Search Results

The SensiLase™ PAD 3000 provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients.

The SensiLase™ PAD 3000 (SensiLase™) Skin Perfusion Pressure System provides measurements of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR). Both measurements may be clinically applied to assess perfusion. Both the SPP and PVR measurements are features of the predicate PV2000 device. The same methods arc applied for measurement of SPP and PVR as the predicate PV2000.

The SPP measurement is performed by applying a pressure cuff capable of occluding skin blood flow (perfusion). The pressure cuff is inflated until the skin perfusion, as detected by a Laser Scnsor Assembly (LSA) underneath the cuff, is determined to be near zero or significantly reduced. The pressure is released until an increase in skin perfusion is determined. The cuff pressure when the skin perfusion increases is the SPP value. SPP is a test used to evaluate peripheral microcirculation.

The measurement of the pulse volume recording (PVR) waveform is a measure of the pulsatile pressure amplitude resulting from a partially inflated cuff encircling the limb. The PVR is used as a more direct measurement of arterial blockage. The test output is a printout of the waveform, which is interpreted by a vascular specialist.

The clinical application and interpretation of the Perfusion , SPP measurements and interpretation of the PVR Waveform is the same as the predicate PV2000.

The provided document is a 510(k) summary for the SensiLase™ PAD 3000 Skin Perfusion Pressure System. It describes the device and its intended use, and states that it is substantially equivalent to a predicate device (PV2000 Vascular Microlaboratory).

However, the document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

• Explicit acceptance criteria: The document doesn't list specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) with associated thresholds as acceptance criteria. Instead, it relies on substantial equivalence to a predicate device.
• Detailed study methodology: There is no description of a specific study, including sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or results of a comparative effectiveness study.
• Standalone performance data: No data is presented for the algorithm's performance without human-in-the-loop.
• Training set information: There is no mention of a training set or how ground truth for it was established.

Based on the provided text, the device's acceptance seems to be based on its substantial equivalence to the predicate device, PV2000 Vascular Microlaboratory, in terms of intended use, technology, features, and performance, rather than specific quantitative acceptance criteria demonstrated through a detailed clinical study presented in this summary.

Here's a breakdown of what can be inferred or extracted from the document, and what is missing:

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

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the SensiLase™ PAD 3000. The primary "acceptance criterion" as conveyed in this 510(k) summary is substantial equivalence to the predicate device, PV2000 Vascular Microlaboratory.

The summary concludes: "The intended use, technology, features and performance of the SensiLase™ PAD 3000 Skin Perfusion Pressure System are substantially equivalent to the predicate PV2000. No new questions of safety or effectiveness are raised." (Section 4.0)

The Study Proving Acceptance Criteria:

The document describes the basis for substantial equivalence but does not detail a specific "study" with test sets, sample sizes, and ground truth establishment in the way typically expected for AI/ML device evaluations. Instead, the demonstration of equivalence relies on the device sharing the same fundamental principles and methods as a previously cleared device.

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

• Sample Size: Not specified. The document does not describe a test set or a study involving a specific number of patients or samples.
• Data Provenance: Not applicable, as no specific test set data is described.

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

• Experts and Qualifications: Not specified. No ground truth establishment process is described for a test set. The document mentions that the interpretation of PVR waveforms is done by a "vascular specialist," but this is in the context of the device's clinical use, not for establishing a ground truth for a performance study.

4. Adjudication method for the test set

• Adjudication Method: Not applicable, as no test set requiring adjudication is described.

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

• MRMC Study: No MRMC comparative effectiveness study is mentioned. This device (SensiLase™ PAD 3000) does not appear to be an AI-assisted device in the context of this 510(k) summary; rather, it's a measurement device for physiological parameters (SPP and PVR). Therefore, "human readers improve with AI vs without AI assistance" is not relevant to the information provided.

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

• Standalone Performance: Not applicable. The device is a direct measurement system, not an algorithm, and the documentation does not describe an algorithm's standalone performance.

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

• Ground Truth Type: Not explicitly stated for a performance study. The device measures physical parameters (SPP and PVR). The "ground truth" for such devices typically relies on the accuracy and precision of the physical measurements themselves, often through calibration against known standards or comparison to established gold-standard measurement techniques, which are not detailed in this summary.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. The document does not describe a training set, as it is a direct measurement device rather than a machine learning or AI product requiring a training phase.

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

• Ground Truth for Training Set: Not applicable, as no training set is described.

Ask a specific question about this device

Ask a specific question about this device

The CapnoProbe Sublingual Tonometer System is indicated for monitoring sublingual PCO2. It is indicated for use in hospital patients. This device is indicated for use by qualified medical personnel only.

The CapnoProbe A System provides a measurement of Sublingual pCO2 (SL CO2). The CapnoProbe A consists of a Disposable Sensor, Instrument, Fiber Optic Interconnect Cable and Calibration Fluid. The Disposable Sensor contains a fiber optic pCO- sensor and temperature sensor. The Disposable Sensor is placed under the tongue for a measurement of pCO2 and temperature. The Disposable Sensor connects to the fiber optic interconnect cable. The fiber optic interconnect cable connects to a software modified ABG Module. The instrument is a software modified Optical CAM and ABO Module. The softwaremodified instruments measures SL CO2 and temperature, displaying SL CO2. The instrument is dedicated to the function as programmed by the software. The instruments are referred to as a CapnoProbe A Monitor and a CapnoProbe A Module. Prior to use the CapnoProbe A System with disposable pCO2 sensor is calibrated with provided tonometered saline. The saline calibration fluid is the same as the predicate SensiCath System initialization fluid.

Acceptance Criteria and Study for CapnoProbe A System

The provided 510(k) summary for the CapnoProbe A System does not explicitly state acceptance criteria in a quantitative table format as commonly seen in modern submissions. Instead, it focuses on demonstrating equivalence to predicate devices through various comparative studies. The underlying acceptance criterion for substantial equivalence is that the CapnoProbe A System performs "equally well" or is "as repeatable" as the predicate devices in relevant contexts.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the provided document, the "acceptance criteria" are inferred from the comparisons made to predicate devices.

2. Sample Size and Data Provenance for Test Set

• Bench Data: No specific sample size is mentioned for the bench data. The data provenance is laboratory conditions using "controlled levels of tonometered saline."
• Animal Study: No specific sample size (number of animals) is mentioned. The study involved "test animals" and compared "pCO2 measurement under the tongue, versus stomach mucosal tissue." No country of origin is specified, but it's implied to be a laboratory setting. This was a prospective study.
• Clinical Data (Volunteer Study): No specific sample size (number of volunteers) is mentioned. The study involved "volunteer and stable subjects" to demonstrate repeatability. No country of origin is specified. This was a prospective study.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish a ground truth for the test sets in the typical sense for medical imaging or diagnostic device studies. The "ground truth" used for comparison appears to be the performance of the predicate device (Tonocap TC-200) or established physiological measurements, rather than a consensus of human experts interpreting data for the CapnoProbe A System itself.

4. Adjudication Method

The document does not describe any adjudication method for establishing ground truth, as the studies primarily focused on comparative performance against a predicate device or controlled laboratory conditions.

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

No MRMC study was conducted or reported. The device is a direct physiological measurement device and not one that typically involves human interpretation of outputs requiring an MRMC study.

6. Standalone Performance

Standalone performance of the algorithm (or device in this context) was implicitly evaluated through the bench, animal, and clinical studies. The device itself, when used without human interpretation in the loop (beyond medical personnel observing the displayed CO2 value), is presented as providing the measurement. The comparison is made directly between the CapnoProbe A System and the predicate Tonocap System.

7. Type of Ground Truth Used

• Bench Data: Controlled levels of pCO2 in tonometered saline served as the ground truth.
• Animal Study: The comparison was made against the predicate Tonocap System's measurement of pCO2 in animal tissues (sublingual and stomach mucosal), implying the predicate's readings served as a comparative "ground truth" or reference for tracking changes.
• Clinical Data: The "repeatability" of the CapnoProbe A System was compared against "published Tonocap clinical data," suggesting that established performance metrics of the predicate device derived from clinical studies served as the reference for repeatability.

8. Sample Size for Training Set

The document does not mention a "training set" in the context of machine learning or AI models, as the CapnoProbe A System is a physical measurement device. Therefore, no sample size for a training set is provided.

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

As there is no mention of a training set, there is no information on how its ground truth would have been established. The device is described as measuring SL CO2 by a fiber optic sensor, implying its operation is based on known physical principles rather than learning from a training dataset.

Ask a specific question about this device

The modified SensiCath Sensor, when used as part of the Point-of-Care Blood gas Monitor System is intended to provide on-demand arterial blood gas monitoring in the operating room and at the bedside for critically ill patients requiring an arterial pressure monitoring line. The ABG information is available to the attending qualified medical professional on demand and within approximately 60 seconds of the time the sample cycle was initiated. The intended use of the modified SensiCath Sensor is the same as the predicate SensiCath Sensor.

It is the intention of Optical Sensors Incorporated (OSI) and Marquette Electronics Incorporated (MEI) to introduce into commercial distribution a modification to the SensiCath Arterial Blood Gas Sensor. The modified sensor has a longer useful life and allows a greater number of ABG measurements. The modified sensor is substantially equivalent to the SensiCath Sensor presented in the SensiCath™ Point-of-Care Blood Gas Monitor System which received Food and Drug Administration (FDA) clearance to market, 510(k) K95 1094. The modified SensiCath Sensor operates with the SensiCath Point-of-Care Blood Gas Monitor System, just as the predicate SensiCath Sensor. As with the predicate sensor, the modified SensiCath Sensor measures blood gas parameters of partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2) and the blood's hydrogen ion concentration, (pH). The modified SensiCath Sensor is manufactured and sterilized by Optical Sensors Incorporated, as is the predicate SensiCath Sensor.

The document describes a medical device, the SensiCath™ Arterial Blood Gas Sensor, and a modification to it. It details the device's intended use and compares the modified version to a predicate device. The performance data section focuses on demonstrating that the modified sensor meets predetermined specifications.

Here's an analysis of the provided text in relation to the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the modified SensiCath Sensor "meets the same performance specifications as the predicate SensiCath Sensor over 144 hours of use and 200 ABG measurements." However, it does not provide a quantifiable table of acceptance criteria or specific performance values for precision and accuracy. It mentions that precision and accuracy tests were conducted, but the actual results or the specific numerical thresholds for acceptance are not detailed.

Without specific numerical acceptance criteria from the document, a precise table cannot be generated. However, based on the text, the implicit acceptance criteria are:

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

• Sample Size: The document does not explicitly state the numerical sample size (number of sensors, number of tests, or number of blood samples) used for the precision and accuracy tests. It only mentions that "Tonometered bovine blood was equilibrated with several gas mixtures" and "measurements were taken."
• Data Provenance: The tests were conducted using "Tonometered bovine blood." This indicates that the data is from a controlled laboratory setting, likely a bench study rather than human clinical data. The study appears to be prospective in the sense that the modified device was tested in a controlled environment to gather performance data. The country of origin of the data is not specified, but the submitting entity is in Minneapolis, MN, USA, suggesting the testing was likely conducted in the USA.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The study described is a technical performance test of a sensor, not a diagnostic study requiring expert interpretation of results to establish ground truth about a patient's condition. The "ground truth" for the sensor's measurements (PO2, PCO2, pH) would be established by the reference measurements from the tonometered blood, not by human experts.

4. Adjudication Method for the Test Set:

Not applicable. This type of performance study does not typically involve an adjudication method as seen in clinical studies where multiple reviewers assess images or clinical outcomes. The "ground truth" for the sensor measurements is determined by the preparation of the tonometered blood, not through human consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not conducted. The reported study focuses on the standalone performance of the device against predefined specifications, not on how human readers' performance with or without the device's assistance.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance study was done. The document describes tests to evaluate the "performance of the modified SensiCath Sensor" itself. This involved measuring its precision and accuracy when applied to tonometered bovine blood. This is an evaluation of the device's technical specifications in a controlled setting, which is inherently a standalone performance assessment.

7. The Type of Ground Truth Used:

The ground truth for the sensor measurements (PO2, PCO2, pH) was established by the known concentrations/parameters of the tonometered bovine blood. Tonometering involves equilibrating biological fluids with gas mixtures of precisely known concentrations, effectively creating a "gold standard" for the gas parameters.

8. The Sample Size for the Training Set:

Not applicable. This document describes a performance validation study for a sensor, not a machine learning model. Therefore, there is no concept of a "training set" in the context of this submission.

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

Not applicable, as there is no training set for this type of device validation.

Ask a specific question about this device

The Olympus System is intended to provide on-demand arterial blood gas monitoring in the operating room and at the bedside for critically ill patients with a pre-existing arterial pressure monitoring line. The ABG information is available to the attending qualified medical professional on demand and within approximately 60 seconds of the time the sample cycle was initiated.

It is the intention of Optical Sensors Incorporated (OSI) to introduce into commercial distribution an Olympus Critical Care Monitoring System (Olympus System). The Olympus System supports modules and sensors used in monitoring critical parameters at the patient bedside. The module and sensor referenced in this submission are the cleared-to-market arterial blood gas module (ABG Module) and SensiCath optical sensor unit (SensiCath Sensor). When the Olympus System includes an ABG Module and SensiCath Sensor, monitoring of arterial blood gas at the point-of-care is accomplished.

The Olympus System has three main components:

• 1. an optical arterial blood gas sensor, hereafter referred to as the SensiCath Sensor.
• 2. a module, the Arterial Blood Gas (ABG) Module, hereafter referred to as the ABG Module and,
• 3. an operator interface (display, control knob) with electrical and mechanical support for the ABG Module, hereafter referred to as the Olympus Monitor.

The provided text describes the Olympus Critical Care Monitoring System, focusing on its arterial blood gas (ABG) monitoring capabilities. The submission refers to a previous 510(k) clearance (K951094) for the "Point-of-Care Blood Gas Monitor System" as its predicate. The document emphasizes that the Olympus System's performance meets the same specifications as the predicate.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the Olympus System performance meets the same performance specifications as the predicate Point-of-Care Arterial Blood Gas Monitoring System (K951094). The specific numerical acceptance criteria for PO2, PCO2, pH, accuracy, and precision are not detailed in this submission but are implicitly referenced as those established for the predicate device.

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

The document does not explicitly state:

• The sample size used for the test set.
• The data provenance (e.g., country of origin, retrospective or prospective) for the performance testing.

It mentions "Precision and accuracy tests were conducted on the Olympus System over the range of ABG specifications" but does not detail the methodology or the data sources for these tests.

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

The document does not provide information on:

• The number of experts used to establish ground truth.
• The qualifications of those experts.

Given that it's an ABG monitor, ground truth would likely be established by a reference laboratory analyzer, not human interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for a test set. This is typically not applicable for objective measurements like blood gas analysis, where ground truth is typically derived from a reference standard.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where human readers are involved. For an automated blood gas monitor, the focus is on the device's ability to accurately measure physiological parameters.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document states: "Precision and accuracy tests were conducted on the Olympus System over the range of ABG specifications. The Olympus System performance meets the same performance specifications as the predicate Point-of-Care Arterial Blood Gas Monitoring System." This indicates that the device itself was tested for its performance characteristics.

7. Type of Ground Truth Used

The type of ground truth used is implied to be reference standard measurements. For blood gas analysis, this would typically involve:

• Calibrated laboratory blood gas analyzers.
• Certified control solutions.
• Potentially spiked blood samples with known concentrations.

The document refers to "ABG specifications," which are objective and quantitative, suggesting comparison against a highly accurate and precise reference method.

8. Sample Size for the Training Set

The document does not provide information on the sample size for a "training set." This term is typically used in the context of machine learning or AI algorithm development. For a device measuring physiological parameters, "training" usually refers to calibration and validation against known standards, rather than a machine learning training set in the conventional sense.

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

Given that there is no mention of a "training set" in the context of an AI/ML algorithm, the document does not describe how ground truth for a training set was established. The "training" of such a device would involve factory calibration and internal quality control procedures, where the device samples are measured against known standards and adjusted if necessary.

Ask a specific question about this device

Ask a specific question about this device