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This document is a "Summary of Safety and Effectiveness" for the Medtronic PS Medical AlgoLine Intraspinal Catheter, submitted to the FDA on March 18, 1997. It describes potential adverse effects and provides a summary of product complaints rather than presenting a study designed to evaluate specific acceptance criteria for a device's performance.

Therefore, the requested information (acceptance criteria and a study proving the device meets them) cannot be extracted from the provided text. The document focuses on listing potential complications and a history of complaints, which are aspects of post-market surveillance or risk assessment, not a pre-market performance study with defined acceptance criteria.

To answer your request, here's an explanation of why the information isn't available in this document:

• No Acceptance Criteria or Performance Study: This document does not describe any specific acceptance criteria for device performance (e.g., a certain percentage of successful catheter placements, a defined rate of complication, or a specific functional outcome that the device must achieve). Consequently, there is no study presented that "proves the device meets the acceptance criteria."
• Focus on Adverse Effects and Complaints: The document is primarily concerned with detailing potential adverse effects associated with intraspinal catheters in general and listing reported complaints for this specific device model. This information is typically part of a regulatory submission to demonstrate awareness of risks and track real-world performance, but not a controlled study against pre-defined performance metrics.

If this were a document about a performance study, the sections would typically include:

1. Objective: Stating what the study aims to measure (e.g., accuracy, sensitivity, specificity, durability, etc.).
2. Methods: Describing the study design, sample size, how data was collected, and how the device's performance was measured.
3. Acceptance Criteria: Quantifiable thresholds for the device's performance that must be met for it to be considered safe and effective.
4. Results: The measured performance metrics.
5. Conclusion: A statement on whether the acceptance criteria were met.

Since none of these elements are present, I cannot fill out the requested table or describe the specific study details.

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