TWO RIVERS POWER LIFT/RECLINE CHAIR by TWO RIVERS, LLC.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Two Rivers Power Lift/Recline Chair." It explicitly states that the device is substantially equivalent to a legally marketed predicate device. This type of document, particularly older 510(k) clearances, often does not include the detailed study information, acceptance criteria, or performance metrics that are typical for more recent PMA or de novo applications, or even more rigorous 510(k)s.

Therefore, many of the requested fields cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the document's content:

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

Acceptance Criteria: Not specified in the document.
Reported Device Performance: Not specified in the document.

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

Not specified in the document. This type of detail is typically not included in a 510(k) clearance letter itself.

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)

Not applicable/Not specified. For a device like a power lift/recline chair, "ground truth" and expert adjudication in the context of diagnostic performance are not relevant. Testing would likely involve engineering specifications, safety standards, and user-centric trials for functionality, none of which are detailed here.

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

Not applicable/Not specified.

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

Not applicable. This is a mechanical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a mechanical device.

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

Not applicable. Performance would likely be assessed against engineering specifications, safety standards, and functional requirements, rather than diagnostic "ground truth."

8. The sample size for the training set

Not applicable/Not specified. This is a mechanical device, not a machine learning model.

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

Not applicable/Not specified.

Summary based on the document:

This document is a regulatory clearance for a physical medical device (a power lift/recline chair), not a diagnostic algorithm or AI system. Therefore, most of the requested information (related to AI performance, ground truth, expert opinions, and reader studies) does not apply or is not present in this type of regulatory correspondence. The approval is based on "substantial equivalence" to a predicate device, meaning it performs similarly and has the same intended use. The detailed testing data supporting this equivalence is typically found in the 510(k) submission itself, not in the clearance letter.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with healthcare. The symbol consists of a staff with a snake winding around it, and wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 17 1999

Mr. Chris Whitaker Two Rivers, LLC P.O. Box 356 204 Soth Broad Street New Tazewell, Tennessee 37825

Re: K991693

Trade Name: Two Rivers Power Lift/Recline Chair Regulatory Class: II Product Code: INO Dated: June 24, 1999 Received: June 28, 1999

Dear Mr. Whitaker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Chris Whitaker

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Mark N Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Two Rivers Power Lift/Recline Chair Device Name:

To be used by the aged or partially disabled individuals to help Indications For Use: them rise to a standing position from a seated position.

Mark M Mulhern

for
cmw (Division
Division
510(k) N

Division Sign-Off) ision of General Restorative Devices 510lk) Number

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

Over-The-Counter Use

ter Use

(Optional Format I-2-96)

Exhibit 2

Regulation Number and Section

§ 890.3110 Electric positioning chair.

(a)
Identification. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.(b)
Classification. Class II. The electric positioning chair 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 non-clinical 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 non-clinical 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 non-clinical 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 non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-1, “Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance,” and ANSI/AAMI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Disturbances—Requirements and Tests”) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, “Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process,” ANSI/AAMI/ISO 10993-5, “Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity,” and ANSI/AAMI/ISO 10993-10, “Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization”) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, “Medical Device Software—Software Life Cycle Processes”) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable;
(9) Appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and
(10) Adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment.