(155 days)
The Foot Weight Alarm is intended for use in the weight bearing training of patients with various orthopedic and neurological disabilities, such as malunion fracture, amputation, and cerebral vascular accident. The Foot Weight Alarm helps train patients by limiting the amount of force placed on the leg or helping a patient to reach a set amount of force in order to facilitate the return to normal gait pattern,
The Foot Weight Alarm is a foot shaped insole device to fit inside the patient's shoe to warn the patient when they are putting too little or too much weight on a limited weight bearing foot. It consists of an Insole, a Shoe Pouch which laces to the shoe, a foot unit which fits in the Shoe Pouch and connects to the Insole, a data cable that is used by a health care professional to program the Foot Weight Alarm unit; and Foot Weight Alarm Calibration System used by the health care professional to program the Foot Unit.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. It describes a 510(k) summary for the "Foot Weight Alarm" device, focusing on:
- Submitter and Device Information: Name, address, contact, submission date, classification, common/proprietary name.
- Classification and Regulation: Class II, regulated as a powered external limb overload warning device.
- Substantial Equivalence: Claimed equivalence to the BarMed Pty. Ltd. Portable Limb Load Monitor BMLLM-100 (K915 326).
- Device Description: Foot-shaped insole with load sensors, shoe pouch, foot unit, data cable, and calibration system.
- Intended Use: Weight-bearing training for patients with orthopedic and neurological disabilities (malunion fracture, amputation, cerebral vascular accident) to limit or achieve a set amount of force on the leg.
- Summary of Safety and Effectiveness: States the device is similar in application and operation to the BarMed LLM-100, and that its safety and effectiveness are comparable. A table compares features like sensors, alarm, portability, and monitor dimensions.
The document lacks details on specific performance metrics, acceptance criteria, or any studies (standalone or comparative effectiveness) with data on accuracy, precision, sensitivity, specificity, or other quantitative measures. It does not mention sample sizes for test or training sets, ground truth establishment, expert qualifications, or adjudication methods.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the studies, as this information is not present in the provided text.
§ 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.