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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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IsoRay, Inc. Lawrence CSERION seeds are indicated for the treatment of malignant disease (e.g., head and neck, brain, breast, prostate, etc.) and may be used in surface, interstitial, and intracavitary applications for tumors with known radiosensitivity. The seeds may be used as a primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as treatment for residual disease after excision of primary tumors.

The IsoRay, Inc. Lawrence CSERION Model CS-1 is a small, cylindrical sealed source which contains the low energy gamma (X-ray) emitting radionuclide, cesium-131, adsorbed onto an internal inorganic substrate. The nominal external seed dimensions (4.5 mm length and 0.8 mm diameter) and patient-contacting material (titanium) are identical to predicate device(s).

The provided text is a 510(k) Summary for the IsoRay, Inc. Lawrence CSERION Model CS-1, a brachytherapy source. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove that the device meets those criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training and test sets is not available in this document.

The document states that the device is "substantially equivalent" to predicate devices based on a comparison of parameters. The "Comparison Chart" on page 0 outlines these parameters. This comparison is the "study" demonstrating the device meets the criteria for substantial equivalence, implying that if the new device's parameters are similar enough to an already approved device, it is considered safe and effective.

Here's a breakdown of what is provided, framed in terms of the closest available information to your request:

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

The document doesn't provide "acceptance criteria" in the traditional sense of a performance study with specific thresholds. Instead, it presents a "Comparison Chart" to demonstrate substantial equivalence to predicate devices. The "acceptance criterion" here is essentially that the new device's parameters are comparable to those of already cleared devices.

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The ATI Medical, Inc. IsoRod Pd-103 Radionuclide Brachytherapy Source is intended for permanent interstitial implantation for the treatment of selected localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, neck, lung, intra-abdominal, pancreas, prostate, and unresectable tumors, or for residual disease after excision of primary or secondary tumors. IsoRod Pd-103 implants may be used concurrently with or following treatment with other interventions, such as external beam therapy or chemotherapy.

The IsoRod implant is a permanently implanted, radioactive device, designed for the treatment of deep- seated tumors. IsoRod implants are comprised of base metallic rods that are coated with radioactive palladium. The radioactive palladium is then encapsulated with a metallic coating.

The base rod is composed of a palladium/cobalt alloy. The rod is 1 millimeter and 10 millimeters in length. The thin layer (0.2 micron) that comprises the radioactive layer is a combination of radioactive and non-radioactive palladium (Pd-103 and Pd-102 respectively). The encapsulation layer of 6-8 microns is pure palladium, a metal that is utilized in permanent implants based on its favorable biocompatibility characteristics.

The activity of each IsoRod implant is between 0.5 mCi and 3.0 mCi. The source is exceptionally isotropic based on the fact that the radioactive material is evenly deposited on the source and is shielded in every direction only by the thin layer of non-radioactive palladium.

The provided text, K020683, is a 510(k) summary for the IsoRod Pd-103 Implant Brachytherapy Source. This document describes a medical device rather than an AI/ML device, and thus the requested information regarding acceptance criteria, study details, and AI/ML-specific metrics (like human reader improvement with AI, standalone algorithm performance, training set details) is not applicable.

The 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through:

• Intended Use: Showing the same indications for use as predicate devices.
• Technological Characteristics: Highlighting similar isotope, apparent activity, and device description.
• Biocompatibility Testing: Confirming the device is biocompatible for its intended use.
• Dosimetry: Mentioning Monte Carlo analysis for dosimetry, with physical dose measurements to be completed.

Therefore, many of the specific questions asked are not relevant to this type of device submission.

However, I can extract the information that is present:

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

• Activity: 0.5 mCi to 3.0 mCi per implant
• Design: Base metallic rods coated with radioactive palladium and encapsulated with pure palladium. Rod is 1mm x 10mm. |
  | Biocompatibility: Safe for permanent implantation | Biocompatibility tests (summarized in Appendix 7) indicate the device is biocompatible under conditions of intended use. (Specific criteria and results not detailed in the summary). |
  | Dosimetry: Appropriate for brachytherapy | Dosimetry determined by Monte Carlo analysis at UCLA using MCNP4C code. Physical dose measurements in a phantom to be completed prior to marketing. (Specific values or ranges not detailed in the summary). |

2. Sample size used for the test set and the data provenance:

• Not applicable. This submission performs no "test set" evaluation in the context of an AI/ML study. The evaluation focuses on comparison to predicate devices and engineering/biocompatibility testing, not clinical performance data from a patient cohort.

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

• 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 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. The device is a brachytherapy source, not an AI-assisted diagnostic or prognostic tool.

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

• Not applicable. The device is a physical radioactive implant, not an algorithm.

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

• For biocompatibility: Ground truth would be established through standardized biocompatibility testing protocols defined by relevant ISO standards (e.g., ISO 10993) which determine material safety for implantation. The summary states these tests were performed, but not the specific "ground truth" method.
• For dosimetry: Ground truth would be established through physical measurements and validated Monte Carlo simulations demonstrating accurate radiation dose distribution.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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