(15 days)
The Rabbit Mobile Standing Frame is a mobile transport device for a child who needs to The itabolt Moone Banding, Frances anding, and requires anterior support from feet to sternum during incremental weight bearing from prone to upright standing. The Rabbit is storiall daring meremental whigh cood head, neck, and upper body control, and is atmized by a chird the dasping of their own volition, but requires support and alignment in weight bearing.
Rabbit Mobile Standing Frame
The provided text is a U.S. FDA 510(k) clearance letter for a medical device. This type of document declares a device to be substantially equivalent to a predicate device already on the market, thereby allowing it to be marketed.
However, a 510(k) clearance does not typically include detailed acceptance criteria or a study proving device performance in the way requested for software or AI medical devices. The FDA's substantial equivalence determination for this physical medical device (a mobile standing frame) is based on demonstrations of similarity in intended use, technology, and safety/effectiveness principles to existing devices, rather than a clinical trial demonstrating specific performance metrics against an acceptance criterion.
Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not present in this document because it is not a requirement for this type of 510(k) clearance for this device.
To directly address your request, based solely on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable. This document is a 510(k) clearance letter, confirming substantial equivalence, not a performance study report. Specific quantitative acceptance criteria or performance metrics for this physical device (Rabbit Mobile Standing Frame) are not detailed within this letter. The FDA's review for this device would have focused on its design, materials, and intended use being substantially equivalent to a predicate device, rather than statistical performance metrics like sensitivity/specificity often seen with diagnostic AI/software.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. No test set or associated data provenance is described in this regulatory clearance letter.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This document does not describe a test set or ground truth establishment process involving experts.
4. Adjudication Method for the Test Set:
- Not applicable. No test set or adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is typically for evaluating the impact of AI on human reader performance in diagnostic tasks. This device is a "Mobile Standing Frame," a physical assistive device. This document does not mention any such study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This device is a physical mobile standing frame, not an algorithm. This document does not mention any such study.
7. Type of Ground Truth Used:
- Not applicable. No ground truth (expert consensus, pathology, outcomes data, etc.) is mentioned as being used for performance evaluation in this clearance letter.
8. Sample Size for the Training Set:
- Not applicable. This document does not describe a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This document does not describe a training set or how its ground truth was established.
In summary: The provided document is a regulatory clearance letter for a physical medical device, not a technical report detailing performance studies or acceptance criteria typically associated with software or AI medical devices. Therefore, the requested information regarding acceptance criteria, study methodologies, and data specifics is not present.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
APR 0 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
R82 A/S c/o Mr. Kirk MacKenzie Snug Seat, Inc. 12801 East Independence Boulevard Stallings, NC 28105
Re: K030882
Trade/Device Name: Rabbit Mobile Standing Frame Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: II Product Code: IPL Dated: March 19, 2003 Received: March 20, 2003
Dear Mr. MacKenzie:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set 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.
{1}------------------------------------------------
Page 2 - Mr. Kirk MacKenzie
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Mulhern
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
STATEMENT OF INDICATIONS FOR USE
The Rabbit Mobile Standing Frame is a mobile transport device for a child who needs to The itabolt Moone Banding, Frances anding, and requires anterior support from feet to sternum during incremental weight bearing from prone to upright standing. The Rabbit is storiall daring meremental whigh cood head, neck, and upper body control, and is atmized by a chird the dasping of their own volition, but requires support and alignment in weight bearing.
for Mark A. Milken
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KO30882 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).