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510(k) Data Aggregation
(266 days)
The ARCEX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).
The ARCES System is a medical device that delivers transcutaneous programmed. Carrier Frequency-enabled electrical spinal cord stimulation (ARCEN Therapy). The System is intended to be used in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals with cervical spinal cord injury (SCI). The stimulation is intended to be delivered transcutaneously and the active electrodes are intended to be placed in direct contact with intact skin, in appropriate locations along or near the spine to elicit desired outcomes. The ARCES System is intended to be used in a medical center setting by patients and their rehabilitation professionals. The primary components of the ARCEX System are: ARCEX Stimulator, ARCEX Stimulator Charger, ARCEX Splitter Box, ARCEX Extension Cables, ARCEX Programmer, Programmer Charger, and ARCEX Case. The ARCES System is intended to be used with the FDA-cleared Axelgaard PALS electrodes (K132422).
Here's a summary of the acceptance criteria and the study that proves the ARCEX System meets those criteria, based on the provided text:
Acceptance Criteria and Device Performance for ARCEX System
The acceptance criteria for the ARCEX System are primarily derived from the special controls outlined by the FDA and the demonstrated clinical benefits. The clinical study aimed to demonstrate improvements in hand sensation and strength.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance and Evidence |
|---|---|---|
| Clinical Effectiveness: Hand Sensation Improvement | Demonstrate improvement in hand sensation. | ISNCSCI-UESS: Mean improvement of 2.9 (SD 4.8, 90% CI 1.8, 3.9) in the device use phase (p < 0.001). This met the pre-specified threshold for success and showed a statistically and clinically significant change with adjunctive device use beyond expected rehabilitation alone. GRASSP—Sensibility: Mean improvement of 0.9 (SD 2.4, 90% CI 0.4, 1.4) in the device use phase (p = 0.003). Dermatome Analysis: Trend of greater change in C6-T1 dermatomes for ISNCSCI-UESS, with C6-C8 covering the hand. |
| Clinical Effectiveness: Hand Strength Improvement | Demonstrate improvement in hand strength. | ISNCSCI-UEMS: Mean improvement of 2.2 (SD 3.2, 90% CI 1.5, 2.8) in the device use phase (p < 0.001). This met the pre-specified threshold for success and showed a statistically and clinically significant change with adjunctive device use beyond expected rehabilitation alone. GRASSP—Strength: Mean improvement of 2.8 (SD 5.4, 90% CI 1.6, 3.9) in the device use phase (p < 0.001). Pinch force: Mean improvement of 4.8 (SD 16.1, 90% CI 1.3, 8.4) in the device use phase (p = 0.002). Grasp force: Mean improvement of 13.7 (SD 27.4, 90% CI 7.8, 19.6) in the device use phase (p < 0.001). Myotome Analysis: Trend of greater improvement in C8 and T1 myotomes for ISNCSCI-UEMS, corresponding with finger flexors and hand intrinsics. |
| Clinical Effectiveness: Functional Task Practice (Implicit) | Indicated for use in conjunction with functional task practice. Improvements in CUE-T and GRASSP-Prehension demonstrate general upper limb function changes, though their specific attribution to the device vs. rehabilitation alone was questioned. | CUE-T: Mean improvement of 5.3 (SD 5.3, 90% CI 4.2, 6.5) in the device use phase (p < 0.001). GRASSP—Prehension Performance: Mean improvement of 1.6 (SD 2.9, 90% CI 0.9, 2.2) in the device use phase (p < 0.001). While statistically significant, the report notes that the linearity of the plots raises questions about the specific attribution to device vs. continuation of intense rehabilitation alone. However, this still represents improvement in conjunction with the system. |
| Safety | No serious adverse events related to the device. Device-related non-serious adverse events are manageable and resolve with intervention. | Three non-device related SAEs occurred. 44 ADEs were possibly device-related (musculoskeletal: spasms, stiffness, pain; skin conditions: sweating, redness, irritation, reactions; burning sensation, paresthesias). These resolved by turning off the device or reducing stimulation. The incidence of these events did not exceed what is expected for this patient population. |
| Non-clinical Performance Testing (Special Control 1) | Characterization of electrical stimulation parameters (waveforms, output modes, amplitudes, duration, frequency, charge). Characterization of impedance monitoring system. Characterization of electrode performance. | Non-clinical performance testing was conducted, conforming to IEC 60601-2-10 2016 Ed. 2.1. The device description provides detailed stimulation parameters (Waveform, Amplitude ranges, Frequencies, Pulse Widths, Ramp-up/Program Durations). The system is intended for use with FDA-cleared Axelgaard PALS electrodes (K132422) which have demonstrated performance. Implicitly, these tests support the intended functioning. |
| Electromagnetic Compatibility & Electrical Safety (Special Control 2) | Performance data must demonstrate EMC, electrical safety and performance, battery safety, and wireless compatibility. | Testing performed to recognized standards: IEC 60601-1-2:2014/A1:2020 (EMC), IEC/TR 60601-4-2:2016 (EM Immunity), ANSI AAMI HA60601-1-11:2015+AMD1:2021 (Home Healthcare), ANSI/AAMI ES60601-1:2005/A2:2021 (Basic Safety/Performance), IEC 60601-2-10:2016 (Nerve/Muscle Stimulator), IEC 62133-2:2017 (Battery Safety), UN38.3.5 (Battery Transport), EN IEC 55035:2017/A111:2020 (EMC Multimedia). |
| Software Verification, Validation & Hazard Analysis (Special Control 3) | Software verification, validation, and hazard analysis must be performed. | Device software and cybersecurity documentation was provided per FDA Guidance (June 2023), categorized as Enhanced. Complete verification and validation of all components (software, hardware, firmware, cybersecurity, wireless compatibility, coexistence) were provided. |
| Biocompatibility (Special Control 4) | Patient-contacting components must be biocompatible. | Electrodes (Axelgaard PALS, K132422) previously cleared and demonstrated biocompatibility. Extension Cables: Biocompatibility testing (cytotoxicity, sensitization, irritation) showed non-cytotoxic, non-sensitizing, non-irritating, and toxicology risk assessment of color additives acceptable. Splitter Box Clip: Biocompatibility testing (cytotoxicity, irritation) showed non-cytotoxic, non-irritating, and toxicology risk assessment of color additives acceptable. All materials listed in Attachment G of FDA Guidance on ISO 10993 with documented safe use; no exclusion criteria applied. |
| Labeling Requirements (Special Control 5) | Labeling must include: summaries of stimulation parameters; instructions for ADM management; contraindication for active implants/wearable defibrillators; typical sensations; accurate placement instructions; cleaning instructions. | The User Manual meets 21 CFR Part 801.109 for prescription devices. Labeling includes: instructions for software navigation for stimulation setup; applying device, operation, typical sensations; summary of electrical stimulation parameters; cleaning instructions. Contraindications and Warnings/Precautions (including those related to ADM and active implants) are explicitly stated in the provided document, implying their presence in the labeling. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Enrolled: 65 participants
- Completed Study (Test Set): 60 participants
- Data Provenance: Prospective, non-randomized, within-subject controlled clinical trial. Data collected from fourteen (14) investigational sites, five (5) of which were located outside of the United States (Canada, the Netherlands, and Scotland).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The study was a clinical investigation assessing patient outcomes (strength, sensation, function) using standardized clinical assessment scales (ISNCSCI-UEMS, GRASSP, Pinch/Grasp force, CUE-T, ISNCSCI-UESS, PGIC). These assessments are often performed by trained clinicians (e.g., neurologists, physical therapists, occupational therapists) specializing in spinal cord injury.
The text does not explicitly state the "number of experts" used to establish the ground truth for the test set in the sense of independent adjudication for each case, nor does it detail their specific qualifications (e.g., "radiologist with 10 years of experience"). However, the assessments themselves constitute the "ground truth" for the study's endpoints, and these are inherently administered and interpreted by qualified clinical personnel at the investigational sites. The study was published in "Nat Med," indicating peer review and a robust methodology, which assumes qualified professionals administered the tests.
4. Adjudication Method for the Test Set
The text does not describe an explicit "adjudication method" in the sense of multiple independent readers reviewing cases. Instead, the study relied on standardized clinical assessment scales administered by trained personnel. The "ground truth" for the effectiveness endpoints (strength, sensation, function) was the scores obtained from these validated instruments. The study design was a within-subject control, where each participant served as their own control (rehabilitation-only phase vs. rehabilitation + ARCEX phase).
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is a transcutaneous electrical stimulator, not an AI-assisted diagnostic or interpretative tool that would involve "human readers" interpreting images or data with and without AI assistance. The study assessed the device's direct therapeutic effect on patients.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not directly applicable to the ARCEX System, as it is a therapeutic device that works in conjunction with a human professional (rehabilitation professional) in a clinic setting. The device delivers programmed electrical stimulation, but its performance is measured by the patient's physiological and functional response, not by an algorithm's classification accuracy. The "without human-in-the-loop" concept doesn't fit a physical therapeutic device like this. However, the software component underwent standalone verification and validation to ensure it performed as intended in controlling the stimulator.
7. The Type of Ground Truth Used
The ground truth used in the clinical study was based on standardized clinical assessment scores reflecting objective physiological and functional changes in patients. These included:
- International Standards for Neurological Classification of Spinal Cord Injury - Upper Extremity Motor Score (ISNCSCI-UEMS) for strength.
- International Standards for Neurological Classification of Spinal Cord Injury - Upper Extremity Sensory Score (ISNCSCI-UESS) for sensation.
- Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) subscales for strength, prehension performance, and sensibility.
- Pinch and grasp forces for strength.
- Capabilities of Upper Extremity Test (CUE-T) for upper limb function.
- Patient Global Impression of Change (PGIC) as a patient-reported outcome.
8. The Sample Size for the Training Set
The provided text describes a single clinical investigation which served as the pivotal study for the de novo submission. It does not mention a separate "training set" as would be typical for machine learning model development. The 60 participants who completed the study are the entirety of the clinical data presented for evaluating the device's safety and effectiveness.
If "training set" refers to the prior data or knowledge informing device development or clinical trial design, the text does not quantify this. It mentions the "rehabilitation-only phase" (Month 0 to Month 2) which served as a within-subject control period, essentially helping to establish a baseline and the expected rate of improvement without the device, before the device was introduced.
9. How the Ground Truth for the Training Set Was Established
As noted above, there isn't a "training set" in the machine learning sense explicitly described. For the purposes of the clinical trial's within-subject control design, the "ground truth" for the rehabilitation-only phase (Month 0 to Month 2) was established by the same standardized clinical assessment scores administered by trained clinical personnel, just as it was for the device-use phase. This allowed for a comparison of improvement rates within the same individuals.
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