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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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The bed mover is intended to assist a single operator in the moving of wheeled beds and stretchers from one location to another within a healthcare facility.

Examples of usage include:

• a single operator may move empty beds to staging or storage areas within the healthcare facility.
• a single operator may move patient-laden beds from one location to another within the healthcare facility.

The IRSG i-mover for beds is a battery-powered, temporary accessory to most wheeled hospitals beds and stretchers. It is unit operated by a single caregiver to assist in the movement of most wheeled hospital beds and stretchers commonly used within a healthcare facility.

Only the caregiver, not the patient, can control this powered assistive device.

This device is not permanently attached to or made a part of the stretcher or bed.

The FDA has classified this device as an accessory to the wheeled bed or stretcher which the device will assist in moving. These beds and stretchers are Class I (hydraulic or manual beds) and Class II (powered adjustable beds and wheeled stretchers). The FDA has classified this device as a Class I device when used with non-patient laden beds and a Class II device when assisting in movement of a patient-laden bed.

The provided text describes a 510(k) summary for the IRSG Bed Mover, a device intended to assist a single caregiver in moving hospital beds and stretchers. However, it does not contain information about acceptance criteria or a study that rigorously proves the device meets those criteria in the way typically expected for a medical device with performance metrics (e.g., accuracy, sensitivity, specificity, or improvement in human performance).

The submission focuses on establishing substantial equivalence to predicate devices based on intended use, basic movement technology, and performance characteristics, but it does not detail specific performance studies with quantitative acceptance criteria.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

1. Table of acceptance criteria and reported device performance: This information is not present. The document focuses on regulatory classification, intended use, device description, and comparison to predicate devices, asserting "substantial equivalence" rather than reporting distinct performance metrics against predefined acceptance criteria.
2. Sample size used for the test set and the data provenance: Not applicable in this context. There isn't a "test set" of data in the sense of a machine learning or diagnostic device that requires data for evaluation. The device is a bed mover, and its evaluation relies on comparison to existing devices and compliance with safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant to a bed mover.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-powered diagnostic tool, so there are no "human readers" in this context, nor an AI component to compare against. Its purpose is mechanical assistance, not diagnostic improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a human-operated mechanical aid, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. The device is a hardware product, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

What is present in the document related to "acceptance criteria" and "study":

The "acceptance criteria" for this type of device, as per the 510(k) summary, are primarily centered around substantial equivalence to predicate devices and compliance with voluntary standards for safety.

• Acceptance Criteria (Implicit - based on 510(k) requirements):

  • Substantial Equivalence: The IRSG Bed Mover must be substantially equivalent in intended use, technological characteristics, and performance to legally marketed predicate devices.
  • Safety Standards: Compliance with relevant voluntary safety standards, specifically IEC 60601-1 (Medical Electrical Equipment – Part 1: General Requirements for Safety).
  • No New Issues of Safety or Effectiveness: The minor differences from predicate devices should not raise new concerns.
  • Biocompatibility: Not applicable since the device does not contact the patient.
  • Labeling and Instructions: Provision of clear labels and manuals for safe operation.

• "Study" (as described):
  The document doesn't describe a formal clinical study or a quantitative performance validation study with specific metrics. Instead, the "study" is implicitly the 510(k) submission process itself, which argues for substantial equivalence based on:

  1. Device Comparison: Directly comparing the IRSG Bed Mover to two predicate devices:
     • Stryker Powered Wheeled Stretcher with Zoom™ Drive Wheel (K022309)
     • Paramed Systems Paraglyde™ DCS TM-1 (FPO, 880.6910, Class II, 510k exempt)
       The comparison asserts that the IRSG bed mover is "substantially equivalent... in function, technological characteristics and intended use."
  2. Safety Standard Compliance: A statement that "The bed mover will comply with the following voluntary standards IEC 60601-1..." This implies that the device was designed to meet these standards, and presumably evidence of this compliance was provided in the full 510(k) submission (though not detailed in the summary).
  3. Risk Assessment (Implicit): Discussion points address potential safety concerns, stating that "The IRSG i-mover for beds does not contact the patient, so biocompatibility is not a concern," and that labeling addresses safe operation.

In summary, for the IRSG Bed Mover, the "acceptance criteria" were met by demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards, rather than through a performance study with quantitative metrics for the device itself.

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The Dyna GLIDE 2600 Roll-in Ambulance Cot is a PROFESSIONAL USE ONLY patient handling device with designed features allowing the Cot to be easily rolled in and out of an ambulance patient compartment. The primary purpose of the Dyna GLIDE 2600 is to ease the medical movement of a patient in an emergency medical situation by qualified and trained Emergency Medical Technicians (EMT)/Attendants.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "Dyna GLIDE 2600 Roll-In Ambulance Cot." This document is a regulatory approval letter and does not contain any information about acceptance criteria, study design, or performance data of the device itself.

Therefore, I cannot provide the requested information about acceptance criteria or a study that proves the device meets those criteria, as it is not present in the given text.

The information I can extract from the document is related to the device's regulatory approval:

• Device Name: Dyna GLIDE 2600 Roll-In Ambulance Cot
• Intended Use: A PROFESSIONAL USE ONLY patient handling device with designed features allowing the Cot to be easily rolled in and out of an ambulance patient compartment. The primary purpose is to ease the medical movement of a patient in an emergency medical situation by qualified and trained Emergency Medical Technicians (EMT)/Attendants.
• Regulatory Class: II
• Premarket Notification Number: K972528 (though it is K972538 at the bottom of page 2)
• Approval Date: July 28, 1997

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The subject stretcher and predicate are intended to be used with the general population to transport patients and to allow for patient care before, during, and after transport. The stretchers may be used in or for various patient care facilities and departments including, but not limited to, ED, transport, PACU, ambulatory surgery, long term care and home care. When fitted with the optional radiolucent surface, the stretcher may be used for acquisition of radiographic images.

A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps.

The provided text is for a 510(k) premarket notification for a wheeled stretcher, a physical medical device, not an AI/ML-based diagnostic or prognostic device. Therefore, the questions related to AI/ML device performance (acceptance criteria based on metrics like sensitivity/specificity, sample size for test sets, expert ground truth adjudication, MRMC studies, standalone performance, training set details) are not applicable.

The document discusses performance standards and testing for the physical device to assure compliance with safety specifications and voluntary standards.

Here's an attempt to extract relevant information, framed within the spirit of your request but acknowledging the different nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. For a physical device like a stretcher, "test set" typically refers to the prototype units manufactured and subjected to various engineering and safety tests. The document doesn't specify the number of prototypes tested but implies that testing was conducted.
• Data Provenance: Not applicable in the context of clinical data. The "data" here would be engineering test results generated internally by Hill-Rom, Inc.

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

• Not applicable. Ground truth, in this context, relates to compliance with engineering and safety standards, not clinical diagnostic accuracy. The "experts" would be the engineering and quality assurance personnel at Hill-Rom, Inc. who perform and verify the tests against established industry standards (UL, IEC, CSA). The document mentions "engineering" identified hazards and developed testing.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like "2+1" are for resolving disagreements among multiple human readers for ground truth establishment. For a physical device, testing is against objective performance specifications and voluntary standards. Pass/fail criteria are defined for each test.

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 a physical stretcher, not an AI/ML diagnostic device.

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

• Not applicable. This is a physical stretcher.

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

• The "ground truth" for this medical device's performance is adherence to established engineering specifications and voluntary national and international safety standards (e.g., UL, IEC, CSA). This is determined through physical testing and measurement, rather than clinical outcomes or expert consensus on a diagnostic finding. The document also mentions a "complete review of hazards associated with the product was performed."

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI/ML algorithm.

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

• Not applicable. This is a physical device, not an AI/ML algorithm.

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