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IAF-SYSTEM is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health. IAF-SYSTEM simulates kneading of tissues by using an inflatable garment.

Subject device consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has four (4) compression chambers. The compression massage direction is from limb end to body center. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body

The provided text describes a 510(k) premarket notification for the IAF-SYSTEM, a powered inflatable tube massager. It details the device's characteristics and compares them to a predicate device (Rapid Reboot Compression Therapy System, K182668) to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in the traditional sense of a clinical trial or performance study comparing a specific metric against a predefined threshold. Instead, it aims to demonstrate substantial equivalence to a predicate device by comparing various technological characteristics and safety standards.

The acceptance criteria are implicitly derived from the similarity to the predicate device and compliance with relevant safety standards. The "reported device performance" is essentially the detailed description of the subject device's features and its conformity to the standards.

While not a direct "acceptance criteria" table, the provided comparison table in the 510(k) summary (pages 5-8) serves as the basis for demonstrating equivalence. Key comparisons include:

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

• Sample Size (Test Set): The document states, "No clinical tests were conducted." Therefore, there is no "test set" in the context of human subjects or clinical data for performance evaluation.
• Data Provenance: Not applicable, as no clinical tests were performed. The evidence for substantial equivalence relies on non-clinical testing and comparison of device specifications to the predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable, as no clinical tests were performed and no "ground truth" for a test set was established using expert consensus. The "ground truth" for demonstrating non-clinical safety is the compliance with recognized standards.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical tests were performed and no test set requiring adjudication was used.

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 not an AI-assisted diagnostic or interpretation system that would typically involve human readers.

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

• Not applicable. This device is a physical therapy device, not an algorithm or AI system subject to standalone performance evaluation in that sense. Its "standalone" performance is measured by its physical and electrical characteristics and compliance with safety standards.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical tests, the "ground truth" is compliance with established engineering and electrical safety standards (e.g., IEC 60601-1, IEC 60601-1-2). The performance of the device against these standards serves as the ground truth for its safety and functional equivalence.

8. The Sample Size for the Training Set

• Not applicable. This device does not employ machine learning or AI that would require a "training set."

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

• Not applicable, as there is no training set for this type of device.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the (implicit) acceptance criteria consists of non-clinical tests and comparison to a predicate device.

• Non-Clinical Tests:

  • Tests Performed: Earth circuit continuity test, leakage current, current absorption, main switch, air hose connector, delivered pressure, display function, programs functionality, top card functionality, safety pressure switch intervention, maximum setting pressure, integrity of inflatable parts.
  • Findings: "device complies with the acceptance criteria of these various tests, documenting that safety and effectiveness are achieved on validation units and on production units (tests are conducted on on-going basis)." This indicates that the device's physical, electrical, and functional characteristics meet the established benchmarks for safety and performance required by the relevant standards (ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012; IEC 60601-1-2 Edition 4.0 2014-02).

• Predicate Device Comparison:

  • The core "study" for substantial equivalence is the detailed comparison of the IAF-SYSTEM to the Rapid Reboot Compression Therapy System (K182668) across all critical aspects (indications for use, technological characteristics, safety features, operational parameters, etc.).
  • The conclusion drawn is that "The technological characteristics are substantially equivalent to the predicate device, meeting the same technical standards." Any differences (e.g., max pressure, cycle time, biocompatibility where not required) are justified as not raising new questions of safety or effectiveness.

In summary, the FDA clearance for the IAF-SYSTEM is based on a demonstration of substantial equivalence to an already legally marketed device through a comprehensive comparison of specifications and compliance with recognized non-clinical safety and performance standards, rather than a clinical study with a test set of human subjects.

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