(507 days)
The intended use is to provide muscle relaxation therapy by delivering a soothing massage.
Legacy-500 Massage Table is an electrically powered, motorized, multifunctional physical therapy table. The intended use is to provide muscle relaxation therapy by delivering a soothing massage. It is designed to travel throughout the back area in a smooth transition but can also stop in one specific area. Pressure of the massage can be adjusted from one (lowest setting) to six (highest setting) and is displayed by six lights. Rollers can massage clockwise or counter-clockwise and the indicator displays the position on the back. The timer allows the table to run from one to thirty minutes shutting power off after treatment time and returning the pressure of the rollers to the lowest setting, at any time during treatment the timer can be manually shut off to stop the table by user or patient. The only patient contacting component is the table top that the patient lays on covered in vinyl upholstery.
This document is a 510(k) summary for a massage table, not a clinical study report for an AI/ML powered medical device. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance metrics is not applicable.
Here's an attempt to address the questions based on the provided text, noting where the information is absent:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or device performance in the context of an AI/ML algorithm. Instead, it demonstrates "substantial equivalence" to predicate devices, which is the regulatory standard for 510(k) submissions. The "performance" is implied by matching features and intended use with already cleared devices.
| Feature (from Comparison Table) | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (Legacy-500) |
|---|---|---|
| Intended use: Designed to release muscle tension and deliver a soothing massage. | Yes | Yes |
| Substantially same size and shape. | Yes | Yes |
| Achieve the same physiological effects. | Yes | Yes |
| Three six-inch diameter massage rollers. | Yes | Yes |
| Clockwise and counter-clockwise roller rotation. | Yes | Yes |
| Adjustable roller pressure (varying degrees of pressure on muscles on back). | Yes | Yes |
| Height of rollers can adjust three inches above baseline table surface. | Yes | Yes |
| 30-minute timer that shuts power off after cycle time and is also used as the safety shut off. | Yes | Yes |
| Have the same type of frame construction. | Yes | Yes |
| Have steel roller carriage. | Yes | Yes |
| Can massage full back or selectable area. | Yes | Yes |
| Have lighted height indicator. | Yes | Yes |
| Have same style electrical components and motors. | Yes | Yes |
| Ten (10) minute recommended treatment time. | Yes | Yes |
| Covered in vinyl upholstery. | Yes | Yes |
| One control / indicator panel at head end of table to prevent patient from kicking controls when getting on. | Variation from predicates accepted | Yes (Difference noted but accepted for SE) |
| Indicator panel at head end and control panel at foot end of table. | Predicates have this | No (Device differs here) |
| Has optional hand-held control and heat option. | One predicate has this | No (Device differs here) |
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. The document describes a physical medical device (massage table), not an AI/ML algorithm tested with a data set. The "test set" in this context would be the physical device itself and its adherence to design specifications compared to predicate devices. There is no mention of data or data provenance.
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. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on images or medical records) is not relevant here. The "ground truth" for a massage table's substantial equivalence is its intended use, design features, and safety compared to established predicate devices, as evaluated by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There is no mention of an adjudication method as would be used for expert review of data in an AI/ML context. The FDA's review process is an assessment against regulatory requirements and comparison to predicates.
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
This information is not applicable. No AI component is described or evaluated in this 510(k) submission. Therefore, no MRMC study or AI assistance effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. There is no algorithm or software component described in this 510(k) submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable in the typical AI/ML sense. The "ground truth" for this medical device submission is effectively the established characteristics, safety, and effectiveness of the legally marketed predicate devices (K010252, K002390, K993461). The manufacturer is demonstrating that their device shares these fundamental characteristics.
8. The sample size for the training set
This information is not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set or corresponding ground truth establishment process described.
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KIII1588 PAGE 1 OF
510(k) Summary as Required by 21 CFR 807.92
| Submitter: | MT Tables, LLC |
|---|---|
| 15 W. Mill Street | |
| Aurora, MO 65605 | |
| Contact Person: | Milburn Tennis |
| (417) 678 2880 | |
| Date Prepared: | 01-02-2012 |
| RE: K111588 | |
| Device Trade Name: | Legacy-500 Massage Table |
| Common Name: | Massage Table, IST, Roller Table |
| 21 CFR 890.5880 | |
| Regulatory Class: | Class II |
| Product Code: | JFB |
| Part 890-: | SEC. 890.5880 Multi-Function Physical Therapy Table |
| Substantial Equivalence: | K010252 Magnum, K002390 Quantum 400, K993461 Quest IST |
Device Description: Legacy-500 Massage Table is an electrically powered, motorized, multifunctional physical therapy table. The intended use is to provide muscle relaxation therapy by delivering a soothing massage. It is designed to travel throughout the back area in a smooth transition but can also stop in one specific area. Pressure of the massage can be adjusted from one (łowest setting) to six (highest setting) and is displayed by six lights. Rollers can massage clockwise or counter-clockwise and the indicator displays the position on the back. The timer allows the table to run from one to thirty minutes shutting power off after treatment time and returning the pressure of the rollers to the lowest setting, at any time during treatment the timer can be manually shut off to stop the table by user or patient. The only patient contacting component is the table top that the patient lays on covered in vinyl upholstery.
OCT 26 2012
{1}------------------------------------------------
Intended Use: Legacy-500 Massage Table is designed to release muscle tension and deliver a soothing massage.
Technological Aspects: A comparison of the device features, intended use and other Information demonstrate that the Legacy-500 Massage Table ls substantially equivalent to the cleared for commercial distribution per K010252, K002390 and K993461.
| Comparison | Legacy-500 | K010252 | K002390 | K993461 |
|---|---|---|---|---|
| Intended use:Designed to release muscletension and deliver a soothingmassage. | Yes | Yes | Yes | Yes |
| Substantially same size andshape. | Yes | Yes | Yes | Yes |
| Achieve the same physiogicaleffects | Yes | Yes | Yes | Yes |
| Three six inch diametermassage rollers | Yes | Yes | Yes | Yes |
| Clockwise and counter-clockwise roller rotation | Yes | Yes | Yes | Yes |
| Adjustable roller pressure toplace varying degree ofpressure on muscles on back | Yes | Yes | Yes | Yes |
| Height of rollers can adjustthree inches above baselinetable surface | Yes | Yes | Yes | Yes |
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| Comparison | Legacy-500 | K010252 | K002390 | K993461 |
|---|---|---|---|---|
| 30 minute timer that shutspower off after cycle time andis also used as the safety shutoff | Yes | Yes | Yes | Yes |
| Have the same type of frameconstruction | Yes | Yes | Yes | Yes |
| Have steel roller carriage | Yes | Yes | Yes | Yes |
| Can massage full back orselectable area | Yes | Yes | Yes | Yes |
| Have lighted height indicator | Yes | Yes | Yes | Yes |
| Have same style electricalcomponents and motors | Yes | Yes | Yes | Yes |
| Ten (10) minuterecommended treatment time | Yes | Yes | Yes | Yes |
| Covered in vinyl upholstery | Yes | Yes | Yes | Yes |
| One control / indicator panelat head end of table toprevent patient from kickingcontrols when getting on oroff table | Yes | No | No | No |
| Indicator panel at head endand control panel at foot endof table | No | Yes | Yes | Yes |
| Has optional hand held controland heat option | No | No | Yes | No |
A comparison of the device features, intended use and other information demonstrates that the Legacy-500 is substantially equivalent to the cleared for commercial distribution per K010252, K002390 and K993461.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MT TABLES, LLC % Mr. Milburn Tennis Owner 15 West Mill Street Aurora, Missouri 65605
Re: K111588
Trade/Device Name: Legacy-500 Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-function physical therapy table Regulatory Class: Class II Product Code: JFB Dated: October 09, 2012 Received: October 09, 2012
Dear Mr. Tennis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
OCT 26 2012
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Page 2 - Mr. Milburn Tennis
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K111588
Device Name: Legacy-500
Indications For Use: The intended use is to provide muscle relaxation therapy by delivering a soothing massage.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K 111588
Page 1 of 1
§ 890.5880 Multi-function physical therapy table.
(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).