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The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue, during laparoscopy.

The Lap.Ox™ Laparoscopic Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion assessment during laparoscopy.

The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.

The Lap.Ox™ Laparoscopic Tissue Oximeter should only be used on adult patients.

The proposed Lap.Ox™ Laparoscopic Tissue Oximeter ("Lap.Ox" or "Device") is a cordless, battery-powered device that estimates the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue. The device includes two components:

• a Reusable Main Unit that shows a digital readout of percent oxygen saturation (StO2) when the system is in contact with tissue (also denoted as "main unit" or "durable"); and
• a Disposable Kit that contains two AA batteries and a sterile single-use disposable consisting of sources, detectors, a laparoscopic tube, and a sheath that is placed around the Reusable Main Unit (denoted as "Disposable").

The Device uses spatially-resolved optical measurements at three wavelengths. The Device displays the StO2 estimate on the built-in screen. The Device is constructed from biocompatible materials that can tolerate bodily fluids. The basic principle of operation of the Lap.Ox Laparoscopic Tissue Oximeter is spectrophotometric oximetry which entails utilizing red and near-infrared light to measure the color of blood and determine an oxygen saturation value.

The provided FDA 510(k) clearance letter for the Lap.Ox™ Laparoscopic Tissue Oximeter details aspects of its regulatory review, including its intended use, technological characteristics, and a summary of performance testing. However, the document does not provide specific acceptance criteria or detailed results of a study proving the device meets those criteria, particularly in the context of clinical performance or accuracy of StO2 measurements with numerical values.

The letter broadly states that "The verification and validation studies demonstrated that Lap.Ox performs as intended" and "ViOptix conducted a clinical study... The results demonstrated that the performance of the Lap.Ox Laparoscopic Tissue Oximeter, on human subjects, is comparable to the predicate device."

Without the actual study report or more detailed submission information, it's impossible to explicitly fill out the table and answer all questions with specific numerical values for device performance and study details.

Based on the provided text, here is what can be inferred and what information is missing:

Acceptance Criteria and Device Performance (Inferred/Missing)

Given the device is an oximeter, typical acceptance criteria would involve accuracy and precision compared to a reference method (e.g., arterial blood gas analysis, or the predicate device's measured values). However, these specific criteria and the measured performance are not detailed in the provided text.

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The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue.

The Intra. Ox™ 2.0 Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.

The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.

The Intra.Ox™ 2.0 Handheld Tissue Oximeter should only be used on adult patients.

The ViOptix Intra.Ox" 2.0 Handheld Tissue Oximeter (device) is a sterile, cordless, battery-powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device includes three components and an accessory: · Main Unit: a re-usable module consists of light sources, detectors, and processing electronics to convert measurements of reflected light into an estimate of StO2;

• Sheath: a single-use, sterile Sheath placed around the Main Unit during device use (provide in the Disposable Kit); and · Battery Pack: a single-use battery (provided in the Disposable Kit) that is paired with the Main Unit to provide power.

The device uses spatially resolved optical measurements. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the Intra.Ox 2.0 Handheld Tissue Oximeter is a single-use disposable constructed from biocompatible materials that and other liquids such as disinfectants and marking materials. The device shares the same technological characteristics as the predicate device (K221010), including principle of operation, StO2 measured parameters, accuracy and range, energy delivered and power source.

The provided text does not contain detailed information regarding the acceptance criteria of a device for regulatory approval or a specific study proving it meets these criteria with the level of detail requested in the prompt.

The document is an FDA 510(k) clearance letter for the ViOptix Intra.OxTM 2.0 Handheld Tissue Oximeter. It states that the device is substantially equivalent to a previously marketed predicate device (K221010). The information provided is primarily about the regulatory basis for clearance, the device's intended use, and a high-level summary of studies performed.

Here's an analysis of what information is available and what is missing based on your specific questions:

1. A table of acceptance criteria and the reported device performance

• Missing. The document does not specify quantitative acceptance criteria (e.g., accuracy, precision targets) for the device's performance, nor does it present a table of reported device performance against such criteria. It generally states that the device "responds appropriately" and "provides clinically relevant information."

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 mentions an "animal study" and "human clinical data from published scientific literature (Gonzalez-Jacobo et al.)".
• Sample Size: The exact sample sizes for both the animal study and the human clinical data are not provided.
• Data Provenance:
  • Animal study: No details on country of origin or whether it was retrospective/prospective.
  • Human clinical data (Gonzalez-Jacobo et al.): No details on country of origin or whether it was retrospective/prospective from the provided text. It merely states it included "multiple surgical" settings.

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)

• Missing. The document does not specify how ground truth was established, nor does it mention the number or qualifications of experts involved in any ground truth determination.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Missing. No information on adjudication methods is present.

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 / Missing. This device is an oximeter, not an AI-assisted diagnostic imaging device that requires human readers to interpret results. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant to this type of device. The document mentions the device provides "comparable information to the existing standard of care" but doesn't quantify improvement in human performance with the device.

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

• The Intra.Ox™ 2.0 Handheld Tissue Oximeter is a standalone device that measures StO2. Its performance as a measurement device is inherent. The studies mentioned (animal and human clinical data) would assess the device's ability to accurately measure oxygen saturation. So, in essence, the "standalone performance" of the device is what these studies would have evaluated.
• Stated from text: "The animal study demonstrates that the Intra.Ox™ 2.0 Handheld Tissue Oximeter responds appropriately to the presence of transient ischemia induced by arterial occlusion" and the human study "demonstrates that the Intra.Ox™ 2.0 Handheld Tissue Oximeter provides clinically relevant information regarding bowel ischemia". This describes its standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the animal study: The ground truth was likely induced "transient ischemia induced by arterial occlusion" which is a physiological challenge.
• For the human study: The "existing standard of care" is mentioned, implying that the device's measurements were compared against established clinical methods for assessing bowel ischemia. The specific nature of this "standard of care" (e.g., pathology, clinical observation, other monitoring devices) is not detailed.

8. The sample size for the training set

• Not applicable / Missing. This is not an AI/ML device that typically has a separate "training set" in the common understanding of machine learning. It's a measurement device. It was likely "calibrated" or developed using internal data, but the document doesn't provide details on sample sizes for such development or calibration processes.

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

• Not applicable / Missing. See point 8.

In summary: The provided document is a regulatory clearance letter, not a detailed clinical study report. It confirms the device's substantial equivalence based on summaries of testing, but it does not contain the granular detail on acceptance criteria, sample sizes, expert involvement, or ground truth establishment that you are requesting. Such details would typically be found in the full 510(k) submission, specifically the non-clinical and clinical test reports, which are not part of this public clearance letter.

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The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue.

The Intra. Ox™ 2.0 Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.

The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.

The Intra. Ox™ 2.0 Handheld Tissue Oximeter should only be used on adult patients.

The ViOptix Intra.Ox 2.0 Handheld Tissue Oximeter is a sterile, cordless, battery-powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device includes three components and an accessory:

• Main Unit: a re-usable module consists of light sources, detectors, and processing ● electronics to convert measurements of reflected light into an estimate of StO>:
• Sheath: a single-use, sterile Sheath placed around the Main Unit during device use . (provide in the Disposable Kit); and
• Battery Pack: a single-use battery (provided in the Disposable Kit) that is paired with the . Main Unit to provide power.

The device uses spatially resolved optical measurements at five wavelengths. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the built-in screen. The Intra.Ox 2.0 Handheld Tissue Oximeter is a single-use disposable constructed from biocompatible materials that can tolerate bodily fluids and other liquids such as disinfectants and marking materials.

The device shares the same indication for use and the same technological characteristics as the predicate device (K191676), including principle of operation, StO2 measured parameters, accuracy and range, energy delivered and power source.

The provided text describes a 510(k) premarket notification for the ViOptix Intra.Ox 2.0 Handheld Tissue Oximeter. The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K191676). Consequently, the "acceptance criteria" and "device performance" are framed in terms of equivalence to the predicate device and meeting specifications, rather than absolute performance metrics against a fixed clinical threshold.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list distinct "acceptance criteria" for the modified device in terms of specific performance thresholds for StO2 accuracy, beyond stating it should perform "as intended" and be "substantially equivalent" to the predicate. The performance data primarily focuses on demonstrating that the modifications did not negatively impact the device's performance compared to the predicate and a "gold standard."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The only specific performance study mentioned with a "test set" is the Heterogeneous Blood Phantom Study. The sample size for this study is not explicitly stated in the provided document. The data provenance is also not explicitly stated, however, it is a non-clinical phantom study rather than a human clinical study, using swine whole blood and an Intralipid solution. This implies an in-vitro or bench-top study, not tied to a specific country of origin in the way clinical data would be. It is a prospective study in the sense that the measurements were actively made for this evaluation.

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)

For the Heterogeneous Blood Phantom Study, the "ground truth" was established by a "gold standard" blood co-oximeter. This implies a technical or laboratory instrument, not human experts. Therefore, no human experts were used to establish ground truth for this particular test.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Since the ground truth was established by a "gold standard" instrument, there was no adjudication method involving human reviewers for the test set.

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 MRMC comparative effectiveness study was done. The device itself is an oximeter, not an AI diagnostic tool requiring human interpretation or assistance augmentation. Clinical testing was explicitly stated as "not required."

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

Yes, the Heterogeneous Blood Phantom Study is a form of standalone performance study. The device, the Intra.Ox 2.0 Handheld Tissue Oximeter, was tested independently, and its measurements were compared to a "gold standard" blood co-oximeter. This test evaluated the algorithm's performance (how it estimates StO2 from optical measurements) in a controlled phantom environment without human intervention in the measurement process itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the Heterogeneous Blood Phantom Study, the ground truth was based on a "gold standard" blood co-oximeter.

8. The sample size for the training set

The document does not provide information on a training set sample size. The submission is for a modification to an already cleared device, and the focus is on demonstrating substantial equivalence through non-clinical performance testing. It is likely that the underlying algorithm was trained during the development of the original predicate device (K191676), but no details are given here for either device.

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

As no information is provided on a training set in this document, there is no information on how its ground truth was established.

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The Intra. Oxim 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (SKO2) in a volume of tissue.

The Intra. OxTM 2.0 Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.

The Intra. Oxim 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.

The Intra. OxTM 2.0 Handheld Tissue Oximeter should only be used on adult patients.

The ViOptix Intra.Ox 2.0 Handheld Tissue Oximeter is a sterile, cordless, battery-powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device includes three components and an accessory:

• . Main Unit: a re-usable module consists of light sources, detectors, and processing electronics to convert measurements of reflected light into an estimate of StO2;
• . Sheath: a single-use, sterile Sheath placed around the Main Unit during device use (provided in the Disposable Kit);
• Battery Pack: a single-use battery (provided in the Disposable Kit) that is paired with the . Main Unit to provide power; and
• . Quality Control (QC) Target: a single-use accessory (provided in the Disposable Kit) that provides an optical check once the Sheath is placed around the Main Unit.

The device uses spatially resolved optical measurements at five wavelengths. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the built-in screen.

The provided text describes the 510(k) premarket notification for the Intra.Ox 2.0 Handheld Tissue Oximeter, asserting its substantial equivalence to a predicate device (Intra.Ox Handheld Tissue Oximeter, K163472). The document details performance data from a heterogeneous blood phantom study and a non-significant risk clinical study to support this claim.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with numerical targets for accuracy or other performance metrics. Instead, it relies on demonstrating "substantial equivalence" to the predicate device through agreement in measurement and physiological response.

The performance is reported in terms of agreement with a "gold standard" (blood cooximeter for the phantom study) and agreement with the predicate device (for the clinical study).

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

• Heterogeneous Blood Phantom Study (Test set): The sample size is not explicitly stated. The study involved measurements in a "heterogeneous phantom prepared with swine whole blood."
• Clinical Study (Test set):
  • Sample Size: "A total of 18 data sets from 18 subjects."
  • Data Provenance: Prospective, healthy human volunteers. The document does not specify the country of origin of the data, but it was an "IRB-approved study."
  • The subjects were "near-evenly distributed over age, gender, and skin color as determined by the Fitzpatrick skin type."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of experts being used to establish a ground truth for either the phantom study or the clinical study in the traditional sense of medical image interpretation.

• Heterogeneous Blood Phantom Study: The "gold standard" for this study was a "blood cooximeter." This suggests a reference instrument rather than expert opinion. The qualifications of a cooximeter operator would typically involve laboratory proficiency but are not specified here.
• Clinical Study: The "ground truth" for the clinical study was the measurement from the predicate device and the physiological response during induced ischemia. This is a comparative study against an existing cleared device, rather than against an expert-determined ground truth.

4. Adjudication Method for the Test Set

No adjudication method is described for either the phantom study or the clinical study. The clinical study involved direct comparison of measurements between the new device and the predicate device, not a human consensus or adjudication process.

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 MRMC comparative effectiveness study was done. This device is a measurement instrument (oximeter), not an AI-powered diagnostic tool requiring human interpretation. Therefore, the concept of human readers improving with or without AI assistance does not apply.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are standalone performance evaluations of the device itself.

• Heterogeneous Blood Phantom Study: Evaluated the Intra.Ox 2.0 Handheld Tissue Oximeter's measurements against a blood cooximeter using a phantom.
• Clinical Study: Evaluated the Intra.Ox 2.0 Handheld Tissue Oximeter's measurements against the predicate Intra.Ox Handheld Tissue Oximeter in healthy human volunteers.

These studies assess the device's ability to measure StO2 and respond to physiological changes directly, without human interpretation as part of the primary measurement.

7. The Type of Ground Truth Used

• Heterogeneous Blood Phantom Study: The ground truth was established by a "blood cooximeter." This is a reference instrument.
• Clinical Study: The ground truth for comparative purposes was the predicate Intra.Ox Handheld Tissue Oximeter and the physiological changes induced by transient ischemia (i.e., the expected deoxygenation curve and StO2 values observed during healthy and compromised tissue states), benchmarked against "literature-reported values." This is a form of comparative ground truth against an established device and physiological understanding.

8. The Sample Size for the Training Set

No training set is mentioned or applicable in the context of this device. The Intra.Ox 2.0 Handheld Tissue Oximeter is a spectrophotometric oximeter that uses fixed algorithms based on physical principles, not a machine learning or AI model 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 device.

Ask a specific question about this device

The Intra. Ox™ Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue.

The Intra. Ox™ Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.

The Intra. Ox™ Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.

The Intra.Ox™ Handheld Tissue Oximeter should only be used on adult patients.

The ViOptix Intra.Ox" Handheld Tissue Oximeter is a sterile, cordless, battery-powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device uses spatially resolved optical measurements at five wavelengths. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the built-in screen. The Intra.Ox Handheld Tissue Oximeter is a single-use disposable constructed from biocompatible materials that can tolerate bodily fluids and other liquids such as disinfectants and marking materials.

ViOptix has made modifications to the cleared Intra.Ox Handheld Tissue Oximeter (K133983) to optimize the design and improve manufacturability. The modified device shares the same indication for use and the same technological characteristics as the cleared device, including principle of operation, StO2 measured parameters, accuracy and range, energy delivered and power source.

The provided text does not contain detailed information on acceptance criteria or a study designed to explicitly prove the device meets those criteria in a quantitative sense with specific performance metrics against a predefined acceptance threshold.

Instead, the document is a 510(k) summary for a modified medical device (Intra.Ox™ Handheld Tissue Oximeter) seeking to demonstrate substantial equivalence to a predicate device (the original Intra.Ox™ Handheld Tissue Oximeter, K133983).

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will extract what is available and indicate where information is missing.

Here's a summary based on the provided text, focusing on the available information regarding the device's performance and the supporting studies for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria with specific thresholds (e.g., "accuracy > X% with a Y% confidence interval") and then report the device's performance against these thresholds. Instead, the performance claims are made in the context of demonstrating substantial equivalence to a predicate device.

The closest to "performance" stated is for Tissue Oxygen Saturation (StO2) Measurement Range:

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

• Heterogeneous Blood Phantom Study: The sample size is not explicitly stated, nor is the data provenance beyond "heterogeneous phantom prepared with swine whole blood."
• Clinical Study:
  • Sample Size: 19 data sets from 19 subjects.
  • Data Provenance: Healthy human volunteers. The country of origin is not specified but it is likely prospective, as it describes a specific study.

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

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) 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

This is not applicable. The device is a tissue oximeter, not an AI-assisted diagnostic tool that human readers would interact with. The clinical study compares the modified device's performance to the predicate device's performance, and both are standalone measurement devices.

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

Yes, standalone performance data was collected in both the Heterogeneous Blood Phantom Study and the Clinical Study, as the device provides direct measurements. The purpose was to compare the modified device's standalone performance to the predicate device's standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Heterogeneous Blood Phantom Study: A "gold standard" blood co-oximeter was used as the ground truth reference.
• Clinical Study: The "ground truth" for the clinical study was the physiological state induced (transient ischemic events temporarily mimicking compromised tissue) and implied "true" StO2 values based on this physiological state and comparison to the predicate device and literature. There is no mention of an independent, higher-level ground truth such as pathology or expert consensus on the physiological state itself, beyond the direct measurement of StO2.

8. The sample size for the training set

This information is not applicable/not provided. The Intra.Ox™ Handheld Tissue Oximeter is a spectrophotometric device, not an AI/machine learning model that typically requires a distinct "training set" in the same way. Its internal algorithms are based on physics and calibration, not statistical learning from a large dataset.

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

This information is not applicable/not provided for the same reason as point 8.

Ask a specific question about this device

The Intra.Ox™ Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue.

The Intra.Ox™ Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.

The ViOptix Intra.Ox™ Handheld Tissue Oximeter is a sterile, cordless, batterypowered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device uses spatially-resolved optical measurements at four wavelengths. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the built-in screen. The ViOptix Intra.Ox™ Handheld Tissue Oximeter is a single-use disposable constructed from biocompatible materials that can tolerate bodily fluids and other liquids such as disinfectants and marking materials.

Here's a breakdown of the acceptance criteria and study details for the Intra.Ox™ Handheld Tissue Oximeter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Device: Intra.Ox™ Handheld Tissue Oximeter (Subject Device)
Predicate Device: T.Ox (formerly ODISsey) Tissue Oximeter

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

• Bench Tests: The sample size for the test set is not explicitly stated in terms of number of data points or phantom measurements. However, it mentions "three different Intra.Ox™ devices as compared to two T.Ox devices" for the agreement test, and "liquid phantoms prepared with Intralipid and swine whole blood" for the correlation test.
• Clinical Study: Data from 11 subjects were analyzed.
• Data Provenance (Clinical Study): The data was collected from healthy human volunteers. The country of origin is not explicitly stated, but the submission is to the US FDA, implying data collected under US regulatory standards or from a region that complies with such standards for submission. The study appears to be prospective as it involved measuring patients during "transient ischemic events."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• The document does not mention the use of experts to establish ground truth for the test set in either the bench or clinical studies. The ground truth for the bench tests was derived from known absorption coefficients in liquid phantoms and the performance of the predicate device. For the clinical study, the ground truth was the physiological changes observed in human volunteers and the measurements from the predicate device.

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method used for the test set.

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 comparative effectiveness study was not done. This device is a direct measurement device (tissue oximeter), not an AI-powered diagnostic tool requiring human interpretation. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

• Yes, a standalone performance assessment was done. The entire performance testing described (both bench and clinical) evaluates the device's ability to measure StO2 independently. The clinical study compares the subject device's readings with those of the predicate device, but it doesn't involve human-in-the-loop interpretation of the device's output. The device itself provides the StO2 estimate.

7. The Type of Ground Truth Used

• Bench Tests: The ground truth for absorption coefficients was established using known values from prepared liquid phantoms. For the comparative performance with the predicate, the predicate device (T.Ox) served as a reference point for "truth" in its StO2 measurements.
• Clinical Study: The ground truth was essentially the physiological states of the human volunteers during induced transient ischemia, as measured by both the subject and predicate devices, and compared against "literature-reported values of skin and muscle transient ischemia." The predicate device (T.Ox) also served as a comparative ground truth.

8. The Sample Size for the Training Set

• The document does not explicitly mention a separate "training set" or its sample size. This type of device (a biophysical measurement instrument) typically relies on validated physical principles and calibration, rather than machine learning models that require distinct training and test sets in the same way an AI diagnostic algorithm would. The development and internal calibration would implicitly use various data, but it's not defined as a "training set" in the context of this submission.

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

• As a dedicated "training set" is not explicitly defined, the method for establishing its ground truth is also not specified. The underlying principles and calibration would be based on established physics and chemistry (e.g., spectroscopy of light absorption by oxygenated and deoxygenated hemoglobin), likely validated through laboratory experiments with known concentrations and conditions.

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The ViOptix ODISsey Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services.

The ODISsey Tissue Oximeter 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 ODISsey Tissue Oximeter is an optically based device that noninvasively estimates the percent oxygen saturation (StO2) in a volume of tissue underneath the sensor.

The T.Ox™ Tissue Oximeter is a lightweight and portable, AC poweroperated, unit with a lithium-ion battery backup that non-invasively estimates the percent oxygen saturation (StO2%) in a volume of tissue underneath the sensor. The console has a color LCD display monitor, a standard one sampling channel (with a two-channel option), and up to two fiber optic sensors. It has adjustable audible and visual alarms for:

· StO2 low and high alarm limits

· Low battery

The T.Ox™ Tissue Oximeter has visual alarms.

The T.Ox™ Tissue Oximeter consists of three parts:

· Small computer console display module

· AC power cord

· Fiber optic sensor(s)

If the console is using two channels, both channels can be used at the same time. Each channel samples and displays data independently of the other channel. Each channel can accommodate one sensor.

The provided text is a 510(k) summary for the ViOptix ODISsey Tissue Oximeter, specifically a special 510(k) submission for changes in patient contact materials and design. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance in estimating oxygen saturation (StO2).

The document states:
"After performing non-clinical performance studies, Biocompatibility to ISO 10993, Packaging Validation, Sterilization Validations and Aging Studies, the data shows that the ODISsey Tissue Oximeter is substantially equivalent to the predicate as an estimate the percent oxygen saturation (StO2) in a volume of tissue."

This indicates that the focus of this specific 510(k) was on demonstrating substantial equivalence for the changes made (sensor use, sterility, packaging, cable cover materials), rather than re-proving the core performance of oxygen saturation estimation. The original predicate device (K042657) would have had performance data for its StO2 estimation, but that information is not present in this document.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study demonstrating performance in estimating StO2 from the provided text.

Based on the provided document, the following information can be extracted, but it primarily relates to non-clinical performance studies for material and design changes, not clinical performance for StO2 estimation:

Acceptance Criteria and Device Performance Study (as described for the changes in this Special 510(k))

Since this is a Special 510(k) for changes in materials and design, the "acceptance criteria" and "device performance" discussed are related to the safety and functionality of these changes to maintain substantial equivalence, rather than a clinical performance study measuring StO2 accuracy.

The document states that "non-clinical performance studies" were conducted. The "reported device performance" in this context is the conclusion drawn from these studies: that the device remains substantially equivalent to its predicate for estimating StO2 despite the changes.

Details of the Study (related to the changes in this Special 510(k))

Due to the nature of this submission being a Special 510(k) for material and design changes, the document does not contain most of the requested information pertaining to a clinical performance study for StO2 estimation. The information below reflects what can be inferred or directly stated about the studies conducted for the changes rather than a full clinical performance study for StO2 accuracy.

1. Sample size used for the test set and the data provenance: Not specified for the non-clinical studies mentioned. These are likely bench tests and material analyses. The origin (e.g., country of origin) is not mentioned. These studies would be retrospective in the sense that they are conducted on the new design before market release.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for the non-clinical biocompatibility, packaging, sterilization, and aging studies. These studies rely on standard protocols and laboratory analysis, not expert consensus on ground truth in a clinical sense.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the non-clinical studies mentioned.

4. 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 an oximeter, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "performance" being discussed for this 510(k) is related to material safety and manufacturing processes, not the standalone accuracy of the StO2 algorithm itself, which was established by the predicate device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical studies, "ground truth" would be established by validated test methods (e.g., chemical analysis for biocompatibility, sterility indicator results for sterilization validation, physical integrity tests for packaging). This is not expert consensus, pathology, or outcomes data in a clinical sense.

7. The sample size for the training set: Not applicable. This document does not describe the development or training of an algorithm for StO2 estimation. It concerns physical device changes.

8. How the ground truth for the training set was established: Not applicable.

Summary of why most fields are "Not Applicable" for this document:

This document is a Special 510(k) for demonstrating substantial equivalence after material and design changes to an already cleared device. It primarily focuses on non-clinical performance, such as biocompatibility, sterilization, and packaging validation. It does not present a clinical performance study or data related to the accuracy of the device's core function (StO2 estimation), as that performance was established for the predicate device (K042657). Therefore, questions related to clinical study design, expert ground truth, reader studies, and algorithm training/ground truth are not addressed in this specific submission.

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The VesseLink is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.

The VesseLink Microvascular Anastomotic Coupler (VesseLink) is a mechanical method for anastomosis, or connection, of small vessels ranging in size from 0.8 mm to 4.3 mm in outer diameter. The VesseLink is intended for use in the end-to-end and end to side vessel anastomosis as well as arterial/venous vein grafts. It is to be used in veins and arteries that are normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.

The provided document does not contain information about acceptance criteria and a study proving a device meets these criteria in the typical sense of a clinical or analytical performance study with specific metrics, sample sizes, and ground truth establishment.

Instead, the document is a 510(k) premarket notification for the "VesseLink Microvascular Anastomotic Coupler System." The core of this submission is to demonstrate substantial equivalence to a predicate device, not to prove performance against predetermined acceptance criteria through a standalone study.

Here's an breakdown based on the provided text, addressing your points where possible, and highlighting what's not present:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as quantifiable metrics with pass/fail thresholds in the provided document. The overarching "acceptance criterion" for this submission is demonstrating substantial equivalence to the predicate device.
• Reported Device Performance: The document states:
  • "Bench testing was performed to demonstrate the product functions as intended and is shown to be substantially equivalent."
  • This is a general statement and does not provide specific performance metrics (e.g., burst pressure, patency rates, leakage rates, etc.) or quantitative results from the bench testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document mentions "bench testing" but does not specify any sample size for this testing.
• It does not mention data provenance (country of origin, retrospective/prospective) for any 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)

• This information is not applicable and not present in the document. The substantial equivalence claim is based on technological characteristics and intended use, not on expert-adjudicated ground truth from a test set of patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable and not present. No multi-reader adjudication process is mentioned for any test set.

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 MRMC or comparative effectiveness study involving human readers or AI assistance was conducted or reported. This device is a mechanical anastomotic coupler, not an AI or diagnostic imaging device.

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

• This is not applicable as the device is a mechanical medical device, not an algorithm or AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For this type of device and submission (510k, substantial equivalence), the "ground truth" essentially refers to documented performance and characteristics of the predicate device, against which the new device's characteristics are compared (e.g., materials, dimensions, mechanism of action, intended use). There is no "ground truth" derived from patient outcomes or expert consensus in the typical sense for this submission.

8. The sample size for the training set

• Not applicable as this is a mechanical device, not an AI or machine learning model that requires a training set.

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

• Not applicable for the same reason as point 8.

In summary:

The provided document details a 510(k) submission for a medical device (VesseLink Microvascular Anastomotic Coupler System) seeking clearance based on substantial equivalence to a predicate device. The "study" mentioned is "bench testing," but no specific quantitative results, sample sizes, or methods for establishing ground truth as would be relevant for an AI or diagnostic device performance study are provided. The focus is on demonstrating similar technological characteristics and intended use to a legally marketed device.

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The ViOptix ODISsey Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services.

The ODISsey Tissue Oximeter 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 ODISsey Tissue Oximeter is an optically based device that noninvasively estimates the percent oxygen saturation (StO2) in a volume of tissue underneath the sensor.

This document describes an animal study used to demonstrate the performance of the ViOptix ODISsey Tissue Oximeter.

1. Table of Acceptance Criteria & Reported Device Performance

Note: The document does not specify quantitative acceptance criteria (e.g., a specific correlation coefficient or accuracy range). The reported performance is qualitative ("excellent correlation").

2. Sample Size & Data Provenance

• Test Set Sample Size: The study used three dog limbs.
• Data Provenance: Animal study, specifically using surgically removed and perfused dog limbs. The country of origin is not specified but is implicitly the location of the ViOptix, Inc. in Fremont, CA, or the testing facility they contracted. This is a prospective study.

3. Number of Experts and Qualifications for Ground Truth

• The ground truth was established by a Radiometer OSM3™ Hemoximeter (CO-Oximeter), which is described as a "gold standard." There is no mention of human experts establishing or adjudicating the ground truth in this specific animal study documentation. The CO-Oximeter itself serves as the reference measurement.

4. Adjudication Method for the Test Set

• None (as ground truth was established by an instrument, not human experts).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not conducted according to this document. The study focuses on comparing the device's readings against a "gold standard" instrument and a predicate device.

6. Standalone (Algorithm Only) Performance Study

• Yes, this constitutes a standalone performance study. The device, the ViOptix ODISsey Tissue Oximeter, directly measured StO2 in tissue, and its output was compared to reference measurements. There is no human intervention in the device's measurement process itself.

7. Type of Ground Truth Used

• Instrumental Gold Standard: The ground truth for tissue oxygen saturation (StO2) was established by a Radiometer OSM3™ Hemoximeter (CO-Oximeter), which is referred to as a "gold standard."

8. Sample Size for the Training Set

• The document does not provide information regarding a training set. This is a performance validation study, not a description of the algorithm development or internal training.

9. How Ground Truth for the Training Set Was Established

• As no information on a training set is provided, the method for establishing its ground truth is not applicable/not available in this document.

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