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IsoSeed I25.S17plus with apparent activities from 0.189 to 1.045 mCi are 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 turnors) or for treatment of residual disease after excision of the primary tumor. Seeds in this apparent activity range may be used to treat superficial, intraabdominal, and intrathoracic tumors. Tumors of the head, neck, lung, pancreas, and prostate (early stages) are commonly treated.

IsoSeed I25.S17plus with total apparent activities greater than 1.045 mCi are indicated for interstitial treatment of tumors which have the following characteristics: unresectable, localized, and moderate radiosensitivity. These seeds may be used for selected radiation as temporary implants. IsoSeed 125.S17plus are 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 IsoSeed I25.S17plus.

IsoSeed I25.S17plus is a radioactive brachytherapy source intended for permanent as well as temporary implantation. IsoSeed 125.S17plus is a cylindrical sealed source containing radioactive lodine-125. The source is 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium according to ASTM F67. The radioactive iodine 1-125 is deposited as silver iodide (Agl) on the surface of a silver bar. The silver bar also serves as an X-ray marker.

lodine-125 has a half-life of 59.41 days. It decays with 100% to Te-125 as a result of electron capture by the radiation of X-rays and y-radiation in the energy range up to 35 keV. The most commonly used activities used for implants are up to 1.045 mCi. Other source strengths for temporary applications are available up to 25 mCi.

IsoSeed I25.S17plus is delivered non-sterile and must be steam sterilized by the user. The device is intended for single use, unless it is used as temporary implant without direct tissue contact.

The provided text describes a medical device, the IsoSeed I25.S17plus brachytherapy iodine-125 source, and its regulatory submission (K140849) for substantial equivalence to existing predicate devices. However, the document does not contain any information regarding acceptance criteria for a device's performance, nor does it describe a study to prove such performance criteria were met.

The document pertains to the device's technical specifications, indications for use, and a comparison to predicate devices to establish substantial equivalence with respect to safety and effectiveness, not a performance study with acceptance criteria.

Therefore, for the information requested I must state that none of the requested information (points 1-9) can be extracted from the provided text as it does not describe a performance study or acceptance criteria for the device.

The document details:

• Device Name: IsoSeed I25.S17plus brachytherapy iodine-125 source
• Classification: Class II, 21 CFR 892.5730 Radionuclide brachytherapy source, Product code KXK
• Predicate Devices: Nucletron SelectSeed I-125 (K002429), Eckert & Ziegler BEBIG IsoSeed I-125 (K033781), Medi-Physics OncoSeed 6711 (K914281)
• Device Description: Cylindrical sealed source, 4.5 mm long, 0.8 mm diameter, titanium capsule, radioactive Iodine-125 deposited as silver iodide on a silver bar. Half-life of 59.41 days.
• Intended Use/Indications for Use: For permanent interstitial implantation of selected localized tumors (low to moderate radiosensitivity), either as primary treatment or for residual disease. Specific activity ranges are detailed for different applications (0.189 to 1.045 mCi for permanent implants; > 1.045 mCi for temporary implants or tumors requiring higher activity).
• Nonclinical Testing: Tests according to ISO 2919 (classified C 63X11), MR compatibility tests (ASTM F2503, ASTM 2052, ASTM 2213, ASTM 2182, ASTM 2119), and Biocompatibility tests (ISO 10993-1, ISO 10993-5, ISO 10993-18). These were performed to support safety claims, not a substantial equivalence determination based on performance.
• Clinical Testing: "Not applicable"

Conclusion: The provided text is a 510(k) summary for a medical device seeking clearance through substantial equivalence. It confirms the physical characteristics, indications, and safety testing (non-clinical) to show it's similar to already approved devices. It explicitly states "Summary of Clinical Testing: Not applicable," which means no clinical performance study was conducted or presented in this document for the purpose of establishing acceptance criteria or proving device performance in that context.

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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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The BEBIG IsoSeeds® Pd-103 are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor.

The BEBIG Pd-103 Radionuclide Brachtherapy Sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intraabdominal 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 IsoSeeds® Pd-103 are cylindrical sealead sources containing Pd-103 radioactivity. The sources are 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium being closed at one end and sealed by a laser weld at the other end in a final step. The metallic palladium-103 is deposited within a porous ceramic tube. 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 wire.

Palladium seeds have a half live of 16,97 days and are available in a range of activity levels. The BEBIG IsoSeeds® Pd-103 are provided non-sterile and must be sterilized prior to use.

The provided text is a 510(k) summary for the BEBIG IsoSeeds® Pd-103 device, which describes a brachytherapy source. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study of device performance against specific acceptance criteria in the manner typically seen for novel software or diagnostic devices.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, as such a study is not typically part of a 510(k) submission for this type of device.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance: The document lists standards and regulations the device complies with (e.g., DIN EN 1441, ISO 9978), but these are not specific performance metrics with acceptance thresholds and measured results in the context of a clinical study.
2. Sample size used for the test set and data provenance: No clinical test set or data provenance is mentioned.
3. Number of experts and their qualifications: No expert ground truth establishment is described.
4. Adjudication method: No adjudication method is mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not relevant to a brachytherapy seed and is not mentioned.
6. Standalone performance study: No standalone performance study against specific clinical metrics is presented.
7. Type of ground truth used: No ground truth in the context of clinical performance is discussed.
8. Sample size for the training set: No training set is mentioned as this is not an AI/ML device.
9. How ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on:

• Device Description: What the device is and how it's constructed.
• Intended Use and Indications: For what purpose the device is used.
• Predicate Devices: Identification of existing, legally marketed devices to which the new device is substantially equivalent.
• Compliance with Standards: A list of international and national standards/regulations that the device manufacturing process and design adhere to (e.g., ISO, DIN EN, FDA QSR). This is the primary "proof" of safety and effectiveness in a 510(k) for this type of medical device – demonstrating that it meets established engineering, quality, and safety standards, and is similar in function and design to already approved devices.

In essence, the "study" proving the device meets criteria in a 510(k) context for a device like this is the demonstration of adherence to these relevant standards and substantial equivalence to predicate devices, rather than a clinical performance study with specific acceptance criteria as you might find for a diagnostic AI product.

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