(63 days)
For adjunctive use in post-traumatic pain syndromes; for management and symptomatic relief of chronic (long term) pain; as an adjunctive treatment in the management of post surgical pain an adjust relaxation of muscle spasms; prevention or retardation of tissue atrophy; increasing blood circulation; muscle re-education; immediate post-surgical stimulation of calf muscles to prevent phlebothrombosis; and maintaining or increasing range of provide philosouncemes , al nerves for the purpose of providing pain relief and to stimulate motor nerves for the purpose of muscle rehabilitation.
Not Found
This is a challenging request as the provided text is a 510(k) clearance letter from the FDA, not a study report or clinical trial summary. Therefore, the document does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the way a modern medical device submission would.
The letter simply states that the FDA has reviewed the submission and found the device to be "substantially equivalent" to legally marketed predicate devices from before May 28, 1976. This means the device met the regulatory requirements for safety and effectiveness based on comparison to an existing device, rather than on specific, prospectively defined performance metrics from a dedicated clinical study.
Therefore, for each point requested, I will explain why the information is not present in the provided text.
Here's an analysis of why the requested information is absent:
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A table of acceptance criteria and the reported device performance:
- Reason for Absence: The FDA 510(k) clearance letter (K980892) is a regulatory document affirming substantial equivalence to a predicate device, not a clinical study report. It does not contain specific performance metrics, acceptance criteria, or a table of reported device performance. For general control devices cleared in 1998, the focus was on demonstrating equivalent intended use and technological characteristics to a predicate device already on the market prior to 1976, rather than hitting specific performance targets in a new study.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Reason for Absence: Since no new clinical study data with a "test set" is described or referenced in the clearance letter, this information is not available. The substantial equivalence pathway for this type of device in 1998 typically relied on established safety and effectiveness of the predicate device, not new clinical data demonstrating specific performance on a test set.
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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):
- Reason for Absence: As no specific "test set" or new clinical study is detailed, the concept of establishing ground truth by experts for a test set is not applicable to the information provided in this regulatory letter.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Reason for Absence: Without a described test set or clinical study, there is no adjudication method to report.
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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:
- Reason for Absence: The device is described as an "ELECDT/PROELECDT SERIES" for pain syndromes and muscle rehabilitation, which suggests an electrical stimulation device, not an AI-based diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and is not mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Reason for Absence: This device is an electrical stimulation device, not an algorithm. Therefore, "standalone" algorithm performance is not applicable or discussed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Reason for Absence: As no new clinical study or specific performance data is provided, the concept of ground truth for a new study is not present in the clearance letter. The "ground truth" for a 510(k) submission of this era and device type would effectively be the established safety and effectiveness of the existing predicate device.
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The sample size for the training set:
- Reason for Absence: The device is a physical electromedical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.
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How the ground truth for the training set was established:
- Reason for Absence: As there is no training set for this type of device, the concept of establishing ground truth for it is irrelevant and not discussed.
In summary, the provided FDA 510(k) clearance letter dated 1998 pertains to a device cleared through the substantial equivalence pathway, which does not typically include the detailed performance metrics, acceptance criteria, or study designs (especially for AI/ML) that are standard for modern device submissions and clinical study reports. The letter confirms the device's clearance based on its equivalence to a predicate device, not on meeting specific, prospectively defined performance criteria from a new clinical study.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).