(112 days)
BioBands is indicated for the relief of nausea. Nausea may be experienced due to a variety of causes, including Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia (Post-Operative) or Chemotherapy.
BioBands is an adjustable wristband that fits on either wrist. The device is composed from nylon and polyester fabric, and features a Velcro closure for easy adjustment. The BioBands wristband has a wooden bead or button sewn into the band's underside. When BioBands is worn by users, the wooden bead applies pressure to the P6 or "nei-kuan" acupuncture point. The gentle pressure applied by the bead to the P6 interrupts the signals that trigger nausea.
The provided text is a 510(k) summary for the BioBands device, which is an acupressure wristband. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data in the way a de novo or PMA submission would.
Therefore, much of the requested information (such as specific acceptance criteria based on performance metrics like sensitivity/specificity, detailed study designs, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not present in this document. The document's purpose is to establish equivalence, not to prove specific performance against quantitative criteria in a new study.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria or report specific device performance metrics (e.g., sensitivity, specificity, accuracy, or reduction in nausea scores) from a new clinical study. The basis for acceptance is substantial equivalence to predicate devices, which implies that if the predicate devices were considered safe and effective for the stated indications, then BioBands, being "similarly constructed" and using the "same principal of operation" for the "same indications for use," would also be considered safe and effective.
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance (Inferred from Substantial Equivalence Basis) |
|---|---|
| Similar design and construction to predicate devices. | BioBands is "similarly constructed" to K033268 and K041877. |
| Same principle of operation as predicate devices. | BioBands utilizes the "same principal of operation" as K033268 and K041877 (applying pressure to P6 point). |
| Same intended use/indications for use as predicate devices. | BioBands is "marketed for the same indications for use" as K033268 and K041877. (Relief of nausea from motion sickness, morning sickness, post-operative, and chemotherapy). |
| Safe and effective for intended use (implied by predicate clearance). | Implied to be safe and effective based on equivalence to cleared predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample size for test set: Not applicable and not mentioned. No specific test set for BioBands performance is described.
- Data provenance: Not applicable. The document relies on the regulatory clearance of predicate devices rather than new clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Number of experts/qualifications: Not applicable and not mentioned. No specific ground truth establishment for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable and not mentioned. No test set requiring expert adjudication is described.
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:
- MRMC study: No. This device is a physical acupressure band, not an AI or imaging device, so an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone study: No. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of ground truth: Not applicable. The "ground truth" here is effectively the prior regulatory clearance of the predicate devices based on their established safety and efficacy, or public domain knowledge about acupressure for nausea. The document doesn't describe establishing new ground truth for BioBands through clinical outcomes or expert consensus.
8. The sample size for the training set:
- Sample size for training set: Not applicable and not mentioned. There is no algorithm or model described that would require a training set.
9. How the ground truth for the training set was established:
- How ground truth was established: Not applicable and not mentioned. No training set or ground truth for it is described.
Summary of Study Information based on the provided document:
The provided 510(k) summary does not describe a new clinical study to establish acceptance criteria or device performance. Instead, it relies on demonstrating substantial equivalence to two legally marketed predicate devices: K033268 ("Sea-Band" wristband) and K041877 (Acu-Strap Motion Sickness Band).
- Basis for Substantial Equivalence: BioBands is described as "similarly constructed" to the predicates, utilizes the "same principal of operation" (applying pressure to the P6 or "nei-kuan" acupuncture point), and is "marketed for the same indications for use" (relief of nausea due to Travel, Pregnancy, Anesthesia, or Chemotherapy).
- No new clinical data/studies presented: The document does not provide details of any specific clinical trials, performance studies, sample sizes, expert-adjudicated ground truth, or statistical analysis for the BioBands device itself. The regulatory acceptance is based on its similarity to already cleared devices.
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