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The Brachytherapy Source Device, with apparent activities between 0.19mCi and 1.01mCi, is indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor. Seeds in this apparent activity range may be used to treat superficial, intra-abdominal, and intra-thoracic tumors. Tumors of the head, neck, lung, pancreas and prostate (early stages) are commonly treated.

The Brachytherapy Source Device, with total apparent activities greater than 1.01mCi, is indicated for interstitial treatment of tumors which have the following characteristics; unresectable, localized, and moderate radiosensitivity. These seeds may be used for selected radiation applications as temporary implants.

The Brachytherapy Source Device is indicated to treat residual tumors concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy. In addition, recurrent tumors may be implanted with seeds.

The Brachytherapy Source Device, Model 9011, is a welded titanium capsule containing Iodine-125 adsorbed onto a silver rod.

Here's an analysis of the provided text regarding the Brachytherapy Source Device, Model 9011.

It's important to note that this document is a 510(k) summary for a medical device, specifically a brachytherapy source. Brachytherapy sources are physical objects that emit radiation for cancer treatment, not a diagnostic AI/ML algorithm. Therefore, many of the requested categories related to AI/ML software performance (like effect size of AI assistance, MRMC studies, ground truth establishment for training, etc.) are not applicable to this type of device. The acceptance criteria and "studies" are focused on the physical characteristics and safety of the radiation source itself, not its diagnostic accuracy or AI performance.

Acceptance Criteria and Device Performance (Brachytherapy Source Device, Model 9011)

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: For a 510(k) submission, "acceptance criteria" are largely based on demonstrating substantial equivalence to a predicate device. This means the new device should be as safe and effective as the predicate, often by meeting the same or equivalent engineering specifications and performance standards. In this case, the predicate's characteristics serve as the de facto acceptance criteria that the new device aims to match or justify deviations from. The substantial equivalence is based on the argument that the modified characteristics (smaller diameter) do not raise new questions of safety or effectiveness, especially since other critical parameters (like capsule material, isotope, length ranges) remained the same.

2. Sample Size for Test Set and Data Provenance

The document does not specify a "test set" in the context of an AI/ML algorithm or a study involving patient data. This is a physical medical device. The "testing" involved:

• Physical Prototypes: "Prototype sources have been manufactured and assessed against predetermined criteria for Design Verification and Design Validation." The exact number of prototypes is not specified.
• Sealed Source Testing: The device was tested according to ISO 2919, which is a standard for sealed radioactive sources. This likely involves a series of physical tests (e.g., temperature cycling, external pressure, impact, vibration, puncture) on a sample of devices to ensure their integrity. The sample size for these specific tests is not explicitly stated in the 510(k) summary, but ISO standards typically define sample requirements.
• Activity Measurements: "Activity measurements have been obtained from NIST Report (Report of Air-Kerma rate measurements)." This refers to calibration and measurement standards from the U.S. National Institute of Standards and Technology.

Data Provenance: Not applicable in the context of patient data as this is a physical device safety and performance evaluation. The provenance of the testing (e.g., "NIST Report") is mentioned, indicating U.S. national standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is a physical device, not a diagnostic imaging or AI algorithm that relies on expert interpretation of data to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" of patient cases requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is relevant to diagnostic imaging devices or AI algorithms where human readers interpret medical images. It is not applicable to a radioactive implantable seed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical brachytherapy source, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on engineering specifications, international standards (ISO 2919), and national metrology standards (NIST).

• Device Specifications: The stated dimensions, materials, and isotope are the design "ground truth."
• Performance Standards: Compliance with ISO 2919 for sealed source integrity ensures the physical safety and containment of the radioactive material.
• Radioactivity Calibration: NIST reports provide the "ground truth" for the accurate measurement of the device's radioactive output (Air-Kerma rate), which is critical for safe and effective dosimetry in patient treatment.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this physical medical device.

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

Not applicable. There is no "training set" for this physical medical device.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets acceptance criteria consists of non-clinical testing focused on the physical and radiological properties of the brachytherapy source.

1. ISO 2919 Testing: The device underwent testing "according to ISO 2919 for sealed sources." This standard specifies the classification of sealed radioactive sources based on their safety requirements and defines a series of environmental and mechanical tests (e.g., temperature, external pressure, impact, vibration, puncture) designed to demonstrate that the source will maintain its integrity and containment of radioactive material under normal and accident conditions. Meeting this standard indicates the physical robustness and safety of the sealed source.
2. NIST Report for Activity Measurements: "Activity measurements have been obtained from NIST Report (Report of Air-Kerma rate measurements)." This confirms that the radioactive output of the device (Iodine-125) has been accurately measured and calibrated to national standards as verified by the National Institute of Standards and Technology. Accurate activity measurement is fundamental for physicians to calculate appropriate treatment dosages for patients.
3. Design Verification and Design Validation: "Prototype sources have been manufactured and assessed against predetermined criteria for Design Verification and Design Validation." This process ensures that the manufactured device meets its design specifications (verification) and fulfills its intended use requirements (validation). This typically involves comparing actual prototype performance against the established design requirements and user needs.

These non-clinical tests demonstrate that the Brachytherapy Source Device, Model 9011, is physically safe, robust, and accurately characterized in terms of its radioactive output, thereby establishing its substantial equivalence to the predicate device despite minor dimensional changes.

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The BEBIG I-125 sources are intended for use in the treatment of turnors, with radioactive sources within or in close proximity to the turnor.

The Brachytherapy Strand Device is indicated for tumors with any of the following characteristics:

• Localized
• Unresectable
• Low to Moderate Radiosensitivity

The tumors may be of the following type:

• Superficial
• Intrathoracic
• Intra-abdominal
• Lung, Pancreas, Prostate, Head and Neck
• Residual following external beam radiation or excision of primary tumor
• Recurrent

The Brachytherapy Strand Device is used for the treatment of localized tumors and is placed into a body cavity or tissue. It consists of a pre-sterilized kit containing a prostate seeding needle and a custom-loaded strand of seeds spaced at a precise distance within absorbable suture. The spacers are made from the same material as the sutures. The customized strand can contain a variable number (1-12) of seeds and/or seeding spacers (maximum 12 components per strand). The stranded Pd-103 and I-125 implants are placed inside the needle. The needle is made from 18 gauge stainless steel

The provided text is a 510(k) Premarket Notification for the BEBIG Brachytherapy Strand Device. It focuses on demonstrating substantial equivalence to predicate devices for its intended use, rather than conducting a performance study with defined acceptance criteria and device performance evaluation as one might find for a diagnostic AI/ML device.

Therefore, the requested information components related to acceptance criteria, detailed study design, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not present in this regulatory document.

However, I can extract the comparison to predicate device table which serves a similar purpose in this context: to show that the new device is comparable to existing, legally marketed devices.

Here's a breakdown of what can be extracted and what cannot:

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

This document does not present acceptance criteria in the format typically seen for a diagnostic or AI/ML device's performance study (e.g., sensitivity, specificity, AUC thresholds). Instead, the "acceptance" for this device is based on demonstrating substantial equivalence to predicate devices. The performance is implied by the comparison of characteristics.

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. This is a medical device for brachytherapy, and the submission is for substantial equivalence based on material and design comparison, not a clinical performance study with a test set of data.

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. Ground truth for a test set is not established for this type of regulatory submission.

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

Not applicable. Adjudication is not relevant for this type of regulatory submission.

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. This is a physical medical device, not an AI/ML diagnostic tool, and therefore MRMC studies are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. Ground truth, in the context of a performance study for AI/ML or diagnostic devices, is not relevant here. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML device requiring a training set.

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

Not applicable.

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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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Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can be used either as primary treatment (such as prostate cancer or unresectable tumors) or treatment for residual disease after excision of the primary tumor or recurring tumors. Tumors of the head, neck, lung, pancreas, prostate (early stages), and other accessible tumors are commonly treated.

The Imagen isoSTARTM I-125 Interstitial Seed, Model IS-12501 uses 131 spheres encapsulated in a titanium tube.

Here's an analysis of the provided text regarding the Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, focusing on acceptance criteria and study details.

Based on the provided 510(k) summary (K991526), this device is a medical implant (brachytherapy seed) and not an AI or software-as-a-medical-device (SaMD). Therefore, most of the requested information regarding AI device acceptance criteria, study design, and ground truth is not applicable. The regulatory pathway for this device is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices, rather than proving performance against specific acceptance criteria through clinical studies in the way an AI/SaMD would.

However, I can extract the relevant information from the provided document as it pertains to medical device approval, even without a direct AI component.

1. Table of Acceptance Criteria and Reported Device Performance

For non-AI medical devices like brachytherapy seeds, "acceptance criteria" are generally related to demonstrating substantial equivalence to existing predicate devices in terms of safety and effectiveness, and meeting relevant performance standards. The provided document doesn't list explicit, quantifiable acceptance criteria in the way a diagnostic AI algorithm might (e.g., "sensitivity > 90%"). Instead, the acceptance is based on demonstrating comparable characteristics and safety/biocompatibility.

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

• Not Applicable in the context of an "AI test set."
• For this type of device, the "testing" refers to bench testing for safety (e.g., radiation leakage, physical integrity) and biocompatibility, not performance on a dataset of patient cases. The document states "has been tested for safety and biocompatibility by standard tests used for radionuclide devices." It does not specify sample sizes or data provenance for these engineering/material tests.

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

• Not Applicable. As this is a physical medical device (radioactive seed), there is no 'ground truth' in the context of expert diagnosis or interpretation of an AI output. The ground truth for such a device would be its physical properties, radiation output, and biological safety/biocompatibility, confirmed through laboratory and engineering tests, not expert interpretation of medical images or data.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "test set" in the sense of medical images or patient data requiring expert adjudication for this device.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study is relevant for diagnostic devices (especially imaging-based AI) where human readers interpret cases. It is not applicable to a radioactive implantable seed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

• For the purpose of substantial equivalence for this brachytherapy seed, the "ground truth" (or basis for comparison) is primarily:
  • Predicate Device Characteristics: The established safety, effectiveness, and technological characteristics of legally marketed I-125 brachytherapy seeds (e.g., Imagyn isoSTAR™ I-125 Interstitial Seed Model IS-12500, EndoSeed, Amersham Model 6711, Mentor IoGOLD).
  • Standard Test Outcomes: Results from "standard tests used for radionuclide devices" confirming physical integrity, radiation safety, and biocompatibility.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI device, so there is no "training set."

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

• Not Applicable. No training set exists for this device.

Summary regarding the device:

The Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, gained 510(k) clearance by demonstrating substantial equivalence to existing predicate devices. The key elements for this determination were:

• Similar technological characteristics (encapsulation method, range of activity).
• No differences in biocompatibility or other safety and effectiveness aspects.
• Confirmation of safety and biocompatibility through "standard tests used for radionuclide devices."
• Identical intended use as predicate devices.

The regulatory process for this device did not involve clinical trials or performance assessments against diagnostic accuracy metrics, as it is a physical therapeutic implant rather than a diagnostic AI/software.

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InterSource125 implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. InterSource125 implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy.

InterSource125 is a hermetically sealed radiotherapeutic source indicated for interstitial implantation. The radionuclide used in InterSource125 is Iodine-125 (I-125). InterSource125 is constructed by placing a platinum / iridium radiopaque marker and I-125 on the surface of a medical grade titanium inner tube. The device is sealed by sliding an outer tube, also medical grade titanium, over the inner tube and laser welding both ends. The resulting device has a hollow center with an inner diameter of 0.37 mm with all body tissue contacting surfaces made from medical grade titanium.

The InterSource125 device, an Iodine-125 seed for brachytherapy, demonstrated substantial equivalence to its predicate device, the Amersham/Medi+Physics Model 6711 Therapeutic Seed Source, rather than a direct performance study against acceptance criteria from a standalone test. The assessment of substantial equivalence was based on a comparison of key characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission, direct "acceptance criteria" as would be seen in a performance study with defined thresholds for metrics like sensitivity or specificity are not present. Instead, the "acceptance criteria" are implied by the similarity to the predicate device's characteristics. The "reported device performance" is the InterSource125's characteristics and its computed radiation distribution compared to the predicate's known characteristics and measured radiation distribution.

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MBI I-125 Brachytherapy Seeds with apparent activities between 3.7 MBq (0.1 mCi) to 37 MBq (1.0 mCi) are indicated for permanent interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, slow growing, and exhibit low to moderate radiosensitivity. Intra abdominal, intrathoracic and superficial tumors may be treated with seeds containing apparent activities within this range. Tumors commonly treated are prostate (early stage), pancreas, head, neck, and lung.

MBI I-125 Brachytherapy Seeds containing apparent activities greater than 37 MBq (1.0 mCi) are indicated for temporary interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, and exhibit moderate radiosensitivity. Temporary implants are indicated in breast, brain and eye tumors.

MBI I-125 Brachytherapy Seeds are indicated for treatment of residual tumors and recurrent tumors following external radiation therapy, hyperthermia, or chemotherapy or concurrent with these treatment modalities.

Each MBI I-125 Brachytherapy Seed external dimensions of 4.55 mm ± 0.35 mm in length and 0.865 mm ± 0.095 mm in diameter. The cylindrical metal casing is titanium having a wall thickness of 0.06 mm ± 0.02 mm laser welded at both ends. Both models: 125SL and 125SH have three to five silver spheres which are used to absorbed iodine-125 and provide X-ray contrast.

The provided text describes the K984446 Premarket Notification 510(k) Summary for the MBI I-125 Brachytherapy Seed. This document is a 510(k) summary, not a detailed study report. Therefore, it focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical or standalone performance studies with specific statistical acceptance criteria and results.

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

Since this is a 510(k) summary demonstrating substantial equivalence, formal acceptance criteria in a statistical sense (e.g., minimum sensitivity/specificity) are not explicitly stated for device performance in the same way they would be for a novel device. Instead, the acceptance criterion implicitly is "substantial equivalence" to the predicate device, Model 6711 by Amersham/Medi-Physics, Inc. (K914281), based on technological characteristics and non-clinical data.

The "reported device performance" is a comparison of key physical and radiation characteristics.

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

• Sample Size: Five I-125 seeds were analyzed for the total radiation fluence distribution. The emission spectra analysis was also performed on an unspecified, but likely small, number of seeds.
• Data Provenance: The data appears to be from non-clinical laboratory testing conducted by Mills Biopharmaceuticals, Inc. The country of origin for the testing facility/data is implied to be the United States (Oklahoma City, Oklahoma, where the company is located). The testing is prospective for the purpose of this submission, meaning it was conducted to support the 510(k) submission.

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. This is a non-clinical device, and the "ground truth" for the test set was established through physical measurements using scientific instruments (e.g., intrinsic Ge detector), not expert human interpretation.

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

Not applicable. There was no human adjudication for establishing "ground truth" from the device's physical and radioactive properties. The measurements are objective scientific data.

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. This document describes a physical brachytherapy seed, not an AI or imaging device involving human readers or interpretation.

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

Not applicable. This is not an algorithm or AI device. The "performance" described is the physical and radiation characteristics of the brachytherapy seed itself. The device functions as intended by its physical properties.

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

The "ground truth" for the non-clinical evaluation was established by objective physical measurements using scientific instrumentation (e.g., intrinsic Ge detector) and comparison to published scientific literature for the predicate device. For example, the total radiation fluence distribution data was compared to published data (Ling, C.C., et al., 1983) for the predicate Model 6711.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this device.

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