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Implant Sciences Model HDR 4454 Source Assembly, with individual activity up to 27Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy.

This source may be used concurrently with or following treatment with other interventions, such as external beam radiation therapy, hyperthermia or chemotherapy.

Implant Sciences Corp. Model HDR-4454 is a singly-encapsulated 160 Ytterbium Brachytherapy Source. It consists of a stainless steel capsule containing solid radioactive feer thium pellets. The pellets are sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.

This document describes a 510(k) premarket notification for a medical device (Implant Sciences Corp. Model HDR-4454 169Ytterbium Brachytherapy Source), which is a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device. It does not describe an AI/ML medical device, and therefore the concepts of acceptance criteria, study design, ground truth, and human-in-the-loop performance as they relate to AI/ML devices are not applicable.

The document states that the device is "substantially equivalent" to a predicate device (Implant Sciences Corp. Model HDR-4140, K042864). This means that the FDA determined that the new device is as safe and effective as a legally marketed device.

Here's how the information provided aligns with your request, even though it's not an AI/ML device:

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

• Acceptance Criteria (Implicit): For a 510(k), the primary acceptance criterion is "substantial equivalence" to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. This is not expressed in a quantitative table for this type of device.
• Reported Device Performance: The document highlights the technological characteristics of the new device (Model HDR-4454 169Ytterbium Brachytherapy Source) and compares them to the predicate (Model HDR-4140). The key performance aspect is that it utilizes photons from 169 Ytterbium, which is similar to the predicate. The FDA's letter states that they have determined the device is substantially equivalent, implying it met the regulatory performance requirements for this type of medical device submission.

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: For this type of device (a physical radioactive source), there isn't a "test set" in the sense of patient data or algorithm performance data. The evaluation for substantial equivalence relies on design specifications, material properties, manufacturing controls, and potentially non-clinical testing (e.g., radiation safety, dose uniformity, mechanical integrity), rather than empirical data from a "test set" of cases.

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 device is not an AI/ML diagnostic tool, so there is no "ground truth" established by experts on a test set of medical images or patient data. The "ground truth" for a brachytherapy source relates to its physical and radio-pharmacological properties, which are verified through various physical and chemical tests, not clinical expert consensus.

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

• Not Applicable: As there is no "test set" in the context of clinical data for an AI/ML device, there is no adjudication method.

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 not an AI/ML device, so no MRMC study looking at human reader performance with or without AI assistance would have been conducted or is 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 concensus, pathology, outcomes data, etc)

• Engineering and Physical Standards: For a brachytherapy source, the "ground truth" would be established by validated engineering specifications, radiation physics principles, material science standards, and potentially preclinical testing results (e.g., dose distribution measurements, mechanical integrity tests).

8. The sample size for the training set

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

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

• Not Applicable: This device is not an AI/ML device, so there is no "training set" or corresponding ground truth.

In summary, this document is a regulatory approval for a physical medical device (a brachytherapy source) based on substantial equivalence to a predicate, not an AI/ML device requiring clinical performance studies with acceptance criteria, ground truth, or human performance evaluations.

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Implant Sciences Model HDR 4140 Source Assembly, with individual activity up to 27Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with other interventions, such as external beam radiation therapy, hyperthermia or chemotherapy.

Implant Sciences Corp. Model HDR-4140 is a doubly-encapsulated 100 tterbium Brachytherapy Source. It consists of a plasma-welded titanium capsule containing solid radioactive 169Ytterbium pellets. The inner capsule is subsequently sealed in a stainless steel outer capsule that is attached to a cable to permit manipulation by the remote afterloading system.

The provided document is a 510(k) summary for the Implant Sciences Corp. Model HDR-4140, a brachytherapy source. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance rather than presenting a detailed study with specific acceptance criteria and detailed performance metrics as one might find for a diagnostic or AI-driven device.

Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not present in this type of regulatory submission. The document primarily establishes the device's technical characteristics and intended use in comparison to existing, cleared devices.

Here's a breakdown of the available information based on your request:

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

This information is not explicitly stated in the provided 510(k) summary. For a brachytherapy source, "acceptance criteria" generally refer to design specifications, material properties, safety standards (e.g., leak integrity, dose uniformity, mechanical integrity), and performance characteristics (e.g., source strength accuracy, stability). The document asserts that the device is "substantially equivalent" to predicate devices, implying that it meets similar performance and safety criteria.

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

This a 510(k) for a physical medical device (a brachytherapy source) and does not involve a "test set" in the context of data anlaysis or algorithm evaluation. Device performance is typically assessed through engineering tests, simulations, and often, phantom studies, but not with "data provenance" in the sense of clinical datasets.

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

This information is not applicable as there is no "ground truth for a test set" in this context. The safety and effectiveness of the device are assessed based on its physical properties and adherence to manufacturing and performance standards, likely evaluated by internal and external engineers/physicists.

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

This information is not applicable as there is no "test set" and no "adjudication method" in the context of expert review of clinical 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:

This is not applicable. The device is a physical brachytherapy source, not an AI or diagnostic imaging device that involves human readers or AI assistance.

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

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

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

As there is no "ground truth" in the typical sense of clinical data validation for an algorithm, this is not applicable. The "truth" here would relate to the physical and radiological properties of the source meeting design specifications and safety standards.

8. The sample size for the training set:

This information is not applicable as the device is not an AI algorithm requiring a training set.

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

This information is not applicable as the device is not an AI algorithm requiring a training set.

Summary of what the document does provide regarding device characteristics and regulatory clearance:

• Device Name: Implant Sciences Corp. Model HDR-4140 169 Ytterbium Brachytherapy Source
• Intended Use: For the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative, or surface irradiation. Can be used as primary treatment for various anatomical sites (cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, breast, sarcomas, and intraoperative radiation therapy). It may be used concurrently with or following other interventions like external beam radiation therapy, hyperthermia, or chemotherapy.
• Technological Characteristics: It is a doubly-encapsulated 169 Ytterbium Brachytherapy Source (containing solid radioactive 169 Ytterbium pellets in a plasma-welded titanium capsule, sealed in a stainless steel outer capsule attached to a cable).
• Comparison to Predicate Devices: The key difference from predicate devices is the use of 169 Ytterbium photons instead of 192 Iridium. The 510(k) submission states that the device is "substantially equivalent" to predicate high dose rate brachytherapy sources, indicating it meets similar safety and effectiveness standards, albeit with a different radioisotope.
• Regulatory Status: Cleared under 510(k) K042864, dated January 6, 2005, indicating substantial equivalence to predicate devices.

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The intended use of Implant Sciences Corp. Seed Link is for the treatment of cancer by temporary or permanent interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.

Implant Sciences Seed Link, containing Implant Sciences 125Iodine Brachytherapy Seeds with individual activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment, such as for prostate cancer or for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors. Seed Link may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.

Seed Link is a radionuclide brachytherapy source designed to incorporate a number of individual brachytherapy "seeds" into an integral assembly, and to maintain the specified spacing between the seeds during treatment. Seed Link incorporates the I-Plant Model 3500 interstitial brachytherapy seed, which has been previously cleared for marketing under 510(k) number K994317. Seed Link is an assembly of I-Plant 3500 interstitial brachvtherapy seeds, sleeves and spacers designed to pass freely through an 18 Gauge thin-walled implant needle (which has an inside diameter of 0.041 inch (1.04 mm)). The length of the assembly is determined by the number of seeds to be joined and the spacing required between seeds. As a minimum, an assembly would contain two seeds and a spacing of 5.5 mm, resulting in an overall length of 14.5 mm. As many as six seeds may be incorporated into an assembly, and the spacing between seeds may be as large as 50 millimeters. The Seed Link shell and sleeve subassembly may also be supplied without attached spacers as individual "seeds".

Implant Sciences' Seed Link 1231odine Brachytherapy Seed Assembly is a radionuclide brachytherapy source designed to incorporate a number of individual brachytherapy "seeds" into an integral assembly, and to maintain the specified spacing between the seeds during treatment. Seed Link incorporates the I-Plant Model 3500 interstitial brachytherapy seed into a titanium sleeve, which is coupled to other seeds by means of a bioresorbable polymer spacer. Seed Link is provided sterile.

The provided document is a 510(k) summary for the Seed Link brachytherapy source. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not present in this type of regulatory submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria and reported device performance in the context of a dedicated performance study. The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device(s).

The key "performance" aspect mentioned is that the Seed Link "is designed to pass freely through an 18 Gauge thin-walled implant needle (which has an inside diameter of 0.041 inch (1.04 mm))." However, no specific acceptance criteria (e.g., success rate, force required) or detailed study results demonstrating this ability are provided in this summary.

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

Not applicable. The document does not describe a performance study with a test set. This is a 510(k) submission, which focuses on substantial equivalence rather than a clinical trial or a standalone performance study with a test set.

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

Not applicable. There is no mention of a test set or ground truth established by experts in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a brachytherapy source, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. This device is a physical medical device (brachytherapy source) and not an algorithm.

7. The Type of Ground Truth Used

Not applicable. The document does not describe a study involving ground truth in the context requested (e.g., expert consensus, pathology, outcomes data). The "ground truth" for a 510(k) is typically the performance and characteristics of the legally marketed predicate device(s).

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/algorithm-based device, there is no training set in the context of machine learning.

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

Not applicable. There is no training set.

Summary of Device and its Claimed Equivalence:

• Device Name: Seed Link
• Manufacturer: Implant Sciences Corp.
• Intended Use: Treatment of cancer by temporary or permanent interstitial, intracavitary, intraluminal, intraoperative, or surface irradiation.
• Technological Characteristics: An assembly of I-Plant Model 3500 interstitial brachytherapy seeds, titanium sleeves, and bioresorbable polymer spacers. Designed to maintain specified spacing between seeds and pass through an 18 Gauge thin-walled implant needle.
• Predicate Devices:
  • Nycomed Amersham I-125 Rapid Strand (K940632)
  • IBT, Inc. Interstrand 125 (K011155)
  • I-Plant Model 3500 interstitial brachytherapy seed (K994317) - this is a component of Seed Link.

The 510(k) submission asserts that Seed Link is substantially equivalent to these predicate devices based on its intended use and technological characteristics. The provided text details the device's design and mechanism but does not present a formal study with acceptance criteria and results as typically found for diagnostic or screening devices.

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Implant Sciences I-Plant Model 3500 (135)odine Brachytherapy Seed)-Sterile with individual activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized turnors. They can be used either as primary treatment, such as for prostate cancer or for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors. I-Plant Model 3500 Brachytherapy Seeds may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.

The Implant Sciences 125 lodine (Model 3500) Brachytherapy Seeds consist of a laser welded titanium capsule containing a silica capillary tube that serves as a substrate for the radioactive iodine source. The tube is positioned around a silver radiopaque x-ray marker that identifies the source location and orientation. The seeds are provided non-sterile and must be sterilized prior to use.

Here's a summary of the acceptance criteria and study information based on the provided text, focusing on the device "Implant Sciences 'I-plant' 125 Iodine Brachytherapy Seeds (Model 3500)":

Acceptance Criteria and Device Performance

The core of the "study" described for this device is centered around demonstrating substantial equivalence to existing predicate devices, particularly in safety and performance characteristics, rather than a clinical efficacy study with human outcomes.

• Temperature resistance
• External pressure resistance
• Impact resistance
• Vibration integrity
• Puncture resistance
  (Explicitly stated: "Data are presented which demonstrate that the Model 3500 seeds satisfy performance requirements for temperature resistance, external pressure resistance, impact resistance, vibration integrity, and puncture resistance as specified by ANSI Standard N43.6-1997.") |
  | Radiation Profile | Consistent with profiles of other Iodine-125 brachytherapy seeds with similar physical geometries. | "The 510(k) Notice also describes further standardized studies which describe the radiation profile of the sources. These profiles are consistent with the data generated from other Iodine-125 brachytherapy seeds with similar physical geometries." |
  | Capsule Leak Testing | Adherence to ANSI standards. | "In addition, capsule leak testing was carried out in accordance with ANSI standards. The results of these studies also support the equivalence of the ISC Model 3500 device to the predicate devices." |
  | Sterilization & Biocompatibility | No new chemical or biological entities introduced to the surface from manufacturing/cleaning. | "The manufacturing and cleaning processes for the seeds introduce no new chemical or biological entities to the surface of the device." (Note: Device is provided non-sterile and must be sterilized by hospital). "The materials from which the Implant Sciences device is fabricated have an established history of use in medical applications, and the specific materials used by Implant Sciences have been thoroughly tested in accordance with applicable guidelines." |

Study Details

• 1. Sample sized used for the test set and the data provenance:

  • The document describes "in vitro studies" and "standardized studies" on the device itself, rather than human patient data. There is no mention of a "test set" in the context of patient data, nor country of origin or retrospective/prospective nature. The "sample size" would refer to the number of devices or components tested in the various engineering and safety assessments (e.g., how many seeds were tested for impact resistance), but this specific number is not provided.
  • Data Provenance: The studies were internal company studies ("summaries of in vitro studies which were conducted to evaluate the safety, and appropriateness of the ISC Model 3500 Brachytherapy Seeds" and "standardized studies which describe the radiation profile").

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

  • Not applicable in the traditional sense of a clinical ground truth. The "ground truth" for the performance criteria (e.g., meeting ANSI standards, physical dimensions) would be established by the specifications of the standards themselves and the measurable properties of the device, likely assessed by qualified engineers and quality control personnel within the company or a testing laboratory. No specific number or qualifications of such "experts" are listed in this summary.

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

  • Not applicable. This concept typically applies to human interpretation of medical images or data. The "test set" here refers to the device and its components undergoing engineering and physical performance tests.

• 4. 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:

  • No, a MRMC comparative effectiveness study was not done. This device is a radioactive implant, not an AI diagnostic tool.

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

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

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

  • The ground truth for this submission is based on engineering standards and direct physical measurements of the device's properties (e.g., dimensions, material composition, radiation output, resistance to physical stressors) as per recognized standards like ANSI/HPS N43.6 - 1997. The ultimate "ground truth" for regulatory clearance is substantial equivalence to legally marketed predicate devices.

• 7. The sample size for the training set:

  • Not applicable. This is not an AI/machine learning device.

• 8. How the ground truth for the training set was established:

  • Not applicable. This is not an AI/machine learning device.

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The Implant Sciences 125 lodine Brachytherapy Seeds with activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial or intracavity implantation or surface application to treat selected localized tumors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The 155 lodine Seeds may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.

The Implant Sciences 125 lodine (Model 3500) Brachytherapy Seeds consist of a laser welded titanium capsule containing a silica capillary tube that serves as a substrate for the radioactive iodine source. The tube is positioned around a silver radiopaque x-ray marker that identifies the source location and orientation. The seeds are provided non-sterile and must be sterilized prior to use.

Here's a breakdown of the acceptance criteria and study information for the Implant Sciences "I-plant" 125 Iodine Brachytherapy Seeds (Model 3500) based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative "acceptance criteria" for clinical performance that would typically be seen in studies evaluating diagnostic accuracy or prognostic prediction. Instead, the "acceptance criteria" are implied by the requirements of the ANSI Standard for Sealed Radioactive Sources (ANSI/HPS N43.6 - 1997) and the demonstration of substantial equivalence to predicate devices. The reported device performance is that the device meets these requirements and is consistent with or equivalent to predicate devices.

Note: The "acceptance criteria" here are based on engineering and safety standards for the device itself, rather than a clinical performance metric like sensitivity or specificity for a diagnostic device.

Study Information

The provided text describes in vitro studies and comparisons to predicate devices, but not a clinical study with human subjects, a test set, or expert-established ground truth in the context of diagnostic or prognostic performance. The focus is on demonstrating physical and functional equivalence and safety according to engineering standards.

Here's what can be extracted based on the document:

1. Sample size used for the test set and the data provenance: Not applicable in the traditional sense of a clinical test set. The data provenance is related to in vitro studies and standardized tests performed by the manufacturer. The document doesn't specify sample sizes for these in vitro tests (e.g., how many seeds were tested for impact resistance).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is compliance with engineering standards (ANSI/HPS N43.6 - 1997) and consistency with known properties of similar devices.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

4. 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 device is a brachytherapy seed, not an AI-assisted diagnostic tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's evaluation is primarily adherence to established engineering and safety standards for sealed radioactive sources (ANSI/HPS N43.6 - 1997) and comparison to the known characteristics and performance of legally marketed predicate devices.

7. The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

8. How the ground truth for the training set was established: Not applicable.

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The Implant Sciences 125 Jodine Brachytherapy Seeds with activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial or intracavity implantation or surface application to treat selected localized tumors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The 125 lodine Seeds may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.

The Implant Sciences 125 Iodine Brachytherapy Seeds consist of a laser welded titanium capsule containing an aluminum clad copper rod that serves as both a substrate for the radioactive iodine source and as a radiopaque x-ray marker. The marker identifies the source location and orientation. The seeds are provided non-sterile and must be sterilized prior to use.

The provided document describes the safety and effectiveness of the Implant Sciences "I-plant" 125Iodine Brachytherapy Seeds (Model 3000) by demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and performance against those criteria through a new clinical study. The device is for brachytherapy treatment of localized tumors.

Here's an analysis based on the information provided, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. The submission relies on in vitro studies and comparison to predicate devices, not a clinical test set from human subjects to evaluate clinical efficacy or performance.
• Data Provenance: The studies mentioned are described as "in vitro studies" and involve tests against ANSI standards. They are not clinical studies from a specific country or collected retrospectively/prospectively from patients. The comparison is primarily against existing predicate device specifications and recognized industry standards.

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

• Not applicable. This submission does not describe a clinical study where expert ground truth was established for a test set. The "ground truth" here is compliance with established engineering and safety standards (ANSI N43.6-1997) and equivalence in characteristics to legally marketed predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. This device is a radioactive implant (brachytherapy seed), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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 or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on:
  • Compliance with ANSI Standard N43.6-1997: For safety and performance parameters like temperature, pressure, impact, vibration, and puncture resistance, and capsule leak testing.
  • Established characteristics of legally marketed predicate devices: For physical dimensions, material composition, activity range, and radiation profiles.
  • Accepted manufacturing and sterilization practices: For ensuring the device does not introduce new chemical or biological entities and requires appropriate sterilization.

8. The Sample Size for the Training Set

• Not applicable. This submission does not involve a training set as it's not an AI/machine learning model. The "studies" mentioned are laboratory/engineering tests and comparisons.

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

• Not applicable, for the same reason as above.

In summary: The submission for the Implant Sciences "I-plant" 125Iodine Brachytherapy Seeds (Model 3000) is a 510(k) Pre-market Notification demonstrating substantial equivalence to existing legally marketed predicate devices. It relies on in vitro studies proving compliance with recognized safety and performance standards (ANSI N43.6-1997) and matching the characteristics of predicate devices, rather than a clinical trial with human subjects. Therefore, many of the requested elements pertaining to clinical studies, AI performance, expert review, and ground truth establishment from patient data are not relevant to this type of regulatory submission.

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