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The SANUWAVE dermaPACE System is indicated to provide acoustic pressure shockwaves in the treatment of chronic. full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm', which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The dermaPACE System is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The dermaPACE System consists of a bench-top Control Console and the PACE Applicator (Figure 1). The PACE Applicator is connected to the Control Console via a six-feet-long cable. The Control Console and PACE Applicator are intended to be reusable. Single use, disposable, sterile sleeves are used to cover the applicator during use. Sterile ultrasound coupling gel ensures proper transfer of the acoustical waves to the treatment area. Both the sterile sleeves and the coupling gel are provided with the device. The PACE Applicator generates shock waves by the electrohydraulic method. A high voltage current (18,000-23,000 Volts) (b) (4) the applicator at its tip which contacts the patient (Figure 2a and b). The acoustic pressure shock waves generated by the device consist of a dominant compressive pressure pulse, low negative pressures, and the tensile wave (Figure 3). The device has multiple output settings, but the software will default to a standard setting of 500 pulses and a frequency of 4 pulses per second.

The information provided describes the de novo classification request for the dermaPACE System, an extracorporeal shock wave device for the treatment of chronic diabetic foot ulcers. The device's acceptance criteria are primarily related to its safety and effectiveness, demonstrated through two prospective, randomized, double-blind, parallel-group, sham-controlled, multi-center studies (Study 1 and Study 2).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• All AEs: 80.4% dermaPACE vs. 78.8% control (p=0.725).
• SAEs: 31.8% dermaPACE vs. 37.4% control (p=0.384).
• TESAEs: 11.2% dermaPACE vs. 20.2% control (p=0.069).
• DR-AEs: 6.5% dermaPACE vs. 2.0% control (p=0.117).
• Osteomyelitis: 0% dermaPACE vs. 3% control.
• No significant change in pain from baseline or between groups. |
  | | | Study 2 (up to 8 treatments):
• All AEs: 61.5% dermaPACE vs. 52.3% control.
• SAEs: 32.3% dermaPACE vs. 21.5% control.
• TESAEs: 32.3% dermaPACE vs. 21.5% control.
• DR-AEs: 3.1% dermaPACE vs. 3.1% control.
• Osteomyelitis: 13.8% dermaPACE vs. 7.7% control. Increased rates of SAE, TESAE, and osteomyelitis observed in Study 2 dermaPACE group, especially with >7 treatments. |
  | Biocompatibility | Patient-contacting components must be biocompatible (per ISO 10993-1). | PACE Applicator coupling membrane: Passed Cytotoxicity (Neutral Red Uptake & MTT), USP Intracutaneous, Sensitization (Kligman Maximization), USP Muscle Implant, and USP Systemic Toxicity tests. |
  | Reprocessing | Reusable components can be reprocessed for subsequent use. | Cleaning and low-level disinfection validated (3 log reduction in bacteria). Reusability study confirmed PACE applicator can deliver pre-programmed pulses after multiple reprocessing rounds. |
  | Electrical Safety & EMC | Complies with relevant standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2). | Complies with ANSI/AAMI ES60601-1:2005/(R2012) + A1:2012 and IEC 60601-1-2: 2007. |
  | Software | Software performs as intended, and all software-related risks are adequately mitigated (based on FDA guidance for MAJOR level of concern). | Adequate documentation (SRS, architecture design, traceability, configuration, fault insertion/white box testing, validation, revision history, unresolved anomalies, usability validation) provided and deemed adequate. V&V testing conducted with satisfactory results. |
  | Performance (Bench) | System produces anticipated and reproducible acoustic pressure shock waves; consistent and repeatable. Technical parameters measured (volume of pressure field, focal volume, peak pressures, energy flux density, energy per pulse, audible noise). | Complies with IEC 61846:1998 (Pressure field characterization) and IEC 60601-2-36:2014 (Focal volume, peak pressures, energy flux density, energy measurements). Measured at no, typical, and maximum compression. |
  | Use Life | Continued system functionality over the labeled use life. | PACE applicator shown to deliver (b)(4) repeatable shock wave pulses during bench testing. Software deactivated and replaced after (b)(4) pulses (set at 19% of total successful pulses as safety factor). |

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set (Clinical Studies):
  • Study 1: 206 subjects randomized (293 screened). 107 dermaPACE, 99 sham-control.
  • Study 2: 130 subjects randomized (261 screened). 65 dermaPACE, 65 sham-control.
  • Total Subjects: 336
• Data Provenance: Prospective, randomized, double-blind, parallel-group, sham-controlled, multi-center studies.
  • Study 1: 22 centers in the US, 1 in England, and 1 in Germany.
  • Study 2: 18 centers in the United States and 1 site in Canada.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set (clinical data).
• However, wound closure was defined as "skin re-epithelialization without drainage or dressing requirements, confirmed over two consecutive visits within 12-weeks (as determined by blinded evaluator)." This implies that the assessment was made by clinical evaluators who were blinded to the treatment assignment. Their specific qualifications (e.g., dermatologists, wound care specialists, years of experience) are not detailed.

4. Adjudication Method for the Test Set

• The document states that "Complete wound closure was defined as skin re-epithelialization without drainage or dressing requirements, confirmed over two consecutive visits within 12-weeks (as determined by blinded evaluator)."
• This suggests that agreement between "blinded evaluators" (plural) was part of the confirmation process, potentially indicating an adjudication method like multiple independent reviews or a consensus approach. However, the specific method (e.g., 2+1, 3+1) is not explicitly detailed.

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 done. This study evaluated the effectiveness of a medical device (extracorporeal shock wave therapy), not an AI algorithm assisting human readers. The clinical studies compared the device (dermaPACE) plus standard of care to sham treatment plus standard of care.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, this device is not an AI algorithm. It is an extracorporeal shock wave device. Therefore, a standalone algorithm performance study is not applicable to this device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The ground truth for the primary effectiveness endpoint (complete wound closure) was based on clinical observation and assessment by blinded evaluators. Specifically, "skin re-epithelialization without drainage or dressing requirements, confirmed over two consecutive visits within 12-weeks (as determined by blinded evaluator)."
• For safety endpoints, the ground truth was based on reported adverse events (AEs), serious adverse events (SAEs), and device-related AEs as observed and assessed by investigators.

8. The Sample Size for the Training Set

• This device is not an AI algorithm; therefore, there is no "training set" in the context of machine learning. The clinical studies served as the pivotal evidence for safety and effectiveness.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no AI training set for this device.

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