(15 days)
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:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | Assist with loading/unloading compatible wheeled stretchers. | Verification and validation demonstrates the Power-LOAD™ meets its functional specifications. The system assists operators in lifting, lowering, and loading/unloading a cot using a battery-powered hydraulic system. Manual operation is possible in case of power loss. |
| Secure Cot During Transport | Secure the ambulance cot during transport. | Verification and validation demonstrates the Power-LOAD™ meets its functional specifications. When the cot is secured in the transport position, it's firmly held. In the event of power loss, the system remains functional for securing the cot. |
| Maximum Safe Working Load | 870 lbs (including cot, patient, and attached equipment). | Verification and validation demonstrates the Power-LOAD™ meets its performance specifications. While the document doesn't explicitly state "tested to 870 lbs," the statement implies satisfactory performance at this load. |
| Safety - Electrical | Compliance with electrical safety standards. | Successfully passed electrical safety testing and complies with IEC 60601-1. |
| Safety - Electromagnetic Compatibility (EMC) | Compliance with EMC standards. | Successfully passed electromagnetic compatibility testing and complies with IEC 60601-1-2 and FCC Parts 15 and 18. |
| Mechanical Integrity/Durability | Withstand abuse scenarios and meet performance. | Physical and mechanical testing performed on individual components and the system, including abuse testing to simulate worst-use scenarios. Test results demonstrated that both individual units and the system meet performance requirements. |
| Software Functionality | Software operates as intended. | Extensive software testing conducted. |
| User Needs | Meet the needs of intended users. | User needs studies were conducted to ensure that user needs are met. |
| Expected Service Life | 7 years. | The document states "The expected service life of the product is 7 years." While not explicitly mentioned as a tested criterion in the performance summary, this is a stated characteristic that the device is intended to meet. The extensive testing and compliance with standards would support this projected lifespan. |
| Compliance with Standards | Adherence to relevant domestic and international standards. | Designed and evaluated according to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-38, IEC 60601-1-4, ANSI/AAMI/IEC 62304, AAMI SW68, ISO 14971, ISO 13485, BS EN 1789, CFR 47 FCC Part 15, and CFR 47 FCC Part 18. |
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.
§ 880.6910 Wheeled stretcher.
(a)
Identification. 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 frame may be fixed or collapsible for use in an ambulance.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.