(164 days)
The IsoAid RSLN is a device intended for the localization of suscipcious tissues (non-palpable lesions) for excision with the use of radioactive seeds.
The IsoAid I-125 Radioactive Seed Localization Needle [IA-RSLN] is a pre-sterilized 18 gauge needle containing a low-activity I-125 Iodine Seed [K011205]. The needle tip is occluded with bone wax to contain the contents prior to implant. The iodine seed is loaded loose or stranded and is provided with or without trailing spacers. The stainless steel needles are provided in lengths: 5cm, 7cm, and 12cm. The device is used to facilitate the introduction of the radionuclide seed into the suspicious tissue. The seed is used singly as a point-source for localization rather than for therapeutic use as in brachytherapy. The device is packaged and labeled and EtO sterilized.
The provided text describes a 510(k) premarket notification for the IsoAid I-125 Radioactive Seed Localization Needle (IA-RSLN). This submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new performance criteria or provide a study proving the device meets specific acceptance criteria in the sense of a new clinical trial.
Therefore, the document does not contain the detailed information typically found in a study designed to prove a device meets acceptance criteria for an AI/CADe system. Specifically, there is no information on:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or the number/qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Types of ground truth used (e.g., pathology, outcomes data).
- Sample size for training sets, or how ground truth for training sets was established.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway.
What is provided in the document regarding "acceptance" and "proof":
The "acceptance criteria" here refers to the criteria for demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission. The "study that proves the device meets the acceptance criteria" is the 510(k) summary itself, which argues for this substantial equivalence based on technological characteristics and intended use.
Here's a breakdown of the relevant information provided, interpreted within the context of a 510(k) submission:
| Category | Information from the Document |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Acceptance Criteria (for 510(k) Substantial Equivalence): The document implies that the "acceptance criteria" are met by demonstrating that the IsoAid I-125 Radioactive Seed Localization Needle (IA-RSLN) has the "same intended use and fundamental scientific technology" as a legally marketed predicate device, and is "safe and effective for its intended use." This involves: |
- Same Indications for Use: Localization of suspicious tissues (non-palpable lesions) for excision with radioactive seeds.
- Similar Device Description: Pre-sterilized 18 gauge needle containing a low-activity I-125 Iodine Seed.
- Compliance with Standards: The device "meets ISO 2919, ISO 9978, and Type A packaging requirements." These are international standards related to radionuclide products and packaging.
Reported Device Performance: The document does not provide a table of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) because it is not a clinical trial report. Instead, performance is implied by the equivalence to the predicate and compliance with technical standards. The conclusion states: "Based on the above, IsoAid LLC believes the RSLN device is substantially equivalent to the predicate device, and is safe and effective for its intended use." |
| 2. Sample size and Data Provenance | Not applicable. This document is a regulatory submission for substantial equivalence based on device design and comparison to a predicate, not a study evaluating human or AI performance on a test set. Therefore, there are no specific "sample sizes" (e.g., number of image cases) or "data provenance" (country of origin, retrospective/prospective) in the context of a performance study. |
| 3. Number of experts for ground truth & qualifications | Not applicable. Ground truth generation by experts is relevant for studies evaluating diagnostic performance (e.g., of an AI algorithm or human reader). This document describes a medical device (a radioactive seed and needle), not a diagnostic algorithm. |
| 4. Adjudication method | Not applicable. Adjudication methods are used to establish a definitive ground truth in diagnostic performance studies. This document is a 510(k) submission for a physical medical device. |
| 5. MRMC comparative effectiveness study | Not applicable. This type of study assesses the impact of AI assistance on human reader performance. The device described, the I-125 Radioactive Seed Localization Needle, is a physical medical device used for localization and excision, not an AI or CADe system that assists human interpretation of medical images. |
| 6. Standalone performance | Not applicable. Standalone performance refers to the algorithm's performance without human intervention. This is a physical medical device, not an algorithm. |
| 7. Type of ground truth used | Not applicable. "Ground truth" in the context of performance studies typically refers to a definitive diagnosis or outcome used to evaluate the accuracy of a diagnostic tool or interpretation. For this device, the "truth" is established by its physical and radioactive characteristics, its intended use matching the predicate, and its compliance with relevant BSI and ISO standards (ISO 2919, ISO 9978, Type A packaging). |
| 8. Sample size for training set | Not applicable. This refers to machine learning models. This document describes a physical medical device. |
| 9. How ground truth for training set was established | Not applicable. This refers to machine learning models. This document describes a physical medical device. |
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.