(243 days)
Acubands are indicated for the relief of nausea. Nausea is a symptom which can be experienced by causes such as motion sickness, morning sickness (pregnancy), chemotherapy and post-operative from anesthesia.
The Acubands consist of a pair of wrist bands with a half-round button affixed to the interior side of the band. The Acubands are made of hook and loop fabric which allows the wrist band to be fully adjustable. The Acuband wrist bands enable the button to apply gentle pressure on the acupressure point, the P6 or Nei-Kuan, point on the inner wrist. This action interrupts the signal that triggers nauses.
This submission primarily focuses on establishing substantial equivalence for the Acuband device based on technological characteristics and intended use compared to predicate devices, rather than presenting a performance study with acceptance criteria. As such, the input document does not contain the information required to populate most of the sections in your request. The device is an acupressure wristband, and the review by the FDA (in 2006) for this type of device typically relied on comparison to previously approved devices of similar design and function, not on extensive performance studies with specific acceptance criteria in the same way a diagnostic or therapeutic medical device might.
Here's an attempt to address the points based on the provided text, highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The submission focuses on substantial equivalence to predicate devices based on design and intended use, not on quantifiable performance metrics with associated acceptance criteria.
2. Sample size used for the test set and the data provenance
Not applicable. No performance study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No performance study data is presented.
4. Adjudication method for the test set
Not applicable. No performance study data is presented.
5. 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. This device is an acupressure wristband, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted or is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an acupressure wristband, not an algorithm.
7. The type of ground truth used
Not applicable. No performance study was conducted that would require a "ground truth" in the typical sense for a medical device performance evaluation. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. This device is an acupressure wristband, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable. This device is an acupressure wristband, not a machine learning algorithm.
Summary based on the provided text:
The provided document is a 510(k) summary for the Acuband, an acupressure wristband. The submission establishes substantial equivalence to previously cleared predicate devices (BioBands, Acu-Strap, Sea-Band, Ezy-Travel Band) based primarily on:
- Intended Use: Both the Acuband and the predicate devices are indicated for the relief of nausea due to various causes (motion sickness, morning sickness, chemotherapy, post-operative from anesthesia).
- Technological Characteristics: The Acuband is described as being constructed in the same manner as the Bio-Bands (K051397). It uses hook and loop fabric for adjustability and features a plastic button to apply pressure to the P6 or Nei-Kuan acupressure point on the inner wrist. The button's dimensions and composition are stated to be similar to those of the predicate devices.
The FDA's review in 2006 concluded that the device was substantially equivalent to legally marketed predicate devices, thereby allowing it to proceed to market under general controls provisions. This type of submission does not typically include a detailed performance study with quantifiable acceptance criteria for a physical device like an acupressure band.
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