SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD

• K Number: K965187
• Device Name: SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD
• Manufacturer: SPARTA SURGICAL CORP.
• Date Cleared: 1997-08-01 ( 220 days)
• Product Code: GZJ , 84G
• Regulation Number: 882.5890
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

For symptomatic relief and management of chronic pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Device Description

Spectrum II, Spectrum Plus, and Spectrum MAX-SD TENS devices

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for TENS devices (Spectrum II, Spectrum Plus, and Spectrum MAX-SD). It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information is typically found in the 510(k) submission itself or in a summary document that details the testing and validation performed to demonstrate substantial equivalence.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study that proves the device meets them based solely on the text provided.

Regulation Number and Section

§ 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).