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Buzzy® is intended to control pain associated with needle procedures (e.g., injections, vascular access, cannulation, lab draws, blood donation, dialysis, cosmetic and dental injections) and the temporary relief of minor injuries (muscle or tendon aches, splinters, and bee stings).

VibraCool® is intended for the temporary relief of minor injuries (muscle or tendon aches) and the treatment of myofascial pain post-surgery. It is also indicated for use prior to or during physical therapy to treat myofascial pain caused by trigger points, restricted motion and muscle tension.

Buzzy® and VibraCool® devices are external use, skin contacting vibration devices that can be used with heat (for VibralCool® Flex, VibraCool® Pro UE and VibraCool® Pro LE)or cold therapy (for all Buzzy® and VibraCool® models) to provide pain relief. The brand names encompass the same two shapes of vibrating devices using the same motor. Buzzy Pro and VibraCool Pro are a new shape with the same motor submitted in this 510K. To accommodate various uses and anatomical locations, the Buzzy and VibraCool devices are available in three different shapes and are provided with different sets of accessories.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the Buzzy® and VibraCool® devices, not a medical imaging AI device. Therefore, much of the requested information regarding AI acceptance criteria, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies is not applicable to this document.

However, I can extract the relevant information concerning the device's performance validation based on the provided text.

Here's the breakdown of what is available and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a tabulated format with numerical targets that the device had to meet for pain reduction. Instead, it refers to a clinical study that evaluated the device's effect on pain.

Implicit "Acceptance Criteria" (based on study results):

• Reduced pain during/after vaccination. The study results show a statistically significant reduction in pain scores for the Buzzy group compared to the control.

Reported Device Performance (from Clinical Study - Table 4):

2. Sample size used for the test set and the data provenance

• Sample Size: N = 60 (for the clinical study in infants).
• Data Provenance: The document does not specify the country of origin. It indicates it was a "Prospective, randomized study" of infants receiving the MMR vaccine.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not explicitly stated as "experts" for ground truth, but "nurses and parents" rated the pain using the FLACC scale. No specific qualifications (e.g., years of experience) are provided for these raters.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not specified. Pain was rated by nurses and parents, but it's not clear if there was any conciliation or adjudication process if their ratings differed.

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 is not an AI device. The study evaluated the direct effect of the Buzzy device on pain compared to a control.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable, as this is a non-AI therapeutic device.

7. The type of ground truth used

• Type of Ground Truth: Pain scores rated by nurses and parents using the FLACC (Faces, Legs, Arms, Cry, Console) scale, which is an observational pain scale. This could be considered observational/clinical assessment data as ground truth.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a non-AI device; there is no "training set" in the context of machine learning. The clinical study described in Table 4 is the validation study for the device's efficacy.

9. How the ground truth for the training set was established

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI model.

Summary of Non-AI Related Information from Document:

The document outlines the FDA's 510(k) clearance for Buzzy® and VibraCool® devices based on their substantial equivalence to a predicate device (K130631 Buzzy®). The primary changes and justifications for substantial equivalence include:

• Addition of VibraCool models: Justified by using the same vibration device, external use, and supporting clinical data for vibration + heat/cold therapy for pain.
• Addition of "Pro" lines (Buzzy Pro, VibraCool Pro): Justified as being identical in materials, motor, circuitry, functionality, and intended use, differing only in shape.
• Updated Indications for Use: Clarified "needle procedures" for Buzzy with examples, and refined VibraCool's indications regarding myofascial pain, stating these clarifications do not introduce new questions of safety/effectiveness.
• Expanded Patient Population: Buzzy with cold pack is now indicated for 1 year and older (vs. 4+), and VibraCool/Pro with hot pack for 12 years and older. This was supported by a clinical study.

Non-Clinical Testing:

• Temperature testing (device surface and skin surface).
• Seal integrity/strength testing of hot packs.
• Shelf stability tests of hot packs.
• Electrical safety and electromagnetic compatibility (IEC 60601-1, IEC 60601-1-11, CFR 47 FCC Part 15).

Clinical Testing:

• A prospective, randomized study evaluated the effect of Buzzy on pain in 60 infants (12-month olds) receiving the MMR vaccine.
• Results: The Buzzy group showed significantly lower average pain scores (FLACC scale) during and after vaccination compared to the control group (p=.001 for both). Pulse was also lower after injection for Buzzy (p=.037).
• Ground Truth: Pain rating by nurses and parents using the FLACC scale.

The conclusion is that based on non-clinical testing and clinical evidence from published studies, the new and modified devices do not raise new issues of safety or effectiveness and are substantially equivalent to the predicate.

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