(269 days)
The Beactive Brace is applied to the upper calf just below the knee such that the pressure pad presses against the soleus muscle located just to the outside of the back of the knee for the purposes of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities. The Beactive® Brace is intended for over-the-counter distribution.
The Beactive® Brace is a brace intended to temporarily reduce lower back pain that radiates down the leg associated with normal household or work activities. The Beactive® Brace is an adjustable, cylindrically-shaped band that fits over the upper calf on either leg. Integrated into the wall of the brace is a disk-shaped protrusion (pressure pad) that projects inward the leg. The pressure pad presses against the soleus muscle located just to the back of the knee. The pressure pad exerts even pressure on the soleus muscle near its origin at the fibula. The Velcro strap is designed to focus the pressure on the pressure pad on the calf. As a soleus muscle compression brace, it uses both compression as well as anterior glide forces onto the proximal tibiofibular joint to temporarily reduce low back pain.
Here's an analysis of the provided text to extract the acceptance criteria and study details for the Beactive® Brace:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a numerical or pass/fail threshold manner. Instead, it describes general effectiveness and safety observations. Based on the provided "Effectiveness" and "Safety" sections, we can infer the following:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Effectiveness: | |
| - Temporary reduction of lower back pain that radiates down the leg associated with normal household or work activities. | - Temporarily reduced low back pain that radiates down the leg associated with normal household or work activities for a majority of subjects. |
- Produced clinically significant reduction in pain (≥30%) in 52% of subjects.
- Pain index reported at 15 minutes and 1 hour (while performing activity or in the worst pain position) declined clinically significantly: 32% (15 min) and 40% (1 hour).
- Clinically significant improvement in the disability index (Oswestry Disability Index Questionnaire) in 12% of subjects in the treatment group (after four days or one week of wear). |
| Safety: | |
| - Absence of adverse events. | - Subjects experienced no adverse events during the clinical trials. - Some subjects experienced an increase in pain, but labeling cautions the user to cease use and consult a physician if this occurs.
- Some individuals may be sensitive to materials, but labeling cautions the user to stop if skin becomes irritated. |
| Biocompatibility: | |
| - Meet biocompatibility standards for medical devices. | - Battery of testing included: Cytotoxicity, Sensitization, Irritation. (Results are not detailed beyond stating they were "conducted"). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for the clinical study. It refers to "a majority of subjects," "52% of subjects," and "12% of subjects," which indicates a quantitative study, but the total 'N' is missing.
- Sample Size: Not specified (referred to as "subjects").
- Data Provenance: Not explicitly stated (e.g., country of origin). It's a clinical study conducted as part of a 510(k) submission, suggesting it was likely conducted in accordance with FDA regulations, but whether it was prospective or retrospective is also not stated. However, the design of "before using," "while performing motion," "while at rest," and "after a week" suggests a prospective design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth independently for the clinical study. The "ground truth" for pain reduction and disability improvement was based on self-reported patient outcomes using established scales (10-point pain scale, Oswestry Disability Index Questionnaire).
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned or implied for the clinical study data or for establishing ground truth. The data appears to rely on direct patient reporting.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC study was performed or mentioned. The clinical study evaluated the Beactive® Brace itself, not its impact on human reader performance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The Beactive® Brace is a physical medical device (limb orthosis), not an algorithm or AI system. Therefore, the concept of an "algorithm only" or "standalone" study does not apply.
7. The Type of Ground Truth Used
- For Clinical Study: Patient self-reported pain levels (10-point pain scale) and disability index scores (Oswestry Disability Index Questionnaire). This is considered outcomes data / patient-reported outcomes.
- For Biocompatibility: Laboratory testing results (Cytotoxicity, Sensitization, Irritation). This is laboratory-based evidence.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as it's not an AI/ML model.
§ 890.3475 Limb orthosis.
(a)
Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.(b)
Classification. Class I (general 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. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.