(87 days)
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 chart patient progress during the course of treatment
The Insight Millennium Plus is a non-invasive, multi-modality physiologic monitoring device. The Insight Millennium Plus contains the following four sensor types: (1) surface EMG used to measure muscle activity, (2) infrared temperature sensor used to measure skin temperature, (3) inclinometer used to measure end-point range of motion, and (4) algometer used to measure patient self-reported pressure sensitivity.
The provided 510(k) summary for the Fasstech Insight Millennium Plus describes a premarket notification for a medical device and its substantial equivalence to predicate devices. It does not contain information about a study that proves the device meets specific acceptance criteria in the context of clinical performance, diagnostic accuracy, or a multi-reader, multi-case study.
The document primarily focuses on establishing substantial equivalence based on device features, technical specifications, and safety design, compared to existing predicate devices.
Therefore, many of the requested elements for describing an acceptance criteria study (such as sample size, ground truth, expert qualifications, MRMC studies, or standalone performance) are not present in the provided text.
Based on the available information, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance specifications for the individual sensors, which can be interpreted as acceptance criteria for the technical performance of the device components. However, these are not clinical acceptance criteria for overall device efficacy or diagnostic accuracy.
| Performance Characteristic | Acceptance Criteria (Specified in 510(k)) | Reported Device Performance (Specified in 510(k)) |
|---|---|---|
| EMG | ||
| Input Bias Current | N/A | Less than 2.0 Picoamperes |
| Differential Input Impedance | N/A | Greater than 1,000,000 Megaohms |
| Common Mode Rejection | N/A | 150 dB |
| Bandwidth | N/A | 20-500 Hz (50/60 Hz notch) |
| Noise | N/A | Less than 0.1 uV (inputs shorted) |
| Range of Motion | ||
| Accuracy | N/A | +/- 1 degree nominal |
| Temperature | ||
| Accuracy | N/A | +0.2ºF nominal |
| Algometer | ||
| Calibrated Range | Not explicitly stated as "acceptance criteria" for the Fasstech Algometer, but predicated on JTECH's range and own stated range for Insight Millennium Plus. | 0-100 lbs |
| Accuracy | Not explicitly stated as "acceptance criteria" for the Fasstech Algometer, but compared to JTECH's "Not Published" accuracy. Fasstech states its own accuracy. | +/- 3% nominal |
| Contact Area | Not explicitly stated as "acceptance criteria" for the Fasstech Algometer, but compared against JTECH's options. | 1.0 cm² |
| Instrument Console | ||
| A/D Converter (bits) | N/A | 12 bit, 8 channel |
Important Note: The "acceptance criteria" in this context are the specified technical performance parameters the manufacturer states the device achieves. The 510(k) process primarily evaluates substantial equivalence to legally marketed predicate devices, not necessarily independent proof of meeting clinical acceptance criteria through a formal study with defined endpoints.
2. Sample size used for the test set and the data provenance:
- Not provided. The document does not describe a clinical test set or data from a study. It focuses on device specifications and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No test set or related ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No test set or adjudication process 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:
- Not applicable/Not provided. The Insight Millennium Plus is a biofeedback device with sensors, not an AI-assisted diagnostic imaging device requiring an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This device is an instrument with sensors; it does not present as an "algorithm only" device in the context of typical standalone performance studies for AI. The section on the "Algometer" explicitly states it is not stand-alone (referring to the Insight Millennium Plus system, not the Algometer component itself being stand-alone).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. As no performance study with a test set is described, no ground truth types are mentioned. The "ground truth" for the device's technical specifications would be the physical measurements taken by the manufacturer during its own testing and calibration.
8. The sample size for the training set:
- Not applicable/Not provided. The document describes a hardware and software system for data acquisition and display, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As above, no training set is described.
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SEP 2 0 2001
Insight Millennium Plus
510(k) Summary
Submitted by:
Company Name: Company Address #1: Company Address #2: Contact Person: Phone Number: Fax Number:
Fasstech 155 Middlesex Turnpike Burlington, MA 01803 Lee Brody 781.229.1500 781.229.9035
Submitted on:
June 22, 2001
510(k) Summary Fasstech Insight Millennium Plus
NE
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/ 1007 8800,
Page 1/5
SKH
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Device Name Section 1:
Biofeedback Device Common or Usual Name: Insight Millennium Plus Proprietary Model Name:
Indications for Use Section 2:
- To measure bilateral differences in surface EMG along the spine 트
- To measure surface EMG along the spine during functional tasks 트
- To measure bilateral differences in skin temperature along the spine 트
- To measure Range of Motion of the three spinal regions 트
- To measure patient self-reported pressure sensitivity in joints and muscles 트
- To chart patient progress during the course of treatment 트
Device Description Section 3:
The Insight Millennium Plus is a non-invasive, multi-modality physiologic monitoring device. The Insight Millennium Plus contains the following four sensor types: (1) surface EMG used to measure muscle activity, (2) infrared temperature sensor used to measure skin temperature, (3) inclinometer used to measure end-point range of motion, and (4) algometer used to measure patient self-reported pressure sensitivity.
Hardware
The Insight Millennium Plus hardware consists of an instrument console and four different sensor types. All four sensor types plug directly into the front panel of the Insight Instrument Console. The Insight Millennium Plus Instrument Console is powered via a UL2601 listed wall mounted power supply. The Instrument Console is connected to a personal computer (IBM compatible) via an isolated serial port connection.
Software
The Insight Millennium Plus software displays real-time surface EMG, spinal Range of Motion, skin temperature and pressure readings, allowing the user to ensure that readings are stable prior to data collection. The Insight Millennium software allows the user to: (1) enter patient information, (2) record surface EMG, spinal Range of Motion, skin temperature and pressure readings, (3) graph surface EMG, spinal Range of Motion, skin temperature and pressure readings, and (4) print out reports.
510(k) Summary Fasstech Insight Millennium Plus
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Predicate Device Section 4:
This section documents the substantial equivalence of the Insight Millennium Plus to legally marketed devices. The Insight Millennium Plus is a modest expansion of the Insight Millennium. The Insight Millennium Plus expansion is limited to the addition of a fourth sensor type. The fourth sensor type is the Insight Algometer. The algometer is a calibrated pressure stimulus device. It measures pressure applied by examiner to elicit a response for pain tolerance, pain threshold, and trigger point tenderness. The Algometer utilized in the Insight Millennium Plus is substantially equivalent to the JTECH Commander™ Algometer (510(k): K971407):
| Fasstech Insight Millennium | (K990778) |
|---|---|
| JTECH Commander™ Algometer | (K971407) |
| Feature | InsightMillennium Plus | InsightMillennium | CommanderAlgometer |
|---|---|---|---|
| Four Channels ofsurface EMG | Yes | Yes | N/A |
| SkinTemperaturemeasurement viainfrared thermalscanner | Yes | Yes | N/A |
| Range of MotionSensor | Yes | Yes | N/A |
| Algometer | Yes | No | Yes |
| UL-2601 listedwall-mountedpower supply | Yes | Yes | N/A |
| Opto-isolatedRS232 output | Yes | Yes | N/A |
| A/D Converter | 12 bit, 8 channel | 12 bit, 8 channel | N/A |
| Algometer SkinContact Area | $1.0 cm^2$ | N/A | $0.5 cm^2$ or$1.0 cm^2$ |
| Instrument BodyMaterial | MachinedAluminum | N/A | MachinedAluminum |
| Instrument BodyCoating | Powder Coated | N/A | Powder Coated |
| Downloadable toPC | Yes | N/A | Yes |
| Range | 0-100 lbs | N/A | 0-100 lbs |
| Accuracy | +/- 3% | N/A | Not Published |
| Skin ContactMaterial | ABS Plastic | N/A | Not Published |
| Stand-alone | No | N/A | Yes |
510(k) Summary Fasstech Insight Millennium Plus
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Section 5: Performance Specification
EMG
Electrodes:
| Calibrated Range: | |
|---|---|
| Input Bias Current: | |
| Differential Input Impedance: | |
| Common Mode Rejection: | |
| Bandwidth: | |
| Noise: | |
| Detector: | |
| Controls: |
Range of Motion
Range: Accuracy: Controls: Physical:
Temperature
Calibrated Range: Accuracy: Sensors:
Controls: Physical:
Size:
Algometer
Calibrated Range: Accuracy: Contact Area: Sensor: Controls: Physical:
Size:
Instrument Console Inputs:
4 ea. Smart Sensors with low-noise preamplifiers integral to electrode assemblies 0.1 - 999 uV Less than 2.0 Picoamperes Greater than 1,000,000 Megaohms 150 AB 20-500 Hz (50/60 Hz notch) Less than 0.1 uV (inputs shorted) Log power detector, 250 mS averaging filter. None
360 degrees +/- 1 degree nominal Enter and Skip Buttons Case Material: Impact resistant, flame retardant ABS. 3.4"H x 3.5"W x 1.25"D. Weight 6.5 oz.
55°F - 120°F +0.2ºF 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 cm2 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.
4 each EMG electrodes 1 each inclinometer
510(k) Summary Fasstech Insight Millennium Plus
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| 1 each temperature sensor | |
|---|---|
| 1 each algometer sensor | |
| Output: | Opto-isolated RS232 (9 pin sub-D jack) |
| A/D converter: | 12 bit, 8 channel |
| Controls: | None |
| Power: | 12V, 500 mA UL-2601 listed wall-mountedpower supply. |
| Physical: | Case Material: Impact resistant, flame retardantABS. |
| 3.5"H x 8.375"W x 9"D. Weight 3 lbs. 11 oz. |
Patient Safety Section 6:
The Insight Millennium Plus patient safety is assured by the following design architecture:
Patient Isolation Circuitry: There are three primary components to the patient isolation circuitry: (a) an external plug-in medical-grade wall transformer. This device is a UL2601 listed wall transformer with an output of 12VDC and 500 mA max. There is also a 1A slow-blow fuse at the wall transformer input,(b) an industry standard DC-to-DC converter that meets the "dielectric withstand" and "leakage current" requirements of the UL2601 standard for Patient Care Equipment with isolated patient leads, and (c) the opto-isolation couplers described in Data Acquisition below.
Processed signals are converted from analog voltages to Data Acquisition / RS232 Data Link: 12 bit digital values by the analog-to-digital converter (ADC). The digital data is sent to and from the serial port of the PC across the isolation barrier via opto-coupler devices. The ADC and a portion of the RSR232 data link are on the patient side of the isolation barrier. The proper use of high voltage opto-couplers provides the dielectric withstand and low leakage current characteristics specified in UL2601. The non-isolated sides of the opto-couplers are then routed to RS232 drivers and receivers which are, in turn, routed to a DB9 connector at the rear panel of the Instrument Console. A standard RS232 serial cable connects the Instrument Console to the PC serial port.
Section 7: Conclusion
The Insight Millennium Plus is substantially equivalent to the two predicate devices. Furthermore, the device is safe and effective for its intended use.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a bird or a stylized human figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2001
Mr. Lee Brody Fasstech 155 Middlesex Turnpike Burlington, Massachusetts 01803
Re: K011964
Trade/Device Name: Insight Millenium Plus Regulation Number: 882.5050 Regulation Name: Biofeedback device Regulatory Class: II Product Code: HCC, HRW Dated: June 22, 2001 Received: June 25, 2001
Dear Mr. Brody:
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 for assured in the encreases in 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 general controls proficturing 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 If your de roo is exassined (too at 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 r reaso oe actived 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 or car) i 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 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.
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Page 2 - Mr. Lee Brody
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
Susan Welker, us
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page | of
510(k) Number (if known): K Oll 964
Insight Millennium Plus Device Name:
Indications for Use:
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 chart patient progress during the course of treatment
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Denes
SL
(Division Sign- 9) Division of General, Restorative and Neurologic Devices
510(k) Number: K011964
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.