(127 days)
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.
| Acceptance Criteria Category (Drawn from tests performed) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Mechanical & Functional Safety | Testing performed according to BS ISO 7176-28:2012. (Implies compliance with standard's requirements for stair-climbing devices.) |
| Climatic Functionality | Testing performed according to ISO 7176-9:2009 (Sections 8.2 - 8.5, 8.8). (Implies safe functionality under different climates.) |
| General Safety | Testing performed according to ISO 7176-14:2022. (Implies general safety of the device.) |
| Static & Fatigue Strength | Testing performed according to ISO 7176-8:2014. (Implies static and fatigue strength.) |
| Brake Fatigue Strength | Testing performed according to ISO 7176-3:2012. (Implies brake effectiveness and fatigue strength.) |
| Biocompatibility | Testing performed according to ISO-10993-10:2010, ISO 10993-5:2009, ISO-10993-23:2021. (Implies biocompatibility with skin contact.) |
| EMC & Electrical Safety | Testing performed according to ANSI AAMI ES60601-1:2005/(R)2012, IEC 60601-1-2:2014, IEC 60601-1-12:2014, IEC 60601-1-6:2013, IEC TR 60601-4-2:2016, AIM 7351731 Rev. 2.00:2017. (Implies compliance with electrical and electromagnetic safety standards.) |
| Cleaning & Disinfection | Testing performed according to AAMI TIR12:2020 and AAMI TIR30:2011. (Implies ability to be cleaned and disinfected.) |
| Mechanical/Electrical Performance (Simulated Use) | Life cycle testing, static/dynamic overload testing, power-wash exposure, shipping verification, manual/continuous stair climb performance. (Implies meeting functional specifications.) |
| Software Verification & Validation | Performed as recommended by FDA guidance ("moderate" level of concern). (Implies software reliability and safety.) |
| Usability | Usability testing conducted to ensure safe and effective operation. (Implies device is user-friendly and safe.) |
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.
§ 890.5150 Powered patient transport.
(a)
Powered patient stairway chair lifts —(1)Identification. A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.(2)
Classification. Class II. The stairway chair lift 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:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of American Society of Mechanical Engineers (ASME) A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the chair in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”);
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety; and
(v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.
(b)
All other powered patient transport —(1)Identification. A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.(2)
Classification. Class II.