(68 days)
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Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The device is described as a "limb load monitoring device to assist in the rehabilitation," indicating its purpose is for monitoring and assessment, not direct therapy or treatment.
No
The device is described as a "limb load monitoring device to assist in the rehabilitation of patients," which suggests a role in monitoring and potentially guiding therapy rather than diagnosing a condition. Its purpose is to "objectively assess[] the amount of weight that is being applied to a lower limb," which is a measurement for intervention, not diagnosis.
No
The description explicitly refers to a "Shoe System," implying a hardware component (the shoe) is integral to the device's function of monitoring limb load.
Based on the provided information, the AccuTread™ Shoe System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The AccuTread™ Shoe System is described as a "limb load monitoring device" that assesses the amount of weight being applied to a lower limb. This involves direct interaction with the patient's body (wearing a shoe) and measuring physical forces, not analyzing biological samples.
- The intended use is for rehabilitation and objective assessment of limb loading. This is a biomechanical and physical therapy application, not a diagnostic test performed on biological specimens.
The description clearly indicates a device used for monitoring and assisting in physical rehabilitation, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The AccuTread™ Shoe System is intended for use as a limb load monitoring device to assist in the rehabilitation of patients with insults to their lower extremities. The device is intended to be used in any situation in which a therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.
Product codes
IRN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lower extremities
Indicated Patient Age Range
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Intended User / Care Setting
therapist and/or patient
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.5575 Powered external limb overload warning device.
(a)
Identification. A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload or an underload in the amount of pressure placed on a leg.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
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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 circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 1999
Ms. Cheryl G. Dyer Regulatory Compliance Specialist Chattanooga Group, Inc. Representing Orthopedic Technology Research, Inc. 4717 Adams Road, P.O. Box 489 Hixson, Tennessee 37343
K991313 Re: AccuTread Shoe System Trade Name: Regulatory Class: II Product Code: IRN Dated: April 14, 1999 April 16, 1999 Received:
Dear Ms. Dyer:
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 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 (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 In addition, FDA may publish further announcements action. 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 - Ms. Cheryl G. Dyer
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,
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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Image /page/2/Picture/0 description: The image shows the logo for Orthopedic Technology Research, Inc. The logo consists of two parts: a square with a stylized "TR" inside, and the letters "OTR" in a bold, sans-serif font. Below the letters, the full name of the company is written in a smaller font. The logo is simple and professional, and it conveys the company's focus on orthopedic technology research.
INDICATIONS
The AccuTread™ Shoe System is intended for use as a limb load monitoring device to The Acca Fread - Oneo Byoten. In inx rehabilitation of patients with insults to their lower montor immod werght bearing adming admission is intended to be used in any situation in which a therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.
(Division Sign-Off) Division of General Resto 510(k) Number
Prescription Use
(Per 21 CFR 801.109)