(269 days)
The PostureTek Shirt provides training to help the wearer use his own muscles to maintain the desired posture, thereby correcting poor posture and improving appearance.
The POSTURETEK spinal curvature monitor is designed to be worn as a shirt, bra, tank top, or the like. Threaded in the garment is a monofilament, the tension of which changes depending upon the wearer's posture. If the wearer's posture is poor, an electronic disc located in the armpit region of the garment gently vibrates, alerting the wearer to correct his or her posture. The POSTURETEK device is easy to use, discrete, and durable.
The provided text is a 510(k) summary for the PostureTek Spinal Curvature Monitor. It focuses on demonstrating substantial equivalence to predicate devices and does not describe a study involving specific performance acceptance criteria or clinical trials.
Therefore, the requested information cannot be extracted from the given text as the document does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance studies.
- Type of ground truth used (e.g., pathology, outcomes data), beyond the general concept of "improper posture."
- Sample size for a training set.
- How ground truth for a training set was established.
The 510(k) summary states the device's intended use is to "provide training to help the wearer use his own muscles to maintain the desired posture, thereby correcting poor posture and improving appearance." It establishes substantial equivalence to existing devices (ZEGRA Posture Trainer K#081540 and Spine Tuner K#951244) based on having the "same intended use of improving posture" and "similar general technological characteristics." It describes the device's mechanism of operation (monofilament tension changes triggering a vibration alert for poor posture) but does not include any performance metrics, clinical study results, or specific acceptance criteria for its effectiveness.
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