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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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