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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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The EOS iViewGT™ Electronic Portal Imaging Device (EPID), as with the predicate iView, is intended to be used with radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

The iViewGT™ EPID is an enhancement to the existing iView Electronic Portal Imaging Device which has previously been cleared for commercial distribution under D.C. K981790. These devices have an established and proven track record for safety. The primary reason for this modification to support solid state detectors for image acquisition. The iViewGTTM EPID does not raise additional types of safety or effectiveness considerations.

The provided text is a K012289 Summary of Safety & Effectiveness for the Elekta Oncology Systems iViewGT™ Electronic Portal Imaging Device (EPID). This document primarily focuses on demonstrating that the iViewGT™ EPID is substantially equivalent to a previously cleared device (iView K981790) and meets relevant safety and quality standards.

Crucially, the provided text does NOT contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria in terms of analytical or clinical performance (e.g., accuracy, sensitivity, specificity).

The document highlights the device's adherence to quality management systems, safety standards, and its intended use as an enhancement to an existing, cleared device. It asserts that the iViewGT™ EPID "does not raise additional types of safety or effectiveness considerations" compared to its predicate. This implies that the 'acceptance criteria' in this context are primarily related to regulatory compliance, manufacturing quality, and substantial equivalence, rather than a clinical performance study with specific metrics.

Therefore, many of the requested sections about acceptance criteria and study details cannot be answered based solely on the provided text.

Here's an attempt to answer the questions based on the available information, noting where information is absent:

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

Regarding a "study that proves the device meets the acceptance criteria," the provided document does not describe a performance study with specific metrics for the iViewGT™ EPID's effectiveness. Instead, it relies on:

• Substantial Equivalence: The primary assertion is that the iViewGT™ EPID is an "enhancement" to the already cleared iView (K981790) and "does not raise additional types of safety or effectiveness considerations."
• Compliance with Standards: Adherence to established safety standards (IEC 60601-1, IEC 60601-2-1, IEC 60950, UL 1950) and quality management systems (ISO 9001, EN 46001, ISO 13485, Medical Device Directive 93/42/EEC Annex II, 21 CFR 820 GMP).
• Hazard Analysis: A hazard analysis was conducted, concluding no new hazards.

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

• No information provided. The document does not describe a test set or data related to clinical or analytical performance.

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)

• No information provided. No test set or ground truth establishment is described.

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

• No information 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

• No information provided. The document does not describe an MRMC study, nor does it mention AI assistance. The device is an EPID, primarily for image acquisition, not an AI diagnostic tool.

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

• Not applicable / No information provided. The iViewGT™ EPID is an image acquisition device for radiation therapy. Its "performance" would likely be in terms of image quality, detector sensitivity, and integration with the treatment system, rather than an algorithm performing a standalone diagnostic task. The document does not mention any standalone algorithmic performance evaluation.

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

• Not applicable / No information provided. Since no performance study is described, there's no mention of a "ground truth" for clinical or analytical performance.

8. The sample size for the training set

• No information provided. The document does not describe a training set. The device is not an AI/ML algorithm in the context of typical training/test sets.

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

• Not applicable / No information provided. No training set or ground truth for it is mentioned.

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The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

The RT Desktop is an enhancement to the SL/SLi Interface (Javelin) which has previously been cleared for commercial distribution. This device has an established and proven track record for safety. The enhancement contains industry standard computer components to address the issue of component obsolescence currently associated with SL/SLi interface (Javelin). The RT Desktop does not raise additional types of safety or effectiveness considerations.

The provided text is a premarket notification for the Elekta Oncology Systems RT Desktop, which is an enhancement to an existing device (SL/SLi Interface). The document focuses on demonstrating that the RT Desktop does not raise new safety or effectiveness concerns compared to its predicate device and complies with various quality and safety standards.

However, the document does NOT contain information regarding a specific study to prove the device's performance against acceptance criteria in the context of clinical efficacy or diagnostic accuracy, which would typically involve metrics like sensitivity, specificity, accuracy, or effect size for AI-assisted workflows.

The "Summary of Safety & Effectiveness" primarily asserts the device's safety and effectiveness through:

• Comparison to a predicate device: Stating the RT Desktop is an enhancement to an already cleared device with a "proven track record for safety."
• Compliance with industry standards: IEC 60601-1, IEC 60601-2-1, IEC 950, UL 1950, CE mark, ISO 9001, EN 46001, Medical Device Directive 93/42/EEC Annex II, and 21 CFR 820.
• Hazard analysis: Concluding it "does not introduce hazards that raise new types of safety or effectiveness considerations."
• Comprehensive user information: Ensuring safe and effective use.

Therefore, I cannot populate the requested table and answer the majority of the questions because the document does not describe a study involving performance metrics for a device that involves clinical outcomes or diagnostic tasks. It's a regulatory submission demonstrating substantial equivalence and safety compliance for a system enhancement, rather than a clinical performance study.

Here's what I can extract based on the provided text, highlighting the absence of the requested performance study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. The document does not describe a performance study with a test set.

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 applicable. No ground truth establishment for a test set is described.

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

• Not applicable. 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

• No. The document does not describe an MRMC study or any AI component. The device is a user interface for linear accelerators.

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

• Not applicable. The device described is a user interface, not a standalone algorithm.

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

• Not applicable. No ground truth is mentioned in the context of a performance study.

8. The sample size for the training set

• Not applicable. The document does not describe an AI/ML algorithm requiring a training set.

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

• Not applicable. No training set or ground truth for it is mentioned.

Conclusion:

The provided document is a regulatory submission for a device enhancement. It demonstrates safety and effectiveness through compliance with standards, comparison to a predicate device, and hazard analysis, rather than through a clinical performance study involving specific acceptance criteria, test sets, or ground truth. The questions posed are highly relevant for AI/ML-driven medical devices or devices where clinical performance metrics (like diagnostic accuracy) are directly being evaluated, which is not the case in this particular submission.

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The FOS iView EPID, as with the predicate SKI 100, is intended to be used with radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

The iView EPID is an enhancement to the existing SRI 100 electronic portal imaging device which has previously been cleared for commercial distribution. The primary reason for the introduction of this device is to address obsolescence issues associated with the image acquisition components and the computer hardware/operating system.

This document is a 510(k) submission for the Elekta Oncology Systems iView Electronic Portal Imaging Device (EPID). It primarily focuses on demonstrating substantial equivalence to a predicate device (SRI 100 EPID) rather than presenting a detailed study with specific acceptance criteria and performance metrics for the new device.

Therefore, for many of your requested items, the information is not explicitly provided in the furnished text. The submission relies heavily on the established safety and effectiveness of the predicate device and the fact that the iView EPID addresses obsolescence issues without introducing new safety or effectiveness concerns.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

This information is not explicitly stated in the provided text. The submission focuses on demonstrating substantial equivalence to an existing device rather than presenting specific performance metrics against pre-defined acceptance criteria for the iView EPID itself. The "reported device performance" is implied to be equivalent to the predicate device.

2. Sample sized used for the test set and the data provenance

Not applicable/Not provided. The document does not describe a new study with a test set of data for the iView EPID's performance. The basis for safety and effectiveness is primarily the predicate device's track record and the assertion that the iView EPID does not raise new issues.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. No new test set data or ground truth establishment is described for the iView EPID's performance.

4. Adjudication method for the test set

Not applicable/Not provided. No new test set data 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 applicable/Not provided. This device is an Electronic Portal Imaging Device (EPID), which is a hardware and software system used in radiation therapy for imaging, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

Not applicable/Not provided. This is not an algorithmic diagnostic device in the sense of AI; it's an imaging device. The document states that it's an enhancement to an existing device, implying its performance is comparable to the predicate.

7. The type of ground truth used

Not applicable/Not provided. No new ground truth is described for the iView EPID. The "ground truth" for its safety and effectiveness relies on the established use of the predicate device (SRI 100) in treating malignant neoplastic diseases, as determined by a licensed medical practitioner.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of a training set as this is not an AI/machine learning device in the context of image analysis or diagnostics that requires a separate training set.

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

Not applicable/Not provided. As there is no mentioned training set, this question is not applicable.

Summary of what the document does provide regarding acceptance criteria and studies:

The document demonstrates that the Elekta Oncology Systems iView EPID meets acceptance criteria primarily through:

• Substantial Equivalence: The core argument is that the iView EPID is an "enhancement" to the existing SRI 100 EPID, which has already been cleared and has a "proven track record for safety." This implies the acceptance criteria for safety and effectiveness are met by virtue of being similar to or better than the predicate.
• Addressing Obsolescence: The primary reason for the new device is to update components and address obsolescence, not to fundamentally change its function or performance in a way that would require new clinical effectiveness studies.
• Compliance with Standards:
  • Safety Standards: The iView EPID has been subject to compliance testing as defined in IEC 601-1 and IEC 601-2-1. Proprietary IT equipment complies with IEC 950 and/or UL 1950.
  • Quality System Standards: Elekta Oncology Systems is a registered medical device manufacturer assessed against ISO 9001, EN 46001, and the Medical Device Directive, 93/42/EEC Annex II. Their software quality system meets ISO 9001, EN 46001, the Medical Device Directive, and US 21 CFR 820 GMP.
  • Regulatory Compliance: The device bears the CE mark, affirming compliance with relevant European Directives (Medical Device Directive, Electromagnetic Compatibility Directive).
• Hazard Analysis: Elekta Oncology Systems conducted a hazard analysis and concluded that the device does not introduce new types of safety or effectiveness considerations.
• Audits: The quality system is subject to periodic internal quality audits and regular, planned, and documented GMP audits by external auditors (SGS Yarsley and FDA).

In essence, the "study" proving the device meets acceptance criteria is a documentation of substantial equivalence, compliance with established safety and quality standards, and internal hazard analysis, rather than a clinical performance study with explicit test sets and ground truth.

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