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The SensiLase® PAD-IQ provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients.

The Sensit.ase® PAD-IQ (PAD-IQ) Skin Perfusion Pressure System provides measurements of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR). Both measurements may be clinically applied to assess perfusion. Both the SPP and PVR measurements are features of the predicate PAD3000 device. The same methods are applied for measurement of SPP and PVR in the PAD-IQ as are applied in the predicate PAD3000.

The SPP measurement relies on the creation of reactive hyperemia. Reactive hyperemia is the transient increase in blood flow that occurs following a brief period of ischemia. The SPP measurement is performed by applying a pressure cull capable of occluding skin blood flow (perfusion) to a peripheral location (arm, leg, toe. finger, etc.). The pressure cuff is inflated until the skin perfusion, as detected by a laser Doppler signal measured underneath the cuff, is determined to be near zero or significantly reduced. The pressure is released until an increase in skin perfusion is determined. The cuff pressure when the skin perfusion increases is the SPP is a test used to evaluate peripheral microcirculation. The SPP neasurement can be useful in identifying patients with peripheral arterial disease (PAD), other alterations in microcirculation, and to aid in the determination of optimum clinical treatment.

The PVR test measures and displays a waveform representing variations in the volume of blood passing through a limb during each cardiac cycle. The PVR test is fully automated and uses a partially inflated pressure cuff to apply slight pressure to the limb. The impact of blood passing through the limb is transferred to the pressure cuff where it is measured as small changes in cuff pressure. The changes are displayed as a PVR waveform. The PVR waveform can be used as a measure of functional severity of occlusive disease and as un objective for later comparisons. The PVR test is sometimes referred to as air plethysmography or volume plethysmography.

The clinical application and interpretation of the SPP measurements and interpretation of the PVR Waveform is the same as the predicate PAD3000.

The differences between the predicate PAD3000 and the PAD-1Q device are summarized as:

• Change from one channel of measurement to two channels of measurement, .
• Modifying device format for increased portability within a clinical environment of use. .
• Inclusion of operation by battery. .

This 510(k) summary describes a device, the SensiLase® PAD-IQ, that is substantially equivalent to a predicate device, the SensiLase® PAD3000. The submission explicitly states that the same methods are applied for measurement of SPP and PVR in the PAD-IQ as are applied in the predicate PAD3000. The differences noted are primarily modifications to the device's physical attributes (two channels of measurement, increased portability, and battery operation) rather than changes to the underlying measurement technology or clinical application.

Therefore, the document does not contain details about a specific clinical study to prove the device meets acceptance criteria. Instead, it relies on the substantial equivalence to the predicate device, stating: "Qualification of the differences between the predicate PAD3000 and the PAD-IQ device are supported by applicable FDA Recognized Consensus Standards, FDA Guidance and applicable test plans." and "The intended use, technology, features and performance of the PAD-IQ are substantially equivalent to the predicate PAD3000. No new questions of safety or effectiveness are raised."

Thus, for most of your requested points, the answer will be that the information is not provided in this document because the device's performance is assumed to be equivalent to the predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Not provided. The document does not describe a new clinical test set for the PAD-IQ. It relies on the established performance of the predicate device.

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

• Not provided. As no new distinct test set is described, this information is not applicable in this context.

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

• Not provided. Not applicable due to the absence of a distinct test set described for the PAD-IQ.

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:

• No. This device is a measurement instrument, not an AI-assisted diagnostic tool for human readers. An MRMC study is not relevant to its intended use.

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

• Yes, implicitly. The device itself performs the measurements (SPP and PVR). The document states, "The PVR test is fully automated." The measurement process is algorithmic and embedded within the device, with clinicians interpreting the output. The performance of these algorithms is considered substantially equivalent to those in the predicate, for which performance would have been established previously.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not provided in this document for a new study. For the original predicate device, the "ground truth" for SPP and PVR measurements would likely have been established through correlation with recognized physiological principles, clinical outcomes, and potentially comparison with other established diagnostic methods for peripheral arterial disease (PAD) and microcirculation assessment.

8. The sample size for the training set:

• Not provided. This device is not described as involving a machine learning or AI "training set" in the conventional sense. Its function relies on established physical principles and signal processing, not a trained AI model.

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

• Not applicable. As noted above, there is no mention of a "training set" for AI in this document.

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