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The Vitalograph Model 7000 Spirotrac is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients. The device is a PC based software application which is intended to be used as a spirometer or connect to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

Spirotrac shall provide a secure PC based medical device software application for creating, adding and recalling subjects and performing Spirometry testing on those subjects. Spirotrac will also link to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject. Spirotrac will integrate and read / display information from Pulse Oximetry devices, Blood Pressure and Weight measurements devices, and ECG test devices. Its primary functions are: 1. Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including VC, FIVC, FVC) and it's subdivisions, The unit also allows for the measurements of Inspiratory and Expiratory Flow rates (PEF, FEFx, etc), indirect measures (e.g. MVV) and Pre-post testing (e.g. Challenge, work shift). 2. Record subject demographic data as input. Interact with existing Vitalograph and compatible third party devices via standard PC communication methods for download of data for storage within the Spirotrac database. 3. Navigation is allowed via the use of a standard PC keyboard and mouse or touchscreen.

Here's a breakdown of the acceptance criteria and study information for the Vitalograph Model 7000 Spirotrac, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not typically a detailed clinical study report proving device performance against specific, pre-defined acceptance criteria in the same way a PMA or de novo submission might. Therefore, some information, especially regarding detailed sample sizes, expert qualifications, and specific "reported device performance" metrics against acceptance criteria (beyond general compliance checks), is not explicitly stated in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device underwent validation testing to ensure performance according to its specifications against current standards. The mentioned standards serve as the de-facto acceptance criteria. The "Reported Device Performance" is generally stated as "All tests and validations demonstrated satisfactory results." Specific numerical performance metrics against each standard are not provided in this summary.

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

The document does not specify a sample size for any clinical test set. The validation appears to be primarily engineering and bench testing against international standards, rather than a clinical study with a patient cohort.

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified, but likely from laboratory testing and calibration rather than patient data from a specific country or retrospective/prospective study type, given it's a spirometer software.

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

This information is not provided as the validation described is against established international technical standards for spirometry. There wasn't a ground truth established by human experts in the typical sense of a diagnostic imaging study.

4. Adjudication Method for the Test Set

Since the validation is described as performance testing against international standards, an "adjudication method" in the context of expert review for ground truth determination is not applicable or described. The standards themselves define the criteria for "correctness" or acceptable performance.

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

An MRMC study was not mentioned or performed. The device is a spirometer software application; its performance is typically evaluated for measurement accuracy and consistency, rather than its impact on human reader interpretation.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance evaluation was done. The document explicitly states: "The Vitalograph Model 7000 Spirotrac underwent validation testing to ensure performance according to its specifications against current standards." This refers to the software's ability to accurately acquire, process, and display spirometry measurements as determined by the listed ISO and ATS/ERS standards.

7. Type of Ground Truth Used for the Test Set

The ground truth for the test set was defined by international technical standards and norms for spirometry (ISO 26782, ATS/ERS 2005, ISO 23747). This implies that the device's measurements were compared against established reference values or methods defined by these standards, likely using simulated lung functions or calibrated devices.

8. Sample Size for the Training Set

The document does not mention a training set size. This device is a spirometer software, and its primary function is measurement and data handling. While it might include algorithms for interpretation (e.g., predicted values, flagging out-of-range results), these are typically based on well-established physiological models and clinical guidelines, not necessarily a machine learning model that requires a "training set" in the modern AI sense.

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

Since a "training set" in the machine learning sense is not mentioned, the method for establishing its ground truth is not applicable or described. The algorithms and computations within the spirometer software would be based on established physiological principles and clinical guidelines rather than learned from a labeled dataset.

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The Abreu BTT 700 System is intended for the continuous monitoring of skin temperature during surgical procedures, recovery room, intensive care, and general patient monitoring. The unit will alert the patient and/or hospital personnel when the monitored temperature exceeds or falls below pre-selected levels.

The Abreu BTT 700 is a device used to measure the temperature of the skin by means of a thermistor coupled with an electronic signal amplification, conditioning, and display unit. As part of its basic design, the thermistor probe is an integral part of a non-disposable "Pen" (covered by a condom), and a disposable "finger." The components of the Abreu BTT 700 consist of a "pen", a disposable "finger", an Interface Module, and a USB A to USB mini cable. The Abreu BTT 700's Interface Module incorporates an onboard computer processing unit which is controlled by a permanently installed software program. Electronic signals received from the thermistor are processed in the Interface Module. With the aid of a computer assisted program, the output is a digital and analog temperature readout. The digital readout is in Celsius and Fahrenheit. The digital analog display is a 270° circular dial illustrating 16-40°C in tenths of a degree

The provided text describes a 510(k) submission for the Abreu BTT 700 Skin Temperature System, claiming substantial equivalence to the YSI Precision 4000 Thermometer. The focus is on technical characteristics and performance, not a multi-reader multi-case comparative effectiveness study or a standalone AI algorithm performance study.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the predicate device's specifications, as the Abreu BTT 700 aims for "substantial equivalence." The "Comparison Table" directly addresses this.

Note on Differences:

• Display: Predicate uses LCD, new device uses Computer Monitor. This is a change in presentation but not a performance metric for accuracy.
• Probes: Predicate uses various, new device uses "Abreu BTT 700 Temperature pen with disposable coverlet or BTT Forehead Finger Sensor." This is a design difference, but the performance (accuracy) is claimed to be equivalent.
• Technology: Predicate uses Precision PTC Thermistor 2250 ohms. New device uses Precision PTC Thermistor 10 K to reduce probe size, isolated with medical grade acrylic. This is a design difference to achieve the same performance.
• Computer Connection: Predicate not available, new device has USB. A new feature, but not a performance metric for temperature accuracy.
• Power Source: Predicate uses internal battery, new device uses USB port, 5 volts @ 175 ma. A design difference.

The claim of substantial equivalence hinges on the "Performance: Laboratory and clinical testing has verified ... accuracy in the clinical environment. Clinical testing was performed on subjects of different age groups: adults, geriatric, and pediatric with results showing performance equivalent to or better than the predicate."

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

The document states: "Clinical testing was performed on subjects of different age groups: adults, geriatric, and pediatric." However, the exact sample size for the clinical test set is not provided in the given text.

The data provenance is implied to be clinical testing of the Abreu BTT 700, making it prospective for this device. The country of origin is not explicitly stated.

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

This information is not provided in the document. The testing appears to be objective measurements against a standard, not requiring expert ground truth in the subjective medical interpretation sense. For a thermometer, the "ground truth" would likely be a highly accurate reference thermometer or a controlled temperature environment, not expert interpretation.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable in the context of device accuracy testing for a thermometer. Adjudication methods (like 2+1, 3+1) are typically used for subjective diagnostic interpretations where expert consensus is needed to establish ground truth.

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 MPMC comparative effectiveness study was done or mentioned. This device is a clinical electronic thermometer measuring skin temperature, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.

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

This concept is not directly applicable to a clinical thermometer in the sense of an AI algorithm. The device itself (Abreu BTT 700) performs the measurement and displays it. Its "standalone" performance is its accuracy and reliability in measuring temperature, which was verified through "Laboratory and clinical testing."

7. The Type of Ground Truth Used

For the accuracy testing, the ground truth would have been established by a highly accurate reference temperature source/method during laboratory testing, and potentially comparison against the predicate device or another established accurate method during clinical testing. It is not "expert consensus," "pathology," or "outcomes data" in this context.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a hardware-based thermometer with embedded software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The permanently installed software program likely performs signal processing and display functions based on fixed algorithms, not learned parameters.

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

This information is not applicable and not provided for the reasons stated in point 8.

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The LIFEBRIDGE B2T System is indicated for use as an extracorporeal blood oxygenation system for patients needing short term, 6 hours or less, cardiac and/or pulmonary support.

The LIFEBRIDGE B2T SYSTEM is a compact, pre-assembled, modular system consisting of: 1. Patient module housing an extracorporeal circuit comprised of several previously 510k-cleared devices. The circuit includes a rigid reservoir bag, a centrifugal pump, oxygenator, arterial filter, active air management system, tubing and connectors. 2. Sensors, including flow, pressure, level and bubble to read system parameters. 3. Control module that contains the electronics and user interface. 4. Base module that contains a touch screen, the main power connection and acts as a stable frame for the system. The following LIFEBRIDGE ByT SYSTEM components have been previously 510(k)-cleared for use in cardiopulmonary bypass: oxygenator, arterial filter, centrifugal pump, level sensors, and bubble detector.

The provided document is a 510(k) summary for the LIFEBRIDGE B2T System, a cardiopulmonary support system. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the way one might expect for novel technology or a software algorithm.

Here's an analysis based on the provided text, addressing your points where information is available:

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

The document does not specify quantitative "acceptance criteria" or present a table of reported device performance in the context of a formal study demonstrating compliance with such criteria. Instead, it states:

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 does not describe a clinical "test set" with a specific sample size or data provenance. The assessment for this device appears to be based on:

• Non-clinical tests: The document mentions "Non-clinical tests performed on the LIFEBRIDGE B2T SYSTEM provide evidence of the safety and effectiveness of the device for its intended use." Details of these tests (e.g., number of runs, specific parameters) are not provided.
• Comparison to predicate devices: The primary argument for approval is based on substantial equivalence to existing, legally marketed cardiopulmonary bypass systems. This implies that the safety and effectiveness of the components and overall system are inferred from the established performance of the predicate devices.

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 to this 510(k) submission. There is no mention of an expert-adjudicated test set or ground truth establishment in the context of human expert review. The submission relies on non-clinical testing and comparison to predicate device characteristics.

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

Not applicable. No expert adjudication method is described because there is no expert-adjudicated test set in the provided 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

Not applicable. This document describes a medical device (a cardiopulmonary support system), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

Not applicable. This is a hardware medical device, not a standalone algorithm.

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

The concept of "ground truth" as typically applied in AI/diagnostic device studies (e.g., expert consensus, pathology, clinical outcomes) is not explicitly detailed in this 510(k) summary. The "ground truth" for demonstrating safety and effectiveness of a cardiopulmonary support system in this type of submission is typically derived from:

• Engineering specifications and performance standards: Non-clinical tests verify the device meets these standards (e.g., flow rates, pressure limits, oxygenation efficiency, material biocompatibility).
• Established performance of predicate devices: The "truth" of what constitutes a safe and effective cardiopulmonary bypass system is based on the long history and regulatory clearance of the predicate devices.

8. The sample size for the training set

Not applicable. This pertains to an AI/machine learning model, which is not what the LIFEBRIDGE B2T System is.

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

Not applicable. This pertains to an AI/machine learning model, which is not what the LIFEBRIDGE B2T System is.

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The intended use of the Wright/Haloscale Respirometer is the measurement and monitoring of the level of lung ventilation achieved by intensive care patients, during anesthesia and post operative recovery.

It measures expired volumes and thus indicates whether adequate ventilation is being achieved, whether in open or closed circuit or spontaneously breathing or mechanically ventilated patients.

The Respirometer is a mechanically driven dial, where the dial indicates gas volume passed, and the mechanism is driven by the kinetic energy in the flowing gas. The device measures expirate gas flow and measurements are unaffected by inspirate gas flow. It has an on/off button to lock the pointer and a reset button to return the pointer to zero when it approaches full scale

Here's an analysis of the provided text regarding the acceptance criteria and study for the Wright/Haloscale Respirometer:

This document is a 510(k) summary for a medical device that measures lung ventilation, and as such, it focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a novel clinical study to establish new acceptance criteria and prove its performance.

Therefore, many of the typical acceptance criteria and study elements you requested (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance with ground truth, etc.) are not applicable or not explicitly detailed in this type of submission. The "study" here is primarily a bench-testing and technical comparison to the predicate device and established technical standards.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

   The "acceptance criteria" for a 510(k) are typically derived from the performance specifications of the predicate device and relevant industry standards. The device's reported performance is then compared to these.

   Acceptance Criteria (from Predicate/Standards)	Reported Device Performance (Wright/Haloscale Respirometer)
   Accuracy
   Tidal Volumes: ± 3% for minute volumes > 5 LPM	Achieved: ± 3% for minute volumes exceeding 5 LPM
   Continuous Flow: ± 4% for minute volumes > 4 LPM	Achieved: ± 4% for minute volumes exceeding 4 LPM
   Continuous Flow: ± 2% @ 16 LPM	Achieved: ± 2% @ 16 LPM
   Continuous Flow: ± 5% to + 10% @ 60 LPM	Achieved: ± 5% to + 10% @ 60 LPM
   Sensitivity
   Starts volume registration at not more than 2.5 LPM	Achieved: Starts volume registration at not more than 2.5 LPM
   Resistance
   Proportional to square of flow rate, not more than 2cm H2O @ 100 LPM	Achieved: Proportional to square of the flow rate and not more than 2cm H2O @ 100 LPM
   Dead Space
   Not specified (implied to be similar to predicate if not mentioned)	Reported: 22 ml
   Permissible Gases
   Not specified (implied to be similar to predicate if not mentioned)	Reported: All respirable gases
   Maximum Temperature
   Not specified (implied to be similar to predicate if not mentioned)	Reported: 55°C (131°F)
   Maximum internal to external pressure
   Not specified (implied to be similar to predicate if not mentioned)	Reported: 30cm H2O
   Maximum Leakage
   60ml/min at 30cm H2O (to ASTM F1208-89)	Achieved: 60ml/min at 30cm H2O (to ASTM F1208-89)
   Maximum Recommended Flow Rate
   Not specified (implied to be similar to predicate if not mentioned)	Reported: 60 LPM (300 LPM continuous flow for short periods)

   Note: "Not specified" for criteria where only the device's reported performance is given means the document doesn't explicitly state the predicate's equivalent spec, but the FDA's acceptance implies it met an unstated or inferred standard.

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

   • Sample Size: Not specified. This would typically involve a series of bench tests using controlled gas flow measurements. The number of repetitions or specific test conditions is not detailed in this summary.
   • Data Provenance: The data provenance is laboratory/bench testing conducted by nSpire Health, Inc. This is not clinical data from patients (retrospective or prospective). The location is implied to be at the manufacturer's facility (Longmont, CO).

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

   • Not Applicable. For a device of this type undergoing a 510(k) for substantial equivalence, clinical expert ground truth is typically not required for the technical characteristics comparison. The "ground truth" for the technical specifications is established by calibrated flow meters and pressure sensors used during bench testing.

4. Adjudication method for the test set

   • Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert opinions, typically in clinical studies or evaluations of subjective interpretations (e.g., image analysis). This is a technical performance assessment, not an expert review.

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

   • Not Applicable. This device is a mechanical respirometer, not an AI-powered diagnostic tool requiring human reader interpretation. No MRMC study was done, and there is no AI component.

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

   • Yes, in essence. The performance data presented (accuracy, sensitivity, resistance, etc.) are inherent characteristics of the device itself, determined through direct measurement during laboratory testing. It operates as a standalone mechanical device without human-in-the-loop performance in the sense of interpretative assistance.

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

   • The "ground truth" for the technical characteristics is based on calibrated physical measurements from standard laboratory equipment (e.g., reference flow meters, pressure gauges) and adherence to established industry standards like ASTM F1208-89.

8. The sample size for the training set

   • Not Applicable. This is a mechanical device, not a machine learning or AI model, so there is no concept of a "training set."

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

   • Not Applicable. Since there is no training set, this question is not relevant.

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The NexLink OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spinal stenosis. fracture/dislocation, atlantoaxial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.

The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the indications specified above.

NexLink OCT is the re-design and modernization of the existing OctaFix svstem. The scope of the NextLink OCT Cervical Plating System will include 1) a modular occipital plate, 2) a selection of precontoured rods, 3) hooks and 4) a refined set of instrumentation. The scope of the project is for Next ink OCT to integrate as an option to the current Nex-Link System. The NexLink OCT Occipital Cervical Plating System components are temporary implants that are used to stabilize the spine (occiput-T3) during the development of a solid spinal fusion in patients with degenerative disease, trauma (including fractures), and tumor pathology.

The provided text describes the NexLink OCT Cervical Plating System. However, it does not contain information about the acceptance criteria, device performance from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, or ground truth details. The document explicitly states that "Clinical data and conclusions were not needed for this device." and relies on "Laboratory and bench testing results" to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can be extracted and the reasons why other information is unavailable:

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

Reasoning: The document states, "Laboratory and bench testing results demonstrate that the proposed device is substantially equivalent to the predicate device." However, it does not specify what specific acceptance criteria these tests were designed to meet (e.g., specific thresholds for strength, fatigue life, etc.), nor does it provide quantitative results of these tests.

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

• Sample Size: Not applicable. No clinical test set was used.
• Data Provenance: Not applicable. The "testing" was non-clinical (laboratory and bench testing).

Reasoning: The document explicitly states, "Clinical data and conclusions were not needed for this device." The evaluation was based on non-clinical laboratory and bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No "ground truth" for a clinical test set was established as no clinical data was required or used.

Reasoning: As no clinical data was used, there was no need for experts to establish ground truth for a clinical test set.

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

• Not applicable. No clinical test set requiring adjudication was used.

Reasoning: No clinical data, no clinical test set, therefore no adjudication method applies.

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.

Reasoning: This is a medical device (cervical plating system), not an AI/software device involving human readers or interpretation of medical images. The concept of "human readers improve with AI" is not relevant to this type of device.

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

• Not applicable. This is a medical device (cervical plating system), not an algorithm or AI.

Reasoning: See above.

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

• Not applicable. The "ground truth" for this device's evaluation was based on engineering and material standards for mechanical testing to demonstrate substantial equivalence to a predicate device, rather than clinical outcomes or diagnostic accuracy.

Reasoning: The device's performance was evaluated through "Laboratory and bench testing results." This implies a comparison to established engineering specifications and benchmarks relevant to spinal implants, not clinical ground truth in the diagnostic sense.

8. The sample size for the training set

• Not applicable. This device is a physical medical implant, not a machine learning model that requires a training set.

Reasoning: The concept of a "training set" belongs to machine learning and AI, which are not relevant to this physical device.

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

• Not applicable. No training set was used.

Reasoning: See above.

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The MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to seven (7.0) liters per minute for periods of up to six (6.0) hours.

The MEDOS HILITE 7000 & 7000 LT Oxygenator consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 7000 hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 7000 LT hollow fiber membrane consists of a Polymethylpentene plasma tight mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a polyester non-porous hollow fiber configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood around the outside of the fibers while water flows through the inner lumen of the fibers and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible and coated with a proprietary coating. The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifugal pump connected through the tubing. The MEDOS HILITE 7000 Oxygenator may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.

The provided text describes the MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or any of the specific details requested regarding sample sizes, ground truth, experts, or AI-related aspects.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive performance studies with specific acceptance criteria and detailed quantitative results.

Here's a breakdown of what can be extracted and what is missing:

The device is a blood oxygenator indicated for extracorporeal oxygenation and carbon dioxide removal from human blood at blood flow rates of 1.0 to 7.0 liters per minute for up to 6.0 hours.

Missing Information:

• Acceptance Criteria Table: The document does not specify any quantitative acceptance criteria or report specific device performance metrics against such criteria (e.g., oxygen transfer rate, CO2 removal rate, pressure drop, hemolysis rates, etc., with specific thresholds).
• Sample Size for Test Set and Data Provenance: This information is not provided. The summary mentions "extensive safety, performance, and validations" and "final testing for the systems," but no details on sample sizes or the nature (retrospective/prospective, country of origin) of the data from these tests are given.
• Number of Experts and Qualifications: Not applicable, as no expert-derived ground truth or review process is detailed concerning a test set.
• Adjudication Method: Not applicable for the same reason as above.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is entirely irrelevant to this type of medical device (a physical blood oxygenator) and is not mentioned. There is no AI component involved.
• Standalone Performance (Algorithm Only): Not applicable, as this is a physical medical device, not an algorithm.
• Type of Ground Truth Used: Not explicitly stated in terms of a "ground truth" as might be used in an AI or diagnostic imaging study. The "test data" likely involved laboratory measurements and possibly animal or human studies to compare to the predicate device's performance.
• Sample Size for Training Set: Not applicable or mentioned, as there is no AI algorithm being trained.
• How Ground Truth for Training Set was Established: Not applicable.

What the document does state regarding testing:

• "The MEDOS HILITE 7000 & 7000 LT Oxygenator has been subjected to extensive safety, performance, and validations prior to release."
• "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications."
• "Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."
• "A review of literature pertaining to the safety and effectiveness has been conducted."
• The conclusion is based on "testing and comparison to the predicate device," asserting equivalence in safety and effectiveness.

In summary, this document is a regulatory submission for a physical medical device (blood oxygenator) focusing on substantial equivalence to a predicate device, not on detailed performance studies with specific statistical acceptance criteria as would be found for a diagnostic or AI-driven device. Therefore, most of the requested specific information is not contained within this text.

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The URok Rocking Wheelchair is intended to provide mobility to persons limited to a sitting position while the rocking mechanism is locked in an upright position.

The wheelchair is intended to redistribute pressures exerted on the buttocks and lower back when rocking or tilted at an angle.

The wheelchair is intended to provide comfort adjustment while rocking or tilted at an angle.

The AMG Medical Inc. URok Rocking Wheelchair is a manually operated, attendant or user propelled, mechanical rocking wheelchair. The device is a lightweight wheelchair, suitable for both indoor and outdoor use.

The device consists of an aluminum frame, one size of rear wheel, and smaller front pivoting casters for steering and turning. The frame is constructed from aluminum tubing that is TIG-welded. This device is a rigid, non-folding type of wheelchair that incorporates a padded, sling style seat. The upholstery meets the requirements of ISO 7176-16, flammability standards.

The AMG URok Rocking Wheelchair includes a rocking feature which permits dynamic pressure management of the seating pressure upon the buttocks. The rocking feature is realized by the placement of two vertically positioned fibrogless Ieaf springs, which are connected to the seat and frame, under the seat's centre of gravity. The balance of the seat upon the springs is precise enough so that the rocking motion may be initiated by the user simply by gently moving the head backward and forward. Safety features such as anti tippers and rock arrestors limit the arc of the rocking motion. The rocking feature can be "locked out" by an attendant so that the device can be used as a wheelchair with no rocking motion.

The AMG URok wheelchair also has a "tilts in space" feature. The rocking mcchanism can be locked in multiple positions to provide "tilt in space" that permits receing meemainst backwards thereby allowing gravity to hold them in position. This is used to help in positioning, comfort, or head control. The tilt in space is initiated by the attendant pushing down on the push handles to tilt the scat and back and locking out the rocking action when the desired angle of tilt is reached.

The rocking feature is released or is locked out by two cable controlled pins that insert into holes within two vertically mounted metal plates located under the seat support tubes. The cables are controlled using bicycle brake type levers in onto bed on the rear push tube or handle.

The Urok Rocking Wheelchair by AMG Medical Inc. had the following acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: "adult human volunteers" (specific number not provided).
• Data Provenance: Not explicitly stated, but the submission is from a Canadian company, so the testing likely occurred in Canada or the US. It appears to be prospective data collection for the purpose of the 510(k) submission.

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

Not applicable. The "ground truth" for this device concerned physical performance and pressure redistribution, not an expert-derived clinical diagnosis or assessment. The pressure redistribution was "observed and recorded," implying measurement rather than expert consensus on a subjective outcome.

4. Adjudication Method for the Test Set:

Not applicable. The performance data involved physical measurements (pressure redistribution) and adherence to engineering standards (ANSI/RESNA), not a subjective assessment requiring adjudication.

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

No. This type of study, common for AI-powered diagnostic tools, was not relevant nor performed for this medical device (a mechanical wheelchair).

6. Standalone Performance Study:

Yes. The mentioned performance data for pressure redistribution and compliance with ANSI/RESNA standards reflect the standalone performance of the device itself.

7. Type of Ground Truth Used:

• Engineering Standards: Conformance to the ANSI/RESNA WC series of wheelchair requirements.
• Direct Measurement/Observation: Pressure redistribution was "observed and recorded" using a pressure recording mat on adult human volunteers.

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical wheelchair, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI.

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

Not applicable, as there is no training set for a mechanical device.

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The ATS SIMULUS Annuloplasty Rings are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

The ATS SIMULUS Annuloplasty Rings are implantable, fully flexible, annular rings (Figure 1). The rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the ring is made of braided Polyester. The ring contains a circumferential flexible radiopaque marker. The entire circumference of the ring is radiopaque. The annuloplasty rings and accessories are designed as an integrated system to ease implantation. Malleable stems connects the double ended sizers to their handle. The rings are available in the following sizes: 23 mm, 27 mm, 31 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner diameter of the ring. Green trigone markers are spaced at 120° from the radial seam, which is located midpoint of the posterior segment.

The provided text is a 510(k) Summary for a medical device called the ATS SIMULUS Annuloplasty Ring. It describes the device, its intended use, and indicates that testing was performed. However, this document does not contain the specific details about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.

The section "8. Testing Summary:" on page 1 states: "Testing included LAL, Sterility Validation, Class IV Biocompatibility tests on the predicate device. Mechanical testing was carried out on complete modified rings and ring components. All test results were satisfactory."

This statement confirms that testing was done and that the results were "satisfactory," but it lacks the granular information required to complete the table and answer the specific questions about acceptance criteria and study methodology.

Therefore, I cannot provide a detailed response to your request based solely on the provided text. The document is primarily focused on demonstrating substantial equivalence to a predicate device for regulatory clearance rather than providing a detailed performance study report.

Here's what can be inferred and what information is missing:

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

• Acceptance Criteria: Not explicitly stated in the provided text. For LAL, Sterility Validation, Biocompatibility, and Mechanical Testing, there would be specific regulatory or internal acceptance criteria (e.g., LAL endotoxin levels below a certain threshold, sterility assurance level (SAL) of 10^-6, specific cytotoxicity or sensitization limits, certain force/stress limits for mechanical tests). These are not published here.
• Reported Device Performance: The text generically states, "All test results were satisfactory." This is not a quantitative or specific performance report.

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

• Sample Size: Not specified for any of the tests mentioned (LAL, Sterility, Biocompatibility, Mechanical).
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission, the testing would have been conducted by or for the applicant (Genesee Biomedical, Inc.) likely in the US, but this is an inference, not stated fact for the data origin. It would be retrospective for the submission, based on tests performed prior to filing.

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

• This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical assessments). The tests mentioned (LAL, Sterility, Biocompatibility, Mechanical) are laboratory-based and generally do not involve "expert consensus" for ground truth in the way clinical studies do. Standards and validated methods define the "ground truth" for these types of tests.

4. Adjudication method for the test set

• Not applicable for the types of tests described (LAL, Sterility, Biocompatibility, Mechanical).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, the document does not mention any MRMC comparative effectiveness study. These are typically for diagnostic devices where human readers interpret results.

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

• Not applicable. This device is an implantable annuloplasty ring, not an algorithm.

7. The type of ground truth used

• For LAL, Sterility, Biocompatibility, and Mechanical testing, the ground truth is established by validated laboratory methods and regulatory standards. For example, sterility is determined by absence of microbial growth in culture, LAL by an enzymatic reaction, biocompatibility by absence of adverse biological responses in standardized tests (e.g., ISO 10993 series), and mechanical performance by meeting engineering specifications under controlled conditions. It's not "expert consensus," "pathology," or "outcomes data" in the clinical sense for these specific tests.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set. The "predicate device" is mentioned for some tests, but that's for demonstrating equivalence, not for training a model.

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

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

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The ATS SIMULUS FC Annuloplasty Bands are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

The ATS SIMULUS FC Annuloplasty Bands are implantable, fully flexible, annular bands (Figure 1). The bands reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the band is made of braided Polyester. The band contains a circumferential flexible radiopaque marker. The entire circumference of the band is radiopaque.

The annuloplasty bands and accessories are designed as an integrated system to ease implantation. Malleable stems connects the double ended sizers to their handle.

The bands are available in the following sizes: 23 mm, 27 mm, 29 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner diameter of the band. Green trigone markers are spaced at 120° from the midpoint of the posterior segment, which is also indicated by a green marker.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ATS SIMULUS FC Annuloplasty Band:

The document (K052899) is a 510(k) premarket notification for a medical device. In this type of submission, the primary goal is to demonstrate substantial equivalence to a previously legally marketed device (predicate device), rather than proving stand-alone effectiveness or a specific clinical benefit beyond what the predicate offers. Therefore, the information provided focuses on comparative aspects and safety/performance characteristics relevant to the predicate.

Based on the provided text, there is no clinical study presented that demonstrates the device meets specific performance acceptance criteria in the way you've outlined for an AI/device performance study.

Instead, the submission relies on:

• Equivalence to a predicate device: The ATS SIMULUS FC Annuloplasty Band is deemed equivalent to the K905175, PTI Annuloplasty Ring (now Genesee BioMedical, Inc. Sculptor® Annuloplasty Ring) based on design, material composition, surgical technique, and intended use. This is the core "proof" of acceptability for a 510(k) submission.
• Non-clinical testing: Safety and fundamental performance are addressed through laboratory and bench tests.

Here's a breakdown of the requested information, indicating where the document provides (or lacks) the specific details:

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

   This specific type of table, with quantitative performance metrics against predefined acceptance criteria, is not provided in the document. The general acceptance criteria are implied by the successful completion of the listed tests and the demonstration of substantial equivalence.

   Acceptance Criteria	Reported Device Performance
   Functionality: Support mitral/tricuspid annulus, restrict expansion of the annulus	Implied: Device description states it "reduce[s] and stabilize[s] the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair." Indications for Use state it "provide[s] support for the mitral or tricuspid annulus and restrict[s] expansion of the annulus." Equivalence to predicate (K905175) based on design, material, surgical technique, and intended use implies similar functionality.
   Biocompatibility: Safe for implantation, no adverse biological reactions	Reported: "Class IV Biocompatibility tests on the predicate device." "All test results were satisfactory." (The document states these tests were done on the predicate device, implying the new device, being substantially equivalent in materials, would also be biocompatible.)
   Sterility: Supplied sterile, nonpyrogenic	Reported: "LAL, Sterility Validation" were performed. "All test results were satisfactory." "The ATS SIMULUS FC Annuloplasty Bands are supplied STERILE (sterilized by gamma radiation) and nonpyrogenic..."
   Mechanical Integrity/Durability: Withstand surgical implantation and in-vivo forces without failure	Reported: "Mechanical testing was carried out on complete modified bands and band components." "All test results were satisfactory." (Specific criteria like tensile strength, fatigue life, etc., are not detailed, but implied to be acceptable based on the "satisfactory" statement and equivalence to predicate.)
   Radiopacity: Entire circumference visible for post-implant assessment (for the FC model)	Reported: "The band contains a circumferential flexible radiopaque marker. The entire circumference of the band is radiopaque." (This is a design feature, and successful visualization would be implicitly confirmed by mechanical/design verification, though no specific imaging study is mentioned as a "performance test" in the summary.)
   Packaging Integrity: Maintain sterility until expiration date	Reported: "The bands will remain sterile until at least the expiration date provided the package is unopened and undamaged." (Successful sterility validation would cover this, but specific packaging test data is not detailed as a separate item beyond sterility validation.)
   Substantial Equivalence: To predicate device (K905175)	Reported: "Equivalence can be seen in the design, material composition, surgical technique and intended use." FDA confirmed: "...the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This is the overarching "performance" criterion for a 510(k) and was met.

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

   • Sample Size: Not specified for any of the tests (LAL, Sterility, Biocompatibility, Mechanical). These are typically laboratory or bench tests with samples taken from manufacturing lots, not patient-based test sets.
   • Data Provenance: Not specified, but generally, for a 510(k), these would be internal laboratory tests conducted by the manufacturer or contracted third-party labs. They are not clinical studies in the sense of patient data.

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

   • This question is not applicable as there is no "test set" in the context of human data or expert review mentioned. The tests are lab-based.

4. Adjudication method for the test set

   • Not applicable. No expert adjudication of a test set is mentioned.

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

   • No. This device is an annuloplasty band (implantable medical device for valve repair), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.

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

   • No. This question is not applicable as the device is not an algorithm or AI system.

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

   • For the non-clinical tests:
     • Biocompatibility: Established scientific standards for biological reactivity (e.g., ISO 10993 series).
     • Sterility: Established microbiology standards (e.g., USP, ISO 11137 for gamma sterilization).
     • Mechanical Testing: Engineering specifications and performance comparisons to the predicate device, likely based on established ASTM or ISO standards for medical device materials and components.
     • Functionality: Implied by design, material, and equivalence to the predicate device.

8. The sample size for the training set

   • Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

   • Not applicable. There is no "training set."

In summary:

The K052899 submission for the ATS SIMULUS FC Annuloplasty Band relies on demonstrating substantial equivalence to an existing predicate device (K905175, PTI Annuloplasty Ring / Sculptor® Annuloplasty Ring) and fulfilling standard non-clinical safety and performance testing requirements. The device is a physical implant, not an AI or diagnostic software, so many of the questions regarding clinical studies, expert review, training sets, and AI performance are not relevant to this type of device submission.

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For in-vitro diagnostic use for measuring platelet aggregation and ATP secretion in whole blood or platelet rich plasma.

The Chrono-log Model 700 Aggregometer measures platelet function on patient samples using electrical impedance in whole blood or optical density in plasma. The Model 700 Aggregometer has the capability to simultaneously measure ATP release with either method using luminescence. The Model 700 Aggregometer is also used to run the Ristocetin Cofactor Assay which is used to diagnose patients with von Willebrands disease. The instrument comes with a starter kit consisting of the following Chrono-log reagents and supplies: ADP, Arachondic Acid, Collagen, Epinephrine, Ristocetin, Thrombin, a CHRONO-LUME® Kit, a Ristocetin Cofactor Kit, cuvettes, stir bars and pipettes. The output of the Model 700 can be connected to either a strip chart recorder or to a Computer. Software is provided the computer interface option. The computer interface option is used to collect data only. The computer is not used for diagnosis or treatment and does not have any control over or input into the Model 700 Aggregometer.

Here's an analysis of the provided text, focusing on the acceptance criteria and study details for the Chrono-log Model 700 Whole Blood Lumi-Aggregometer:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than establishing explicit acceptance criteria with pre-defined thresholds for performance. The "acceptance criteria" here are implicitly linked to achieving a high correlation with the predicate devices, indicating comparable performance.

Here's a table summarizing the reported device performance, with the understanding that the "acceptance criteria" were met by demonstrating strong correlation:

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