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The intended use of the SIEMENS branded ARTISTE™, ONCOR™ and PRIMUS™ family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.

The LINAC.is a high-dose and high-dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy-{IMRT}, and when used in conjunction with the PreScision™ option, supports precision stereotactic applications. The stereotactic applications include single-session radiosurgery, fractionated stereotactic radiation therapy, fractionated stereotactic intensity modulated radiation therapy for lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.

The syngo@workspaces includes a number of syngo@based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

The PreScision™ Option package is an optional feature to the existing SIEMENS ARTISTE™, ONCOR™ and PRIMUS™ family of medical linear accelerator devices [LINAC]. The basic design, safety features and function of the LINAC remain unchanged. The PreScision features upports Stereotation Therapy (SRT) and Stereotactic Radio-surgery (SRT) using the conventional linear accelerator and subsystems for the delivery of precision high dose X-Ray photon energy for treatment of lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.

The PreScision option supports the delivery of up to 2,000 (± 2%) MU / Minute X-Ray photon beam for either single-session radiosurgery or hypo-fractionated stereotactic treatment using a calibrated 6.67 MV photon energy spectrum consisting of an unflattened beam geometry, a selectable field size of 5cm x 5 cm up to 40cm x 40 cm, collimated by any validated third party stereotactic accessory such as a stereotactic cone or a Multi-leaf collimator, with or without the use of patient motion detection or physiologic gating.

The control console will support the PreScision feature with one unflattened beam energy labeled as "7UF" to differentiate from the previous 6 MV unflattened beam energy used by the predicate Stereo feature. The 7UF option replaces the existing "Stereo" option previously cleared under the PRIMUS™ (K993425) and ONCOR™ (K031764, K060226) and ARTISTE (K072585) devices.

The unflattened X-Ray photon energy spectrum is similar to the 6 MV energy spectrum as used by the PRIMUS™, ONCOR™, ARTISTE Linear Accelerator systems for the predicate Stereo option and is similar to the energy spectrum of the TomoTherapy Hi-Art system as described in Section 11, Design Description.

The SIEMENS linear accelerator product requirements for the PreScision™ option consists of the following:

A SIEMENS ARTISTE™, ONCOR™ or PRIMUS™ Family of Linear Accelerators with the minimum configuration of:

• COHERENCE™ Therapist Workspace or the syngo® Radiation Therapist (RTT) with . embedded PRIMEVIEW™ Record and Verify system or the RT Express™ system for the ONCOR™or ARTISTE™ linear accelerator systems.
• PRIMEVEIW 3i Record and Verify system used with the PRIMUS™ linear accelerator . system.
• 58 leaf multi-leaf collimator (MLC) marketed as 3D-MLC, 82 leaf MLC marketed as . OPTIFOCUS™ or the 160 Leaf MLC for:
  • Stereotactic Radiotherapy 0
  • Stereotactic Radiosurgery o
  • Fixed fields, 0
  • o Auto-sequenced,
  • 0 Arc (Rotation) and
  • Intensity Modulated Radiation Therapy (IMRT) treatment delivery methods, 0
• . MLC interface to support the SIEMENS ModuLeaf MLC (K030609) for precision Stereotactic or Stereotactic Radiosurgery Radiation TherapyTreatments.
• . Gating interface to support Third party, cleared, gating devices for physiologic or patient motion detection.
• . Stereotactic mode to support Third party, cleared, stereotactic hardware and patient fixation positioning devices.
• An amorphous Silicon (aSi) flat panel electronic portal imaging device (EPID) marketed as . OPTIVUE 1000ST
• patient treatment couch; 550 TxT™ (K050422), or the ZXT™ (K910971).

Here's a breakdown of the acceptance criteria and the study information for the Siemens Medical Solutions USA, Inc. Oncology Care Systems PreScision™ Option, based on the provided document:

This document is a 510(k) summary for a medical device (PreScision™ Option). 510(k) summaries, by their nature, do not typically contain detailed clinical study results or performance data in the way a scientific publication would. Instead, they focus on demonstrating substantial equivalence to predicate devices, often through technical characteristics and a summary of verification and validation testing.

Therefore, the information for some of your requested points will be limited or inferred from the types of testing typically performed for such devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or a dedicated performance table in terms of clinical outcomes or diagnostic accuracy for the PreScision™ Option itself.

Instead, it relies on demonstrating that the PreScision™ Option, while adding new capabilities (unflattened beam energy for SRT/SRS), maintains the fundamental design, safety features, and function of the existing linear accelerators and achieves performance similar to its predicate devices. The "performance" described is primarily about the technical capabilities and safety of the system.

Here's an inferred table based on the provided text:

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a sample size for a test set in the context of clinical data or patient cases, nor does it indicate data provenance (country of origin, retrospective/prospective).

For a device like this (an option for a linear accelerator), "testing" primarily refers to:

• Engineering verification and validation (V&V): This involves extensive technical testing of the hardware and software components, dose measurements, beam characteristics, safety interlocks, and system integration. This kind of testing does not typically involve patient "test sets" in the clinical sense.
• Pre-clinical testing: This might involve phantom studies, but the document doesn't detail such studies with specific sample sizes.

The statement "Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by software development, verification of requirements and validation testing" refers to this internal engineering V&V process.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable in the context of this 510(k) submission. The PreScision™ Option is a treatment delivery system, not a diagnostic device that requires expert-established ground truth for a test set of medical images or patient diagnoses. The "ground truth" for such a device would be its ability to safely and accurately deliver the prescribed radiation dose according, to physical and geometric specifications, as determined by physics and engineering measurements.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as point 3. There is no mention of an adjudication method as there is no "test set" of clinical cases requiring expert interpretation and consensus.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned. This type of study is relevant for diagnostic devices that AI would assist human readers with (e.g., radiologists interpreting images). The PreScision™ Option is a radiation therapy delivery system, not an AI-driven diagnostic tool.

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

This question is largely not applicable in its typical sense for this device. The PreScision™ Option is an option for a linear accelerator system, which is inherently a "human-in-the-loop" device (operated by radiation therapists, guided by treatment plans created by dosimetrists/physicians and approved by radiation oncologists). There isn't a standalone algorithm that performs a diagnostic or treatment decision-making task in isolation.

The "standalone" performance would relate to the physical characteristics of the unflattened beam and its delivery, which would be measured in a controlled environment (e.g., using phantoms and dosimeters), rather than an "algorithm only" performance for a clinical task. The document details that the "PreScision features supports Stereotation Therapy (SRT) and Stereotactic Radio-surgery (SRT) using the conventional linear accelerator and subsystems for the delivery of precision high dose X-Ray photon energy."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state a "ground truth" in the clinical sense (like pathology for cancer diagnosis). For a radiation delivery device, the "ground truth" for its performance would be established through:

• Physics measurements: Verification that the radiation beam (energy, dose rate, field size, uniformity) meets specified physical parameters.
• Engineering specifications: Conformance of hardware and software components to design requirements.
• Safety standards: Adherence to international safety standards for medical electrical equipment and radiation safety.

The 510(k) process primarily relies on demonstrating that the device meets safety and performance requirements through these types of physical and technical verifications, rather than clinical ground truth from patient data, unless it introduces a new clinical claim requiring such validation.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is expected as the PreScision™ Option is not an AI/machine learning-based device in the sense that it requires a "training set" of data for an algorithm. It's an enhancement for an existing radiation therapy delivery system.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" (see point 8), this question is not applicable.

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