(258 days)
ActiSpec® is a small limb worn activity monitor designed for documents associated with applications in physiological monitoring. The device intended use is to analyze limb activity associated with movement during sleep. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.
ActiSpec® consists of a pair of toe bands containing firmware within the toe band housing, and an offline data download, scoring, and report generation tool. The ActiSpec® toe band is a small, battery-operated activity monitor worn on the big (great) toe. ActiSpec® typically is packaged as a pair of toe bands, one for each big toe.
ActiSpec® measures, records, and scores movements caused by the contraction of the tibialis anterior muscle responsible for movement of the big toe and dorsiflexion of the ankle and foot. These movements are detected by the accelerometer.
The intention is for the patient to wear the toe bands only while sleeping for five (5) consecutive nights. After the fifth night, the patient returns the toe bands to Sleep Modus and a report is generated for the care provider.
The generated report contains statistical information regarding the movements of the patient each night including a graph showing those movements. The report is in the form of a PDF document emailed to the care provider.
ActiSpec® has a 2-year shelf life in addition to a 120-hour active data collection period. Device activation occurs upon removal of the toe bands from the light-proof packaging.
The provided text discusses the ActiSpec Activity Monitor, its intended use, and its equivalence to predicate devices. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test and training sets, or information about expert adjudication, MRMC studies, or ground truth establishment relevant to performance metrics. The document is a 510(k) summary focused on demonstrating substantial equivalence rather than a detailed clinical study report.
Therefore, much of the requested information cannot be extracted directly from this document. I will highlight the information that is present and explicitly state where the requested details are not available.
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document states, "Testing has been performed to demonstrate that the ActiSpec® meets the predetermined specifications." However, it does not detail what those specifications are (acceptance criteria) or present a table of results against them. It only mentions a "bench comparison was performed between ActiSpec® and the predicate ActiTrainer device."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "bench comparison" but does not specify the sample size or data provenance for any testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The type of testing described (bench comparison to a predicate device) does not typically involve expert-established ground truth in the way a clinical study for diagnostic accuracy would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. An MRMC study is not mentioned. The device, an activity monitor, is not described as having an "AI" component that would assist human readers in interpretation; it records and scores movements.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the ActiSpec® as a device that "measures, records, and scores movements" and generates a report. This suggests a standalone, algorithm-only performance, as it is designed to objectively quantify activity. The core function is automated measurement and scoring. The report is then provided to a "care provider." The document states, "comparison testing demonstrates that the event recording capabilities of the devices are substantially equivalent" to the predicate ActiTrainer. This comparison would implicitly be of the standalone performance of the ActiSpec's recording capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the ground truth for "event recording capabilities" was established by comparison to the predicate device, ActiTrainer. The specific mechanism of how "ground truth" was defined during this bench comparison (e.g., a reference standard for movement detection against which both devices were measured, or if accuracy was defined solely by agreement with the predicate) is not detailed. It is mentioned that "ActiSpec shares the same acceleration sensitivity with the predicate ActiTrainer but utilizes a fixed acceleration threshold of 0.1g while the ActiTrainer allows the user to define the movement threshold," indicating a comparison of their acceleration detection and scoring.
8. The sample size for the training set
This information is not provided in the document. The document describes the device, not the development process with training sets.
9. How the ground truth for the training set was established
This information is not provided in the document, as no training set is discussed.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2015
Sleep Modus, Inc. c/o Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive Suite 280 Richardson, Texas 75080-4403
Re: K143512
Trade/Device Name: ActiSpec Activity Monitor Regulation Number: 21 CFR 890.5360 Regulation Name: Measuring Exercise Equipment Regulatory Class: Class II Product Code: ISD Dated: July 30, 2015 Received: July 31, 2015
Dear Ms. Rutherford:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143512
Device Name ActiSpec Activity Monitor
Indications for Use (Describe)
ActiSpec® is a small limb worn activity monitor designed for documents associated with applications in physiological monitoring. The device intended use is to analyze limb activity associated with movement during sleep. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
| Submitter: | Sleep Modus, Inc.1201 Richardson Drive, Suite 280-BRichardson, TX 75080 | ||||
|---|---|---|---|---|---|
| Contact Person: | Sleep Modus, Inc.Mr. Stanford P. HudsonPresident1201 Richardson Drive, Suite 280-BRichardson, TX 75080TEL: 214-405-4055sphudson@sleepmodus.com | ||||
| Date Prepared: | December 10, 2014 (revised August 17, 2015) | ||||
| Trade Name: | ActiSpec® Activity Monitor | ||||
| Common Name: | Activity Recording Device | ||||
| PrimaryClassification Name: | Measuring exercise equipment | ||||
| Product Code: | ISD | Class 2 | 890.5360 | ||
| Predicate Devices: | K080545K040554 | ActiTrainerActiGraph | ActiGraph, LLCManufacturing Technology, Inc. | ||
| Device Description: | ActiSpec® consists of a pair of toe bands containing firmware within the toe bandhousing, and an offline data download, scoring, and report generation tool. TheActiSpec® toe band is a small, battery-operated activity monitor worn on the big(great) toe. ActiSpec® typically is packaged as a pair of toe bands, one for each bigtoe.ActiSpec® measures, records, and scores movements caused by the contraction ofthe tibialis anterior muscle responsible for movement of the big toe and dorsiflexionof the ankle and foot. These movements are detected by the accelerometer.The intention is for the patient to wear the toe bands only while sleeping for five (5)consecutive nights. After the fifth night, the patient returns the toe bands to SleepModus and a report is generated for the care provider.The generated report contains statistical information regarding the movements of thepatient each night including a graph showing those movements. The report is in theform of a PDF document emailed to the care provider.ActiSpec® has a 2-year shelf life in addition to a 120-hour active data collectionperiod. Device activation occurs upon removal of the toe bands from the light-proofpackaging. | ||||
| Statement ofIntended Use: | ActiSpec® is a small limb worn activity monitor designed for documenting physicalmovements associated with applications in physiological monitoring. The device'sintended use is to analyze limb activity associated with movement during sleep. Theunit can also be used to assess activity in any instance where quantifiable analysis ofphysical motion is desirable. |
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Summary of Technological Characteristics: ActiSpec® utilizes an accelerometer to monitor the occurrence of motion. The firmware utilizes a specified time base which defines an epoch. The firmware accepts notifications from the accelerometer of changes in acceleration that exceed a specified threshold. If a notification occurs within an epoch, then the firmware marks that epoch location to indicate the movement within onboard non-volatile memory. Otherwise, it marks the location to indicate that no movement occurred within that epoch. As described previously, ActiSpec® measures, records, and scores movements caused by the contraction of the tibialis anterior muscle
The accelerometer is configured to notify firmware if the slope of acceleration exceeds the threshold. The accelerometer, as configured by firmware, has an effective sample rate of 10Hz and draws minimal current during non-sampling periods which enables the ActiSpec® device to achieve the 120-hour active time without requiring firmware to continually extract samples from the chip.
The ActiSpec® toe band and battery are disposable with the accelerometer, microcontroller, non-volatile memory, and optical activation circuit being re-usable (recyclable) electronics.
When compared to the predicate devices, all share the same indications for use, are battery operated wearable activity recording devices, feature offline scoring and data processing, share the same device category, nature of body contact and duration of contact, and are non-sterile.
A few minor differences do exist between the proposed ActiSpec and the predicate devices. Most of these differences are driven by ActiSpec® being designed to be worn on the big toe while the ActiTrainer is worn on the wrist or foot and ActiGraph is worn on the wrist, ankle, or waist. Because the ActiSpec® is worn on the toe, the device is smaller and lighter. Also, the ActiSpec is to be used for one recording cycle and is worn only during sleep, so the requirements on the battery, memory, and recording time are less than that of the predicates which are typically worn for 24 hours a day for seven consecutive days.
The ActiSpec shares the same acceleration sensitivity with the predicate ActiTrainer but utilizes a fixed acceleration threshold of 0.1g while the ActiTrainer allows the user to define the movement threshold. The ActiSpec has an epoch period of 0.5 seconds, which is the minimum duration of candidate movements according to standard scoring of periodic limb (foot) movements during sleep. The ActiTrainer allows for an epoch to be a minimum of 1.0 seconds to a maximum of 4 minutes. In spite of these differences, comparison testing demonstrates that the event recording capabilities of the devices are substantially equivalent.
Testing has been performed to demonstrate that the ActiSpec® meets the Summary of Non-Clinical Data: predetermined specifications. In addition, a bench comparison was performed between ActiSpec® and the predicate ActiTrainer device. Test Data:
Sleep Modus, Inc. considers the ActiSpec® to be substantially equivalent to the Conclusion: predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.
§ 890.5360 Measuring exercise equipment.
(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.