Search Results

IsoSphere is indicated for implantation after tumor resection in the breast to deliver the prescribed radiation dose to the tumor bed and any residual tumor in the remaining margins.

The IsoSphere is a modification to the Advantage Strand™/Advantage Load™/Secure Strand Brachytherapy Kit cleared in 510(k) K113210 on August 10, 2012. Whereas the predicate device delivers radioactive brachytherapy seeds and spacers via numerous needles, one at a time in a linear design, the IsoSphere delivers multiple radioactive brachytherapy seeds and spacers within a Secure Strand sleeve to an excision site in the breast in one sphere-shaped configuration.

The IsoSphere is a 4 cm, spherical shaped device with hollow channels that contain radioactive brachytherapy seeds and spacers, depending on physician prescription. The device is composed of bioabsorbable copolymer (PLA) material, which is identical to the Secure Strand material. The IsoSphere is supplied with either Advantage I-125® seeds or Advantage Pd-103® seeds and spacers which are identical to those cleared in K113210. IsoSphere is supplied sterile for single use.

A sterile, single-use, non-radioactive 4cm Sizing Sphere is included in each package to assure a proper fit in the excision site. The package also contains one pair of sterile, radiation attenuating gloves.

The provided FDA 510(k) clearance letter for the IsoSphere device does not describe a study that validates the device meets acceptance criteria related to a specific clinical performance metric (e.g., diagnostic accuracy for an AI device).

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Advantage Strand/Advantage Load Brachytherapy Kit) through non-clinical performance testing, material characterization, and a comparison of intended use, indications for use, and technical specifications.

Therefore, many of the requested criteria regarding clinical study design, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the information provided in this 510(k) summary. The device in question is a physical brachytherapy device, not a diagnostic AI/software device that would typically undergo such clinical performance evaluations.

However, I can extract and present the acceptance criteria and performance data for the non-clinical tests conducted to demonstrate the device's safety and effectiveness in its operational context.

Acceptance Criteria and Reported Device Performance (Non-Clinical)

The IsoSphere device underwent performance and design integrity testing designed to ensure its physical and functional attributes are maintained after manufacturing, sterilization, and aging.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Study Details (Based on provided 510(k) Summary - Non-Clinical Focus)

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: The document does not specify the exact number of samples (devices) used for each individual test (e.g., X number of units for sterile barrier integrity, Y for seal strength). It refers to "test samples" for Stability Testing and "Two sets of samples" for Design Integrity Testing (one aged for four months, one for six months).
   • Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be from internal testing conducted by IsoAid, LLC in the USA. The tests are non-clinical, focusing on the physical device itself. The data is prospective, generated specifically for this submission.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

   • Not Applicable. This is a physical medical device (brachytherapy source), not an AI/diagnostic imaging device that would require human expert interpretation or ground truth establishment for its performance validation in a clinical context. The "ground truth" here is determined by physical measurements, material properties, and visual inspection against engineering specifications.

3. Adjudication Method for the Test Set:

   • Not Applicable. See point 2. The tests are objective physical and material tests, not subjective interpretations requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. This type of study is relevant for AI-powered diagnostic devices to assess the impact of AI assistance on human reader performance. The IsoSphere is a physical brachytherapy device.

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

   • No. This is relevant for AI devices. The IsoSphere is a physical device; its performance is inherent to its design and materials as demonstrated through the non-clinical tests.

6. The Type of Ground Truth Used:

   • Engineering Specifications / Physical Measurements / Material Compliance. For the non-clinical tests, the "ground truth" is defined by established engineering and material science standards (e.g., ASTM, ISO standards, internal specifications for dimensions, seal strength, and material integrity). Visual inspection confirms the absence of physical damage.

7. The Sample Size for the Training Set:

   • Not Applicable. There is no "training set" in the context of this device. This is not a machine learning or AI device that undergoes training.

8. How the Ground Truth for the Training Set Was Established:

   • Not Applicable. See point 7.

Ask a specific question about this device