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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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