(94 days)
The Intellihab system is intended to strengthen the quadricep muscle stimulation to provide symptomatic temporary pain relief associated with knee osteoarthritis and improvement of the knee joint mobility when the recommended treatment regimens are followed.
In addition, the Intellihab System is indicated for the following:
- Retardation or prevention of disuse atrophy
- Evaluation of joint mobility by measuring and recording range of motion .
The Intellihab System is indicated for adults of 22 years of age and older.
Intellihab System is a remote monitoring electrical muscle stimulator (or Neuromuscular Electrical Stimulation (NMES) therapy) with an integrated digital goniometer for osteoarthritis pain relief and joint mobility improvements. Intellihab device is used to apply an electrical current through a power regulated output closed-loop feedback NMES system to provide relief of knee pain associated with osteoarthritis. The stimulator is intended for medical purposes that continuously contracts muscle groups for an intended therapeutic application and allows for remote monitoring of therapeutic data by the healthcare Providers. The stimulator is provided with an integrated battery powered digital goniometer that allows for measurement of knee joint range of motion. The stimulator along with the digital goniometer is placed over or in proximity to affected joint. The Intellihab System includes a provider portal allowing for remote monitoring of collected patient data through Intellihab mobile app and API interface.
The CyMedica Intellihab System is an electrical muscle stimulator with an integrated digital goniometer for osteoarthritis pain relief and joint mobility improvements, and for the retardation or prevention of disuse atrophy.
1. Table of Acceptance Criteria & Reported Device Performance:
The document does not explicitly present a table of "acceptance criteria" with specific numeric thresholds that the Intellihab system had to meet for each performance metric, as might be specified for a new device submission. Instead, it aims to demonstrate substantial equivalence to a predicate device (CyMedica e-vive® System, K163067) and supports its new indications for use through clinical study results.
The clinical study evaluated the effectiveness and safety of the device. The "acceptance criteria" for effectiveness are implicitly tied to demonstrating statistically significant and clinically meaningful improvements in pain, stiffness, and function compared to sham treatment, particularly in a "Per Protocol Therapy Compliant (PPTC)" population.
Here's a summary of the effectiveness results in the PPTC population where statistical significance was observed, which could be interpreted as meeting certain performance "criteria":
| Performance Metric (Endpoint in PPTC Group at Week 12) | Acceptance Criteria (Implicit) | Reported Device Performance (Intellihab NMES PPTC) | Reported Device Performance (Sham Low Voltage NMES) | P-value |
|---|---|---|---|---|
| Treatment Responder Rate for VAS General (≥30% improvement) | Show statistically significant improvement over sham | 67% | 46% | 0.043 |
| Treatment Responder Rate for WOMAC Pain Subscale (≥30% improvement) | Show statistically significant improvement over sham | 64% | 42% | 0.029 |
| Treatment Responder Rate for WOMAC Stiffness Subscale (≥30% improvement) | Show statistically significant improvement over sham | 62% | 36% | 0.011 |
| Percentage Change from Baseline (PCFB) for WOMAC Pain Subscale | Show statistically significant improvement over sham | -36.8% (reduction) | -26.6% (reduction) | 0.038 |
| PCFB for KOOS JR Pain Subscale | Show statistically significant improvement over sham | -43.2% (reduction) | -27.7% (reduction) | 0.010 |
| PCFB for WOMAC Stiffness Subscale | Show statistically significant improvement over sham | -44.7% (reduction) | -17.4% (reduction) | 0.002 |
| PCFB for KOOS JR Stiffness Subscale | Show statistically significant improvement over sham | -39.8% (reduction) | -14.5% (reduction) | 0.010 |
| PCFB for WOMAC Function Subscale | Show statistically significant improvement over sham | -40.1% (reduction) | -24.5% (reduction) | 0.029 |
| PCFB for KOOS JR Function Subscale | Show statistically significant improvement over sham | -39.3% (reduction) | -19.7% (reduction) | 0.029 |
For safety, the acceptance criterion was "no serious adverse events directly attributed to the device that introduced a new risk compared to the predicate device."
Reported Safety Performance: 9 (8.5%) adverse events in the Treatment group and 3 (6.1%) in the sham group. Only 3 device-related adverse events (1.9%) were reported in the treatment group, and none were serious or led to study discontinuation. These events (calf muscle spasms, pain consistent with electric shock, skin marks consistent with burn) were consistent with the predicate device and did not introduce new risks.
2. Sample Size for Test Set and Data Provenance:
- Sample Size (Clinical Study - Test Set):
- Total subjects screened: 177
- Total subjects enrolled: 159
- Total subjects randomized: 156
- Treatment NMES group: 106 subjects
- Sham Low Voltage NMES group: 50 subjects
- Per Protocol Therapy Compliant (PPTC) population (Treatment NMES): 69 subjects at week 4, 61 at week 8, and 45 at week 12 (61.3% of ITT Treatment NMES group). The sham group in the PP population analysis remained the same as the ITT sham population (50 subjects).
- Data Provenance: The study was a "randomized, sham controlled, double-blind, multi-center study performed at 7 sites in the USA." This indicates the data is from the USA and is prospective.
3. Number of Experts and Qualifications for Ground Truth:
The document describes a clinical study using patient-reported outcome measures (VAS, WOMAC, KOOS JR) and functional tests. The ground truth for effectiveness is based on these patient-reported scores and objective functional assessments, not on expert adjudication of diagnostic images or interpretations. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of diagnostic accuracy studies (e.g., radiologists interpreting images) is not directly applicable here. The study design implicitly relies on the established validity and reliability of the chosen clinical assessment tools.
4. Adjudication Method for the Test Set:
Not applicable in the context of this device and study type. There was no adjudication panel for the primary and secondary endpoints, as these involved patient self-reporting (pain, stiffness, function) and objective physical assessments (e.g., TUG test, chair rise test).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This study evaluated the direct effectiveness of the device as a therapeutic intervention against a sham control, not the improvement of human readers' performance with AI assistance.
6. Standalone (Algorithm Only) Performance:
The document mentions a "remote monitoring electrical muscle stimulator (or Neuromuscular Electrical Stimulation (NMES) therapy) with an integrated digital goniometer for osteoarthritis pain relief and joint mobility improvements." The effectiveness study was performed with patients using the device, which is a therapeutic device intended for human use, not solely an algorithm for diagnostic interpretation in a standalone mode. The Intellihab system comprises a hardware device (stimulator, goniometer, garment) and software components (mobile app, web services). While the software controls aspects of the therapy and data collection, the "performance" evaluated in the clinical study is that of the integrated system and its therapeutic effects on the patient, not a standalone algorithm.
7. Type of Ground Truth Used:
The ground truth for effectiveness was established through:
- Patient-reported outcome measures: Visual Analog Scale (VAS) for pain (nominated activity, general, walk, rest), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for pain, stiffness, and function, and Knee Injury and Osteoarthritis Outcome Score (KOOS JR) for pain, stiffness, and function.
- Objective functional assessments: Isometric quadriceps strength, Timed Up and Go (TUG) test, repeated chair rise test, and three-minute walk test.
8. Sample Size for the Training Set:
The document describes a clinical study for evaluating the device's effectiveness, not a study for training an AI/ML algorithm. Therefore, there is no "training set" in the context of this submission. The term "training set" typically applies to machine learning models.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set for an AI/ML algorithm in this submission.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).