The SensiLase™ PAD 3000 provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients.

Device Description

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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the date JUN - 4 2004 on the left side. On the right side, there is the text "OPTICAL SENSORS INCORPORATED" and the number K040654. There is a black diamond shape in the middle of the image with lines coming out of it.

Summary of Safety and Effectiveness

Company Name:	Optical Sensors Incorporated.7615 Golden Triangle DriveEden Prairie, MN 55344
Contact:Phone:Fax:	Paulita LaPlante, President and CEO(952) 947-9545(952) 944-6022
Summary Date:	March 11, 2004
Trade Name:	SensiLase™ PAD 3000 Skin Perfusion Pressure System
Common Name:	Blood Flowmeter
Classification Name:	21 CFR 870.2100, Flowmeter, Blood; Class II,Product Code: DPW; Product Code:
Predicate Device:
	510(k) Number: K951486
	Manufacture: Vasamedics, LLC
	Trade Name: Model PV2000 Vascular Microlaboratory

1.0 Description of Device

{1}------------------------------------------------

The clinical application and interpretation of the Perfusion , SPP measurements and interpretation of the PVR Waveform is the same as the predicate PV2000.

Intended Use 2.0

The SensiLase™ PAD 3000 provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients.

Technology 3.0

The SensiLase instrument contains a laser diode that is used when performing the skin perfusion pressure measurement. Laser specifications are:

Power exiting LSA: 2.3 milliwatts (typical), 3.0 milliwatts maximum. l.
1. Wavelength: 785 nm
Laser Classification per 21CFR1040.10 : Class I 3.
Laser Classification per IEC 60825-1: Class 1M 4.

The same technology was applied in the predicate PV2000 device.

Conclusions 4.0

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.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 2004

Optical Sensors Incorporated c/o Mr. Gary Syring Principal Consultant Quality & Regulatory, LLC 800 Levanger Lane Stoughton, WI 53589

Re: K040654

SensiLase™ PAD 3000 Regulation Number: 21 CFR 870.2100 Regulation Name: Flowmeter, Blood, Cardiovascular Regulatory Class: Class II (two) Product Code: DPW Dated: March 11, 2004 Received: March 12, 2004

Dear Mr. Syring:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Mr. Gary Syring

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that 1 271 0 resumes or over device complies with other requirements of the Act that I DA has made a doted regulations administered by other Federal agencies. You must or any I catal statutes and states and the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT an 0077; mooning (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by oversions (Sections 531-542 of the Act); 21 CFR 1000-1050. product in the letter will allow you to begin marketing your device as described in your Section 510(k) Fins letter will and w you'ls ough finding of substantial equivalence of your device to a legally premance moticated wice results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you t the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (2001) 37 + 1055 - 1055 - 105.97) you may obtain. Other general information on your premaintentifically.com (e obtained from the Division of Small Manufacturers, Itsponsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

NAerain May

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: SensiLase™ PAD 3000____________________________________________________________________________________________________________________________________________

Indications For Use:

The SensiLase™ PAD 3000 provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

ﻨﻪ:::: ﻣ

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

C Mesar Miff

ardiovascular Devices Division of

KO40654 510(k) Number_

Page 1 of 1

Regulation Number and Section

§ 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).