(206 days)
The DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece 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 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The DUOLITH SD1 with C-ACTOR 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 DUOLITH SD1 with the C-ACTOR Sepia Handpiece uses an electromagnetically generated shock wave produced within the hand-held applicator. The shock wave is generated by discharging a high voltage capacitor located in the Control Unit into a cylindrically shaped coil system in the C-ACTOR Handpiece which is surrounded by a cylindrical metallic membrane. The transient magnetic field produced by the coil induces eddy currents in the metal membrane, causing it to repel from the coil, producing a pressure wave. The membrane is immersed in water and the pressure wave produced by the membrane propagates through the water to a concentric parabolic reflector, where it is reflected to a focal point outside of the Handpiece in front of the reflector. The DUOLITH SD1 with C-ACTOR incorporates micro-processor control of the operating parameters.
Here's an analysis of the provided text regarding the DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided FDA 510(k) summary does not explicitly list "acceptance criteria" in a quantitative, measurable format for performance, as might be found in a clinical trial protocol. Instead, it describes compliance with design specifications, safety standards, and then reviews clinical literature to demonstrate effectiveness.
Here's an interpretation of the performance claims based on the clinical literature review:
| Acceptance Criterion (Inferred from Clinical Literature) | Reported Device Performance |
|---|---|
| Effectiveness in achieving complete wound healing for chronic diabetic foot ulcers. | 54-70% complete wound healing at 13-20 weeks (reported from five independent studies). |
| Effectiveness in reducing wound area for chronic diabetic foot ulcers. | 35-80% reduction of wound area at 7-20 weeks (reported from five independent studies). |
| Safety for intended use. | Demonstrated through nonclinical verification and validation testing, hazard analysis/risk management (all risks mitigated), biocompatibility testing (ISO 10993-1:2009), and conformity to general safety (IEC 60601-1:2012; IEC 60601-6:2013), EMC (IEC 60601-1-2:2014), and RFID immunity (AMI 7351731) standards. |
| Compliance with design specifications. | All tests required by the verification and validation plan were completed and passed. |
| Substantial equivalence to predicate devices (DERMAPACE and ORTHOGOLD). | Demonstrated through technological characteristics comparison and the clinical effectiveness data being comparable to the expected outcomes for such devices. |
| Software validation. | Software validated to be of a Moderate level of concern. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: The document refers to a "review of published literature" that included "89 chronic soft tissue wounds having a range of etiologies including diabetes mellitus." This suggests that the clinical evidence is based on data from 89 patients (cases), at least, with a focus on chronic diabetic foot ulcers within that group. It's unclear if all 89 specifically had diabetic foot ulcers, but the indications for use focus on this specific condition.
- Data Provenance: The document states "The reports from five independent studies." This implies the data were collected from multiple sources, likely different medical institutions or research groups. The country of origin is not specified, nor is whether the studies were retrospective or prospective, though typical clinical studies used for such purposes are prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. As this relies on a literature review of previously published studies, the methodology for establishing ground truth within those original studies is not detailed here.
4. Adjudication Method for the Test Set
This information is not provided. As this relies on a literature review, the adjudication methods of the individual studies are not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done, or at least not described in this 510(k) summary. The document focuses on the device's standalone performance based on existing clinical literature, not on how human readers would improve with AI assistance. The DUOLITH SD1 is a therapeutic device, not a diagnostic AI tool, so an MRMC study comparing human reader performance with and without AI assistance would not be applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The entire clinical performance section describes the standalone effectiveness of the DUOLITH SD1 device in treating diabetic foot ulcers. The device itself is a therapeutic modality, and its "performance" is its ability to heal wounds or reduce wound area, independent of any human interpretive intervention like with an AI diagnostic algorithm. The results presented (wound healing rates, wound area reduction) represent the direct outcomes of using the device.
7. The Type of Ground Truth Used
The "ground truth" used in the clinical studies reviewed would be clinical outcomes data. Specifically:
- Complete wound healing (defined clinically, likely by visual inspection and measurement).
- Reduction of wound area (measured clinically).
8. The Sample Size for the Training Set
This information is not applicable/not provided because the DUOLITH SD1 is a medical device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves iterative design, engineering, and nonclinical testing to meet specifications, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As explained above, the device does not employ a machine learning model that would need a "training set" with established ground truth. Its development relies on engineering principles and nonclinical testing to ensure it meets performance specifications and safety standards.
§ 878.4685 Extracorporeal shock wave device for treatment of chronic wounds.
(a)
Identification. An extracorporeal shock wave device for treatment of chronic wounds is a prescription device that focuses acoustic shock waves onto the dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must be conducted to demonstrate that the system produces anticipated and reproducible acoustic pressure shock waves.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate that the reusable components of the device can be reprocessed for subsequent use.
(4) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety of the device.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Performance data must support the use life of the system by demonstrating continued system functionality over the labeled use life.
(7) Physician labeling must include:
(i) Information on how the device operates and the typical course of treatment;
(ii) A detailed summary of the device's technical parameters;
(iii) Validated methods and instructions for reprocessing of any reusable components; and
(iv) Instructions for preventing hearing loss by use of hearing protection.
(8) Patient labeling must include:
(i) Relevant contraindications, warnings, precautions, adverse effects, and complications;
(ii) Information on how the device operates and the typical course of treatment;
(iii) The probable risks and benefits associated with the use of the device;
(iv) Post-procedure care instructions; and
(v) Alternative treatments.