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The Panther StereoSeed module is intended to create a plan that is optimized for seed locations and needle directions, allowing needles to be inserted in any angle in order to avoid critical structures.

Panther StereoSeed is an optional software module that has been added to the existing Prowess Panther Brachy system to produce a seed implant plan that is optimized for seed locations and needle directions. The key distinction between Panther StereoSeed and traditional brachytherapy systems is that StereoSeed allows plans to be created such that bones and critical structures can be avoided.

The provided text does not contain detailed acceptance criteria or a study that definitively "proves" the device meets specific performance criteria in a quantitative sense with specific metrics and thresholds. Instead, it describes a substantial equivalence submission to the FDA for the Panther StereoSeed device.

Based on the information provided, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific quantitative performance acceptance criteria in the typical "accuracy/sensitivity/specificity" sense. The "acceptance criteria" are broad and relate to safety and effectiveness, as demonstrated by verification and validation testing, and comparison to predicate devices.

• Verification and validation testing performed in-house and at a beta-site, demonstrating the device "met its predetermined specifications, demonstrated substantially equivalent performance to the predicate device, functions as intended, and is safe and effective for its specified use."
• Relevant regression testing conducted to ensure no unanticipated negative impact from changes. |
  | Intended Use Fulfillment | Device "is intended to create a plan that is optimized for seed locations and needle directions, allowing needles to be inserted in any angle in order to avoid bones and critical structures," and V&V testing confirms it "performs as intended." |
  | Substantial Equivalence | "Panther StereoSeed is substantially equivalent to predicate devices... for the purposes of premarket clearance... rationalization for substantial equivalence is further evidenced through discussion of similar technological characteristics... as well as test results." |
  | Compliance with Regulations | Designed and implemented according to established Prowess Inc. design and development and quality management procedures, and complies with international standards (ISO 14971:2007, IEC 62304, IEC 62083) and FDA's QSR, 21 CFR 820. |
  | No New Safety/Effectiveness | "Its use does not raise any new safety or effectiveness concerns when compared to the predicates." |

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

• Sample Size for Test Set: The document mentions "real patient cases" were used for beta testing at the user site. However, the exact number of cases or the sample size of the test set is not specified.
• Data Provenance: The beta testing was conducted at the Department of Minimal Invasive Cancer Center of Inner Mongolia Cancer Hospital (IMCH) in Hohhot City, China, using "real patient cases." This suggests the data was retrospective (using existing patient data) or, less likely but possible, prospective (patients treated during the beta test), but the document does not explicitly state which. Given "real patient cases" and a beta test, it's more likely retrospective in nature, or a mix, to evaluate the planning system.

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

The document mentions "beta testing at the Department of Minimal Invasive Cancer Center of Inner Magnolia Cancer Hospital (IMCH) in Hohhot City, China using real patient cases." It also states, "Detailed methods of mitigating these potential risks have been identified by the development team, and verified by clinical physicists contracted by Prowess and determined to be adequate."

• The number of experts involved in establishing ground truth for the test set is not specified.
• The qualifications of the experts involved in verifying risks are mentioned as "clinical physicists contracted by Prowess." No specific experience level is given. It is implied that these physicists, or other clinical personnel at IMCH, would be the experts using and evaluating the device and its output in real patient cases, thereby implicitly contributing to the "ground truth" assessment of plan quality and safety, but this is not explicitly detailed as a ground truth establishment process.

4. Adjudication Method for the Test Set:

None is mentioned. The beta testing was conducted to "obtain feedback and to verify the results of in-house testing in a user environment." This suggests an evaluation rather than a formal adjudication process for establishing a definitive ground truth by consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document describes a substantial equivalence submission, which typically does not involve MRMC comparative effectiveness studies with human readers. The comparison is primarily between the device's features and its predicate devices, validated through technical testing and user-site feedback.

6. If a Standalone (algorithm only without human-in-the-loop performance) Study was done:

Yes, in-house verification and validation (V&V) testing was performed. "Functional testing was conducted both in-house... Verification and validation testing has demonstrated that Panther StereoSeed has met its predetermined specifications, demonstrated substantially equivalent performance to the predicate device, functions as intended, and is safe and effective for its specified use." This implies testing of the algorithm's performance against specifications without direct human intervention as part of the primary performance metric.

7. The Type of Ground Truth Used:

For the in-house V&V, the "ground truth" would be established by the predetermined specifications for the software and potentially synthetic data or established clinical scenarios. For the beta testing with "real patient cases," the "ground truth" would likely be evaluated against clinical judgment and established treatment planning principles by the clinical users at IMCH, but this is not explicitly detailed as a formal "ground truth" labeling process in the document. No mention of pathology or outcomes data as ground truth is made.

8. The Sample Size for the Training Set:

This information is not provided in the document. The Panther StereoSeed is described as an "optional software module" that "produce[s] a seed implant plan that is optimized for seed locations and needle directions." The text implies an optimization algorithm rather than a machine learning model that requires a distinct "training set." Therefore, a traditional "training set sample size" may not be applicable in the sense of supervised learning.

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

This information is not provided. As noted above, the device's description suggests it might not rely on a traditional machine learning "training set" with established ground truth labels, but rather on optimization algorithms built upon predefined rules and clinical principles.

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