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510(k) Data Aggregation
(136 days)
DolorClast Radial
The DolorClast® Radial is indicated for:
- Relief of minor muscle aches and pains
- Temporary increase in local blood circulation
- Activation of connective tissue
The DolorClast® Radial is a portable radial pressure pulse device with an integrated air compressor. The DolorClast® Radial system is composed of the DolorClast® Radial console, handpiece, interchangeable applicator heads, and optional cart. Swiss DolorClast® Gel, previously approved under P050004, is also provided for coupling the treatment applicator to the patient's skin.
The DolorClast® Radial console generates and controls the pressure pulse frequency and intensity. Air pressure from the console drives a projectile within the handpiece against the applicator head to generate the pressure pulses at the set frequency and intensity. Device activation is done by the practitioner via a trigger button on the handpiece. The applicator at the distal end of the handpiece transmits the radial pressure pulses to the targeted tissues via the coupling gel applied to the treated skin.
This document is an FDA 510(k) summary for a medical device (DolorClast® Radial), which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial for diagnostic performance. Therefore, many of the requested elements (e.g., sample sizes for training/test sets, ground truth establishment for AI, MRMC studies, expert qualifications) are not applicable or not present in this type of regulatory submission.
However, based on the provided text, I can extract information related to the device's functional performance testing against internal protocols.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several functional performance tests and generally states that "All tests were passed," indicating the device met internal EMS protocols. Specific numerical acceptance criteria are generally not provided in this summary, but the reported performance is that the device met those criteria.
| Acceptance Criterion (Internal EMS Protocol) | Reported Device Performance |
|---|---|
| System Functional Performance Testing | |
| Compressor activation only when handpiece trigger pressed | All tests were passed (confirming activation met pre-defined tolerance). |
| Pressure output at each pressure setting met pre-defined pressure setting tolerance | All tests were passed (confirming pressure output met pre-defined tolerance). |
| Correct operation of console at all treatment settings (including Smart Protocols and Special Modes) | All tests were passed (confirming correct operation). |
| Correct device response to error conditions | All tests were passed (verifying correct device response). |
| Correct operation of handpiece (pressure adjustment, starting/stopping treatment, recording piston use) | All tests were passed (confirming correct operation). |
| Acoustic output characterization (Displacement of applicator heads) | Displacement of applicator heads: 0.18 - 0.28 mm |
| Acoustic output characterization (Maximum penetration depth) | Maximum penetration depth: 40 mm |
| Acoustic output characterization (Energy flow density) | 0.29 mJ/mm² at 4 bar; 0.14 mJ/mm² at 2.4 bar |
| Acoustic output characterization (Positive peak pressure amplitudes) | 17 MPa at 4 bar; 11.24 MPa at 2.4 bar |
| Acoustic output characterization (Negative peak pressure amplitudes) | 10 MPa at 4 bar; 7.2 MPa at 2.4 bar |
| Acoustic output characterization (Derived focal acoustic pulse energy) | 5.9 mJ at 4 bar*; 2.2 mJ at 2.4 bar* |
| Acoustic output characterization (Derived pulse-intensity integral (max)) | 0.29 mJ/mm² at 4 bar; 0.14 mJ/mm² at 2.4 bar |
| Acoustic output characterization (Rise time) | 3.2 µs |
| Acoustic output characterization (Compressional pulse duration) | 2.6 µs (1st peak); 62.7 µs (1st phase) |
| Lifetime Testing | |
| Console functions and meets specs for 7 years or 50,000,000 pulses | All tests were passed (confirming specified useful lifetime). |
| Handpiece functions and meets specs for 2 years or 5,000,000 pulses | All tests were passed (confirming specified useful lifetime). |
| Applicators function and meet specs for 2 years or 5,000,000 pulses | All tests were passed (confirming specified useful lifetime). |
| Biocompatibility (Applicator tips and gel) | Previously approved under P050004; no changes to material/manufacturing. |
| Transportation Testing (ISTA 2A and ISTA 3A) | All tests were passed (devices and accessories functional after conditioning). |
| Software Validation (IEC 62304 Ed 1.1) | Software validated in software testing and system level testing. |
| Electrical Safety and EMC (IEC 60601-1:2005 + A1:2012, IEC 60601-1-2:2014) | Demonstrated to comply with stated standards. |
Note: The document states "Averaged across all applicator sizes" for derived focal acoustic pulse energy.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated for any of the performance tests. The testing described appears to be engineering verification and validation, likely involving a limited number of test units or prototypes.
- Data Provenance: The origin of the data is stated as "internal EMS protocols" and "internal EMS testing." It is prospective testing conducted specifically for this regulatory submission on the device itself. No mention of geographical data origin (e.g., country) is made as it's not a clinical data study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study assessing diagnostic performance against a "ground truth" established by experts. The "ground truth" for these tests refers to engineering specifications and regulatory standards.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert interpretations.
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
Not applicable. This device is a therapeutic massager, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical therapeutic device, not an algorithm. Its performance is inherent in its physical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" effectively used for this regulatory submission is adherence to engineering specifications, internal EMS protocols, and recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2, ISTA 2A/3A). For biocompatibility, the "ground truth" was established by prior approval (P050004) of identical materials.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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