(330 days)
The 5000Z System (OTC) is intended for the symptomatic relief and management of pain in the upper and lower extremities (arms and legs).
"To be used 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 5000Z System (OTC) is a compact battery operated transcutaneous electrical stimulator that delivers a micro-current to the surface area of our patented conductive Silver-Thera E.M. garment electrodes to provide electrical stimulation for pain. It is designed not to exceed 100 volts across the garment electrodes. The technical Specifications for the 5000Z Stimulator can be found in Exhibit E. It is microprocessor controlled, allowing for easy setup of the treatment parameters and precise control of each setting, with a garment electrode dedicated to the upper or lower extremities. The system incorporates a proprietary connection from the stimulator to the electrodes that renders the device unusable without the dedicated electrodes. It is designed for ease of patient use with clearly marked intensity buttons.
The provided text is a 510(k) Summary for the Prizm Medical, Inc. 5000Z System (OTC), a Transcutaneous Electronic Nerve Stimulator (TENS). This summary describes the device, its intended use, and indicates its substantial equivalence to a predicate device.
However, the submission does not contain a study or data proving the device meets acceptance criteria in the way a clinical trial or performance study would for a novel medical device. Instead, the 510(k) process relies on demonstrating "substantial equivalence" to a legally marketed predicate device.
Therefore, many of the specific questions regarding acceptance criteria, study data, sample sizes, expert ground truth, and comparative effectiveness related to a performance study cannot be answered from the provided document.
Here's a breakdown of what can be inferred and what is not available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for a new performance study. The core "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: The document states: "The primary function of the 5000Z System (OTC) is the same as the Micro-ZTM Stimulation System, Axelgaard Mfg. Co. UltraStim Kit and Woodside Biomedical ReliefBand® and raises no new questions of safety and effectiveness." This is the "performance" claim in the context of a 510(k) – that its performance is equivalent to established devices in terms of safety and efficacy for its intended use. Specific quantitative performance metrics (e.g., pain reduction scores, error rates) from a new study are not provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. There is no mention of a test set or associated data from a performance study for the 5000Z System.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. Ground truth for a performance study is not discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication for a performance study is not discussed.
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. The device is a Transcutaneous Electronic Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or imaging device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical TENS unit, not an algorithm. Its function is to deliver electrical stimulation for pain.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. Ground truth for a performance study is not discussed. The "truth" in a 510(k) is the demonstration of substantial equivalence to a predicate, meaning it performs as safely and effectively as an already legally marketed device.
8. The sample size for the training set
- Not applicable/Not provided. There is no mention of a training set as this is not an AI/Machine Learning device requiring such data.
9. How the ground truth for the training set was established
- Not applicable/Not provided. Same as above.
Summary based on the document:
The provided document details a 510(k) premarket notification for the Prizm Medical, Inc. 5000Z System (OTC). The mechanism for "proving" the device meets acceptance criteria in this context is through demonstrating substantial equivalence to existing, legally marketed predicate devices (Micro-ZTM Stimulation System, Axelgaard Mfg. Co. UltraStim Kit, and Woodside Biomedical ReliefBand®).
The document explicitly states: "The primary function of the 5000Z System (OTC) is the same as the Micro-ZTM Stimulation System, Axelgaard Mfg. Co. UltraStim Kit and Woodside Biomedical ReliefBand® and raises no new questions of safety and effectiveness." This declaration serves as the basis for its "acceptance."
The FDA's letter (APR 1 5 2005) confirms that they "have determined the device is substantially equivalent... to legally marketed predicate devices." This is the "proof" required for a 510(k) pathway, rather than a clinical study with detailed performance metrics against pre-defined acceptance criteria. The FDA, however, did add specific warnings/limitations to the labeling regarding potential underlying serious conditions that the device should not be used for without physician consultation.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).