(105 days)
The Martin Chair Model C4S1 is indicated for providing mobility to persons limited to a sitting position. It is also specifically indicated to transfer a patient to and from the Martin Examination Table.
The Martin Examination Table is indicated for use during diagnostic examinations or surgical procedures to support and position a patient.
The Martin Chair Model C4S1 mechanical wheelchair is an indoor/outdoor wheelchair that has a base with two larger rear wheels and two smaller front wheels and a seat. The wheelchair is intended to be manually propelled by a person seated in the wheelchair or by an attendant or clinician. The device is made from composites of steel, plastics and fabrics. The wheelchair is for use by adult persons.
The wheelchair can be secured to a compatible, electrically elevated examination table which allows for the seat of the wheelchair to become part of the examination table. This removes the need for the patient to be lifted during transfer from the wheelchair to the examination table. The wheelchair is latched to the examination table and the side frame and wheels are removed for the examination. The sides and wheels are replaced prior to lowering the examination table allowing the wheelchair to be used according to its intended use.
The Martin Examination Table is a 510(k) exempt device, 21 CFR 878.4960, product code LGX. It is an accessory to the Martin Chair. It is a device intended as a powered examination table to provide positioning and support to patients during general examinations and procedures. It is intended for medical purposes as an electrically operated table with movable components that can be adjusted to various positions, the same intended use as other currently marketed powered tables. The Martin Examination Table is a standard powered examination table that includes standard components and features of other currently marketed powered examination tables including side rails for additional safety. The Martin Examination Table includes latches under the seat cushion that are compatible with the fixed metal receivers of the Martin Chair Model C4S1,
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Koso506 Martin Chair C4S1:
Important Note: The provided document is a 510(k) Summary for a mechanical wheelchair, which is a relatively low-risk Class I device. As such, the depth of performance testing and the types of studies typically required for more complex or higher-risk devices (like those involving AI algorithms, for instance) are not present here. The questions you've asked are more geared towards AI/software as a medical device (SaMD) clearances. I will answer them to the best of my ability based only on the provided text, and will explicitly state if information is not available.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Wheelchair Performance (Martin Chair C4S1) | |
| Meets applicable FDA recognized ANSI/RESNA consensus standards for mechanical wheelchairs. | "The Martin Chair Model C4S1 mechanical wheelchair meets the applicable FDA recognized ANSI/RESNA consensus standards tested by Human Engineering Research Laboratories (HERL) for mechanical wheelchairs and has successfully passed testing." |
| Meets flame retardant standards. | "Data within the 510(k) demonstrates successful performance against flame retardant standards." |
| Examination Table Performance (Martin Examination Table) | |
| Meets UL 60601-1 standard. | "The Martin Examination Table has been tested to in accordance with standards: UL 60601-1" |
| Meets UL 60601-1-2 standard. | "The Martin Examination Table has been tested to in accordance with standards: UL 60601-1-2" |
| Meets CSA 22.2 No 601-1 standard. | "The Martin Examination Table has been tested to in accordance with standards: CSA 22.2 No 601-1." |
Study Details
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The document states that the devices (Martin Chair C4S1 and Martin Examination Table) were "tested" and "passed testing" according to specific standards (ANSI/RESNA, UL, CSA). These standards typically involve a defined number of test samples (e.g., specific units of the wheelchair or examination table) for various mechanical, safety, and performance evaluations, but the exact number isn't detailed in this summary.
- Data Provenance: Not explicitly stated. The testing was performed by "Human Engineering Research Laboratories (HERL)" for the wheelchair and implicitly by a qualified entity for the examination table standards (UL/CSA). The country of origin of testing data is not mentioned, but given the US FDA submission, it's presumed to be from a reputable testing facility. The nature of these tests is prospective (the actual devices are subjected to specified physical tests).
-
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)
- This question is not applicable to the type of device and testing described. The "ground truth" for a mechanical wheelchair and examination table is established by direct physical measurement, stress testing, and functional evaluation against engineering and safety standards, not by expert interpretation of data like in medical imaging. The "experts" involved would be engineers and technicians at the testing laboratories (HERL, UL, CSA labs) who are qualified to perform and interpret the results of these standards-based tests. Their specific numbers and qualifications are not detailed in this 510(k) summary.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 are used for human interpretation tasks, especially in clinical studies or for establishing ground truth in AI model training/testing. This submission pertains to physical device testing against established engineering and safety standards, where outcomes are typically objectively measured (e.g., "passed" or "failed" a specific physical test).
-
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 is relevant for AI-assisted image interpretation or diagnostic tools, where human readers (e.g., radiologists) are involved. This submission is for a mechanical wheelchair and examination table, which do not involve human "readers" or AI assistance in a diagnostic context.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a mechanical wheelchair and an examination table; it does not contain an AI algorithm. Therefore, "standalone" algorithm performance is not relevant.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is objective compliance with recognized consensus standards (ANSI/RESNA for wheelchairs, UL/CSA for examination tables) and physical performance criteria (e.g., successful flame retardancy, meeting specified mechanical stress tolerances, electrical safety adherence). There is no "expert consensus" or "pathology" in the sense of medical diagnosis; rather, it's engineering and safety validation.
-
The sample size for the training set
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
-
How the ground truth for the training set was established
- Not applicable, as there is no AI or machine learning "training set" for this device.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).