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The Elekta Synergy™ System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

The Elekta Synergy™ System is an enhancement to the previously reported Precise Treatment Systems Digital Accelerator (formally designated the SL/SLi Series, D.C. K963624) and its commercially available options.

The provided text describes the Elekta Synergy™ System as an enhancement to a previously reported device (Precise Treatment Systems Digital Accelerator, K963624) and its commercially available options. However, it does not include detailed information regarding specific acceptance criteria, device performance, a study conducted to prove it meets acceptance criteria, sample sizes, expert qualifications, or ground truth establishment methods in the way typically expected for a detailed product validation.

Instead, the document focuses on:

• Safety and Effectiveness Justification: Stating that the device does not raise new safety or effectiveness concerns compared to its predicate device and is considered an enhancement.
• Compliance with Standards: Highlighting compliance with international safety standards (IEC 60601-1, IEC 60601-2-1), CE mark, ISO 9001, ISO 13485, Medical Device Directive 93/42/EEC Annex II, and US 21 CFR 820.
• Quality Management System: Describing established and documented Quality Management System, internal audits, and external GMP audits by SGS Yarsley and FDA.
• Hazard Analysis: Concluding that the device does not introduce new hazards, and the level of concern for the device is "Major."
• Substantial Equivalence: The FDA letter confirms the device's substantial equivalence to legally marketed predicate devices, allowing it to be marketed.

Given the information, a table of acceptance criteria and reported device performance cannot be generated with specific numerical values for performance metrics. The document generally asserts safety and effectiveness without providing quantitative clinical study results for the new components of the Elekta Synergy™ system.

Therefore, many sections of your request cannot be fulfilled due to the absence of this information in the provided text.

Here's what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document does not describe a specific test set or clinical study for the new device components, but rather relies on the predicate device's established safety and effectiveness and compliance with regulatory standards.

3. 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)

• Not provided. No explicit "ground truth" establishment for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not provided. No test set or adjudication method is described.

5. 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

• Not provided. This is not an AI-assisted device; it's a radiation therapy system. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This isn't an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not explicitly stated for the "Elekta Synergy™ System" components. The safety and effectiveness are based on the proven track record of the predicate device (Precise Treatment Systems Digital Accelerator) and compliance with regulatory/quality standards.

8. The sample size for the training set

• Not applicable / Not provided. The document doesn't describe a machine learning model with a training set.

9. How the ground truth for the training set was established

• Not applicable / Not provided. The document doesn't describe a machine learning model with a training set or ground truth establishment for it.

In summary, the provided text is a summary of safety and effectiveness for a 510(k) submission, emphasizing regulatory compliance and substantial equivalence to a predicate device, rather than detailed performance metrics from a comparative clinical trial for a novel device.

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