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Lesion-Loc I-125 Seed/Needle is indication of lesions (as shown by mamnogram or ultrasound) in the breast or other tissue under the direct supervision of a qualified physician. The device is "single-use sterile device". Lesion-Loc I-125 Seed/needle is not intended for permanant implantation and should be removed in a few days after implantation. It us to be used in conjunction with the Gammaprobe® (IntraMedical Imaging) for localization of lesions (as shown by a mammogram or ultrasound images) in the breast and other tissues.

The Lesion-Loc I-125 Seed/Needle is intended for clinical use in the marking of lesions with the seed in close proximity to or within the lesion site. The lesion (as seen in a mammogram or ultrasound image) is then located using an appropriate hand held gamma radiation detector.

Lesion-Loc I-125 Seed/Needle contains a source 4.5 mm long and 0.8 mm in diameter. The source consists of a welded titanium capsule with a 0.05 mm thick wall and a silver rod, which is about 4 mm length with the active material as silver iodide on the surface, welded inside the titanium capsule. The seed is contained in a needle. The needles used are standard 18 gauges available commercially in lengths up to 15 cm. The I-125 seed is loaded inside the needle. The radioactive seeds are introduced into the lesion area as directed by a radiologist per Written Directive and prescription. The devices are packaged in a pouch with label and provided sterile.

The provided text is a 510(k) summary for the "Lesion-Loc I-125 Seed/Needle." This document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in terms of diagnostic performance. Performance data is mentioned as being performed by the contract manufacturer according to ISO standards, but no specific study details are provided within this document regarding clinical accuracy or diagnostic utility for lesion localization.

Therefore, many of the requested items cannot be fully answered based on the provided text, as it does not describe a clinical study for diagnostic performance.

Here's what can be extracted and what cannot:

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

The document does not specify quantitative acceptance criteria for diagnostic performance of the device in localizing lesions, nor does it present a study demonstrating such performance. It states that "A number of performance tests are done by Theragenics on the seed as per ISO 2919," which refers to radiation safety and integrity standards for radioactive sources, not diagnostic localization accuracy.

Therefore, a table of acceptance criteria and reported diagnostic performance cannot be created from this document.

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, as no diagnostic performance study with a test set is described.

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, as no diagnostic performance study with a test set is described.

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

Not applicable, as no diagnostic performance study with a test set is described.

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 radioactive seed/needle for lesion localization, not an AI diagnostic algorithm. There is no mention of an MRMC study or AI assistance.

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

Not applicable. This is a physical medical device (radioactive seed/needle), not an algorithm.

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

Not applicable, as no diagnostic performance study with ground truth is described. The device is used to mark lesions identified by other imaging modalities (mammogram or ultrasound).

8. The sample size for the training set

Not applicable, as no AI/algorithm training is involved for diagnostic performance.

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

Not applicable, as no AI/algorithm training is involved for diagnostic performance.

Summary of available information related to performance/safety (from the document):

• Performance Data: "A number of performance tests are done by Theragenics on the seed as per ISO 2919." (ISO 2919 specifies methods for testing sealed radioactive sources to establish their classification in terms of mechanical, thermal, and other properties).
• Technological Characteristics: The device uses a Theragenics Corporation AgX100 seed (K103319) which "typically has less radioactive strength than those used for brachytherapy." The seed decays by electron capture, emitting characteristic photons and electrons, with titanium walls absorbing electrons while photons pass through. A hand-held gamma radiation detector is used to locate the seed/lesion.
• Conclusion on Equivalence: "The technological characteristics and intended use of the Lesion-Loc I-125 Seed/Needle is substantially equivalent as the predicate device: Best® Localization Needle with I-125 Source." It also notes that the OEM Theragenics Corporation Model AgX100 "has been certified as safe, biocompatible and has been in clinical use for radiation therapy use without complaints."

The document focuses on establishing substantial equivalence based on device design, materials, and safety standards (ISO 2919) rather than presenting a clinical study of diagnostic accuracy for lesion localization.

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