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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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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.

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Hutchinson Technology Incorporated's InSpectra St02 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 St02 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 is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). The InSpectra StO2 is composed of the following components: Monitor and Optical Cable and The InSpectra StO2 Sensor.

The provided text does not contain information about specific acceptance criteria or a study that evaluates the device against these criteria in a detailed manner. The document is a 510(k) summary for the InSpectra StO2 Tissue Oxygenation Monitor, and while it states that "All test results verify that the device meets or exceeds all predetermined specifications," it does not elaborate on what those specifications or the "extensive testing" entailed.

Therefore, I cannot provide the requested table, sample sizes, expert qualifications, or adjudication methods based on this text. The other information requested, such as MRMC studies, standalone performance, and ground truth establishment, is also absent from these documents.

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Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, 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™ 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™ 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, Patient Cable, Patient Interface, Printer, Optical Converter, Set-up Accessories, and Inspectra System Software.

The provided text outlines the submission of a Special 510(k) for a modified device, the InSpectra™ Tissue Spectrometer System, Model 325. However, it does not contain the detailed acceptance criteria or the specific study results that prove the device meets these criteria. The document states that "All test results verify that the device meets or exceeds all predetermined specifications," but does not list these specifications or the performance metrics.

Therefore, for the requested information, many fields will be marked as "Not provided in the input text."

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not provided in the input text.
• Data Provenance: Not provided in the input text (e.g., country of origin, retrospective or prospective). The submission is from Hutchinson, MN, USA.

The document indicates "extensive testing" was conducted to verify adherence to requirements, but does not detail the nature or scale of this testing for the test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of experts: Not provided in the input text.
• Qualifications of experts: Not provided in the input text.

4. Adjudication method for the test set:

• Not provided in the input text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done. The device described is a non-invasive monitoring system for measuring tissue oxygen saturation (StO2), not an AI-assisted diagnostic imaging device that human readers would interpret. Therefore, the concept of human readers improving with AI assistance is not applicable to this device.

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

• Yes, implicitly. The InSpectra™ Tissue Spectrometer System, Model 325, measures an "approximated value of percent hemoglobin oxygen saturation in tissue (StO2)." It is a standalone monitoring device. While clinicians interpret the StO2 readings, the device itself provides the measurement without human input into the measurement process. The "Test Conclusions" state that "All test results verify that the device meets or exceeds all predetermined specifications," which implies testing of the device's performance in isolation.

7. The type of ground truth used:

• Not explicitly stated, but for a device measuring "percent hemoglobin oxygen saturation in tissue (StO2)," the ground truth would typically be established by:
  • Direct, invasive measurements (e.g., blood gas analysis of tissue samples): This is a common method for validating non-invasive oximetry devices.
  • Other established gold-standard non-invasive methods: If such a method exists for tissue oxygen saturation.
  • Physiological models or controlled experiments: Where tissue oxygenation levels can be precisely manipulated and known.

8. The sample size for the training set:

• Not applicable as this seems to be a hardware device with an algorithm for calculating StO2, rather than a machine learning model that requires a distinct training set. The text refers to "predetermined specifications" and "extensive testing" for the modified device itself.

9. How the ground truth for the training set was established:

• Not applicable (as per point 8).

Summary of what the document does provide:

• Device Name: InSpectra™ Tissue Spectrometer System, Model 325
• Intended Use: Noninvasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2). Indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
• Predicate Device: InSpectra™ Tissue Spectrometer System, Model 325, (K042020)
• Rationale for Equivalence: Based on design, technological characteristics, intended use, and extensive testing, the modified device is substantially equivalent to the unmodified predicate device and raises no new issues of safety or effectiveness.
• Conclusion: "All test results verify that the device meets or exceeds all predetermined specifications."

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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:

1. 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.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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 relevant. The InSpectra™ is a tissue spectrometer, not an AI-assisted diagnostic tool that requires human reader interpretation in the context of MRMC studies.
6. 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned for any studies.
8. The sample size for the training set: Not mentioned.
9. 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.

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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.

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.

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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.

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.

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The Biospectrometer - NB 1111 is intended to noninvasively and continuously measure hemoglobin oxygen saturation:

• in the ear lobe with the 3mm probe
• in the arm, leg, or shoulder with the 15mm probe. The value of these measurements in disease states has not been demonstrated.

The Biospectrometer - NB Oximeter Model 1111 is a spectrophotometric monitoring system which measures an approximated value of percent hemoglobin oxygen saturation in tissue (S,O2). More specifically, the Biospectrometer - NB Oximeter measures the percent hemoglobin oxygen saturation of blood contained within the volume of tissue illuminated by the noninvasive probe. The S.O2 value is a function of the relative contribution of arterial, venous, and capillary blood.

The system consists of a patient probe (either 3mm or 15mm) containing optical fibers for transmitting light to tissue and receiving reflected light which is returned to a photo-sensitive detector. The nonsterile probe is designed to be placed on intact skin. The second system component is a monitor containing a spectrometer, light assembly, microprocessor, power supply, display monitor and kevboard. The third type of system component includes two (reference) canisters for use in calibration of the system. The Biospectrometer - NB Oximeter Model 1111 is AC operated.

The Biospectrometer - NB Oximeter Model 1111 measures an approximated value of the percent oxygen saturation of hemoglobin based on spectrophotometric measurement principles. Spectrophotometric measurements of hemoglobin have been well described by numerous authors. Today, spectrophotometric oximeters are commonly used clinically. By measuring absorbencies at suitable wavelengths, the ratio of oxygenated hemoglobin to total hemoglobin can be determined.

The depth of tissue measured by the Biospectrometer - NB Oximeter Model 1111 probe is determined by the probe design. The HTI Biospectrometer - NB 15mm probe measures to a maximum depth of 20mm. The 3mm probe measures to a maximum depth of 4mm.

The provided text K963903 for the "Biospectrometer - NB Oximeter Model 1111" does not contain specific acceptance criteria, a study proving device performance against such criteria, data provenance, expert ground truth details, adjudication methods, MRMC study results, or training set information.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor details about a study that proves the device meets specific criteria, as that information is not available in the provided text.

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