The intended use of the Sonic Palpometer is to assess patient sensitivity to tactile stimulus by providing quantification of fingertip pressure, for tactile response procedures and freatments that use digital palpation.

Device Description

The Palpometer is a simple device that combines the fine motor and sensory attributes of manual examination with the precision measurements made with pressure gauges. By measuring the amount of pressure between the device and a soft tissue, the Palpometer standardizes pain response by controlling the pressure of the examiner's palpating finger. The Palpometer consists of a thin sensor, positioned on the palpating portion of the examiner's finger. The sensor changes its electrical resistance caused by varying the pressure exercised by the examining finger. The Palpometer beeps in a different tone as you pass through each programmable pressure threshold (of which there are five).

AI/ML Overview

The Palpometer is a device designed to quantify fingertip pressure during digital palpation to assess patient sensitivity to tactile stimuli. The provided documentation (K060125) describes the device and references several studies to demonstrate its equivalence and performance relative to conventional pain measurement methods.

Here's an analysis of the acceptance criteria and the studies mentioned:

1. Table of Acceptance Criteria and the Reported Device Performance

The submission does not explicitly state formal "acceptance criteria" with specific quantitative thresholds that the device must meet for approval. Instead, it presents a summary of "Substantial Equivalence Data" by comparing the Palpometer's performance with established methods of pain measurement found in published literature. The reported performance focuses on correlations, reliability, and differences in statistical significance.

Acceptance Criteria (Inferred from study outcomes and comparisons)	Reported Device Performance (as described in the studies cited)
Intraobserver reliability (compared to conventional methods)	Atkins et al. (1992): Intraobserver error of 0.12 for Palpometer vs. 0.2 for conventional method (in rheumatoid arthritis tender joint scores), indicating superior reliability.
Construct Validity / Correlation with conventional measurements (indicating agreement or ability to measure the same underlying construct)	Atkins et al. (1992): Correlation coefficient between Palpometer and conventional measurements increased from 0.62 to 0.78 (excluding less sensitive instruments), indicating a high level of construct validity.
Interobserver agreement/reliability (demonstrating consistency across different observers)	Bendtsen et al. (1995): Sum of tenderness scores by two observers using conventional palpation differed significantly (P=0.0003), while results did not differ using pressure-controlled palpation (P=0.89), demonstrating improved interobserver reliability with the Palpometer.
Correlation with pain intensity (demonstrating the device's ability to measure pain)	Bendtsen et al. (1995): Positive linear correlation between pressure and pain intensity (P=0.00006) in headache tender point scores.
Correlation with conventional scores / Test-retest reliability (in specific conditions like fibromyalgia)	Bennet et al. (1996): Good correlation (point estimates >0.7) between Palpometer and conventional scores in fibromyalgia. Test-retest measurements showed similar correlation (>0.7), indicating good reliability.
Ability to show a linear relationship between pressure and pain (as expected in controls)	Bendsten et al. (1997): In controls, a linear relationship between pressure and pain was found in a double logarithmic plot (slope (ß) was 3.5 ± 0.66 log mm/log Uj P<0.00001), consistent with expected physiological response.
Similar responses to conventional dolorimeters (demonstrating comparable measurement capabilities)	Neufeld et al. (2000): Similar responses before and after manipulation of cranial muscles with Dolorimeter threshold measurements and tenderness measurement with the Palpometer in headache-prone patients. (See Fig 3 & 4 in original paper).
Calibration capability with standard dolorimeters (demonstrating quantitative measurement potential)	Bendtsen et al. (1994): A pressure algometer (Somedic) was used to relate arbitrary units of the Palpometer to tone, effectively calibrating the Palpometer against a standard dolorimeter.
Construct Validity demonstrated by similar response to tender point measurements with dolorimeter and reproducibility (comparable to other established devices/methods)	Puttick et al. (1995): Construct Validity is demonstrated by similar response to tender point measurements with the dolorimeter at highly reproducible measurements with Palpometer, showing lesser but still good reliability (in fibromyalgia). Atkins and Zielinski (1997) comment: Highlighted that inconsistency in technique and failure to secure the sensor could lead to sub-optimal performance, implying proper use achieves good results.

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

The document references several published research papers and abstracts rather than a single dedicated test set for the FDA submission. Therefore, the sample sizes and data provenance vary across the cited studies:

Atkins, C. J. et al. (1992): "An electronic method for measuring joint tenderness in rheumatoid arthritis."
- Sample Size: Not specified in the provided summary, would require consulting the original paper.
- Data Provenance: Not specified in the provided summary (likely prospective, clinical study as typical for such research).
Bendtsen, L., Jensen, R., Jensen, N.K. and Olesen, J.R. (1995): "Pressure controlled palpation: A new technique which increases the reliability of manual palpation."
- Sample Size: Not specified in the provided summary, would require consulting the original paper.
- Data Provenance: Not specified in the provided summary (likely prospective, clinical study).
Bennet, R., Atkins, C.J., Zielinski, A., and Makosinski, A. (1996): "A miniaturized pain-measuring device called an electronic Palpometer worn on the examiner's finger links a pressure gauge to conventional manual palpation."
- Sample Size: Not specified in the provided summary, would require consulting the original abstract/paper.
- Data Provenance: Collaborative study between University of Victoria (Canada) and Oregon Health Sciences University (USA). Likely prospective.
Bendsten, L., Norregaard, J., Jensen, R., Olesen, J. (1997): "Evidence of qualitatively altered nociception in patients with fibromyalgia."
- Sample Size: Not specified in the provided summary, would require consulting the original paper.
- Data Provenance: Not specified in the provided summary (likely prospective, clinical study).
Neufeld, J.D., Holroyd, K.A., and Lipchik, G.L. (2000): "Dynamic assessment of abnormalities in central pain transmission and modulation in tension-type headache sufferers."
- Sample Size: Not specified in the provided summary, would require consulting the original paper.
- Data Provenance: Not specified in the provided summary (likely prospective, clinical study).
Bendtsen, L., Jensen, R., Jensen, N.K. and Olesen, J.R. (1994): "Muscle palpation with controlled finger pressure: New equipment for the study of tender myofascial tissues."
- Sample Size: Not specified in the provided summary, would require consulting the original paper.
- Data Provenance: Not specified in the provided summary (likely prospective, clinical study).
Puttick, M.P.E., et al. (1995): "Reliability and reproducibility of fibromyalgic tenderness: measurement by electronic and mechanical dolorimeters."
- Sample Size: Not specified in the provided summary, would require consulting the original paper.
- Data Provenance: Not specified in the provided summary (likely prospective, clinical study).
Atkins, C.J., and Zielinski, A. (1997): "Comment on Article by Puttick, M.P.E., et al."
- Sample Size: N/A (commentary on a previous study).
- Data Provenance: N/A (commentary).

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

The concept of "ground truth" in these studies is primarily clinical observation and assessment by human examiners, often involving measurement techniques (conventional palpation, other dolorimeters, VAS scores). The studies focus on comparing the Palpometer's measurements to these human-derived "ground truths" or benchmarks.

The studies often involve "observers" or "examiners" (e.g., "two different observers" in Bendtsen et al. 1995).
The qualifications of these experts are not explicitly stated in the summary, but they are implied to be medical professionals (e.g., those experienced in rheumatoid arthritis, headache, or fibromyalgia assessment) contributing to clinical research published in medical journals. Without access to the full papers, specific qualifications (e.g., "radiologist with 10 years of experience") cannot be determined.

4. Adjudication Method for the Test Set

The provided summaries of the studies do not explicitly detail adjudication methods for disagreements between observers.

Bendtsen et al. (1995) does note that "the sum of tenderness scores recorded by two different observers using conventional palpation differed significantly (P=0.0003) where results did not differ using pressure controlled palpation (P=0.89)." This implies a comparison of agreement rather than a formal adjudication process to resolve discrepancies, likely using statistical methods.
Other studies focus on correlations and reliability metrics, which inherently account for agreement/disagreement without necessarily requiring a separate adjudication step to define a single "ground truth."

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, a MRMC comparative effectiveness study was not done in the context of an AI-assisted interpretation versus unassisted human interpretation.
The Palpometer itself is a diagnostic tool that standardizes the human act of palpation, providing objective pressure measurements. It is not an AI algorithm that assists in interpretation of medical images or data.
The studies instead compare the Palpometer-assisted palpation method to conventional manual palpation or other dolorimeters.
- Effect Size Example: In Atkins et al. (1992), the Palpometer reduced intraobserver error from 0.2 (conventional) to 0.12, and increased the correlation coefficient from 0.62 to 0.78. This indicates an improvement in objective measurement and reliability when using the device compared to unassisted manual palpation.

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

Not applicable. The Palpometer is a human-in-the-loop device. It is designed to be worn on an examiner's finger to quantify the pressure they apply during palpation. It does not operate as a standalone algorithm without human interaction. Its function is to enhance and standardize the human examination process.

7. The Type of Ground Truth Used

The "ground truth" in these studies is primarily established through:

Expert Clinical Assessment / Conventional Measurements: This includes traditional manual palpation scores, tender joint scores, tender point scores, and Visual Analog Scale (VAS) scores for pain.
Other Standardized Measurement Devices: Comparisons are made to other dolorimeters and algometers (e.g., Pressore Monitor, micro-emed-system, Dynatron 2000, Somedic pressure algometer, Chatillon dolorimeter). These devices are themselves established as tools for quantifying pressure or pain thresholds.
Physiological Relationships: For example, the discovery of a "linear relationship between pressure and pain in a double logarithmic plot" (Bendsten et al., 1997) serves as a biological ground truth expectation against which the device's measurements are validated.

8. The Sample Size for the Training Set

Not applicable / Not explicitly defined. The Palpometer is a hardware device with an embedded microprocessor and programmed thresholds. It does not appear to use machine learning or AI that would require a "training set" in the conventional sense for an algorithm.
The "programming" of its five pressure thresholds would likely be based on engineering specifications and potentially clinical input, but not iterative learning from a large "training set" of data.

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

Not applicable. As explained above, there is no conventional machine learning "training set" for an algorithm. The device's operational parameters (e.g., pressure thresholds for different tones) would be established through engineering design, calibration against known physical pressures, and potentially clinical validation relating these pressure levels to clinically relevant palpation forces.

Summary

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K060125

Image /page/0/Picture/1 description: The image is a logo for Palpometer Systems Inc. The logo features a stylized representation of a palpometer, with a circular sensor head and a stem extending downwards. The company name, "PALPOMETER SYSTEMS INC," is arranged in an arc above the sensor head, following the curve of the circle.

MAR 16 2006

PALPOMETER SYSTEMS INC PO Box 3075 STN CSC R Hut McKenzie Avenue Victoria, BC, Canada V8W 3W2 Telephone: 250.472.4321 Fax: 250.472.4321 Email: info@palpometer.net

Website: www.palpometer.net

510(k) Summary

Submitted by: Palpometer Systems Inc PO Box 3075 STN CSC R Hut McKenzie Ave Victoria, BC V8W 3W2 Tel: (250) 721-6502 Fax: (250) 721-6497
Contact: Lindsay Roach

Summary Prepared on January 6th, 2006

Trade Name: Sonic Palpometer

Common Name: palpometer

Classification Name: Miniature pressure transducer (per 21 CFR 890.1615)

Although there is no legally marketed predicate device for the Palpometer (as stated in the 513(g) device classification letter, reference: C030037, See Appendix B) these are devices in the same product code to which we are claiming some level of equivalence:

Device	Applicant	510(k)	DecisionDate	Device websiteinformation
Pressore Monitor	Cleveland MedicalDevices, Inc.	K954670	10/30/1995	http://www.clevemed.com/products/rehab/pm/index.html
micro-emed-system	novel electronics,inc.	K902967	09/17/1990	http://www.novel.de/pdf/flyer/eng/rls_eng.pdfhttp://www.novel.de/pdf/flyer/eng/emed_eng_ver2.pdf
Dynatron 2000	Dynatronics Corp.	K880912	03/15/1988	http://www.dynatronics.com/chronicpain/dynatron/http://www.mdall.ca/"dynatron"
emed-f-system	novel gmbh	K871690	05/15/1987	http://www.novel.de/pdf/flyer/eng/rls_eng.pdf
ZEUS MicroWristSurgical System *	Intuitive SurgicalInc., ComputerMotion	ApprovedClass 3device		http://www.intuitivesurgical.com

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Image /page/1/Picture/0 description: The image shows the number 406000 at the top. Below the number is the number 1 followed by a dash. The numbers are written in a handwritten style. The image is a simple black and white picture.

Image /page/1/Picture/1 description: The image shows the logo and contact information for Palpometer Systems Inc. The logo features the company name surrounding a circular design. The contact information includes a PO Box address, a street address, the city and postal code, telephone and fax numbers, an email address, and a website. The phone and fax numbers are 250.472.4321.

The ZEUS MicroWrist Surgical System is not in the same Product Code as the Palpometer, however it uses the same Interlink FSR pressure sensor.

Description:

Intended Use:

The intended use of the Palpometer is to assess patient sensitivity to tactile stimulus by providing quantification of fingertip pressure, for tactile response procedures and treatments that use digital palpation.

Technological Characteristics:

The technological characteristics of the Palpometer are equivalent to several different devices. Like the Pressore Monitor, the Palpometer is a battery operated device that measures the amount of pressure between the device and soft tissue. The Palpometer uses a commercially available pressure sensor that converts mechanical inputs to analog signals similar to the Micro-emedsystems by novel electronics Inc. This sensor is the same one that is used in sensitive devices such as electronic infusion pumps, robotic controlled surgical systems (the Zeus MicroWrist Surgical System) and radiotherapy equipment to measure applied pressure. A programmed microprocessor, resistors, capacitors, reed switch, and piezoelectric speaker make up the other components. The level of pressure is indicated by the speaker that beeps at different tones depending upon the amount of pressure applied. The components are sealed inside a solid aluminum casing. The Palpometer is held in place on the finger by a Velcro strap.

Substantial Equivalence Data:

As there is no legally marketed predicate device (513(g) C030037, See Appendix B) a summary of the data and conclusions drawn from comparing the Palpometer to conventional means of pain measurement is included in the attached table.

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STANDARD MEASUREMENTS OF PAINCOMPARED WITH THE SONICPALPOMETER	SOURCE OF DATA	Results
Manual palpationTender joint scores inrheumatoid arthritis	Atkins, C. J. et al. (1992). An electronic method formeasuring joint tenderness in rheumatoid arthritis.Arthritis & Rheum, 35:407-10	P. 409. Analysis of the modified electronic scores showed anintraobserver error of 0.12 compared with 0.2 for theconventional method. The correlation coefficient between thePalpometer and conventional measurements was increasedfrom 0.62 to 0.78 when the less sensitive instrument wasexcluded, indicating a high level of construct validity.
Tender point scores inheadache	Bendtsen, L., Jensen, R., Jensen, N.K. and Olesen, J.R.(1995) Pressure controlled palpation: A new techniquewhich increases the reliability of manual palpation.Cephalalgia 15, 205-210	P. 206. The sum of tenderness scores recorded by two differentobservers using conventional palpation differed significantly(P=0.0003) where results did not differ using pressure controlledpalpation (P=0.89). A positive linear correlation betweenpressure and pain intensity was found (P=0.00006).
Tender point scores infibromyalgia	Bennet, R., Atkins, C.J., Zielinski, A., and Makosinski, A.(1996) A miniaturized pain-measuring device called anelectronic Palpometer worn on the examiner's finger linksa pressure gauge to conventional manual palpation.Collaborative study between University of Victoria withthe Oregon Health Sciences University. Abstract inProceedings of the 8th International Congress on Pain,August 1996, Vancouver, BC.	There was a good correlation (point estimates >0.7) between thePalpometer and conventional scores. Test retest measurementsshowed a similar correlation (>0.7).
Visual analog scale in fibromyalgia	Bendsten, L., Norregaard, J., Jensen, R., Olesen, J.(1997) Evidence of qualitatively altered nociception inpatients with fibromyalgia. Arthritis & Rheum, 40:98	P. 99. In controls there is a linear relationship between pressureand pain in a double logarithmic plot in which the slope (ß) was3.5 ± 0.66 log mm/log Uj P<0.00001
Dolorimeters (algometers)Handheld pain thresholdmeter (pain diagnostics andthermography NY) inheadache	Neufeld, J.D., Holroyd, K.A., and Lipchik, G.L. (2000)Dynamic assessment of abnormalities in central paintransmission and modulation in tension-type headachesufferers. Headache, 40:142-151	P. 148. Similar responses before and after manipulation ofcranial muscles with Dolorimeter threshold measurements andtenderness measurement with the Palpometer in headacheprone patients. See Fig 3 & 4.
Pressure Algometer Somedicto in tender myofascialmuscles	Bendtsen, L., Jensen, R., Jensen, N.K. and Olesen, J.R.(1994) Muscle palpation with controlled finger pressure:New equipment for the study of tender myofascialtissues. Pain, 59, 235-239	P. 236. A pressure algometer Somedic was used to relatearbitrary units of the Palpometer to tone. In this fashion, astandard dolorimeter was used to calibrate the Palpometer.
Chatillon in fibromyalgia	Puttick, M.P.E., et al. (1995) Reliability and reproducibilityof fibromyalgic tenderness: measurement by electronicand mechanical dolorimeters. Journal of MusculoskeletalPain. 3:3-14	P. 4. ConstructValidity is demonstrated by similar response totender point measurements with the dolorimeter at highlyreproducible measurements with Palpometer show lesser butstill good reliability.
Chatillon in fibromyalgia	Atkins, C.J., andZielinski, A. (1997) Comment on Articleby Puttick, M.P.E., et al. Reliability and reproducibility offibromyalgia tenderness, measurement by electronic andmechanical dolorimeters. Journal of MusculoskeletalPain, 5:127-131	Atkins and Zielinski comment on the Puttick article indicatingthat inconsistency in technique and failure to secure the sensorthe examining finger resulted in sub-optimal performance by thePalpometer.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".

MAR 1 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Palpometer Systems, Inc. c/o Intertek Testing Services Mr. Daniel W. Lehtonen Staff Engineer - Medical Devices 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K060125

Trade/Device Name: Sonic Palpometer Regulation Number: 21 CFR 890.1615 Regulation Name: Miniature pressure transducer Regulatory Class: I Product Code: IKE Dated: March 2, 2006 Received: March 3, 2006

Dear Ms. Lehtonen:

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 – Mr. Daniel W. Lehtonen

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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.

elmoe

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K060125

Device Name: Sonic Palpometer

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

elmdel

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

KOSOL25 510(k) Number.

Regulation Number and Section

§ 890.1615 Miniature pressure transducer.

(a)
Identification. A miniature pressure transducer is a device intended for medical purposes to measure the pressure between a device and soft tissue by converting mechanical inputs to analog electrical signals.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.