(160 days)
ForceGuard is used to sense the amount of weight applied to the plantar surface of the foot. The device alerts the wearer and/or therapist with a repeating tone when the weight exceeds the pre-selected value.
ForceGuard will be used on patients who have bone, connective tissue or soft tissue damage who also have been instructed by a physician to limit the weight being placed on a lower limb.
ForceGuard Model 2090 consists of 3 components; footpad, electronics module, and leg band. The leg band is worn around the patient's ankle. The electronics module attaches to the leg band. The footpad, a flexible, fluid filled chamber, plugs into the electronics module and is worn under the plantar surface of the patient's foot inside suitable footwear.
The function of the leg band is to secure the electronics module to the patient's ankle. The function of the footpad is to sense the weight being placed through the patient's lower extremity. The electronics module functions as the user interface, processes information from the footpad and alarms when the weight on the footpad exceeds the selected weight.
The provided text describes a medical device, ForceGuard Model 2090, but it does not contain any information about a study that tests the device's performance against specific acceptance criteria in the context of AI or expert evaluation.
The document is a 510(k) summary, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It focuses on comparing the new device to existing predicate devices (Force Guard I and Pelimit) based on technological and performance characteristics.
Therefore, many of the requested information points, particularly those related to a study with acceptance criteria, sample sizes, expert involvement, and AI performance, cannot be extracted from this document.
However, I can extract information related to the device's specified performance characteristics (which can be considered de facto acceptance criteria based on the predicate device's performance).
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (based on predicate device comparison):
| Performance Characteristic | Acceptance Criteria (from Predicate Device - Force Guard I) | Reported Device Performance (ForceGuard Model 2090) |
|---|---|---|
| Weight Selections | 20, 30, 50, 70 lbs | 20, 30, 50, 70, 90 lbs |
| Durability (Controller) | 90 day warranty | 1 year warranty |
| Durability (Footpad) | 90 day warranty | 90 day warranty |
| Energy Source | Not replaceable | Replaceable |
| Accuracy | +/- 5 lbs | +/- 5 lbs or up to 10% |
| Low battery alarm | Audio | Audio |
| Malfunction alarms | Audio | Audio and Visual |
| Materials | Common | Common |
Note: The "acceptance criteria" here are inferred from the performance characteristics of the predicate device, which the new device is demonstrating substantial equivalence to or improvement upon. The document does not explicitly state "acceptance criteria" in a statistical or study-based sense.
Information NOT available in the provided text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not described.
- 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, as this is not an AI device and no such study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is not an algorithm-only device in the AI sense.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not described in terms of a formal study or ground truth establishment. The "ground truth" for performance is likely based on engineering measurements against specifications.
- The sample size for the training set: Not applicable, this is not an AI device requiring a training set in that context.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices, not a study report detailing performance against specific acceptance criteria using a test set with expert-established ground truth or involving AI.
§ 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.