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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:

• 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. |

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The IsoAid Brachytherapy Kit is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.
The IsoAid Brachytherapy Kit is indicated for tumors that are localized, unresectable, or have low to moderate radiosensitivity.

The IsoAid Brachytherapy Kit is a pre-sterilized kit containing brachytherapy needle and a custom-loaded strand (K013975 or K103449 or Secure Strand) of seeds spaced at a precise distance within absorbable suture. The strand is optional, when no strand is requested the seeds and spacers are custom-loaded directly into the needle. A maximum total of 20 seeds and spacers can be loaded into a needle. The spacers (K010621 or K103449) are made from the same material as the sutures. The stranded Pd-103 (K033770) and I-125 (K011205) implants are placed inside the needle. Bone Wax (K024372 or Ethicon, Inc. Bone Wax) is used at the tip of the need to keep the implants from falling out. The needle is made from 18-gauge stainless steel.

This submission, K113210, for the IsoAid Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit, primarily focuses on demonstrating substantial equivalence to predicate devices through material and design comparisons, and biological safety testing. It does not present a study with specific performance acceptance criteria for the device's clinical effectiveness (e.g., accuracy, sensitivity, specificity) in tumor treatment.

The "Conclusions" section states: "Based on the results of the bench and animal tests performed it is concluded that these tests demonstrate that the Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit is as safe, as effective, and performs as well as or better than the predicate devices." This implies that the device is deemed to meet acceptance criteria through comparison to existing, cleared devices and adherence to established standards for safety and material integrity, rather than a clinical performance study with predefined metrics.

Here's a breakdown based on the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, the submission does not define specific performance acceptance criteria in terms of clinical effectiveness (e.g., tumor response rates, survival). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices in terms of:

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

The document does not describe a clinical "test set" in the context of device performance on patients. The "tests" mentioned are bench and animal tests focused on material properties, biocompatibility, and degradation. No sample sizes for these specific bench or animal tests are provided in this summary, nor is data provenance in terms of country of origin or retrospective/prospective study design, as these are typically not relevant for material and biocompatibility testing as presented.

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

Not applicable. This type of information is relevant for studies involving human interpretation or clinical outcomes, which are not described here.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or clinical endpoint data requiring adjudication in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study would compare human reader performance with and without AI assistance for tasks like image interpretation or diagnosis. The device described is a physical medical implant, not an AI-driven diagnostic or assistive tool.

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

No. This also pertains to AI algorithm performance.

7. The Type of Ground Truth Used

For the bench and animal tests:

• Biological Ground Truth: Established through adherence to recognized international standards (ISO 10993 series and ASTM F1635-11) for biocompatibility, material properties, and degradation. Passing these standard tests serves as the "ground truth" for the device's safety and material performance.
• Design/Functional Ground Truth: Established by direct comparison to the physical and functional characteristics of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no training set involved, as this is not an AI/ML device.

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

Not applicable. There is no training set.

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The IsoAid Brachytherapy Kit is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy. The IsoAid Brachytherapy Kit is indicated for tumors that are localized, unresectable, or have low to moderate radiosensitivity.

The IsoAid Brachytherapy Kit is a pre-sterilized kit containing brachytherapy needle and a custom-loaded strand (K013975) of seeds spaced at a precise distance within absorbable suture. The strand is optional, when no strand is requested the seeds and spacers are custom-loaded directly into the needle. A maximum total of 20 seeds and spacers can be loaded into a needle. The spacers (K010621) are made from the same material as the sutures. The stranded Pd-103 (K033770) and I-125 (K011205) implants are placed inside the needle. Bone Wax (K024372) is used at the tip of the need to keep the implants from falling out. The needle is made from 18-gauge stainless steel.

The provided document is a 510(k) Summary for the IsoAid Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit. This type of regulatory submission establishes substantial equivalence to a predicate device and typically does not include detailed studies with acceptance criteria, sample sizes for test/training sets, expert consensus, or specific performance metrics in the way a clinical trial or device validation study might.

Instead, substantial equivalence is determined by comparing the new device's technological characteristics and indications for use to a legally marketed predicate device. The information provided heavily focuses on this comparison rather than presenting a performance study with acceptance criteria.

However, based on the provided text, I can infer the "acceptance criteria" through the comparison to the predicate device, as the primary goal of this submission is to show that the new device is as safe and effective as the predicate.

Here's an attempt to structure the information based on your request, understanding that the "study" here is essentially the substantial equivalence discussion, and not a traditional performance study as you might expect for AI/software devices.

Acceptance Criteria and Device Performance Study for IsoAid Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are implicitly met if the new device demonstrates substantial equivalence to a predicate device in terms of indications for use, technological characteristics, and safety/effectiveness. The performance evaluation is primarily a comparison.

Note: For devices like this, "performance" is often related to manufacturing specifications, radiation characteristics (which are standardized for isotopes), and mechanical properties, not typically evaluated with metrics like sensitivity/specificity or human reader improvement. The document does not detail these specific engineering tests, but they would have been part of the underlying design controls.

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

This document does not describe a clinical "test set" in the context of diagnostic accuracy or AI performance as you might expect. The "testing" for a device like this in a 510(k) submission primarily involves:

• Bench testing to ensure manufacturing specifications, sterility, and mechanical integrity are met.
• Comparison of technical specifications and intended use to a legally marketed predicate device.

Therefore, there is no mention of a "sample size for a test set" or "data provenance" from clinical cases here. The evaluation is largely based on technical specifications and regulatory comparison.

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

Not applicable. This is not a study requiring expert-established ground truth for a test set of clinical data. The "ground truth" for a medical device's performance in a 510(k) context is often established by adherence to recognized standards, established material properties, and the known safety/efficacy profile of its predicate device and active components (radioisotopes).

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

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 brachytherapy kit, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

6. 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 or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc)

The "ground truth" for this regulatory submission is established through:

• Predicate device's safety and effectiveness: The Bebig Brachytherapy Strand Device (K040339) is a legally marketed device whose safety and efficacy have been previously established.
• Material specifications and established medical use: Components like Pd-103 and I-125 brachytherapy seeds have well-understood radiation characteristics and are standard in clinical practice. The materials used (e.g., absorbable suture, stainless steel) have established biocompatibility and properties.
  The submission essentially argues that because the new device is substantially equivalent in design, materials, and intended use to the predicate, its safety and effectiveness are also equivalent.

8. The Sample Size for the Training Set

Not applicable. There is no AI algorithm or "training set" for this type of device.

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

Not applicable. There is no AI algorithm or "training set" for this type of device.

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The ISOAID Palladium Brachytherapy Seeds is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.

The IsoAid palladium-103 seeds are spherical sealed sources of palladium-103. The outer capsule of the source is sealed titanium. The specifications for the IsoAid device are the same as for the predicate.

Here's an analysis of the provided text regarding the acceptance criteria and study for the IsoAid Palladium Brachytherapy Seeds:

Based on the provided documents, it's evident that this 510(k) submission is for a medical device (IsoAid Palladium Brachytherapy Seeds) and not an AI/ML powered device. Therefore, the questions related to AI/ML specific aspects like AI performance, human readers with/without AI assistance, standalone algorithm performance, training set, and AI-specific ground truth methods are not applicable.

The approval for this device is based on substantial equivalence to a predicate device, the TheraSeed Palladium-103 Model 200 Implant, rather than a clinical study proving its performance against acceptance criteria in the context of an AI/ML diagnostic or prognostic tool.

Here's a breakdown of the requested information based on the provided text, focusing on what is applicable to a substantial equivalence submission for a traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance

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 this is a substantial equivalence submission for a physical device, not an AI/ML algorithm requiring a test set for performance evaluation. The "study" is a comparison to a predicate device.

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 this is a substantial equivalence submission for a physical device, not an AI/ML algorithm. The "ground truth" for this submission are the established specifications and safety profile of the predicate device.

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

Not applicable, as this is a substantial equivalence submission for a physical device, not an AI/ML algorithm.

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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

The ground truth used here is the performance and safety profile of the legally marketed predicate device (TheraSeed Palladium-103 Model 200 Implant) as accepted by the FDA. The submission demonstrates that the new device has identical specifications and intended use as the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary of the Study (Substantial Equivalence):

The "study" or evidence provided to the FDA for the IsoAid Palladium Brachytherapy Seeds is a comparison against a legally marketed predicate device, the TheraSeed Palladium-103 Model 200 Implant (K010283). The applicant asserts that the IsoAid device has identical specifications and intended use to the predicate device. The comparative data (presented in the table) directly shows that critical parameters such as material (titanium capsule), manufacturing method (laser weld), physical dimensions (length, diameter), radioactive properties (half-life, apparent activity), and application method are all the "same" as the predicate.

The acceptance criteria are effectively the specifications and previously accepted safety/efficacy profile of the predicate device. The IsoAid device "meets" these criteria by being demonstrably identical across all relevant engineering and performance characteristics. The FDA's issuance of a substantial equivalence determination signifies that they agreed the new device is as safe and effective as the predicate device, without requiring new clinical trials due to the direct equivalence.

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