Search Results
Found 3 results
510(k) Data Aggregation
(443 days)
NEWMARK, INC.
The Painmaster MCT Patch is indicated for:
-temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
-temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
-symptomatic relief of chronic, intractable pain.
The Painmaster MCT Patch operates in a single non-programmable microcurrent mode, delivering a pulsed monophasic waveform that provides electrical stimulation to the body to relieve pain. The Painmaster MCT Patch consists of two electrodes mounted on adhesive material connected by a small-diameter wire. One electrode contains the control unit that includes a small circuit board, a battery, and an LED light.
The provided text is a 510(k) summary for the Painmaster MCT Patch, which is a transcutaneous electrical nerve stimulator. It states that "Additional performance testing was not required to determine the substantial equivalence of this device because the device is the same as the device previously cleared via 510(k) K090442, K130114 and MCT F5 model K013167."
Therefore, this document does not contain information about acceptance criteria or specific studies proving the device meets those criteria for the current submission (K151995). Instead, it relies on prior clearances.
However, a usability study was conducted for one of the predicate devices (K090042). While not explicitly acceptance criteria in terms of performance metrics, the "usability study" section can be interpreted as demonstrating the device meets criteria related to user comprehension and proper application.
Here's the information extracted, specifically focusing on the usability study as it's the only performance-related study mentioned for a predicate device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Usability Study) | Reported Device Performance |
|---|---|
| Users could correctly identify themselves as candidates for treatment. | Achieved |
| Users could properly assemble the device. | Achieved |
| Users could properly apply the device according to the instructions for use. | Achieved |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (presumably prospective, as it was a study conducted for a prior submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable for a usability study. The "ground truth" would be the successful completion of tasks by the users themselves.
4. Adjudication Method for the Test Set
- Not applicable as this was a usability study, not a diagnostic or comparative effectiveness study requiring adjudication. The assessment would likely be based on observers' evaluation of user behavior.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study was not done. This device is a transcutaneous electrical nerve stimulator, not an algorithm-based diagnostic tool.
7. Type of Ground Truth Used
- For the usability study, the ground truth was based on observed user behavior and comprehension of the instructions for use and device application.
8. Sample Size for the Training Set
- Not applicable, as this was a usability study (for a predicate device) and clinical performance was not re-evaluated for the current submission.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
Ask a specific question about this device
(90 days)
NEWMARK, INC.
The Painmaster MCT Patch is indicated for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
The Painmaster MCT Patch operates in a single non-programmable microcurrent mode, delivering a pulsed monophasic waveform that provides electrical stimulation to the body to relieve pain. The Painmaster MCT Patch consists of two electrodes mounted on adhesive material connected by a small-diameter wire. One electrode contains the control unit that includes a small circuit board, a battery, and an LED light.
The provided 510(k) summary for the Painmaster MCT Patch (K130114) states that no additional performance testing or clinical data was required for this submission. The device is considered substantially equivalent to a previously cleared device (K090042) because it has the same technological characteristics and intended use.
Therefore, the specific information requested about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for the current submission is not available in the provided text, as these studies were not conducted for K130114.
The summary does mention a usability study conducted in support of the previous submission (K090442), which demonstrated that users could correctly identify themselves as candidates for treatment and properly assemble and apply the device. However, details of its acceptance criteria or specific performance metrics are not provided.
Based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable for K130114. No new performance testing or clinical trials were conducted for this submission. The device was deemed substantially equivalent to a predicate device (K090042) without requiring new data.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for K130114. No new test set was used for performance evaluation in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for K130114.
4. Adjudication Method
Not applicable for K130114.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study was not conducted for K130114.
6. Standalone Performance Study
No. A standalone performance study was not conducted for K130114.
7. Type of Ground Truth Used
Not applicable for K130114.
8. Sample Size for the Training Set
Not applicable for K130114. No new training set was used for this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable for K130114.
Ask a specific question about this device
(120 days)
NEWMARK, INC.
The Painmaster MCT Patch is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
The Painmaster MCT Patch operates in a single non-programmable microcurrent mode, delivering a pulsed monophasic waveform that provides electrical stimulation to the body to relieve pain. The Painmaster MCT Patch consists of two electrodes mounted on adhesive material connected by a small-diameter wire. One electrode contains the control unit that includes a small circuit board, a battery, and an LED light.
This device (Painmaster MCT Patch) is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for over-the-counter (OTC) use for temporary pain relief. The submission for this device, K090042, relies on substantial equivalence to previously cleared devices rather than new performance studies demonstrating its effectiveness.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No performance acceptance criteria were explicitly stated or required for this 510(k) submission. The submission is based on substantial equivalence to a predicate device that was previously cleared for prescription use (K013167, Model 7500 Microcurrent TENS Device, Version F5), and other OTC TENS devices (K033122, K060222). | Substantial Equivalence: The Painmaster MCT Patch is deemed substantially equivalent to the predicate devices because its technological characteristics are identical to the F-5 version cleared under K013167, and its intended use for OTC pain relief is a subset of the previous prescription clearance and identical to other OTC TENS devices. |
| Usability (for OTC use) | A usability study was conducted and demonstrated that "users could correctly identify themselves as candidates for treatment, and could properly assemble and apply the device according to the instructions for use." However, specific quantitative acceptance criteria for this study (e.g., success rates, error rates) are not provided in this summary document. |
2. Sample Size Used for the Test Set and Data Provenance:
- Performance Testing: "Additional performance testing was not required to determine the substantial equivalence of this device for OTC use because the device is the same as the device previously cleared for prescription use via 510(k) #K013167." Therefore, there was no new test set for performance evaluation. The data provenance for the previous clearance (K013167) is not detailed in this document.
- Usability Study: The document states "A usability study was conducted," but does not specify the sample size for this study. The data provenance (country of origin, retrospective/prospective) for the usability study is also not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable for performance testing. As stated above, no new performance testing was conducted that would require a test set with expert-established ground truth.
- Not applicable for the usability study in the way typically thought of for clinical image-based or diagnostic device studies. The "ground truth" for a usability study would be the ability of users to correctly perform tasks, which is typically observed and recorded by trained researchers, not established by clinical experts.
4. Adjudication Method for the Test Set:
- Not applicable. No new performance test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The submission relies on substantial equivalence and a usability study for OTC use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This is not applicable. The device is a physical TENS patch, not an algorithm or AI system.
7. The Type of Ground Truth Used:
- For the original prescription clearance (K013167), this document does not specify the ground truth used (e.g., pain scales, patient outcomes, etc.).
- For the current OTC clearance, the "ground truth" for the usability study was the observation of users successfully understanding instructions and applying the device. This is a form of empirical observation of user behavior.
8. The Sample Size for the Training Set:
- Not applicable. This device is hardware for electrical stimulation; it does not involve machine learning or AI that would require a "training set" of data in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no AI/ML training set.
Ask a specific question about this device
Page 1 of 1