To measure bilateral differences in surface EMG along the spine
To measure surface EMG along the spine during functional tasks
To measure bilateral differences in skin temperature along the spine
To measure Range of Motion of the three spinal regions
To measure patient self-reported pressure sensitivity in joints and muscles
To measure Heart Rate
To chart patient progress during the course of treatment

Device Description

The Insight Discovery is a non-invasive, multi-modality physiologic monitoring device. The Insight Discovery contains the following six sensor types: (1) surface EMG used to measure muscle activity, (2) infrared temperature sensor used to measure skin temperature, (3) algometer used to measure patient self-reported pressure sensitivity, and (4) heart rate sensor to measure heart rate, (5) an inclinometer used to measure end-point range of motion, and (6) a wireless version of the inclinometer.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Insight Discovery device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Insight Discovery device are directly derived from its specifications, which are stated to be identical to its predicate device, the Insight Millennium III, with the exception of the added wireless inclinometer. Since this is a 510(k) submission primarily focused on substantial equivalence rather than de novo approval, the "acceptance criteria" are essentially the documented performance specifications that demonstrate it functions as intended and is comparable to a legally marketed device.

Device Feature/Parameter	Acceptance Criteria (Specification)	Reported Device Performance (as stated in the document)
EMG
Electrodes	4 ea. Smart Sensors with low-noise preamplifiers	4 ea. Smart Sensors with low-noise preamplifiers
Calibrated Range	0.1 - 999 uV	0.1 - 999 uV
Input Bias Current	Less than 2.0 Picoamperes	Less than 2.0 Picoamperes
Differential Input Impedance	Greater than 1,000,000 Megaohms	Greater than 1,000,000 Megaohms
Common Mode Rejection	150 dB	150 dB
Bandwidth	20-500 Hz (50/60 Hz notch)	20-500 Hz (50/60 Hz notch)
Noise	Less than 0.1 uV (inputs shorted)	Less than 0.1 uV (inputs shorted)
Detector	Log power detector, 250 mS averaging filter.	Log power detector, 250 mS averaging filter.
Controls	None	None
Temperature
Calibrated Range	55°F - 120°F	55°F - 120°F
Accuracy	±0.2°F nominal	±0.2°F nominal
Sensors	Two thermopile, fixed 2.5" apart (center-to-center)	Two thermopile, fixed 2.5" apart (center-to-center)
Controls	Enter button	Enter button
Algometer
Calibrated Range	0-100 lbs.	0-100 lbs.
Accuracy	±3% nominal	±3% nominal
Contact Area	1.0 cm²	1.0 cm²
Sensor	One pressure transducer attached to a stiff rod.	One pressure transducer attached to a stiff rod.
Controls	Enter button	Enter button
Heart Rate Sensor
Sensor Type	IR Plethsmograph (attached to finger with Velcro)	IR Plethsmograph (attached to finger with Velcro)
Output Voltage	5 - 50 mV, typical at rest	5 - 50 mV, typical at rest
Output Impedance	1 kΩ, nominal	1 kΩ, nominal
Weight	28 grams	28 grams
Sensor Size	15 x 15 x 6.3 mm	15 x 15 x 6.3 mm
Single Inclinometer
Range	360 degrees	360 degrees
Accuracy	±1 degree nominal	±1 degree nominal
Axes	One	One
Controls	Enter and Skip Buttons	Enter and Skip Buttons
Dual Inclinometer
Range	360 degrees	360 degrees
Accuracy	±1 degree nominal	±1 degree nominal
Axes	Three	Three
Controls	None	None
Bluetooth Type	Class 1 / +7dBm 5 mW	Class 1 / +7dBm 5 mW

The Study Proving Device Meets Acceptance Criteria:

The provided document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a full clinical study with specific acceptance criteria beyond direct comparison to the predicate's established performance.

The "study" proving the device meets acceptance criteria is fundamentally a comparative analysis of specifications and functional equivalence to the predicate device (Insight Millennium III, K023209).

Evidence of Equivalence: The document explicitly states: "The Insight Discovery is equivalent to this legally marketed device in the following ways: The physical characteristics and electrical characteristics (performance characteristics) of the Insight Discovery are identical as to the Insight Millennium III, as cleared by FDA. The only difference is the addition of an optional wireless dual inclinometer in the place of the standard wired inclinometer."
Performance Specification Section: Section 5, "Performance Specification," lists the detailed technical specifications for all components (EMG, Temperature, Algometer, Heart Rate Sensor, Single Inclinometer, Dual Inclinometer, Instrument Console). These specifications are presented as the device's inherent performance. The implication is that these specifications are the acceptance criteria, and by design and manufacturing, the device embodies these specifications.

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

Test Set Sample Size: The document does not describe a "test set" in the context of human subject trials or a specific dataset for algorithm evaluation. This is a medical device hardware and software combination that measures physiological parameters. The "testing" likely involved engineering verification and validation against the stated specifications, and possibly bench testing or limited in-house user testing to confirm functionality. No patient sample size for performance evaluation is mentioned.
Data Provenance: Not applicable, as there's no mention of a clinical data set or patient data used for evaluation of the device's performance within this submission beyond its technical specifications. The focus is on the device's hardware and software capabilities.

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

Not applicable. This submission does not involve a diagnostic algorithm or AI where "ground truth" is established by experts on a test set. The device itself is a measurement tool. Its accuracy is determined by its technical specifications (e.g., Temperature Accuracy: ±0.2°F nominal, Inclinometer Accuracy: ±1 degree nominal) rather than an expert consensus on a subjective interpretation.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set requiring adjudication in this context.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or AI algorithms that assist human readers in interpretation. The Insight Discovery is a physiological monitoring device that provides objective measurements.

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

Not applicable in the typical sense of an AI algorithm. The device itself performs measurements; its "standalone performance" is its ability to accurately measure the specified physiological parameters according to the listed specifications, which is assumed by its design and substantial equivalence to the predicate. There is no distinct "algorithm" performance test described separate from the device's overall functionality.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is its engineering specifications and metrology. For instance, the accuracy of the temperature sensor (±0.2°F nominal) would be validated against a calibrated temperature reference. The inclinometer's accuracy (±1 degree nominal) would be validated against a known angle. This is standard for measurement devices. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. The Insight Discovery is a measurement device, not an AI/ML algorithm that requires a "training set" in the context of machine learning. Its functionality is based on established engineering principles and sensor technology.

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

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

Summary

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ATTACHMENT 4

AUG 16 2007

Insight Discovery

510(k) Summary

Submitted by:

Company Name: Company Address #1: Company Address #2: Contact Person: Phone Number: Fax Number:

Fasstech 76 Treble Cove Road, #2 North Billerica, MA 01862 Lee Brody 978.663.2800 978.663.0999

Submitted on:

April 13, 2007

Insight Discovery 510(k) Summary

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Section 1: Device Name

Proprietary Model Name: Common or Usual Name: Regulatory Name: Regulation Number: Product Code: Regulatory Class:

Insight Discovery Diagnostic Electromyograph Diagnostic Electromyograph 21 CFR 890.1375 IKN II

Section 2: Indications for Use

I To measure bilateral differences in surface EMG along the spine
To measure surface EMG along the spine during functional tasks .
. To measure bilateral differences in skin temperature along the spine
I To measure Range of Motion of the three spinal regions
l To measure patient self-reported pressure sensitivity in joints and muscles
. To measure Heart Rate
미 To chart patient progress during the course of treatment

Section 3: Device Description

Hardware

The Insight Discovery hardware consists of an instrument console and six different sensor types. The sensor types plug directly into the front panel of the Insight Instrument Console, with the exception of the wireless inclinometer. The Insight Discovery Instrument Console is powered via a UL2601 listed power supply. The Instrument Console is connected to a personal computer (IBM compatible) via an isolated USB port connection.

Software

The Insight Discovery software displays real-time surface EMG, spinal Range of Motion, skin temperature, pressure, and heart rate readings, allowing the user to ensure that readings are stable prior to data collection. The Insight Discovery software allows the user to: (1) enter patient information, (2) record surface EMG, spinal Range of Motion, skin temperature, pressure and heart rate readings, (3) graph surface EMG, spinal Range of Motion, skin temperature, pressure and heart rate readings, and (4) print out reports, including an integrated report containing the results of all five recording types.

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Section 4: Predicate Device

This section documents the substantial equivalence of the Insight Discovery to a legally marketed device. Specifically, this section documents the substantial equivalence of Insight Discovery to the following product:

Manufacturer	Predicate Device Name	510(k) Number
Insight Millennium III	Fasstech	K023209

The Insight Discovery is equivalent to this legally marketed device in the following ways:

The physical characteristics and electrical characteristics (performance characteristics) of the . Insight Discovery are identical as to the Insight Millennium III, as cleared by FDA. The only difference is the addition of an optional wireless dual inclinometer in the place of the standard wired inclinometer.
The Insight Discovery differs from the legally marketed device in the following ways:
l The addition of an optional wireless dual inclinometer
. The extension of the Insight software to interface with the new inclinometer

Feature	Insight Discovery	Insight Millennium III
Four Channels of surface EMG	Yes	Yes
Skin Temperature measurement via infrared thermal scanner	Yes	Yes
Range of Motion Sensor	Yes	Yes
Algometer	Yes	Yes
UL-2601 listed power supply	Yes	Yes
Heart-rate measure using IR Phethsmograph	Yes	Yes
Wireless version of the inclinometer	Yes	N/A

Predicate Device Comparison Chart

Section 5: Performance Specification

Insight Discovery 510(k) Summary

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The Insight Discovery specifications are summarized below and are identical to Insight Millennium III (except for the addition of the Dual Inclinometer):

EMG

Electrodes:

Calibrated Range: Input Bias Current: Differential Input Impedance: Common Mode Rejection: Bandwidth: Noise: Detector: Controls:

Temperature

Calibrated Range: Accuracy: Sensors:

Controls: Physical:

Size:

Algometer

Calibrated Range: Accuracy: Contact Area: Sensor: Controls: Physical:

Size:

Heart Rate Sensor Sensor Type

Output Voltage: Output Impedance: Weight: Sensor Size:

Single Inclinometer Range: Accuracy: Axes: Controls:

4 ea. Smart Sensors with low-noise preamplifiers integral to clectrode assemblies 0.1 - 999 uV Less than 2.0 Picoamperes Greater than 1,000,000 Megaohms 150 dB 20-500 Hz (50/60 Hz notch) Less than 0.1 uV (inputs shorted) Log power detector, 250 mS averaging filter. None

55°F - 120°F +0.2°F nominal Two thermopile, fixed 2.5" apart (center-tocenter) Enter button Case Material: Impact-resistant, Aluminum with 0.5" ABS Plastic Outer Ring. 5.5"L x 3.5"W x 2.5"H. Weight 15 oz.

0-100 lbs. +3% nominal 1.0 cm4 One pressure transducer attached to a stiff rod. Enter button Case Material: Impact-resistant, Aluminum with 3.0" ABS Plastic Stiff Rod. 5.5"L x 1.75"W x 2.5"H. Weight 9 oz.

IR Plethsmograph (attached to finger with Velcro) 5 - 50 mV, typical at rest 1 kΩ2, nominal 28 grams 15 x 15 x6.3 mm

360 degrees +/- 1 degree nominal One Enter and Skip Buttons

Insight Discovery 510(k) Summary

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	Physical:	Case Material: Impact resistant, flame retardant ABS.
		3.4"H x 3.5"W x 1.25"D. Weight 6.5 oz.
	Dual Inclinometer
	Range:	360 degrees
	Accuracy:	+/- 1 degree nominal
	Axes:	Three
	Controls:	None
	Bluetooth Type:	Class 1 / +7dBm 5 mW
	Physical:	Case Material: Impact resistant, flame retardant ABS.
		(1) 3.9"L x 2.0"W x 0.8"D. Weight 2.9 oz.
		(2) 1.4"L x 1.4"W x 0.6"D. Weight 1.8 oz.
	Instrument Console
	Inputs:	4 each EMG electrodes1 each inclinometer1 each temperature sensor1 each algometer sensor1 each Heart Rate sensor
	Output:	Isolated USB
	A/D converter:	16 bit, 16 channel
	Controls:	None
	Power:	12V, 500 mA UL-2601 listed power supply.
	Physical:	Case Material: Impact resistant, flame retardant ABS.
		3.5"H x 8.375"W x 9"D. Weight 3 lbs. 11 oz.

Section 6: Patient Safety

The Insight Discovery patient isolation is assured by the following two electrical isolation barriers:

1 . Medical-Grade Universal Power Supply: This device is a UL2601 compliant AC line to 12 VDC, 28 W converter. This internal power supply is partitioned from all other circuitry via an earthed steel chassis. The power supply accepts 85-264 VAC, and 47-63 Hz via a IEC 60320 fused input module.
This supply provides low-level isolated power to the Non-Patient Side of the Insight Discovery circuitry, as well as power to the DC-to-DC isolation converter that powers to the Patient Side (see #2 below).
1. DC-to-DC Patient Isolation Converter: This converter is a UL2601 compliant DC-to-DC converter, and meets the dielectric withstand and leakage current requirements of the UL2601 standard for Patient Care Equipment with isolated patient leads.
  This converter supplies all power to patient-applied parts and related circuitry. Each of the direct patient-applied parts have individual current limiters for fault condition.

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In addition, the Patient Side of the Insight Discovery is isolated from the host PC as follows:

Signals are converted from analog voltages to 16 bit 3. Optically Isolated Data Link: digital values by the analog-to-digital converter (ADC). The digital data is sent to and from the USB of the PC across an optically isolated data link.
This optical link is UL2601 compliant, providing the dielectric withstand and low leakage current characteristics specified in UL2601.

Section 7: Conclusion

The Insight Discovery is substantially equivalent to the predicate device. Furthermore, the device is safe and effective for its intended use.

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Image /page/6/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Fasstech % Intertek Testing Services NA, Inc. 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087 ATTN: Daniel W. Lehtonen

DEPARTMENT OF HEALTH & HUMAN SERVICES

AUG 1 6 2007

Re: K063447

Trade/Device Name: Insight Discovery Diagnostic Electromyograph Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyograph Regulatory Class: Class II Product Code: IKN, HCC Dated: August 2, 2007 Received: August 3, 2007

Dear Mr. 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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Millham

Mark N. Melkerson 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):

Device Name: Insight Discovery

Indications for Use:

To measure patient self-reported pressure sensitivity in joints and muscles To measure Heart Rate

To chart patient progress during the course of treatment

Prescription Use (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)

Mudk N. Willians

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

510(k) Number K06344

Page of

Regulation Number and Section

§ 890.1375 Diagnostic electromyograph.

(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).