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The Vital Sync™ System is intended for display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. It is not intended for alarm notification, nor is it intended to control any of the independent bedside devices it is connected to.

The Vital Sync™ System is a bedside data management system that receives historic digital data produced by primary external devices through device specific cables, accepts manual data entry, and displays and stores this information for review and archiving by healthcare professionals.

Acceptance Criteria and Device Performance for the SOMANETICS VITAL SYNC SYSTEM

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Vital Sync™ System indicates that a comparative study with specific acceptance criteria and performance metrics was not performed in terms of human reader studies or algorithm performance. Instead, the substantial equivalence was demonstrated through bench testing and verification and validation activities.

Conclusion from Testing: The results demonstrate substantial equivalence with the predicate device. The device and its revised indications for use are substantially equivalent to the predicate device and do not raise new questions of safety and effectiveness.

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

The provided document does not mention a clinical test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The submission explicitly states: "Clinical testing was not required to establish substantial equivalence." The evaluation was based entirely on bench testing and verification and validation activities.

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

No experts were used to establish ground truth for a clinical test set because, as stated, "Clinical testing was not required." The "ground truth" for the bench testing was based on the "published specifications of both the predicate and the current device."

4. Adjudication Method for the Test Set

No adjudication method was used for a clinical test set, as no clinical testing was performed.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The submission focuses on the system's ability to display and record physiological parameters, not on interpretation or diagnostic effectiveness involving human readers.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm-only) performance study was performed in the context of diagnostic accuracy or interpretation. The device's function is to receive, display, and store data. The "performance data" refers to the system's functionality, reliability, and compatibility with external devices, which was evaluated through bench testing.

7. Type of Ground Truth Used

The "ground truth" for the verification and validation activities was primarily based on the published specifications of both the predicate device and the Vital Sync™ System itself. This means the system's output (e.g., received data, display accuracy, storage integrity) was compared against the expected behavior as defined by the technical specifications.

8. Sample Size for the Training Set

The document does not mention a "training set" or any machine learning/AI components where a training set would typically be used. The system's functionality was evaluated through traditional software and hardware verification and validation, not through a data-driven model training process.

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

As no training set was utilized, the concept of establishing ground truth for a training set is not applicable to this submission.

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The noninvasive INVOS 5100C is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in individuals greater than 2.5 kg at risk for reduced-flow or no-flow ischemic states. It is also intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor in any individual.

The INVOS 5100C is a 2 wavelength, diffuse reflectance spectroscopy system employing near infrared light to estimate the percentage of hemoglobin saturated with oxygen in tissue underneath the sensor. An adhesive sensor containing a light source and 2 photodiodes is applied to the skin over the tissue of interest and the returning light is analyzed for oxyhemoglobin and deoxyhemoglobin light absorption. Absorption signals from the photodiode closer to the light source are subtracted from those from the farther photodiode where the returning photons penetrate more deeply in the tissue. This suppresses absorption events originating in the outer layers of tissue that are common to both photodiodes, including the effects of skin pigmentation and subcutaneous tissues. This method of "spatial resolution" also allows estimation of scattering to improve measurement accuracy.

The provided text describes a 510(k) premarket notification for the SOMANETICS OxyAlert NIRSensors (models IS-C and IS-S accessories) for use with the INVOS 5100C System.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than explicit performance acceptance criteria in terms of specific numerical thresholds (e.g., accuracy, sensitivity, specificity). The core acceptance criterion is that the new sensors are as safe and effective as the predicate device.

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

• Sample Size: Not explicitly stated in the provided text. The document only mentions "Bench testing." There's no information on the number of subjects or samples used in this bench testing.
• Data Provenance: Not explicitly stated. The nature of "bench testing" suggests it was likely controlled laboratory testing. There's no mention of country of origin, nor whether the data was retrospective or prospective.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

Given that the study was "bench testing" for a device measuring regional hemoglobin oxygen saturation, the ground truth would likely involve a validated reference measurement instrument or method, rather than expert interpretation of images or clinical assessments by human experts in the typical sense.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not mentioned. The nature of "bench testing" typically involves direct comparison to a reference standard, rather than adjudication of human interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement with AI vs. Without AI Assistance:

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This is not an AI-assisted diagnostic or interpretative device; it's a physiological monitoring sensor.
• Effect Size of AI Improvement: Not applicable, as this is not an AI device designed to assist human readers in interpretation.

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

• This device is a sensor and monitoring system. Its primary function is to measure physiological parameters directly. The "performance data" mentioned refers to the device's ability to accurately measure these parameters. As such, the performance described is akin to a standalone performance for the sensor, comparing its output to a known reference. However, it's not an "algorithm only" device in the sense of image analysis software; it's a hardware sensor that produces data based on its measurement principles.

7. The Type of Ground Truth Used:

• Ground Truth: The document states "Bench testing is submitted demonstrating the substantial equivalence of the new sensors with modified photodiodes for the stated indication." For a "two wavelength, diffuse reflectance spectroscopy system employing near infrared light to estimate the percentage of hemoglobin saturated with oxygen in tissue," the ground truth for "performance data" would typically involve:
  • Reference Oximetry or Spectroscopy: Comparison against a gold standard or a highly accurate reference oximeter/spectrometer under controlled conditions.
  • Simulated Tissues or Phantoms: Use of known optical properties in phantoms to verify measurement accuracy.
  • In-vitro testing: Testing under laboratory conditions with known concentrations of oxyhemoglobin and deoxyhemoglobin.
    The document does not specify which type of ground truth was used, only that performance data was submitted from "bench testing."

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable/not mentioned. This device is not described as using a machine learning or AI model that requires a "training set" in the conventional sense. The "bench testing" described is for validation and verification against a predicate device and known measurement principles, not for algorithm training.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set or machine learning algorithm.

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The noninvasive INVOS 5100C is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in individuals greater than 2.5 kg at risk for reduced-flow or no-flow ischemic states. It is also intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor in any individual. The clinical value of trend data has not been demonstrated in disease states. The INVOS System should not be used as the sole basis for diagnosis or therapy.

The INVOS 5100C is a 2 wavelength, diffuse reflectance spectroscopy system employing near infrared light to estimate the percentage of hemoglobin saturated with oxygen in tissue underneath the sensor. An adhesive sensor containing a light source and 2 photodiodes is applied to the skin over the tissue of interest and the returning light is analyzed for oxyhemoglobin and deoxyhemoglobin light absorption. Absorption signals from the photodiode closer to the light source are subtracted from those from the farther photodiode where the returning photons penetrate more deeply in the tissue. This suppresses absorption events originating in the outer layers of tissue that are common to both photodiodes, including the effects of skin pigmentation and subcutaneous tissues. This method of “spatial resolution” also allows estimation of scattering to improve measurement accuracy.

The provided text is a 510(k) Premarket Notification for the SOMANETICS INVOS 5100C Cerebral/Somatic Oximeter System. The document focuses on establishing substantial equivalence to a predicate device (Somanetics INVOS 5100C Cerebral/Somatic Oximeter System, K080769) for revised indications for use and labeling.

Based on the provided text, the specific details regarding acceptance criteria and a study proving those criteria are not explicitly present. The document states: "Extensive literature references and clinical studies are submitted demonstrating the substantial equivalence of the device for its stated indication." However, it does not provide the details of these studies, including acceptance criteria, sample sizes, ground truth establishment, or performance metrics.

Therefore, I cannot fully answer all the requested questions with the provided input. Below is an outline of what can and cannot be extracted:

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

• Acceptance Criteria: Not explicitly stated in the provided text.
• Reported Device Performance: Not explicitly stated in terms of specific metrics against acceptance criteria. The document only mentions "extensive literature references and clinical studies... demonstrating the substantial equivalence."

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

• Sample Size for Test Set: Not explicitly stated.
• Data Provenance (country of origin, retrospective/prospective): Not explicitly stated.

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

• Not explicitly stated.

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

• Not explicitly stated.

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/Not stated. The device is an oximeter, not an AI-powered diagnostic imaging tool that would typically involve human reader studies in this context. The document refers to "regional hemoglobin oxygen saturation of blood," which is a physiological measurement.

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

• The INVOS 5100C is an oximeter system, which inherently functions as a standalone measurement device. Its performance relates to its accuracy in measuring regional hemoglobin oxygen saturation. No "algorithm only" performance separate from the device itself is detailed in terms of a study.

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

• Not explicitly stated. For an oximeter, the "ground truth" would typically involve a reference standard for blood oxygen saturation measurements (e.g., co-oximetry of arterial or venous blood samples) for accuracy studies.

8. The sample size for the training set:

• Not explicitly stated. The document refers to "extensive literature references and clinical studies" but does not detail their methodology or if a "training set" in the machine learning sense was involved.

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

• Not explicitly stated.

Conclusion Drawn from the Testing (as stated in the document):

"The conclusion drawn is that the revised indications for use and labeling are substantially equivalent to the predicate device and do not raise new questions of safety and effectiveness."

In summary, the provided text does not contain the detailed information necessary to answer most of your questions about specific acceptance criteria and study methodologies, as it is a 510(k) summary focused on substantial equivalence rather than a detailed clinical study report.

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The noninvasive INVOS 5100C is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. The prospective clinical value of data from the INVOS System has not been demonstrated in disease states. The INVOS System should not be used as the sole basis for diagnosis or therapy.

The INVOS 5100C is a 2 wavelength, diffuse reflectance spectroscopy system employing near infrared light to estimate the percentage of hemoglobin saturated with oxygen in tissue underneath the sensor. This is similar to the noninvasive technology widely used in pulse oximeters to monitor oxygen saturated hemoglobin percentage in arterial blood. An adhesive sensor containing a light source and 2 photodiodes is applied to the skin over the tissue of interest and the returning light is analyzed for hemoglobin and deoxyhemoglobin light absorption. Absorption signals from the photodiode closer to the light source are subtracted from those from the farther photodiode where the returning photons penetrate more deeply in the tissue. This suppresses absorption events originating in the outer layers of tissue that are common to both photodiodes, including the effects of skin pigmentation and subcutaneous tissues. The INVOS 5100C tissue oximeter is a multi-channel monitor with continuous recording and display of readings of regional tissue hemoglobin oxygen saturation from 4 separate sensors simultaneously. The monitor is connected to 2 preamplifiers, each of which in turn supports 2 sensors. It has USB connectivity for dynamic data capture, storage and transfer as well as a digital output port.

The SOMANETICS INVOS 5100C is a cerebral/somatic oximeter system. The provided document is a 510(k) Premarket Notification. Substantial equivalence was claimed for the INVOS 5100C system against the INVOS 5100B, and the FDA determined it was substantially equivalent.

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

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

The provided document does not explicitly state specific quantitative "acceptance criteria" for the INVOS 5100C or detailed "reported device performance" against those criteria. It states: "Performance data and extensive literature references were submitted demonstrating the substantial equivalence of the device for its stated indication."

The general conclusion drawn from testing regarding performance is: "INVOS System can respond with significant changes during isolated desaturation events in kidney and gut tissues. Monitoring the body with the INVOS System can include organ or intestinal oxygenation as well as skeletal muscle tissue oxygen saturation changes depending on the anatomy." This describes a capability rather than a quantified performance metric against a specific threshold.

Therefore, a table of acceptance criteria and reported performance cannot be generated from the given text. The FDA's decision was based on "substantial equivalence" to a predicate device, which implies the new device performs acceptably similarly to the predicate, but specific performance metrics are not detailed here.

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 does not specify the sample size used for any test set or the data provenance (country of origin, retrospective/prospective). It generally mentions "Performance data and extensive literature references were submitted."

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)

The document does not provide information on the number or qualifications of experts used to establish ground truth for any test set.

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

The document does not mention 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

The INVOS 5100C is an oximeter, a device that measures and displays physiological parameters (regional hemoglobin oxygen saturation). It is not an AI-powered diagnostic tool that human readers would use to interpret images or other complex data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device type and was not performed.

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

The device itself is a standalone monitor: "The noninvasive INVOS 5100C is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation...". The description focuses on the device's ability to measure and trend, not on an algorithm operating in isolation without a human connecting the sensor and interpreting the displayed trend. The concept of "standalone (algorithm only)" as typically applied to AI/ML devices is not directly relevant here, as the device's primary function is direct measurement.

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

The document does not specify the type of ground truth used for performance evaluation, beyond the general statement "Performance data and extensive literature references were submitted." For an oximeter, ground truth would typically refer to a gold standard measurement of tissue oxygen saturation, but no details are provided here.

8. The sample size for the training set

The INVOS 5100C is described as a "2 wavelength, diffuse reflectance spectroscopy system" and mentions "subtracting" absorption signals, indicating a hardware-based measurement and processing method rather than an AI/ML system that would require a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable to this device.

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

As there is no mention or indication of a "training set" for an AI/ML algorithm, this question is not applicable.

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The noninvasive INVOS 5100B is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain of an individual. It also is intended for use as an adjunct trend monitor of hemoglobin oxygen saturation of blood in a region of skeletal muscle tissue beneath the sensor in infants, children, or adults at risk for reduced-flow or no-flow ischemic states. The prospective clinical value of data from the INVOS System has not been demonstrated in disease states. The INVOS System should not be used as the sole basis for diagnosis or therapy.

The principles of operation of the cerebral oximeter system are based on the assumption that hemoglobin exists in two principal forms in the blood: oxygenated hemoglobin (HbO2) and reduced hemoglobin (Hb). Functional oxygen saturation (SO2) is defined as the ratio of oxyhemoglobin (HbO2) to total hemoglobin (HbO2 + Hb) and is commonly presented as a percentage.

SO2 = (HbO2 / (HbO2 + Hb)) * 100%

Since oxygenated and reduced hemoglobin are different colors and absorb light as a known function of wavelength, selected wavelengths of light can be used to assess the relative percentage of these two constituents. This fundamental approach of assessing the color of blood using various wavelengths of light to measure hemoglobin oxygen saturation trends is used in all currently marketed oximetry systems.

For cerebral monitoring, a disposable sensor of medical grade materials is applied to the patient's forehead (Figure 1). The sensor incorporates a light source and two return signal detectors at different predetermined distances from the light source. The signal detector nearest the light source (3 cm) is considered the "shallow detector" and the further detector from the light source (4 cm) the "deep detector."

While the light reaching the deep detector has sampled about the same amount of skin, scalp, and skull as the light reaching the shallow detector, it has sampled more brain tissue. This difference is used to help separate out the brain signal and suppress anatomical differences in patients. The additional information unique to the deep signal return is predominately from brain tissue blood which is composed mostly of venous blood. The information contained in the shallow and deep signal returns is processed by an algorithm to measure changes in hemoglobin oxygen saturation in a small region of tissue beneath the sensor, predominately in the brain.

For non-cerebral monitoring, a somatic sensor which is similar to the cerebral sensor is placed on skeletal muscle in an area free of large fat deposits, bony protuberances and hair. Since the tissue being interrogated is relatively homogeneous, the resultant rSQ2 index is an average of the hemoglobin oxygen saturation of blood in the region of tissue below the sensor.

The SomaSensor is connected to a preamplifier (1.4 x 7.65 x 3.75 in.) which is placed close to the patient and amplifies the rSO2 signal. The signal is then carried to a display unit (8.4 x 9.6 x 8.5 in.) where the values and trends are displayed on the screen. The display unit controls all functions of the system with selections made by keys with onscreen labels. The system will operate for up to 120 minutes on battery, enabling patient transport without loss of data.

The Somanetics INVOS 5100B Oximeter System, including the SSFB Somatic SomaSensor, was granted substantial equivalence based on prior clinical studies and nonclinical testing that demonstrated its performance. The provided document does not explicitly present a table of acceptance criteria with numerical targets and direct comparisons to device performance for this specific 510(k) submission. Instead, it relies heavily on the substantial equivalence to previously cleared devices (INVOS 5100, Spectros Corporation T-Stat™ 303, and Hutchinson InSpectra) and results from previous studies.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table with acceptance criteria outlined for this specific submission. However, it references performance characteristics from a previous animal study for skeletal muscle tissue monitoring.

2. Sample Sizes and Data Provenance:

• Test Set (for the mentioned animal study related to somatic sensor): The document states an "animal study using isolated perfused porcine limbs" was conducted. The specific number of limbs or animals used is not provided.
• Data Provenance:
  • Adult Hypoxia Study: Not explicitly stated, but typically these are conducted in controlled clinical environments, likely in the US given the submission to the FDA. Retrospective/Prospective is not specified.
  • Pediatric Cath Lab Study: Not explicitly stated, but likely clinical data collected in a hospital setting, probably in the US. Retrospective/Prospective is not specified.
  • Animal Study (Somatic Sensor): Porcine limbs, prospective in nature. Country of origin not specified.
  • Multiple Peer-Reviewed Studies: Referencing existing literature, data provenance would vary by study.
  • Two Published Studies (Exercise): Referencing existing literature, data provenance would vary by study.
• The 510(k) submission itself primarily relies on substantial equivalence and previously established performance, rather than new, large-scale clinical trials for the specific 5100B device.

3. Number of Experts and Qualifications for Ground Truth:

• The document does not specify the number of experts or their qualifications for establishing ground truth for any of the studies mentioned.
• For the cerebral studies, the "ground truth" was established by co-oximetry analysis of blood samples, which is considered a gold standard for blood oxygen saturation measurement. This is an objective measurement rather than an expert interpretation.
• For the animal study, the "ground truth" was also a direct measurement, implied to be derived from the isolated perfused porcine limbs' blood oxygen saturation.

4. Adjudication Method:

• Not applicable/Not specified. Since objective measurements like co-oximetry were used as ground truth, expert adjudication methods (like 2+1 or 3+1 for imaging consensus) were not relevant or mentioned.

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

• No. An MRMC comparative effectiveness study was not done or reported in this document. The INVOS 5100B is a trend monitor, not an interpretive diagnostic device that relies on human reader input in the same way imaging AI does. Therefore, a study to assess how human readers improve with AI assistance is not relevant to this type of device.

6. Standalone Performance Study:

• Yes, in essence. The reported performance from the adult hypoxia study, pediatric cath lab study, and the animal study on porcine limbs demonstrate the standalone performance of the INVOS System in tracking oxygen saturation against a gold standard (co-oximetry or direct measurement). The device is intended to provide measurements, and its accuracy in doing so is what these studies assessed.

7. Type of Ground Truth Used:

• Objective Measurement/Physiological Gold Standard:
  • For cerebral oxygen saturation, the ground truth was established using co-oximetry analysis of blood samples.
  • For skeletal muscle tissue, the ground truth was also a direct measurement of blood oxygen saturation in the isolated perfused porcine limbs.

8. Sample Size for the Training Set:

• The document does not provide information on the sample size used for training any algorithms within the INVOS 5100B system. This product pre-dates the widespread use of deep learning and large-scale training sets as discussed in modern AI/ML medical devices. The device's operation is based on established principles of near-infrared spectroscopy and algorithmic processing of light absorption, likely with parameters developed through engineering and calibration, rather than extensive "training sets" in the contemporary AI sense.

9. How Ground Truth for Training Set was Established:

• As the document does not refer to a distinct "training set" in the context of modern AI/ML, it does not describe how ground truth for such a set was established. The device's underlying principles and algorithms would have been developed and validated through scientific understanding of optical properties of blood and tissue, and engineering calibration, possibly against reference measurements in laboratory settings or smaller physiological studies.

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The CorRestore™ Patch System Processed Bovine Pericardial Patch is intended for cardiac reconstruction and repair.

The CorRestore Patch is an oval tissue patch made from glutaraldehyde fixed boyine pericardium. It is intended to be used as an intracardiac patch for cardiac reconstruction and repair. It is identical to other marketed bovine pericardium patches except that it incorporates an integral suture bolster (also made of fixed bovine pericardium) in the shape of an oval ring and is packaged with accessories needed for cardiac repair and reconstruction. The CorRestore Patch comes as a kit including a patch and suture strip (1.4 x 16 cm), both manufactured from processed bovine pericardium. Optionally included is a set of various sutures needed for implantation. To assist the surgeon in determining the appropriate size, a separate disposable sizer kit is offered. A silicone balloon (CRB) is optional to allow the surgeon to check left ventricular diastolic volume prior to closure.

The provided text is a 510(k) Premarket Notification for the SOMANETICS CORRESTORE PATCH SYSTEM. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, ground truth types, or training set details.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA)."

This indicates that the FDA's acceptance of this device is based on its substantial equivalence to an existing (predicate) device, the Chase Medical Cardiovascular Patch Kit (K022093), rather than on a new study demonstrating performance against a specific set of acceptance criteria. The document describes the device and its intended use but does not present a performance study with detailed acceptance criteria and results.

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The CorRestore patch is intended for use as an intracardiac patch for cardiac reconstruction and repair.

The CorRestore Patch is an oval tissue patch made from glutaraldehyde fixed bovine pericardium. It is intended to be used as an intracardiac patch for cardiac reconstruction and repair. It is identical to other marketed bovine pericardium patches except that it incorporates an integral suture bolster (also made of fixed bovine pericardium) in the shape of an oval ring and is packaged with accessories needed for cardiac repair and reconstruction. The CorRestore Patch comes as a kit including a patch and suture strip (1.4 x 16 cm), both manufactured from processed bovine pericardium. Optionally included is a set of various sutures needed for implantation. To assist the surgeon in determining the appropriate size, a separate disposable sizer kit is offered.

This submission is a 510(k) premarket notification for the CorRestore™ Patch System. The device is an intracardiac patch made from glutaraldehyde-fixed bovine pericardium. The purpose of this submission is to introduce a new suture supplier, Genzyme, for the sutures packaged with the CorRestore™ Patch System.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This is a 510(k) submission for a change in suture supplier for an existing device. It does not involve performance criteria for the device itself or a study to demonstrate such performance against specific acceptance criteria. The submission focuses on demonstrating substantial equivalence to the predicate device despite the change in suture supplier.

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

Not applicable. No new performance testing was conducted that would require a test set. The submission states, "The CorRestore patch is equivalent in indications for use, size, shape, material, manufacturing processes, sterilization, packaging, instructions and intended use to the predicate CorRestore Patch System, K011487. The only change is the addition of a new suture supplier, Genzyme."

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

Not applicable. No new clinical or performance study was conducted that would require expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. No test set was used.

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

Not applicable. This is not a study involving human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a medical implant, not a software algorithm.

7. Type of Ground Truth Used

Not applicable. No new ground truth was established as no new performance study was conducted. The ground for substantial equivalence rests on the comparison to the existing predicate device.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set.

Summary of the Study and Acceptance Criteria:

The "study" in this context is the 510(k) submission process itself, where the manufacturer demonstrates that the modified device (CorRestore™ Patch System with Genzyme sutures) is substantially equivalent to a legally marketed predicate device (CorRestore™ Patch System with previous sutures, K011487).

Acceptance Criteria for Substantial Equivalence (Implicit in 510(k) Process):

The device must meet the following criteria (as implied by the 510(k) summary):

• Same Indications For Use: The CorRestore™ Patch with Genzyme sutures is intended for the same use as the predicate device: "as an intracardiac patch for cardiac reconstruction and repair."
• Same Technological Characteristics, OR Different Technological Characteristics with Evidence of Safety and Effectiveness: The submission explicitly states "The only change is the addition of a new suture supplier, Genzyme." It then argues that the new sutures are packaged in the same way with appropriate labeling, and the packaging prevents liquid sterilant from contacting the sutures. This implies that the change in suture supplier does not alter the fundamental safety or effectiveness of the CorRestore™ Patch itself. The sutures themselves would have their own pre-market notification (510k) status.

Reported Device Performance (in the context of this submission):

The "performance" demonstrated is that the device, with the new suture supplier, maintains substantial equivalence to the predicate device. This is primarily a regulatory and manufacturing assessment, not a performance study in the traditional sense of clinical outcomes or diagnostic accuracy.

The key statement is: "The CorRestore™ Patch is substantially equivalent to the predicate device." This assertion, accepted by the FDA in their approval letter (K031586), serves as the "proof" that the device meets the implicit acceptance criteria for substantial equivalence under this 510(k). The FDA's letter explicitly states, "We have reviewed your Section 510(k) premarket notification...and have determined the device is substantially equivalent...to legally marketed predicate devices."

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The noninvasive INVOS 3100A Cerebral Oximeter should be used in adults as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood in the brain of an individual. Because INVOS values are relative within an individual, the INVOS should not be used as the sole basis for decisions as to diagnosis or therapy. The value of data from the INVOS has not been demonstrated in disease states.

The principles of operation of the cerebral oximeter system are based on the assumption that hemoglobin exists in two principal forms in the blood: oxygenated hemoglobin (HbO>) and reduced hemoglobin (Hb). Functional oxygen saturation (SO2) is defined as the ratio of oxyhemoglobin (HbO2) to total hemoglobin (HbO2 + Hb) and is commonly presented as a percentage.

SO2 = (HbO2 / (HbO2 + Hb)) * 100%

Since oxygenated and reduced hemoglobin are different colors and absorb light as a known function of wavelength, selected wavelengths of light can be used to assess the relative percentage of these two constituents. This fundamental approach of assessing the color of blood using various wavelengths of light to measure hemoglobin oxygen saturation trends is used in all currently marketed oximetry systems.

A disposable sensor of medical grade materials is applied to the patient's forehead (Figure 1). The sensor incorporates a light source and two return signal detectors at different pre-determined distances from the light source. The signal detector nearest the light source (3 cm) is considered the "shallow detector" and the further detector from the light source (4 cm) the "deep detector."

While the light reaching the deep detector has sampled about the same amount of skin, scalp, and skull as the light reaching the shallow detector, it has sampled more brain tissue. This difference is used to help separate out the brain signal and suppress anatomical differences in patients. The additional information unique to the deep signal return is predominately from brain tissue blood which is composed mostly of venous blood. The information contained in the shallow and deep signal returns is processed by an algorithm to measure changes in hemoglobin oxygen saturation in a small region of tissue beneath the sensor, predominately in the brain.

The SomaSensor is connected to a preamplifier (1.75 x 7.4 x 5.4 in.) which is placed close to the patient and amplifies the rSO2 signal. The signal is then carried to a display unit (6.5 x 12.5 x 13.5 in.) where the values and trends are displayed on the screen. The display unit controls all functions of the system with selections made by keys with on-screen labels. The system will operate for up to 20 minutes on battery, enabling patient transport without loss of data.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size and Data Provenance:

   • Test Set: 20 volunteers (19 light and 1 dark-skinned; 12 males, 8 females; ages 20-36, median 26.5 years).
   • Data Provenance: The study was a "volunteer hypoxia study," implying a prospective study conducted with human volunteers. The text does not specify the country of origin of the data, but given the submission to the US FDA, it likely took place in the US or a region with comparable medical standards.

2. Number of Experts and Qualifications for Ground Truth for Test Set:

   • The document implies clinical experts (medical professionals) were involved in placing catheters and analyzing blood samples for co-oximetry. However, the exact number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not explicitly stated. The ground truth relies on objective blood gas analysis.

3. Adjudication Method for the Test Set:

   • Not Applicable in the traditional sense of human consensus on subjective assessments. The ground truth (fSO2) was derived from objective measurements (arterial and jugular venous blood sample oxygen saturations analyzed on a co-oximeter) and a calculated formula. One data point was rejected due to sampling errors, and one subject's absolute data was rejected due to a low Signal Quality Index but their trend data was still used. This suggests objective exclusion criteria rather than human adjudication of ambiguous cases.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not conducted for this device. The study compared the device's performance against a physiological ground truth (blood oxygen saturation) rather than comparing human reader performance with and without AI assistance.

5. Standalone Performance:

   • Yes, the clinical study evaluated the standalone performance of the INVOS 3100A Cerebral Oximeter. The device's rSO2 readings were compared directly to the calculated fSO2 from blood samples, without human intervention in interpreting the INVOS readings for the performance metrics.

6. Type of Ground Truth Used:

   • The ground truth used was a calculated estimate of regional oxygen saturation (fSO2) derived from:
     • Objective physiological measurements: arterial blood oxygen saturation (SaO2) and jugular venous blood oxygen saturation (SjvO2) obtained via catheters.
     • Co-oximetry: analysis of blood samples on a co-oximeter.
     • A formula: fSO2 = (0.25 * SaO2) + (0.75 * SjvO2).

7. Sample Size for the Training Set:

   • The document does not explicitly mention a separate training set for the device's algorithm. The provided information focuses on the "volunteer hypoxia study" used for clinical testing and demonstrating substantial equivalence. It's possible the algorithm was developed (i.e. 'trained') using earlier, internal data that is not detailed in this 510(k) summary, or the algorithm is based on established physical principles rather than a data-driven machine learning model requiring a distinct training set as typically understood today. The device described operates on principles of light absorption by hemoglobin, a well-understood physical phenomenon.

8. How Ground Truth for Training Set Was Established:

   • As a training set is not explicitly mentioned, the method for establishing its ground truth is also not described. If this device relies on a fixed algorithm based on established physiological optics, a "training set" in the machine learning sense might not be applicable or relevant to its regulatory submission.

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