(84 days)
The SensiLase™ PAD 3000 provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients.
The SensiLase™ PAD 3000 (SensiLase™) 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 PV2000 device. The same methods arc applied for measurement of SPP and PVR as the predicate PV2000.
The SPP measurement is performed by applying a pressure cuff capable of occluding skin blood flow (perfusion). The pressure cuff is inflated until the skin perfusion, as detected by a Laser Scnsor Assembly (LSA) 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 value. SPP is a test used to evaluate peripheral microcirculation.
The measurement of the pulse volume recording (PVR) waveform is a measure of the pulsatile pressure amplitude resulting from a partially inflated cuff encircling the limb. The PVR is used as a more direct measurement of arterial blockage. The test output is a printout of the waveform, which is interpreted by a vascular specialist.
The clinical application and interpretation of the Perfusion , SPP measurements and interpretation of the PVR Waveform is the same as the predicate PV2000.
The provided document is a 510(k) summary for the SensiLase™ PAD 3000 Skin Perfusion Pressure System. It describes the device and its intended use, and states that it is substantially equivalent to a predicate device (PV2000 Vascular Microlaboratory).
However, the document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:
- Explicit acceptance criteria: The document doesn't list specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) with associated thresholds as acceptance criteria. Instead, it relies on substantial equivalence to a predicate device.
- Detailed study methodology: There is no description of a specific study, including sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or results of a comparative effectiveness study.
- Standalone performance data: No data is presented for the algorithm's performance without human-in-the-loop.
- Training set information: There is no mention of a training set or how ground truth for it was established.
Based on the provided text, the device's acceptance seems to be based on its substantial equivalence to the predicate device, PV2000 Vascular Microlaboratory, in terms of intended use, technology, features, and performance, rather than specific quantitative acceptance criteria demonstrated through a detailed clinical study presented in this summary.
Here's a breakdown of what can be inferred or extracted from the document, and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the SensiLase™ PAD 3000. The primary "acceptance criterion" as conveyed in this 510(k) summary is substantial equivalence to the predicate device, PV2000 Vascular Microlaboratory.
| Acceptance Criterion (Inferred from Substantial Equivalence) | Reported Device Performance (as stated in the summary) |
|---|---|
| Intended Use: Noninvasive measurement of SPP and PVR waveforms on extremities of patients. | Fulfills this intended use. "The SensiLase™ PAD 3000 provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients." (Section 2.0, Indications For Use) |
| Technology: Use of laser diode for SPP measurement. | Uses a laser diode with similar specifications to the predicate: "Power exiting LSA: 2.3 milliwatts (typical), 3.0 milliwatts maximum. Wavelength: 785 nm" (Section 3.0) |
| Features: Provides SPP and PVR measurements. | Provides both SPP and PVR measurements. "Both the SPP and PVR measurements are features of the predicate PV2000 device." (Section 1.0) |
| Performance: Measurement methods for SPP and PVR are the same as the predicate. Clinical application and interpretation are the same as the predicate. | "The same methods are applied for measurement of SPP and PVR as the predicate PV2000." "The clinical application and interpretation of the Perfusion , SPP measurements and interpretation of the PVR Waveform is the same as the predicate PV2000." (Section 1.0) |
The summary concludes: "The intended use, technology, features and performance of the SensiLase™ PAD 3000 Skin Perfusion Pressure System are substantially equivalent to the predicate PV2000. No new questions of safety or effectiveness are raised." (Section 4.0)
The Study Proving Acceptance Criteria:
The document describes the basis for substantial equivalence but does not detail a specific "study" with test sets, sample sizes, and ground truth establishment in the way typically expected for AI/ML device evaluations. Instead, the demonstration of equivalence relies on the device sharing the same fundamental principles and methods as a previously cleared device.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document does not describe a test set or a study involving a specific number of patients or samples.
- Data Provenance: Not applicable, as no specific test set data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Experts and Qualifications: Not specified. No ground truth establishment process is described for a test set. The document mentions that the interpretation of PVR waveforms is done by a "vascular specialist," but this is in the context of the device's clinical use, not for establishing a ground truth for a performance study.
4. Adjudication method for the test set
- Adjudication Method: Not applicable, as no test set requiring 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 MRMC comparative effectiveness study is mentioned. This device (SensiLase™ PAD 3000) does not appear to be an AI-assisted device in the context of this 510(k) summary; rather, it's a measurement device for physiological parameters (SPP and PVR). Therefore, "human readers improve with AI vs without AI assistance" is not relevant to the information provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is a direct measurement system, not an algorithm, and the documentation does not describe an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth Type: Not explicitly stated for a performance study. The device measures physical parameters (SPP and PVR). The "ground truth" for such devices typically relies on the accuracy and precision of the physical measurements themselves, often through calibration against known standards or comparison to established gold-standard measurement techniques, which are not detailed in this summary.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. The document does not describe a training set, as it is a direct measurement device rather than a machine learning or AI product requiring a training phase.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as no training set is described.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).