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The SLi Series Linear Accelerators and MLCi products are improvements of the existing SL Series and the Philips MLC products which have previously been cleared for commercial distribution.

This document is a summary of safety and effectiveness information for the Philips SLi Series Linear Accelerators and MLCi products. It is not a study report and does not contain the kind of detailed information requested about acceptance criteria, device performance, sample sizes, expert ground truth, or adjudication methods for a medical device study designed to assess diagnostic or predictive performance.

Instead, this document focuses on demonstrating that the SLi Series Linear Accelerators and MLCi products are improvements of existing, previously cleared devices and meet various regulatory and quality standards for safety and effectiveness.

Therefore, I cannot extract the requested information from this document.

Here's an explanation of why the requested details are not present and what the document does convey:

1. Table of acceptance criteria and reported device performance: This document does not present specific performance metrics like sensitivity, specificity, accuracy, or any quantitative "acceptance criteria" for a diagnostic or predictive task. It states that the devices are "improvements" and do not raise additional safety or effectiveness concerns compared to predicate devices. It also mentions compliance with safety standards (IEC 601-1, IEC 601-2-1, IEC 950, UL 1950) and regulatory directives (CE mark, European Medical Device Directive, Electromagnetic Compatibility Directive, CFR Title 21). However, these are compliance statements, not performance metrics derived from a clinical study.

2. Sample sizes used for the test set and data provenance: No clinical test set or data provenance is mentioned. The document refers to "past experience with substantially equivalent predicate devices" and "compliance testing" against international safety standards, but not a specific study with a defined test set.

3. Number of experts used to establish the ground truth for the test set and qualifications: This information is not relevant to the compliance focus of this document and is not present.

4. Adjudication method for the test set: Not applicable as no such test set is described.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. This document is not about evaluating human reader performance with or without AI assistance.

6. Standalone (algorithm only) performance: Not applicable as these are linear accelerators and MLCs, not AI algorithms designed for standalone diagnostic performance.

7. Type of ground truth used: Not applicable as a diagnostic/predictive ground truth is not being established or evaluated. The "effectiveness" here refers to the device performing its intended function in a safe manner, as evidenced by compliance with standards and similarity to predicate devices.

8. Sample size for the training set: Not applicable. These devices are hardware (linear accelerators and multi-leaf collimators) and software systems, not machine learning models that are "trained."

9. How the ground truth for the training set was established: Not applicable.

What the document does convey about "acceptance criteria" and "study":

The "acceptance criteria" can be inferred as:

• Being an improvement over existing, cleared devices (SL Series Linear Accelerators and Philips MLC).
• Not raising additional types of safety or effectiveness considerations compared to predicate devices.
• Having an "established and proven track record for safety" through predicate devices.
• "Safe and effective when used as directed" by accompanying documents.
• Compliance with internationally recognised safety standards: IEC 601-1, IEC 601-2-1, IEC 950, UL 1950.
• Bearing the CE mark, affirming compliance with relevant European Directives (Medical Device Directive, Electromagnetic Compatibility Directive).
• Compliance with the Code of Federal Regulations, Title 21: Food and Drugs.
• Being developed under an established and documented Software Quality Management System (ISO 9001, EN 46001, UK Department of Health GMP, US 21 CFR 820 GMP).
• Hazard analysis confirming no new hazards and a "moderate" level of concern.

The "study" or "proof" that the device meets these criteria comes from:

• Comparison to predicate devices: The devices are described as "improvements of the existing SL Series and the Philips MLC products which have previously been cleared for commercial distribution."
• Compliance testing: "The SLi Series Linear Accelerators and MLCi products have been subject to compliance testing as defined in the internationally recognised safety standards IEC 601-1 and IEC 601-2-1."
• Quality System: Development under a robust Software Quality Management System that is regularly audited internally and externally (UK Department of Health, SGS Yarsley, FDA).
• Hazard Analysis: Conducted by PMS-R, concluding no new hazards and a moderate level of concern.
• Regulatory Affirmations: Bearing the CE mark and adherence to CFR Title 21.

In summary, this document is a regulatory submission demonstrating compliance and equivalence, not a clinical performance study.

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