(83 days)
the device is a motorized device intended for medical purposes to assist in transfer of patient to and from beds, chairs, treatment facilities. wheelchairs or transport vehicles.
the Savion Industries "Medi-Cruiser" model MS777 Stretcher is a motorized patient transport stretcher / trolley. This device is a motorized device intended for medical purposes to assist in the transfer of patients to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.
The provided text is for a 510(k) summary for a "Motorized Patient Transport Stretcher" (Savion Industries "Medi-Cruiser" Model MS777). This type of device is a physical medical instrument, not a software device or an AI model, and therefore the concepts of acceptance criteria, study data, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable in the way they would be for an AI/ML medical device.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and compliance with safety standards for electrical and electromagnetic compatibility, as well as quality systems regulations.
Here's how to interpret the provided information in the context of a non-AI medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance:
For this device, "acceptance criteria" and "reported device performance" are primarily related to compliance with recognized medical device standards and demonstrating equivalence to existing legally marketed devices, rather than statistical performance metrics like sensitivity or specificity.
| Acceptance Criterion (Compliance Objective) | Reported Device Performance (Demonstrated Compliance) |
|---|---|
| Substantial Equivalence: To predicate devices (Stryker ZOOM® Motorized Stretchers / Hausted POWERTRAN series stretcher) in function, intended use, basic technology, and performance characteristics. | The submission explicitly states: "The Savion Industries "Medi-Cruiser" MS777 Stretcher is substantially equivalent to the ZOOM® Motorized Stretchers and to The Hausted® POWERTRAN M Series Stretcher in function and intended use." "Any minor differences described in the submission between the Savion Industries "Medi-Cruiser" MS777Stretcher and that of the predicate devices, does not raise any new issues of safety or effectiveness. The intended use, basic technology, and performance characteristics of the systems are the same." The FDA's 510(k) clearance letter confirms this finding: "We have... determined the device is substantially equivalent...". |
| Electrical Safety: Compliance with general requirements for safety of medical electrical equipment. | The device is designed to assure compliance with IEC 60601-1 (Electrical Safety). Electrical testing is certified by an accredited testing facility. The stretcher will comply with voluntary standard IEC 60601-1 (1988, Amendment 1 1991-11, Amendment 2 1995-03) and UL 2601-1 (2nd Ed.) and CAN/CSA C22.2 No. 601.1-M90. |
| Electromagnetic Compatibility (EMC): Compliance with EMC requirements and tests. | The device is designed to assure compliance with IEC 60601-1-2 (Electromagnetic Compatibility). The stretcher will comply with voluntary standard IEC 60601-1-2 (First Edition, 1993-04). |
| Quality System Compliance: Adherence to established quality management standards for medical devices. | Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications. These reports are maintained as required by ISO 9001:2000 and ISO 13485 Quality Systems Regulations. Design controls have been applied in accordance with FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001. An assessment of known and reasonable hazards has been conducted to ensure that any risk is as low as reasonably possible. |
| Risk Management/Hazard Assessment: Identification and mitigation of known and reasonable hazards. | An assessment of known and reasonable hazards has been conducted to ensure that any risk associated with the device as of the date of product release is as low as reasonably possible. |
| Labeling and Manuals: Provision of clear and safe operation information. | The labels and labeling (Operator's and Maintenance Manuals) provide information for the safe operation by the caregiver/user and the intended operation features. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. For a physical device like a stretcher, performance is evaluated through engineering tests (e.g., electrical safety, EMC, mechanical load testing) rather than a "test set" of data points. These tests typically involve a specific number of units from the production line or prototypes to verify compliance with standards. The document doesn't specify the number of units tested.
- Data Provenance: Not applicable in the context of an AI/ML device. The "data" here refers to test results from physical device testing, which would be generated in a lab setting, likely in Israel (where Savion Industries is located) or by an accredited international testing body. It's a prospective testing process on physical devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts & Qualifications: Not applicable. "Ground truth" in the AI/ML sense (e.g., expert labels on images) is not relevant for this device. The "truth" is established by adherence to engineering performance standards and regulatory requirements. The "experts" involved would be the engineers performing the tests, the quality assurance team, and the regulatory affairs personnel ensuring compliance. A design review was conducted by a "cross-functional team, including but not limited to regulatory, quality, engineering, technical writing and manufacturing."
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. There is no ambiguous "ground truth" that requires adjudication. Tests either pass or fail based on objectively defined criteria in the standards (e.g., leakage current levels, mechanical stability).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- MRMC Study: Not applicable. MRMC studies are used to evaluate the performance of diagnostic devices, often AI-assisted, by comparing human reader performance with and without AI assistance across multiple cases. This is a motorized stretcher, a therapeutic/transport device, not a diagnostic one.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance: Not applicable. This is a physical medical device. There is no algorithm or AI component to assess for standalone performance. The "device" itself operates with human interaction (caregivers).
7. The Type of Ground Truth Used:
- Type of Ground Truth: Not applicable in the AI/ML sense. For this device, the "ground truth" is defined by:
- Regulatory Standards: (e.g., IEC 60601-1, IEC 60601-1-2, UL 2601-1, CAN/CSA C22.2 No. 601.1-M90, FDA 21 CFR 820.30, ISO 9001:2000, ISO 13485).
- Predicate Device Performance: The "truth" of what is safe and effective is established by the existing, legally marketed predicate devices to which the new device demonstrates substantial equivalence.
- Engineering Specifications: Internal design and performance specifications against which the device is tested.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. There is no "training set" for a physical medical device in the AI/ML context. The design and manufacturing process are informed by engineering principles, industry best practices, and regulatory standards, not by machine learning training data.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable. As there's no training set, there's no associated ground truth to establish.
§ 890.3690 Powered wheeled stretcher.
(a)
Identification. A powered wheeled stretcher is a battery-powered table with wheels that is intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions).(b)
Classification. Class II (performance standards). The powered wheeled stretcher is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9, and the following conditions for exemption:(1) Appropriate analysis and nonclinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;
(2) Appropriate analysis and nonclinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;
(3) Appropriate analysis and nonclinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;
(4) Appropriate analysis and nonclinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and nonclinical testing must validate that the device components are found to be nonflammable;
(9) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the battery in the device performs as intended over the anticipated service life of the device;
(10) Adequate labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device in the intended use environment; and
(11) Appropriate risk assessment including, but not limited to, evaluating the dimensional limits of the gaps in hospital beds, and mitigation strategy to reduce entrapment.