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The intended use of the Dalton Lift Chair, Model LC-106 is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.

The Dalton Lift Chair, Model LC-106 is intended to provide lift assistance for persons who have difficulty rising from a seated position to a standing position. It uses standard AC power from an electrical outlet. The device is mainly made of a welded steel frame, upholstery fabric and foam. The chair is assembled to welded steel lifting frame mechanism having a 24V DC motor/actuator powered by AC power from an electrical outlet. A hand-held control device engages the actuator to position the chair to recline, sitting, or standing position.

This document is a 510(k) Summary for the Dalton Lift Chair, Model LC-106. It details the device's characteristics and its substantial equivalence to a predicate device, rather than presenting a study to prove the device meets acceptance criteria. No information about acceptance criteria or specific study results is provided beyond non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the device's performance. Instead, it lists the device's technical specifications and compares them to a predicate device to establish substantial equivalence.

The non-clinical testing for the Dalton Lift Chair LC-106 included:

• IEC 60601-1:1988/A1:1991/A2:1995 for basic safety: "All tests were completed successfully."
• IEC 60601-1-2 for Electromagnetic Compatibility: "All tests were completed successfully."
• California Technical Bulletin No. 117: Test Procedure and Apparatus for Testing the Flame Retardance of Resilient Filling Materials Used in Upholstered Furniture: Tests were conducted. (Implied successful, as it contributes to the conclusion of substantial equivalence).
• Biocompatibility (Upholstery Fabric): Evaluated for Cytotoxicity per ISO 10993-5 and for Skin Irritation and Dermal Sensitization per ISO 10993-10. (Implied successful).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as no clinical test set or data relevant to a diagnostic performance study was conducted. The evaluation was based on non-clinical testing and comparison to a predicate device.

3. 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 information is not applicable as no clinical test set requiring expert-established ground truth was performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as no clinical test set requiring adjudication was performed.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a mechanical lift chair, not an AI-assisted diagnostic tool.

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

A standalone performance evaluation in the context of an algorithm or AI was not performed. This is a mechanical device.

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

For the non-clinical testing, the "ground truth" would be the specifications and requirements defined by the relevant standards (e.g., IEC 60601-1, IEC 60601-1-2, California Technical Bulletin No. 117, ISO 10993). The device's performance was compared against these standard requirements.

8. The sample size for the training set

This information is not applicable. There is no mention of a training set as this is a mechanical device, not an AI or algorithm-based system that requires machine learning training.

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

This information is not applicable as there was no training set.

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The intended use of the Relay is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Not Found

This document is a 510(k) summary for the Relay powered wheelchair (K101611) and does not contain information about acceptance criteria or a study proving that a device meets such criteria.

The 510(k) letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices. It lists the device name "Relay" and its regulation number and name. However, it does not include details on specific performance metrics, clinical studies, or acceptance criteria typical for product performance evaluations.

Therefore, I cannot provide the requested information based on the provided text.

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The intended use of the TACAMO Manual Wheelchair is to provide mobility to persons limited to a sitting position.

The DALTON INSTRUMENT CORPORATION Model TACAMO is a manually operated, self propelled, manual, mechanical wheelchair. The primary design function and use is to provide mobility to persons who may be restricted to a sitting position. This product may also be used as an attendant propelled patient transport device in a health care environment such as a hospital, nursing home or long term care facilities. The product has standard manual wheelchair features. It consists of the frame, 24" rear wheels with hand rims for propelling the chair, and 8'' front casters for steering and turning. The wheelchair frame is constructed from both 1.25" and 1" outside diameter(OD) round, mechanical, steel tubing. The side frames are of welded construction and are secured to the remaining frame members using screws and bolts. This device is a rigid, "non folding" type wheel chair that incorporates a solid seating surface. TACAMO also comes with wheelchair cushion and seating system. TACAMO also includes a "Tilt in Space" feature which allows the seat and back of the wheelchair to be tilted. This feature is used for those patients who require a tilt feature for stability, comfort or head control. It also serves as an attendant aid in those situations where a patient need to be tilted to be fed, or attended to in some situations. The "Tilt in Space" feature is manually operated and is activated by two release levers located at the rear of the wheelchair. Adjusting the tilt is achieved by squeezing the two release lever handles inward simultaneously. When the levers are squeezed, flexible cables attached to each release lever disengage gear rack segments from independent actuator rods which are notched to match the teeth of the gear segments. Once the desired tilt angle has been obtained, the handles are released and the chair will remain at the angle chosen. The chair has a tilt angle range of 30 degrees and 30 degrees of reclining angle.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not specify a separate "test set" in the context of typical AI algorithm evaluation with a specific sample size, country of origin, or retrospective/prospective nature. Instead, the performance is demonstrated through adherence to established wheelchair international standards. This implies that the device was physically tested against the specified parameters of these standards. The data provenance would be the results of these physical tests, likely conducted at the manufacturer's facility or a certified testing lab.

3. Number and Qualifications of Experts for Ground Truth:

Not applicable in the context of this type of device submission. Ground truth is established by the specifications and methodologies within the RESNA and ISO standards, not by expert consensus on particular data points. The "experts" would be the engineers and technicians who conducted the tests according to the standard protocols and interpreted the results against the standard's criteria.

4. Adjudication Method:

Not applicable. Device performance is determined by meeting objective industrial standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a physical medical device (manual wheelchair), not a diagnostic or AI-driven imaging device that would typically undergo MRMC studies.

6. Standalone Performance Study:

Yes, a standalone performance was done in the sense that the device was tested independently against the published international standards (RESNA ANSI/RESNA WC/Vol.1-1998 and DIS ISO 7176 (1992) Part 8). The stated compliance confirms its standalone performance against these benchmarks.

7. Type of Ground Truth Used:

The ground truth used is based on established, internationally recognized engineering and safety standards for wheelchairs. This includes quantitative measurements and test procedures for static, impact, and fatigue strengths, as well as general requirements for wheelchairs.

8. Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI algorithm that requires a "training set" of data. The design and manufacturing processes are informed by engineering principles and safety standards, rather than machine learning from data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" in the context of this device. The design specifications and manufacturing processes are guided by recognized engineering practices and the requirements outlined in the RESNA and ISO standards.

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