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The Smileyscope System's Therapy Mode is a prescription-use intual reality system intended to provide adjunctive treatment based on guided relaxation and other evidence-based behavioral methods for patients aged 4-1 years who can cooperate and interact with the device at a developmentally appropriate level. The Smileyscope Therapy Mode is intended to temporarily reduce and/or manage pain and temporarily relieve acute procedural with needle procedures (e.g., venipuncture, IV placement, vaccination, port access, subcutaneous injections). The device is not intended to treat anxiety disorders or specific phobias (e.g. trypanophobia).

Smileyscope is an immersive virtual reality (VR) device, consisting of Hardware and Software components. In Smileyscope Therapy mode, the device delivers 3-dimensional virtual reality treatment based on guided relaxation and other evidence-based behavioral methods to temporarily reduce pain and temporarily relieve acute procedural anxiety in individuals undergoing needle procedures. This prescription-use device uses pre-loaded software on a proprietary hardware and software platform to deliver treatment. The Smileyscope device is supplied with a USB charger and USB cable to facilitate charging.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Smileyscope System (Therapy Mode):

Background Note: This document is a 510(k) summary, which often focuses on establishing substantial equivalence to a predicate device rather than presenting a full, detailed clinical study report. Therefore, some specific details about the study methodology (e.g., precise expert qualifications, detailed adjudication methods for ground truth) might not be explicitly stated in this type of summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the "Special Controls" applied to the predicate device, which the Smileyscope Therapy Mode aims to meet, and the "Clinical Performance Testing" results presented.

• Emergency Department study (N=123): Nil adverse effects in treatment arm.
• Outpatient Pathology study (N=129): 3 mild adverse effects in treatment arm.
  Overall, "safe, with no significant adverse effects." Adverse effects were mild (nausea, dizziness, headache, vomiting) and self-limiting. |
  | 2. Patient-contacting components are biocompatible. | Met: Biocompatibility evaluation performed per FDA guidance (ISO 10993-1:2018) for surface-contacting, limited duration (intact skin) components. Tests included Cytotoxicity, Sensitization, Intracutaneous Reactivity. |
  | 3. Software verification, validation, and hazard analysis performed. | Met: Documentation provided for "Minor" Level of Concern software, including requirements, traceability, revision history, V&V, hazard analysis, and cybersecurity. |
  | 4. Electromagnetic compatibility (EMC) and electrical, mechanical, and thermal safety testing performed. | Met: Conformance declared to harmonized standards (e.g., IEC 60950-1, EN 62368-1 for electrical safety; EN 301 489 series, EN 55032/55035 for EMC). |
  | 5. Labeling includes warnings for nausea/motion sickness, discomfort, and summary of clinical testing. | Implied Met: Labeling is listed as a migration measure for identified risks (nausea/motion sickness, discomfort, ineffective treatment, use error). A summary of clinical testing is provided in the 510(k) (and presumably in the actual labeling). |
  | II. Clinical Effectiveness Criteria (from study results): | |
  | Temporarily reduce and/or manage pain (primary effectiveness endpoint). | Met:
• Emergency Department study: Child Self-Rated Pain (Faces Pain Scale-Revised) reduction of -1.78 units with Smileyscope Therapy Mode vs. control (p=0.018).
• Outpatient Pathology study: Child Self-Rated Pain (Faces Pain Scale-Revised) reduction of -1.39 units with Smileyscope Therapy Mode vs. control (p=0.034). |
  | Temporarily relieve acute procedural anxiety (secondary effectiveness endpoint). | Met: Both studies "substantially reduced the secondary endpoint of procedural anxiety." (Specific quantitative results for anxiety are not provided in this summary table). |

2. Sample Size Used for the Test Set and Data Provenance

The "test set" here refers to the subjects in the clinical performance studies.

• Sample Size:

  • Emergency Department study: 123 (64 in Smileyscope Therapy Mode arm, 59 in Control arm).
  • Outpatient Pathology study: 129 (63 in Smileyscope Therapy Mode arm, 66 in Control arm).
  • Combined N = 252 (Enrollment N=254, but treatment group totals 252).

• Data Provenance:

  • Country of Origin: "Outside of the United States only". The specific countries are not mentioned in this summary.
  • Retrospective or Prospective: These were "randomized clinical studies" and referenced as "randomized controlled studies," implying a prospective design. Given that they are published in a peer-reviewed journal and were used for regulatory submission, this is a strong indication of prospective data collection.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

• The summary does not explicitly state the number of experts or their qualifications for establishing ground truth, as the primary effectiveness endpoint was "Child Self-Rated Pain (Faces Pain Scale-Revised)." This is considered a patient-reported outcome (PRO).
• For the secondary endpoint of "procedural anxiety," again, no specific expert involvement for ground truth is mentioned. Procedural anxiety in children is often assessed using validated scales administered by trained researchers or clinicians, or through observational measures.

4. Adjudication Method for the Test Set

• The summary does not explicitly state an adjudication method (e.g., 2+1, 3+1, none) for the test set. Given that the primary endpoint was child self-rated pain, and the studies were randomized controlled trials, the outcome measure itself (Faces Pain Scale-Revised) is directly reported by the patient. Adjudication of such an endpoint by external experts is generally not performed.
• For other aspects of the study (e.g., adverse event reporting, study protocol adherence), there would have been standard clinical trial monitoring and oversight, but this is not detailed as a "ground truth" adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done in the context of human readers with vs. without AI assistance.
• This device is a virtual reality behavioral therapy device, not an AI-powered diagnostic or assistive tool for human readers. Its primary function is to deliver therapeutic content directly to the patient to reduce pain and anxiety, rather than to assist a human in interpreting data or making a diagnosis. The studies compared the device's therapeutic effect against a control condition.

6. Standalone Performance (Algorithm Only)

• Yes, in essence, standalone performance was done for the "algorithm only" (the therapeutic virtual reality program). The studies measured the direct effect of the Smileyscope Therapy Mode on patients, where patients interacted solely with the device (software content running on specific hardware) and clinicians administered it.
• There was no "human-in-the-loop" component in the sense of a human interpreting AI output or making decisions based on AI assistance. The human (clinician) used the device as a tool, and the "performance" here refers to the device's therapeutic effect on the patient, which was measured directly in the clinical trials against a control.

7. Type of Ground Truth Used

• The primary ground truth used for effectiveness was patient-reported outcomes (PROs), specifically "Child Self-Rated Pain (Faces Pain Scale-Revised)."
• For safety, reported adverse events were the ground truth.

8. Sample Size for the Training Set

• The document does not mention a training set sample size. Because this device delivers virtual reality behavioral therapy, the "algorithm" is the behavioral therapy program itself, not a machine learning model that requires a separate training set in the typical sense.
• The development of the VR experience and its behavioral techniques would have been informed by existing evidence-based behavioral methods, but this is a different concept than a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

• As there's no explicit mention of a machine learning training set in the document, establishing ground truth for such a set is not applicable here.
• The "ground truth" for the device's therapeutic approach is implicitly based on "guided relaxation and other evidence-based behavioral methods" which are established practices in psychology and pain management. The clinical studies then validated if the VR delivery of these methods achieved the intended therapeutic effect.

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