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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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