(308 days)
The ES-160 is intended for use in pain relief. It can be used by a physician on his patients. This is a prescription device and should be used under continued medical supervision. The intended use of the Pointer F-3 is identical. It does not have curative value, but relieves pain symptoms.
The ES-160 is designed to be used in the treatment of chronic, acute and post-operative pain.
The device consists of a battery powered portable instrument with a remote grounding pole and a hand held locator/stimulator probe. Six output channels are grounding polo and time. The grounding pole is held in order to make contact with the skin. Moving the probe tip across the skin identifies places where the risk of skin burns is low. Auditory signals as well as a meter reading indicate when this has occurred. Holding the probe in place and pushing the stimulation button generates low level electrical pulses as long as the button is pressed.
The provided text is a 510(k) summary for the ES-160 Transcutaneous Electrical Nerve Stimulator (TENS) unit. It focuses on demonstrating substantial equivalence to a predicate device, the Pointer F-3 (K904388), rather than presenting a study specifically designed to establish acceptance criteria and prove the device meets them through performance testing with human subjects or a large test set.
Therefore, many of the requested elements for describing an acceptance criteria study are not present in the provided document.
Here's an analysis based on the available information:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Safety: Device operates without raising new safety concerns compared to predicate. | "Details of electrical output are different but new safety concerns are not raised by the differences." |
| Technological Characteristics: Similar modes (location, stimulation), battery type, output waveform (for stimulation), controls for skin burn risk and intensity regulation. | "Both devices use four 1.5 volt batteries. Both devices have a location mode and a stimulation mode. The location output of both devices is DC current. During stimulation the electrical output for both devices is square waveform pulses." |
| Intended Use: Identical intended use for pain relief, prescription use only, with similar contraindications/warnings. | "The ES-160 is intended for use in pain relief... This is a prescription device... The intended use of the Pointer F-3 is identical." |
| Compliance with Standards: Meets relevant electrical and electromagnetic compatibility (EMC) standards. | Lists 11 EN and IEC standards. |
Explanation: The document's primary goal is to show the ES-160 is "substantially equivalent" to an already marketed device (Pointer F-3). This means the device doesn't necessarily need to meet new, quantitative performance acceptance criteria in a clinical trial setting. Instead, the "acceptance criteria" are effectively that the device's technological characteristics and intended use are similar enough to the predicate that it raises no new questions of safety or effectiveness.
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Sample Size for Test Set and Data Provenance:
- Not Applicable/Not Provided. The submission does not detail a study with a test set of patients or a dataset to prove performance against specific clinical acceptance criteria. The "performance data" listed refers to compliance with electrical and safety standards, not clinical efficacy data.
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Number of Experts for Ground Truth and Qualifications:
- Not Applicable/Not Provided. No ground truth establishment is described for a clinical performance study. The "ground truth" here is essentially the regulatory acceptance of the predicate device.
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Adjudication Method for Test Set:
- Not Applicable/Not Provided.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is a TENS unit, not an imaging or diagnostic device where an MRMC study would typically be performed.
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Standalone (Algorithm Only) Performance Study:
- No. This device is a physical medical device providing electrical stimulation, not an algorithm.
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Type of Ground Truth Used:
- Not Applicable/Not Provided in the context of a clinical performance study. The "ground truth" for the submission is the regulatory acceptance and safety/efficacy profile of the legally marketed predicate device (Pointer F-3), and compliance with recognized safety and electrical standards.
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Sample Size for Training Set:
- Not Applicable/Not Provided. The document describes a physical medical device, not a machine learning algorithm that would require a training set.
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How the Ground Truth for the Training Set Was Established:
- Not Applicable/Not Provided.
In summary, this 510(k) submission relies on demonstrating substantial equivalence to a predicate device and compliance with applicable safety standards, rather than proving performance against quantitative acceptance criteria through a specific clinical study with a detailed test set and ground truth establishment.
§ 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).