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The brachytherapy source is intended to treat localized, unresectable tumors with low to moderate radiosensitivity. Tumors may be recurrent or residual, following external beam or excision of primary tumor.

The I-Seed Model AgX100 is an Iodine 125 brachytherapy source. A silver rod serves as the substrate for the I-125 and as a radiopaque marker and is contained within a titanium tube sealed at both ends with a laser welded dome. The seed is 4.5 mm long and 0.8 mm in diameter.

The provided text describes the regulatory filing (K103319) for a medical device, the I-Seed Model AgX100, which is an Iodine 125 brachytherapy source. However, the document does not contain the information requested in your prompt regarding acceptance criteria and the study that proves the device meets those criteria for an AI/ML-driven device.

The document primarily focuses on the device's physical characteristics, intended use, comparison to predicate devices, and adherence to established manufacturing and safety standards for medical devices (e.g., ISO standards, 21 CFR 820.30 - Design Controls). It describes "Design Verification" and "Design validation and verification testing" to demonstrate compliance with performance specifications, but these are general statements about the physical device, not related to an AI/ML component.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Details about a test set (sample size, provenance).
• Information on experts used for ground truth establishment.
• Adjudication methods.
• Any mention of a Multi-Reader Multi-Case (MRMC) study.
• Stand-alone algorithm performance.
• Type of ground truth (e.g., pathology, outcomes data).
• Training set sample size or how its ground truth was established.

The only "acceptance criterion" mentioned is for leak testing of the sealed source, which is "

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The Point of Care Stranding System provides a method for the physician to custom configure and assemble sterile TheraSeed® strands in the operating room at the time of the implant procedure.

The Point of Care System may also be used to custom load sterile I-Seed in non-stranded configurations.

The Point of Care Stranding System is designed to facilitate intra-operative treatment planning by providing a means of joining sterile TheraSeed® sources with sterile spacers of varying lengths to form the desired strand configuration. The device also facilitates transfer of the sterile strand either directly into a CP Medical brachytherapy needle, or via a transfer tube into a MICK style applicator needle. The device system consists of the following components: Assembly Device, Seed Magazine, Spacer Cartridges, Stylet, and Transfer Tube (optional).

Here's an analysis of the acceptance criteria and the study information for the Point of Care Stranding System based on the provided text:

The document does not provide specific numerical acceptance criteria for device performance (e.g., minimum tensile strength, maximum displacement). Instead, it states that the device's functional performance was verified in accordance with the design specifications. This suggests that internal, proprietary design specifications were used as the acceptance criteria, but their details are not disclosed in this document.

The document describes a Design Verification study which encompassed bench testing and user validation.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria are not provided, a table cannot be fully completed. However, based on the text, we can infer the general categories of acceptance and the reported successful performance.

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

• Sample Size for Test Set: Not specified. The document mentions "bench testing" and "User Validation" but does not quantify the number of devices, strands, or users involved in these tests.
• Data Provenance: Not specified, but given the manufacturer is based in Buford, GA, USA, and the 510(k) is submitted to the FDA, it is highly probable the testing was conducted in the USA or under US regulatory oversight. The study is prospective in nature, as it is a design verification conducted to demonstrate the device meets its design specifications before widespread commercialization.

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

• Number of Experts: Not specified.
• Qualifications of Experts: The "User Validation" involved users who could "successfully use" the device. While not explicitly stated to be "experts," it can be inferred that these users would be healthcare professionals (e.g., physicians, nurses, technicians) who are familiar with brachytherapy procedures, as they are assembling, transferring, and implanting strands. The document does not specify their exact qualifications or experience level.

4. Adjudication Method for the Test Set

Not applicable. The described verification is a technical and functional performance test, not one involving subjective interpretations or disagreements requiring an adjudication method (like reading medical images). The "User Validation" would likely have involved clear pass/fail criteria for successful assembly, transfer, and integrity, rather than a consensus-based adjudication process.

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 device is a mechanical stranding system for brachytherapy, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

Not applicable. As noted above, this is a mechanical device, not an algorithm, so the concept of standalone performance for an algorithm does not apply. The device's "standalone" functional performance was tested via bench testing, ensuring it performed as designed without direct human intervention after initiation (e.g., the press-fit mechanism functions).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is its design specifications and intended functional outcome.

• For bench testing: The ground truth was whether the device's mechanical actions (e.g., pressing solid spacers into seed endcups to link alternating seed-spacer pairs) occurred as geometrically and mechanically specified, and whether the resulting strand met physical integrity requirements (e.g., acceptable bond strength, correct spacing).
• For User Validation: The ground truth was the successful assembly, transfer, and intact implantation of the strand as evaluated by the users. This is essentially an objective functional outcome.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of data.

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

Not applicable, as there is no training set for this type of device.

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TheraLoad™ is a sterile prostate-seeding kit containing TheraSeed® (Pd-103) or I-Seed (I-125) seeds and spacers custom loaded according to the treatment plan.

The brachytherapy source is intended to treat localized, unresectable turnors with low to moderate radiosensitivity. Tumors may be recurrent or residual following external beam or excision of primary tumor and may be superficial, intrathoracic (head, neck, lung), or intra-abdominal (pancreas, prostate).

TheraLoad™ is a sterile prostate-seeding kit containing TheraSeed® (Pd-103) or I-Seed (I-125) seeds and bioabsorbable spacers custom loaded according to the treatment plan.

The variable seed spacing available with TheraLoad™ allows the treating medical physicist to specify individual patient prescriptions. The customized order can contain a variable number of seeds and/or spacers (1-12 total components). The treating medical physicist determines the total number of active seeds required for each order.

The spacer material is biocompatible and commonly used in implantable medical devices.

Here's a summary of the acceptance criteria and the study information for the TheraLoad™ Custom Loaded Needles, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on design verification and validation testing to ensure compliance with device performance specifications and safety, as well as substantial equivalence to a predicate device. The acceptance criteria are largely defined by adherence to specific international and national standards related to sterilization, packaging, and microbiological methods. The 'reported device performance' is that the device met these standards and achieved functionality, safety, and substantial equivalence.

2. Sample size used for the test set and the data provenance:

This document describes a design verification and validation (V&V) study for a medical device. It does not provide specific sample sizes for individual tests. The focus is on demonstrating that the device meets engineering and safety specifications through adherence to recognized standards. The data provenance is implied to be internal testing conducted by Theragenics Corporation as part of their design control process. There is no mention of specific country of origin for test data or whether it was retrospective or prospective in the clinical sense, as this is a device design validation, not typically a clinical trial.

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

Not applicable. The "ground truth" for this type of device (brachytherapy needles and spacers) is established by adherence to engineering specifications and international standards for sterilization, packaging, and material properties. It does not involve expert medical interpretation in the same way an AI diagnostic or prognostic device would. The "experts" involved would be engineers, microbiologists, and other technical specialists performing the V&V tests, but their number and specific qualifications are not detailed in this summary.

4. Adjudication method for the test set:

Not applicable. This is a design verification and validation study against established engineering and technical standards, not a clinical study requiring adjudication of expert opinions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. This device is a component for brachytherapy and its evaluation focuses on physical and biological safety, not on diagnostic performance or human-in-the-loop clinical effectiveness that would necessitate an MRMC study.

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

Not applicable. The device itself is a physical medical product (custom-loaded needles), not a software algorithm or AI system.

7. The type of ground truth used:

The ground truth used for this device is based on engineering specifications, material science, and compliance with recognized international and national standards related to sterilization, packaging integrity, and biocompatibility. For example, for sterility, it relies on microbiological methods and a substantiated sterilization dose (25 kGy) according to AAMI TIR 27:2001 and ISO 11137:1994.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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