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TheraSeed® Palladium-103 Implants are indicated for tumors with any of the following characteristics:

• . Localized,
• Unresectable,
• Low to moderate radiosensitivity.
  The tumors may be of the following types:
• . Superficial;
• . Intrathoracic;
• . Intra-abdominal;
• 트 Lung, pancreas, prostate, head and neck;
• . Residual following external beam or excision of primary tumor;
• . Recurrent.

The Pd-103 Seed Implant Kits will be offered using TheraSeed® Palladium-103 Implants, which are produced and marketed commercially by Theragenics, Inc. under the 510(k) K010283. There is no change to the seeds produced by Theragenics and marketed under the name TheraSeed® Palladium-103 devices. These seeds will be packaged in various sterile and non-sterile configurations. These configurations are the same as the predicate described in K043246.

The provided text is a 510(k) Summary for a medical device called "Palladium-103 Seed Implant Kits." This summary is a regulatory document submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) submission for this type of device (radionuclide brachytherapy source) typically does not include detailed clinical studies with acceptance criteria for device performance in the same way that a diagnostic AI device or a new therapeutic device would.

Instead, the core of this submission focuses on demonstrating substantial equivalence to an existing approved device. This means showing that the new device has the same intended use, technological characteristics, and principles of operation as a predicate device that is already on the market. The "performance data" referred to in Section G typically relates to engineering and manufacturing tests to ensure the seeds meet established specifications, not clinical outcomes from a study proving efficacy or diagnostic accuracy.

Therefore, many of the requested points in your prompt are not applicable to this specific document as they pertain to clinical performance studies, which are not usually required or presented for a 510(k) of this nature.

Here's an attempt to answer your questions based on the provided text, highlighting what is and isn't available:

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

This information is not provided in the 510(k) summary. For a brachytherapy seed, acceptance criteria would typically involve physical and radiological specifications (e.g., activity, dose rate, seed dimensions, uniformity) and the performance would be measured against these. However, this document states: "The principles of operation and fundamental scientific technology have not changed. Reference K043246 and K010283 for a detailed description." and "The appropriate testing for the Palladium-103 Seed Implant Kits was conducted." This implies that the device meets the same specifications as the predicate devices, but the specific criteria and performance values are not detailed in this summary.

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

This information is not applicable/not provided. This 510(k) does not describe a clinical test set or clinical study comparing the new device against a ground truth for diagnostic or therapeutic efficacy. It relies on substantial equivalence to predicate devices that have prior approval and established safety and effectiveness.

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)

This information is not applicable/not provided. There is no clinical test set described where ground truth would need to be established by experts.

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

This information is not applicable/not provided. No clinical 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

This information is not applicable/not provided. This device is a brachytherapy seed, not an AI diagnostic or assistance tool. Therefore, an MRMC study related to human readers and AI is irrelevant to this submission.

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

This information is not applicable/not provided. This is not an algorithmic device.

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

This information is not applicable/not provided. No clinical studies with ground truth are described in this 510(k) summary. The "ground truth" for this device's approval is its substantial equivalence to previously approved devices and compliance with established manufacturing and performance specifications for brachytherapy seeds.

8. The sample size for the training set

This information is not applicable/not provided. This device does not use machine learning or AI that would require a "training set."

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

This information is not applicable/not provided. This device does not use machine learning or AI that would require a "training set."

Summary regarding K060636:

The 510(k) summary for the Palladium-103 Seed Implant Kits primarily establishes substantial equivalence to existing predicate devices (TheraSeed® Palladium-103 Implants and BrachySource® Brachytherapy Seed Implants). The key arguments are:

• Identical intended use: The indications for use for the Palladium-103 Seed Implant Kits are explicitly stated to be unchanged from the predicate device (Theragenics 510(k), K010283).
• Identical design and fundamental scientific technology: The device uses the same TheraSeed® Palladium-103 Implants produced by Theragenics, Inc., and the configurations for packaging are the same as another predicate (K043246).
• "Appropriate testing" was conducted: This refers to engineering and manufacturing tests to confirm the new device (specifically, the kits and configurations) meets established specifications for brachytherapy seeds, confirming it is not different in terms of safety and efficacy from the predicate.

In essence, the study that "proves the device meets the acceptance criteria" in this context is the comparison to the predicate devices and the internal quality testing, rather than a clinical trial with a defined test set, ground truth acquisition, or human reader performance metrics.

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