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AOS Interstitial Templates, Needles, and Accessories are indicated for use in adults where Brachytherapy of the cervix or prostate is an accepted clinical practice.

AOS Interstitial Templates, Needles, and Accessories are designed for interstitial Brachytherapy treatments of the cervix and prostate. The Templates are designed to be sutured to the perineal area in order to fix the geometry of the Template Need into the cervix or prostate. AOS Templates are made of silicone, with holes in a circular pattern, typically spaced 1 cm (Center-to center). AOS Templates are supplied in two configurations to accommodate a prostate or GYN treatment. The Template is sutured in place and Template Needles are inserted into the Template. The number and type of Template Needles is dependent on the model of Afterloader. Additional accessories are required in vaginal cases. The AOS GYN Templates have a large hole with a quide strip. The matching AOS Vaginal Guide Tube is inserted in this hole, lining up the guide groove. The Vaginal Guide is pushed to the desired depth and the large O-Ring is slipped over the Vaginal Guide. The AOS Collar is then used to push the Vaginal Guide until it can be slipped over and on to the Template. The O-Ring's elasticity tightens down and provides sufficient tension to hold the Vaqinal Guide in place. Each Vaginal Guide has six (6) Needle grooves for the insertion of additional Template Needles as required. Where an Afterloader is used, the Template Needles are connected to the Afterloader via an appropriate connector. If the Template Needle has a female Luer Adaptor on the proximal end, connection to the AOS Universal Connecting Guide Tube, P/N SGJ0007, provides an unobstructed pathway for the source wire or cable from the Afterloader to the appropriate distance as determined by the Afterloader. Some Afterloaders provide a transfer tube, which is connected to the other end slips over the plain end of the Template Needle and is tightened down to hold and connect the Template Needle.

The provided text is a 510(k) summary for the AOS Interstitial Templates, Needles, and Accessories. This document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, not a study report detailing specific acceptance criteria and performance data for the device itself.

Therefore, the information you've requested (acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not present in the provided text.

The document explicitly states:

• "Nonclinical testing were not performed as device is identical to the predicate device." This indicates that no new performance studies (clinical or non-clinical) were conducted for this specific submission because the device is considered identical to a previously cleared predicate and relies on the predicate's established safety and effectiveness.

In summary, I cannot generate the requested table and study details based on the provided text, as the document focuses on regulatory equivalence rather than presenting an independent performance study with specific acceptance criteria and results for the new device.

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The purpose of AOS Interstitial Templates, Needles and Accessories is to provide and enclosed pathway for application of radioactive source(s) into the body or surface of the body for radiation therapy (brachytherapy).

Alpha-Omega Services (AOS) Templates, Template Needles and Accessories provide a fixed array of needles, via the template. AOS Templates are made of silicone, with holes in a circular pattern, typically spaced 1 cm (center-to center). AOS templates are supplies in various sizes to accommodate treatment sites as prostate, rectum, or vagina.

The Template is sutured in place and Template Needles are inserted into the holes of the Template. The number and type of Template needles is dependant on the model of Afterloader or if the manual LDR method is used, which consists of strands or ribbons of discrete sources.

Additional accessories are required in vaginal cases. The AOS GYN Templates have a large hole, with a guide strip. The matching AOS Vaginal Guide Tube is inserted in this hole, lining up the guide strip with the guide grove. The Vaginal Guide is pushed do the desired depth and the large O-Ring is slipped over the Vaginal Guide. The AOS collar is then used to push the O-Ring along the Vaginal Guide until it can be slipped over and on to the grooved ring on the Template. The O-Ring's elasticity tightens down and provides sufficient tension to hold the Vaginal Guide in place. Each Vaginal Guide has six (6) Needle grooves for the insertion of additional Template Needles as required.

Template Needles may have a plain end or some sort of attachment device, such as a female luer adaptor if an Afterloader is to be used. If the Manual LDR method is used, typically a Template Needles with or without a collar is chosen. Where an Afterloader is used, the Template Needles are connected to the HDR Afterloader via an appropriate connector. If the Template Needle has a female Luer Adaptor on the proximal end, connection to the AOS Universal Connecting Guide Tube (K964910) provides an unobstructed pathway for the source wire or cable from the Afterloader to the appropriate distance as determined by the Afterloader. Some Afterloaders provide a transfer tube, which is connected, to the Afterloader while the other end slips over the plain end of the Template Needles and is tightened down to hold and connect the Template Needle.

The provided text, K062823, is a 510(k) Summary for medical devices and does not contain information about a study that measures the device's performance against specific acceptance criteria. This document is a regulatory submission demonstrating substantial equivalence to previously marketed devices, rather than a performance study.

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

• Nature of the Document: A 510(k)
  Summary for substantial equivalence primarily focuses on comparing the new device's design, materials, intended use, and other characteristics to those of predicate devices that are already legally marketed. Its goal is to demonstrate that the new device is "as safe and effective" as the predicate, not to prove performance against specific quantitative criteria through a new study.
• Absence of Performance Data: The document explicitly states under "PERFORMANCE STANDARDS": "No performance Standards for Brachytherapy Applicators are in effect at this date." This indicates that there are no pre-defined quantitative benchmarks that the device needed to meet through a new performance study.
• Substantial Equivalence Section: The "SUBSTANTIAL EQUIVALENCE" section directly compares the "NEW DEVICE" to "PREDICATE" devices, listing qualitative similarities (e.g., "share the same design," "constructed of the same materials," "Single Use Only"). The only difference noted is that the new devices are sterile, while the predicates were non-sterile. This comparison does not involve quantitative performance metrics.
• Conclusion: The conclusion states: "The Conclusion drawn from the above is that the AOS Interstitial Templates, Needles & Accessories are equivalent in safety and efficacy to their predicate devices." This reinforces that the submission aims to establish equivalence, not to report on new performance study results.

Therefore, since no performance study demonstrating meeting acceptance criteria is described in the provided text, I cannot fill in the table or answer the other questions about such a study.

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