(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.
§ 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.