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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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The BEBIG I-125 sources are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor. The BEBIG brachytherapy I-125 sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intra-abdominal and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.

The BEBIG I-125 sources are cylindrical sealed sources containing iodine-125 radioactivity. The sources are 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium, and is sealed at each end by laser weld. The iodine-125 is deposited within a porous ceramic tube as silver iodide (AgI). A radiopaque marker is located in the center of the ceramic tube to serve as an x-ray marker. The radiopaque marker is composed of gold alloy. I-125 has a half live of 59.46 days and decays by electron capture with emission of characteristic photons and electrons. The titanium wall of the 1-125 source absorbs the electrons. The BEBIG I-125 sources are available in a range of activity levels. The most commonly used source activity levels for permanent implants are 0.2-0.6 mCi, other source strengths, in particular for temporary applications, are available according to customer specific order. The sources are provided non-sterile and must be sterilized before use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BEBIG IsoSeed I-125:

The provided 510(k) summary does not describe a study where the device's performance was measured against specific acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (BEBIG Brachytherapy Iodine-125 Source, K021343).

Therefore, I cannot fill out all sections of your request as a study proving device performance against acceptance criteria was not conducted or reported in this document. The "reported device performance" in the table will reflect the general description of the device's characteristics and its intended use, rather than specific measured performance metrics.

Here's the information extracted and limitations based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not define explicit "acceptance criteria" in terms of measurable performance targets for a new study. Instead, the "acceptance criteria" here are implied by the claim of substantial equivalence to the predicate device, meaning the new device should possess similar characteristics and intended use. "Reported device performance" is derived from the description of the device itself.

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

• Not applicable. This document is a 510(k) summary demonstrating substantial equivalence to a predicate device, not a report of a new performance study with a test set of data. The "test set" implicitly refers to the characteristics of the new device itself as compared to the predicate, rather than a dataset used to evaluate its performance.

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

• Not applicable. No ground truth establishment by experts is described as part of this 510(k) submission. The equivalence is based on comparing device specifications and intended use.

4. Adjudication Method for the Test Set

• Not applicable. No adjudication method is mentioned, as there was no "test set" in the context of a new performance study.

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

• No. This type of study would be relevant for devices that interpret images or require human readers in their use. This document describes a brachytherapy source, not an AI or diagnostic imaging device involving human reader interpretation. No MRMC study was performed or reported.

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

• No. This is not an AI or algorithm-based device. A standalone performance study for a medical device like this would typically involve bench testing (e.g., leakage, dimensions, activity verification) and possibly animal or clinical studies to demonstrate safety and effectiveness if substantial equivalence could not be established. The document explicitly states that the device is identical to the predicate (K021343), implying that the predicate's prior clearance and associated testing are sufficient, supported by the manufacturing quality system.

7. The Type of Ground Truth Used

• Not applicable. In the context of a 510(k) leveraging substantial equivalence, the "ground truth" is effectively the established knowledge and clearance of the predicate device. The new device's specifications and manufacturing processes are compared against the predicate's known characteristics.

8. The Sample Size for the Training Set

• Not applicable. Training sets are relevant for machine learning algorithms. This document does not describe the development or evaluation of such an algorithm.

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

• Not applicable. As above, no training set or machine learning algorithm is discussed.

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The BEBIG I-125 sources are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor.
The BEBIG brachytherapy I-125 sources are indicated for the treatment of selected localized turnors. These sources are commonly used to treat superficial, intra-abdominal and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.

The BEBIG I-125 sources are cylindrical sealed sources containing iodine-125 radioactivity. The sources are 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium, and is sealed at each end by laser weld. The iodine-125 is deposited within a porous ceramic tube as silver iodide (AgI). A radiopaque marker is located in the center of the ceramic tube to serve as an x-ray marker. The radiopaque marker is composed of gold alloy.
I-125 has a half live of 59.46 days and decays by electron capture with emission of characteristic photons and electrons. The titanium wall of the I-125 source absorbs the electrons.
The BEBIG I-125 sources are available in a range of activity levels. They are provided nonsterile and must be sterilized before use.

This document is a 510(k) summary for a medical device (BEBIG brachytherapy I-125 source), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The document explicitly states:

"In Summary, the BEBIG brachytherapy I-125 sources are substantially equivalent to a legally marketed device. Quality System Controls assure the device is substantially equivalent to the predicate device with respect to its performance, safety, and effectiveness."

This means the submission relies on the established safety and effectiveness of the predicate device (UroMed Brachytherapy Iodine-103 Source, K982226) and adherence to quality system regulations, rather than a new performance study to defined acceptance criteria.

To directly answer your request based only on the provided text, the following would be reported:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to the predicate device and adherence to regulatory standards.
• Reported Device Performance:
  • "Technically identical" to the UroMed Brachytherapy Iodine-103 Source.
  • Intended Use: Treatment of cancer with radioactive sources in close proximity to or within the tumor.
  • Indications for Use: Treatment of selected localized tumors (superficial, intra-abdominal, intrathoracic, head, neck, lung, pancreas, prostate), alone or in combination with external beam radiation.
  • Physical Characteristics:
    • Cylindrical sealed source.
    • Contains iodine-125 radioactivity.
    • 4.5 mm long, 0.8 mm in diameter.
    • Outer capsule: titanium, sealed by laser weld.
    • Iodine-125 deposited as silver iodide (AgI) within a porous ceramic tube.
    • Radiopaque marker: gold alloy in the center of the ceramic tube.
    • Half-life of I-125: 59.46 days.
    • Decays by electron capture with emission of characteristic photons and electrons (titanium wall absorbs electrons).
    • Available in a range of activity levels.
    • Provided non-sterile, must be sterilized before use.

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

• Not applicable/Not provided. This document does not describe a performance study involving a test set of data. It describes a medical device and its intended use, asserting substantial equivalence to a predicate device.

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

• Not applicable/Not provided. No ground truth establishment is described as there is no specific performance study outlined.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. No test set or adjudication method is described.

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

• No. No MRMC study or any comparative effectiveness study is mentioned. This document focuses on the device's technical specifications and substantial equivalence, not its clinical efficacy improvement with human-AI interaction.

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

• No. This device is a physical brachytherapy source, not an algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission.

7. The Type of Ground Truth Used:

• Not applicable/Not provided. No performance study requiring a distinct "ground truth" (like pathology or outcomes data for diagnostic accuracy) is described. The "ground truth" for this submission is implicitly the established safety and efficacy of the predicate device and adherence to manufacturing standards.

8. The Sample Size for the Training Set:

• Not applicable/Not provided. This document does not describe a machine learning algorithm or any training set.

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

• Not applicable/Not provided. As there is no training set mentioned, no ground truth establishment for it is described.

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