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The Secure Lock transfer guide tubes have been developed to enable the connection of Varian's VariSource iX and 200 afterloaders and other third party applicators. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's turnor site.

Transfer guide tubes are non-myasive products that have no direct patient contact.

The Luer transfer guide tubes have been developed to enable the connection of Varian's VariSource iX and 200 afterloaders and other third party applicators that include a Luer style connection. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tunnor site.

Transfer guide tubes are non-invasive products that have no direct patient contact.

The Luer interstitial extenders have been developed to enable the connection of Luer transfer guide tube to Kobold Interstitial Needles. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site.

Interstitial extenders are non-invasive products that have no direct patient contact.

i) Kobold Secure Lock Transfer Guide Tube Set™
Each tube is numbered to ensure correct connection of the applicator channel with the corresponding afterloader channel. Only a physician who has been trained in the appropriate afterloader systems should use the Secure Lock transfer guide tubes. These transfer guide tubes are compatible with VariSource iX and VariSource 200 afterloaders.

ii) Kobold Interstitial Extender Set™
Each extender is numbered to ensure correct connection of the interstitial extenders and corresponding (1) transfer guide tube and (2) interstitial needle. Only a physician who has been trained in the appropriate afterloader systems should use the interstitial extenders.

The provided document is a 510(k) premarket notification for two medical devices: the Kobold Secure Lock Transfer Guide Tube Set™ and the Kobold Interstitial Extender Set™. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with acceptance criteria.

Therefore, the document does not contain the kind of information typically found in a study demonstrating how a device meets specific performance acceptance criteria. It primarily compares the new devices to existing predicate devices based on design, materials, indications for use, and general characteristics.

Here's a breakdown of why the requested information cannot be extracted from this document:

• Acceptance Criteria and Reported Device Performance: This document does not list specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or detailed performance metrics from a study that evaluates these criteria. The approval is based on "substantial equivalence" to predicate devices.
• Sample Size, Data Provenance, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set: These are elements of a clinical or performance study that are not included in a 510(k) summary focused on substantial equivalence for non-invasive accessory devices. The document explicitly states "Performance Tests: Not Required" for the conclusion summary (Page 7).
• Type of Ground Truth: Since no clinical or performance study with a test set is described, there's no mention of how ground truth would be established (e.g., pathology, expert consensus).

The document does, however, discuss:

• Bench Top Testing: On page 7, it states: "Extensive testing in accordance with known standards is documented by the manufacturer. The standards are specifications for the materials used in surgical implant applications, predicate brachytherapy devices and manufacturer's acceptance procedures for finished devices." This indicates that some internal technical testing was performed to ensure the device's functionality and material compliance, but specific results and acceptance criteria for these tests are not provided in this summary.
• Substantial Equivalence: The core of this 510(k) is to demonstrate that the new devices are substantially equivalent to predicate devices. This means they share the same intended use, fundamental technological characteristics, and are as safe and effective. The tables provided (Pages 4-6) directly compare characteristics of the new devices with their predicates.

In summary, a table of acceptance criteria and proven device performance, as well as details about sample sizes, ground truth, and study methodologies, are not present in this 510(k) summary because the approval pathway relies on demonstrating substantial equivalence to existing devices rather than meeting specific performance thresholds through a new clinical or extensive performance study.

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The CT/MRI Compatible HDR Fletcher Type Applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus is accepted by up-to-date clinical guidelines.
The CT/MRI Compatible HDR Henschke Type Applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus is accepted by up-to-date clinical guidelines.

1. The CT/MRI Compatible HDR Fletcher Type Applicator Set™ design is based on the conventional modified Fletcher GYN applicator with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation boost to the cervix and parametrical tissues in conjunction with external beam radiation therapy. The set consists of precision manufactured intrauterine tandems and a pair of interlocking colpostats with Fletcher type unshielded ovoids ranging in size from 1cm to 3cm. All components are designed to allow for customization of the treated geometry. The distance between the ovoids is adjustable with a lock knob. Four different tandems are provided: one straight, one with a slight curvature of 15 degrees, one with medium curvature of 30 degrees, and one with a maximal curvature of 45 degrees.
2. The CT/MRI Compatible HDR Henschke Type Applicator Set™ design is based on the conventional modified Henschke GYN applicator with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation boost to the cervix and parametrical tissues in conjunction with external beam radiation therapy. The set consists of precision manufactured intrauterine tandems and a pair of interlocking colpostats with Henschke type unshielded ovoids ranging in size from 2cm to 3cm. All components are designed to allow for customization of the treated geometry. The distance between the ovoids is adjustable with a lock knob. Four different tandems are provided: one straight, one with a slight curvature of 15 degrees, one with medium curvature of 30 degrees, and one with a maximal curvature of 45 degrees.

The provided 510(k) summary for the "Kobold Applicator Kits" does not contain information typically found in a study proving a device meets acceptance criteria for AI/ML-based medical devices. The document concerns a physical medical device (applicators for radiation treatment) and focuses on demonstrating substantial equivalence to a predicate device rather than performance against specific analytical or clinical metrics.

Therefore, many of the requested categories for AI/ML device studies, such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable or not present in this document.

However, based on the provided text, I can infer the "acceptance criteria" and how the device "meets" them within the context of a 510(k) submission for a physical device.

Acceptance Criteria and Device Performance (Inferred from 510(k) context):

The primary "acceptance criterion" for this 510(k) submission is Substantial Equivalence to a legally marketed predicate device (Mick® Ring Type GYN Applicator Set with K-011657). The "study" demonstrating this involves a comparison of various device characteristics.

Explanation of Non-Applicable/Missing Information for AI/ML Context:

1. A table of acceptance criteria and the reported device performance: Provided above, inferred from the substantial equivalence claim.
2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI/ML algorithm requiring a test set of data. The "testing" mentioned is mechanical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in the AI/ML sense for this physical device.
4. Adjudication method: Not applicable. No AI/ML performance to adjudicate.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable. This is a physical medical device.
7. The type of ground truth used: Not applicable in the AI/ML sense. The "ground truth" for a physical device might refer to engineering specifications or validated material properties against known standards, which are mentioned as referenced in "Appendix A."
8. The sample size for the training set: Not applicable. No AI/ML model.
9. How the ground truth for the training set was established: Not applicable. No AI/ML model.

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The CT/MRI Compatible Sure-guide Vaginal Cylinder Set is indicated for use in any patient case where High Dose Rate (HDR) radiation treatment of the vagina is acceptable by up-to-date clinical and practice guidelines.
The CT/MRI Compatible Sure-guide Stump Vaginal Cylinder Set is indicated for use in any patient case where High Dose Rate (HDR) radiation treatment of the vagina is acceptable by up-to-date clinical and practice guidelines.
The CT/MRI Compatible Miami HDR Set is indicated for use in any patient case where High Dose Rate (HDR) radiation treatment of the cervix, vagina, and uterus is acceptable by up-to-date clinical and practice guidelines.

1. Vaginal

The CT/MRI compatible Sure-guide Vaginal Cylinder Set design is based on conventional cylindrical HDR delivery systems with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation as definitive treatment, adjuvant treatment, or as a treatment boost to the vaginal walls with or without external beam radiation therapy. The set consists of a precision manufactured Sure-guide cylinders of varied diameters for optimal radiation treatment delivery and anatomical customization.

2. Stump

The CT/MRI Compatible Sure-guide Stump Vaginal Cylinder Set design is based on conventional cylindrical HDR delivery systems with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation as definitive treatment, adjuvant treatment, or as a treatment boost to the vaginal walls with or without external beam radiation therapy. The set consists of a precision-manufactured Sure-guide Stump Cylinders of varied diameters for optimal radiation treatment delivery and anatomical customization.

3. Miami

The CT/MRI Compatible Sure-guide Miami HDR applicator Set is designed according to the conventional modified Miami applicator with a click fit connector interface. This applicator is particularly useful when the vaginal vault space is limited or narrow due to tumor, restricted anatomy, or fibrosis. It can also be useful to treat tumors that extend from the uterus or cervix down onto the vaginal wall. The set consists of a precision manufactured intrauterine tandems and a full set of variable diameter Miami cylinders (all components are designed to allow for customization of the treated geometry). The distance that the tandem is inserted can be customized for each case. Four differing tandems are provided: one straight, one slight curvature, one medium curvature, and one maximal curvature. These allow for maximal accommodation of the uterine flexure.

The provided text describes K123941, the Kobold Sure-guide Vaginal Cylinder Set, Kobold Sure-guide Stump Vaginal Cylinder Set, and Kobold Sure-guide Miami Cylinder Set. This is a 510(k) submission, meaning the manufacturer is claiming substantial equivalence to a predicate device, rather than proving safety and efficacy through extensive clinical studies with acceptance criteria in the same way a novel device might.

Here's a breakdown based on the information available:

Acceptance Criteria and Reported Device Performance

The submission states that "FDA has not established special controls or performance standards for this device," and "Performance Tests: Not Required." Since this is a substantial equivalence claim, the "acceptance criteria" are primarily met by demonstrating similarity to the predicate device in aspects like intended use, design, materials, and functional characteristics.

The "reported device performance" is framed in terms of substantial equivalence to the predicate device (K-033371, Intracavity BrachyTherapy Applicators).

Study Information

The submission does not describe a traditional clinical study with defined acceptance criteria for a novel device. Instead, it focuses on demonstrating substantial equivalence to a predicate device. Therefore, many of the requested study details are not applicable or not provided.

1. Sample size used for the test set and the data provenance: Not applicable. This submission relies on benchtop testing and comparison to a predicate device, not a clinical test set with patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a clinical test set is not established for this type of submission.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 physical applicator for brachytherapy, not an AI-powered diagnostic or treatment planning tool that would involve human readers or AI assistance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical performance evaluation. The "ground truth" here is the established safety and effectiveness of the predicate device, to which the new device is compared.
7. The sample size for the training set: Not applicable. There is no machine learning or AI component to this device.
8. How the ground truth for the training set was established: Not applicable.

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