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Baylis Pain Management Generator-TD; Model PMG-115-TD (For Domestic Use) and Model PMG-230-TD (For International Use) is indicated for use to create lesions during neurological lesion procedures, and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The Baylis PMG-TD is to be used in conjunction with separately approved probes such as Baylis Transdiscal Probe, Oratec Spinecath™ and Baylis Pain Management Probes.

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The provided text is a 510(k) premarket notification letter from the FDA to Baylis Medical Company, Inc. It grants substantial equivalence for the "Baylis Pain Management Generator-TD Model: PMG-115-TD (For Domestic Use) PMG-230-TD (For International Use)."

This document does not contain any information about:

• Acceptance criteria or reported device performance in a table format.
• A study proving the device meets acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

The letter explicitly states that "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050." This indicates that the 510(k) process primarily assesses substantial equivalence to a predicate device, rather than requiring the submission of detailed performance studies against pre-defined acceptance criteria as would be typical for a PMA or de novo submission.

Therefore, I cannot provide the requested information based on the text provided.

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