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Xpedition transports a patient with a mobility-limiting medical condition or injury, who is physically able to maintain a seated position while restrained, up or down a set of stairs. Xpedition is intended for use in residential and commercial environments, including pre-hospital environments, emergency, and non-emergency applications. All operators, including healthcare professionals such as emergency medical service personnel and medical first responders, must be trained by a qualified trainer before product use.

The Stryker Xpedition™ Powered Stair Chair is a seated patient transport device with handles and a powered belt and track system. The chair is designed to support and transport a maximum weight of 500 1b (227kg) up and down stairs. The chair is intended for patients who weigh 50 lb (23 kg) or more and can remain seated in the chair while secured by patient restraint straps. Handles at the head and foot ends allow operators to control the chair during powered or manual ascent or descent on stairs. Operators can push and maneuver the chair over various types of terrain expected in commercial and residential environments, as well as lift patients over obstacles. The chair has a removable patient containment system with attachment points for the chest and waist to secure a patient during transport. A fold-out footrest can be deployed for secure feet placement. A removable, rechargeable battery powers electrical functions including the motorized drive system for traversing stairs, speed selection, direction, ground lighting activation, battery capacity feedback, drive activation buttons, and LED visual feedback networks. User interfaces at the back of the chair and the top handle allow for drive system control. The chair has several mechanical activations including wheel locks to prevent unintended motion on ground, a latch to fold or unfold the chair, a track deployment mechanism to deploy the stair driving track system, and top and bottom handle length adjustment activations. Options include the footrest and head end flip-up carry handles.

The provided document describes the Stryker Xpedition™ Powered Stair Chair (K222818), a device intended for patient transport. However, it does not include specific quantitative acceptance criteria or a study that directly proves the device meets such criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (C-Max +, K130864) through non-clinical performance data, rather than establishing and meeting discrete performance acceptance criteria for a novel AI/software-driven medical device. The tests performed are in accordance with various ISO and IEC standards to demonstrate safety, effectiveness, and general functionality.

Therefore, many of the requested fields cannot be directly extracted from the provided text, as they pertain to specific types of studies (e.g., AI performance, multi-reader multi-case studies, ground truth establishment) that are not detailed for this device.

Here's an attempt to answer based on the available information, with many points noted as "Not Applicable" or "Not Provided" due to the nature of the submission (a 510(k) for a physical medical device, not an AI/software device with diagnostic or predictive capabilities).

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device (powered stair chair) and not an AI or diagnostic software, explicit "acceptance criteria" in terms of clinical accuracy metrics (like sensitivity, specificity, AUC) are not defined in the document. Instead, the "performance" is demonstrated by meeting various engineering and safety standards.

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

• Sample size: Not applicable in the context of clinical "test sets" for diagnostic or AI performance. The document describes non-clinical engineering and safety tests, which typically involve specific test units of the device under controlled conditions. The number of such units is not specified.
• Data provenance: Not applicable. The tests are lab-based engineering and safety assessments of the device itself, not data collected from patients or a specific population.

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

• Number of experts: Not applicable. Ground truth for diagnostic accuracy is not relevant here. The "truth" in these tests is compliance with engineering standards and functional specifications, typically verified by test engineers.
• Qualifications of experts: Not provided, but implied to be qualified engineers and technicians for the various standards.

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

• Adjudication method: Not applicable. This concept is typically for resolving discrepancies in expert opinion for ground truth in medical imaging or diagnostic studies. The tests described are objective, pass/fail based on engineering standards.

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. This type of study is for evaluating AI-assisted diagnostic performance. The Xpedition™ is a powered patient transport device, not a diagnostic tool.
• Effect size: Not applicable.

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

• Standalone performance: Not applicable. This concept is for AI algorithms. The device's "performance" is its mechanical and electrical function, which is assessed during the non-clinical tests. While it has powered functions, it still requires human operators.

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

• Ground truth: For this type of device, the "ground truth" is defined by compliance with established engineering and safety standards (e.g., ISO, IEC, AAMI). The "truth" is whether the device performs as specified and meets the limits/requirements of these standards, which are based on extensive industry consensus for safety and performance.

8. The sample size for the training set

• Sample size for training set: Not applicable. This device is not an AI/machine learning model that requires a training set of data.

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

• Ground truth for training set: Not applicable.

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The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician with prescription privileges determines that temperature therapy is necessary or desirable.

Indications for use for the Altrix system include:

a. Maintain pre-set body temperature as determined by the physician

b. Maintain normal body temperature during surgical procedures

c. For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn units, and medical/surgical units

d. Adult and pediatric patients

e. Monitoring and controlling patient temperature

f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients

Altrix components include the controller, reusable hose set(s), thermal transfer devices, patient temperature probes and reusable adaptor cable(s). The controller regulates water temperatures between 4.0 - 40.0° C and circulates the heated or cooled water via hose set(s) through the thermal transfer device(s). A graphical display provides the user an interface for selecting desired water or patient temperature settings, operating modes, help menus and other key parameters. Visual indicators are displayed to inform the user of system status or when the user must confirm a setting selection. The system's water temperature and flow outputs are monitored to ensure optimal system operation.

Note: The provided text is a 510(k) summary for a medical device (Altrix Precision Temperature Management System). It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device. This document focuses on regulatory approval and does not contain detailed information about a clinical study or performance evaluation with specific acceptance criteria and outcome metrics that would typically be found in a study report.

Therefore, for aspects like acceptance criteria expressed numerically, sample sizes for test sets, expert involvement in ground truth establishment, MRMC studies, and detailed standalone performance, the information is not present in the provided text. The document primarily discusses bench testing for software modifications and mentions "acceptable results" without quantifying them.

Here's an attempt to structure the answer based on the provided text, highlighting where information is absent and where inferences might be drawn from the context of regulatory submission:

The provided document describes the 510(k) submission for the Altrix Precision Temperature Management System, focusing on modifications to the device's software, minor components, and labeling. The core of the submission is to demonstrate substantial equivalence to a previously cleared predicate device (Altrix Precision Temperature Management System - K152266).

Given the nature of a 510(k) summary for modifications, the "study" proving the device meets acceptance criteria is primarily an engineering verification and validation process, not a clinical trial with human subjects testing the primary efficacy of the device.

Acceptance Criteria and Device Performance (Inferred from Regulatory Context)

Since this 510(k) is for modifications, the acceptance criteria would revolve around demonstrating that the modifications do not adversely affect the device's safety and effectiveness and that the modified device continues to meet the performance specifications established for the original predicate device. The "reported device performance" is described qualitatively as "successfully completed" and "acceptable results."

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not specified quantitatively. The testing involved "non-clinical bench testing." This typically implies testing on devices themselves rather than a dataset of patient images or readings.
   • Data Provenance: Not applicable in the traditional sense of patient data. The "testing" refers to the verification and validation of software and hardware changes on the device itself.
   • Retrospective or Prospective: Not applicable as it's bench testing, not a clinical data study.

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

   • Not Applicable. As this was bench testing for software and minor component modifications, the "ground truth" would be established by engineering specifications, validated test protocols, and potentially expert review of the software design and functionality, rather than human experts labeling medical data.

3. Adjudication method for the test set:

   • Not Applicable. There is no mention of human adjudication for the test results described, as the testing focuses on internal device performance against specifications.

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

   • No. An MRMC study was not conducted. This device is a thermal regulating system, not an imaging AI diagnostic aid, and the submission is for device modifications, not a de novo AI product. The text does not mention any AI components assisting human readers.

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

   • Partially Applicable / Assumed. The "Software modifications were also validated to user needs with acceptable results" and "Non-clinical bench testing was successfully completed to verify the software modifications meet specified requirements" implies testing the algorithm's performance in isolation to ensure it functions as intended based on its design specifications. However, specific standalone performance metrics (e.g., accuracy, precision for a measurement) are not provided in this summary.

6. The type of ground truth used:

   • Engineering Specifications / Functional Requirements. For software and hardware modifications, the "ground truth" is defined by the device's design specifications, functional requirements, and the expected output under various conditions, as opposed to clinical outcomes or expert consensus on patient data.

7. The sample size for the training set:

   • Not Applicable. This is a 510(k) for modifications to a traditional medical device, not a machine learning or AI model development that requires a "training set" of data.

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

   • Not Applicable. (See point 7).

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The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician with prescription privileges determines that temperature therapy is necessary or desirable.

Indications for use for the Altrix system include:
a. Maintain pre-set body temperature as determined by the physician
b. Maintain normal body temperature during surgical procedures
c. For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn units, and medical/surgical units
d. Adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients

The Altrix Temperature Management Wraps are the patient contact accessory for the Altrix Precision Temperature Management System. The Wraps are applied around the patient's thigh and torso. The Wraps are made from multiple layers of materials sealed together. A hose is used to connect the Wraps to the Altrix controller device.

The provided document is a 510(k) premarket notification for a medical device called "Altrix Temperature Management Wraps". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of study typically associated with AI/ML-based medical devices (e.g., studies for diagnostic accuracy, sensitivity, specificity, or human improvement with AI assistance).

The device in question, a temperature management wrap, is a physical device that circulates temperature-controlled water for body temperature regulation. It is not an AI/ML-driven diagnostic or assistive device. Therefore, the questions about MRMC studies, standalone algorithm performance, expert ground truth adjudication, training set sizes, and deep learning model specific criteria are not applicable to the information contained in this 510(k) submission.

This document primarily assesses the device's safety and performance through non-clinical bench testing and compliance with recognized standards, and compares its technological characteristics to a legally marketed predicate device.

Given this context, I will address the relevant points based on the provided text, and explicitly state when a question is not applicable.

Acceptance Criteria and Device Performance (for a physical temperature management wrap)

Since this is a physical device aiming for substantial equivalence to a predicate, the "acceptance criteria" are primarily established by compliance with recognized safety and performance standards for thermal regulating systems and demonstration of equivalent physical and functional characteristics to the predicate. The "reported device performance" refers to the successful completion of these tests.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

• ANSI/AAMI ES60601-1:2005 (R)2012 and A1 2012, C1: 2009(R) 2012 and A2:2010/(R)2012 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance)
• IEC80601-2-35: 2009 (Safety and Essential Performance of Heating Devices Using Blankets, Pads or Mattresses) | "Altrix Wraps were designed and/or tested to be in compliance with the relevant sections of the following standards: ... AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009(R)2012 And A2:2010/(R)2012 ... IEC 80601-2-35 Ed 2.0 - 2009-10 ... The results of the non-clinical bench and standards testing concluded Altrix Wraps are substantially equivalent to the predicate device." |
  | Biocompatibility | Adherence to ISO 10993 series (ISO 10993-1, ISO 10993-5, ISO 10993-10) | "Biocompatibility: ISO 10993-1; ISO 10993-5; ISO 10993-10" (under Predicate Comparison Table indicating "Same" as predicate). "Altrix Wraps were designed and/or tested to be in compliance with the relevant sections of the following standards: ... AAMI / ANSI / ISO 10993-1:2009/(R) 2013 ... AAMI / ANSI / ISO 10993-5:2009/(R) 2014 ... AAMI / ANSI / ISO 10993-10:2010." The results concluded substantial equivalence. |
  | Device Function & Performance | Expected performance in temperature warming/cooling, mechanical overload conditions, environmental stability, and packaging integrity. | "Non-Clinical bench testing was successfully completed to verify Altrix Wraps function and performance to specified requirements. Bench testing included temperature warming and cooling performance, mechanical overload conditions, environmental, and packaging." |
  | Risk Management | Compliance with ISO 14971 (Application of Risk Management To Medical Devices) | "Altrix Wraps were designed and/or tested to be in compliance with the relevant sections of the following standards: ISO 14971 Second Edition 2007-03-01 - Medical Devices - Application Of Risk Management To Medical Devices." The results concluded substantial equivalence. |
  | Substantial Equivalence to Predicate Device (Rapr-Round) | The device should have the same intended/indications for use, basic principles of operation, basic design, operational characteristics, and comparable technological characteristics, or any differences do not raise new questions of safety and effectiveness. | "The Altrix Wraps and Rapr Round share the same basic principles of operation, intended/indications for use, basic design, operational and technical characteristics. The Altrix Wraps are substantially equivalent to the predicate Rapr·Round." The comparison table (Table 5-1) explicitly states "Same" for Indications for Use, Anatomical Site, Sterility, Basic Safety and Essential Performance Standards, Basic Safety and Essential Performance for Heating Devices, and Biocompatibility. The material is noted as "Different" but this was addressed through testing to still demonstrate equivalence overall. The conclusion states: "Based on Altrix Wraps' technological characteristics, completed non-clinical bench testing and comparison with the predicate device, we conclude that Altrix Wraps are substantially equivalent to the predicate Rapr·Round device." |

Addressing Specific Questions (in the context of this device type):

1. A table of acceptance criteria and the reported device performance: See the table above. The "acceptance criteria" here are largely defined by adherence to recognized standards and successful outcomes of non-clinical bench tests demonstrating equivalent performance to the predicate.

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

   • Sample Size for Test Set: Not applicable in the context of human data or AI model testing. The "test set" here refers to the physical samples of the Altrix Temperature Management Wraps and components used for various non-clinical bench tests (e.g., temperature warming/cooling performance, mechanical overload, environmental, packaging), and material samples for biocompatibility testing. The specific number of wraps/components tested for each bench test is not specified in this summary, which is typical for a 510(k) summary as detailed test protocols and results are in the full submission, not the public summary.
   • Data Provenance: Not applicable as this is not a study involving human patient data or AI algorithm performance on such data. The data originates from internal engineering and biocompatibility laboratory testing conducted by Stryker Medical.

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. This device does not involve subjective assessment or diagnostic interpretation where "ground truth" established by human experts is required (as it would be for an AI diagnostic algorithm). The "ground truth" for this device is based on objective, quantifiable physical properties, performance metrics, and adherence to engineering and safety standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method.

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 is not an AI/ML device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" (or basis for verification) for this physical device is primarily:

   • Objective Engineering Specifications: Defined performance parameters for temperature regulation, mechanical durability, etc.
   • Recognized Industry Standards: Compliance with ISO and ANSI/AAMI standards for medical electrical equipment, heating devices, biocompatibility, and risk management.
   • Predicate Device Characteristics: The established safety and performance profile of the legally marketed predicate device (Altrix Precision Temperature Management System - Rapr-Round).

8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model.

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The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician with prescription privileges determines that temperature therapy is necessary or desirable.

Indications for use for the Altrix system include:
a. Maintain pre-set body temperature as determined by the physician
b. Maintain normal body temperature during surgical procedures
c. For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn units, and medical/surgical units
d. Adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients

The Altrix Precision Temperature Management System components include the controller, reusable hose set(s), thermal transfer devices, patient temperature probes and reusable adaptor cable(s). The controller regulates water temperatures between 4.0° C (39.2° F) and 40.0° C (104.0° F) and circulates the heated or cooled water via hose set(s) through the thermal transfer device(s). A graphical display provides the user an interface for selecting desired water or patient temperature settings, operating modes, help menus and other key parameters. Visual indicators are displayed to inform the user of system status or when the user must confirm a setting selection. The system's water temperature and flow outputs are monitored to ensure optimal system operation.

The controller can supply water to an individual or multiple thermal transfer devices simultaneously with each of these circuits monitored separately. Three operating modes are available to facilitate patient care: Automatic, Manual and Monitor. The patient temperature probe is used with the controller to provide closed loop feedback for automatic patient temperature management and monitoring. The controller alarms activate visual and audible indications for when safety parameters are exceeded or it detects system function or performance irregularities. The Altrix system also includes the ability to provide a patient temperature output reference signal to be connected to a non-specific third party device/system.

The provided document is a 510(k) premarket notification for the Altrix Precision Temperature Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device (Medi-Therm Hyper/Hypothermia System) through a comparison of technological characteristics and non-clinical bench testing.

Therefore, the acceptance criteria and study information requested typically associated with clinical performance studies (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training) are not fully available or directly applicable in the same way as they would be for a device that relies on clinical performance data for its clearance.

Here's a breakdown of the information that is available, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (like sensitivity, specificity, accuracy) using a clinical dataset. Instead, the "acceptance criteria" for this premarket notification are demonstrated through:

• Substantial Equivalence: The primary acceptance criterion is that the Altrix device is substantially equivalent to the predicate device (Medi-Therm Hyper/Hypothermia System) in terms of indications for use, technological characteristics, safety, and performance.
• Compliance with Standards: The device must comply with relevant recognized safety and performance standards.
• Successful Bench Testing: Non-clinical bench testing must successfully verify the device's function and performance to specified engineering requirements.

Table of Performance (derived from "Technological Characteristics and Substantial Equivalence Summary" and "Bench and Standards Testing"):

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

• Not Applicable in a clinical sense. The device relies on non-clinical bench testing, not a clinical "test set" of patient data. The provenance of the bench testing data would be from Stryker Medical's internal labs.

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 clinical test set with human-established ground truth was used for this 510(k) clearance, as clinical testing was deemed not required.

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

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

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 is not an AI-assisted diagnostic device, and no MRMC study was conducted.

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

• Not Applicable. This device is a temperature management system, not an algorithm, and its performance is evaluated through engineering and functional testing.

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

• For the non-clinical bench testing, the "ground truth" refers to engineering specifications, physical measurements (e.g., temperature, flow rates), and compliance with recognized industry standards. These are objective, measurable criteria.

8. The sample size for the training set

• Not Applicable. There is no mention of a training set as this is not a machine learning/AI device.

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

• Not Applicable. No training set was used.

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The Power-LOAD™ cot fastening system (model 6390) is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 lbs, which includes the weight of the ambulance cot, patient, and equipment attached to the cot (i.e. oxygen bottles, monitors, and/or pumps). The intended users of the device will be trained professionals including: emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers. The expected service life of the product is 7 years.

The Power-LOAD system secures an ambulance cot within an emergency transport vehicle/ambulance. Power-LOAD includes a trolley that attaches to the cot during the loading and unloading process, a transfer assembly that facilitates linear motion of the trolley and an anchor assembly that attaches to a floor plate mounted to the vehicle floor. When a Power-LOAD-compatible cot is securely attached to the trolley, a batterypowered hydraulic system assists the operators in lifting, lowering and loading and unloading a cot. When the cot is secured in the transport position, Power-LOAD can interface with and inductively charge compatible model 6506 Power-PRO™ XT and 6516 Power-PROTM IT ambulance cots. In the event of power loss, the system remains functional for securing the cot within the vehicle. In this case, loading and unloading of the cot would be achieved manually, as is standard practice today. There will be three cots compatible with Power-LOAD, Power-PRO XT, Power-PRO IT and Performance-PRO XT.

The Stryker Power-LOAD™ Cot Fastener System (K113598) is a medical device intended to assist with loading and unloading compatible wheeled stretchers (ambulance cots) into and out of transport vehicles, and to secure the cot during transport. The device has a maximum safe working load of 870 lbs.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a distinct "test set" in terms of patient or case data because this device is a mechanical fastening system, not a diagnostic or therapeutic device that processes patient-specific data.

• Test Set: The "test set" here refers to the actual physical devices (Power-LOAD™ systems and their components) and compatible ambulance cots used in validation testing.
• Sample Size: The document refers to "individual components and of the final device," "individual units and system," suggesting that multiple units or components were tested. However, a specific numerical sample size for the devices tested is not explicitly stated.
• Data Provenance: Not applicable in the traditional sense of patient data. The testing was performed internally by Stryker Medical, a division of Stryker Corporation (based in Portage, MI, USA), and involved independent third-party laboratories for electrical and EMC compliance (InterTek Testing Services, Ohio, USA). The testing is prospective as it's part of the product development and validation process.

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

This is not directly applicable in the context of this device. "Ground truth" usually refers to a definitive diagnosis or outcome for a diagnostic/AI system. For a mechanical medical device:

• "Ground Truth" Equivalents: The "ground truth" for the Power-LOAD™ system would be its adherence to engineering specifications, safety standards, and functional requirements as determined by expert engineers, quality assurance personnel, and regulatory specialists.
• Experts: The document mentions "trained professionals including: emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers" as intended users, and "User needs studies were conducted to ensure that user needs are met." These users would have provided feedback, indirectly establishing whether the device meets their practical "ground truth" requirements for usability and functionality in real-world scenarios. However, the exact number and detailed qualifications of these individuals are not specified. Engineering and quality control experts within Stryker and at accredited testing facilities would also contribute to establishing the "ground truth" of performance against specifications.

4. Adjudication Method for the Test Set:

Not applicable in the typical sense of adjudicating conflicting expert opinions. The testing relies on objective measurements against predefined specifications and industry standards. For user needs studies, there might have been consensus-building or statistical analysis of user feedback, but no specific adjudication method 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:

This type of study is not applicable to the Power-LOAD™ Cot Fastener System. This device is a mechanical patient transport accessory, not an imaging or diagnostic AI-assisted system that involves "readers" or diagnostic cases.

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

This is not applicable. The Power-LOAD™ is a physical device with a human operator in the loop for loading, unloading, and control, even if it has automated assistance features. There is no isolated "algorithm" performance to assess separately from human interaction.

7. The Type of Ground Truth Used:

The "ground truth" for the Power-LOAD™ system is established through a combination of:

• Engineering Specifications: The device is designed to meet specific technical requirements (e.g., lift capacity, dimensions, operational speed).
• International and Domestic Standards: Compliance with recognized safety and performance standards (e.g., IEC, ISO, FCC, BS EN).
• User Needs/Feedback: Input from trained professionals ensures the device is practical and effective in its intended use environment.
• Abuse Testing: Simulating worst-case scenarios to ensure robustness and safety beyond normal operating conditions.

8. The Sample Size for the Training Set:

This is not applicable. The Power-LOAD™ system does not involve an AI algorithm that requires a "training set" of data. Its development and validation are based on engineering design, physical prototyping, and empirical testing.

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

This is not applicable as there is no training set for an AI algorithm.

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