxygenation Monitor System (Model 650 and accessories), K100915).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It only broadly mentions "extensive testing."

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.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

The document describes a standalone device (an oximeter) that measures tissue oxygen saturation. It does not mention any AI component or human readers/interpreters in the context of a comparative effectiveness study. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed according to this document.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the device is described as a standalone monitoring system that performs measurements directly. The statement "Hutchinson Technology Inc. has conducted extensive testing of the InSpectra™ StO2 Spot Check System to verify adherence to requirements. All test results verify that the device meets or exceeds all predetermined specifications" implies that performance was assessed for the device itself.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of "ground truth" used for validation. For a tissue oximeter, ground truth would typically involve comparison to a reference method for oxygen saturation, or clinical outcomes that correlate with tissue oxygenation. However, these specific details are not provided.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of the device's development or testing. This suggests that the device's core functionality (measuring StO2 using near-infrared technology) likely relies on established biophysical principles and algorithms rather than a machine learning model requiring a distinct training phase with a labeled dataset.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for a machine learning model, the "ground truth" for a training set is not applicable to the information provided.

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