Search Results

The CT/MR Tandem and Ovoid Set is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR Brachytherapy.

{{overview}}

This FDA clearance letter describes a new device, the "CT/MR Tandem and Ovoid Set," but it does not describe a study involving AI or software performance evaluation. The document focuses on the substantial equivalence of this physical medical device (an applicator for brachytherapy) to a predicate device, primarily through mechanical, material, and compatibility testing.

Therefore, I cannot extract information related to acceptance criteria for AI model performance or a study proving that an AI device meets acceptance criteria, as the provided text doesn't contain such a study.

The document discusses:

• Biocompatibility Testing: Ensuring the materials are safe for patient contact.
• Magnetic Resonance Testing (MR): Confirming the device is MR safe/compatible.
• Cleaning, Disinfection, and Sterilization Testing: Verifying the device can be properly cleaned and sterilized for repeated use.
• Human Factors Validation Study: To ensure the device is user-friendly and performs as intended for its users and environment.
• Mechanical and Acoustic Testing: To demonstrate the device performs as intended and meets design specifications.

These tests are for the physical device's safety and effectiveness, not for an AI algorithm's diagnostic or predictive performance.

Therefore, I cannot fill in the requested table and details for AI-related performance.

Ask a specific question about this device

The Intracavitary/Interstitial System is intended for cancer treatment of the uterus, cervix, and vagina using HDR or PDR brachytherapy.

The Intracavitary/Interstitial System is a device with two (2), hollow, open-ended catheters which connect to applicator sets with ovoids, ring caps or templates on the distal end.

The guide tubes extend outside of the patient. An interstitial needle is guided through the guide tube from outside the patient to an interstitial hole in the applicator. The proximal end of the guide tube contains a fixation mechanism for fixing the needle insertion depth between needle insertion and removal of the implant.

The Intracavitary/Interstitial System is intended to be used with the following required accessories: Plastic Needles (K120341) and Leak Stop Channel Markers (K152018).

I am sorry, but based on the provided FDA 510(k) clearance letter for the Intracavitary/Interstitial System (K250289), there is no information provided regarding acceptance criteria for device performance, nor is there a study described that proves the device meets such criteria in terms of clinical or algorithmic performance.

The document primarily focuses on:

• Administrative details of the 510(k) clearance: Device name, regulation number, product code, date of clearance, contact information.
• Device description and intended use: What the device is and what it's used for (brachytherapy for uterus, cervix, vagina).
• Comparison to a predicate device: Highlighting similarities in intended use, technological characteristics, materials, anatomical sites, MR compatibility, and use environment.
• Non-clinical performance testing: This section details engineering and safety tests like biocompatibility, cleaning/disinfection/sterilization, human factors, mechanical/acoustic, MR compatibility (physical properties under MR, not clinical performance), and electromagnetic compatibility (EMC). It also lists various consensus standards followed during design and evaluation.

Specifically, the document does NOT contain any of the following information requested in your prompt:

1. A table of acceptance criteria and reported device performance related to a clinical outcome or algorithmic performance metric. The "performance data" mentioned is exclusively for non-clinical, engineering, and safety assessments.
2. Sample size used for a test set or data provenance for any clinical performance evaluation. No clinical test set is described.
3. Number of experts, qualifications, or adjudication methods for establishing ground truth. This is relevant for studies involving human interpretation or AI performance assessment, which are not detailed here.
4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study information or effect sizes.
5. Standalone (algorithm only) performance.
6. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical or AI performance study.
7. Sample size for a training set or how ground truth was established for a training set. These are relevant for AI/ML device submissions, but this document describes a physical medical device, not an AI algorithm for diagnosis or treatment planning.

Conclusion:

The provided 510(k) letter demonstrates that the Intracavitary/Interstitial System (a physical medical device) has undergone various engineering, safety, and compatibility tests to show it is as safe and effective as its predicate. However, it does not detail any clinical performance study, nor does it refer to an AI/ML component where acceptance criteria for diagnostic/prognostic accuracy or human-in-the-loop performance would be relevant. The performance data presented are purely non-clinical validation steps for a hardware device.

Therefore, I cannot populate the requested tables or provide details on the study proving the device meets performance criteria in the way you've outlined, as that information is not present in the given text.

Ask a specific question about this device

The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vaqina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.

The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.

The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization.

The intended patient population includes adult female patients whose cancer can be treated using HDR brachytherapy, as determined by the prescribing physician. The subject device is intended to be used in a healthcare or treatment facility by trained and qualified personnel.

The key performance characteristics of this applicator set are as follows:

• . The ability to customize the relative depth of the tandem and ovoids, as well as adapt to different anatomies with three tandem angles (15°, 30°, 45°) and a movable cervical stop.
• 3.5 mm diameter intrauterine tandems allow for easy insertion into the cervical channel helping provide maximum patient comfort.
• The tandems and the pivot assembly are made from strong, lightweight titanium.
• Four different ovoid sizes to allow for varying anatomy.
• . Channel marking on the intrauterine tandems and colpostat tandems for easy identification.
• . Ability to image the patient using CT imaging.
• Ability to image the patient using MR imaging.
• Optional interstitial ovoids for more complex cases with guide tubes to allow for the needles to be preloaded outside of the patient and locked into place.
• . Compatible with cervical sleeves to allow easy multiple fraction and help provide maximum patient comfort and eliminate the risk of perforation.
• Can be manually or machine cleaned, disinfected and steam sterilizable.
• Can be securely connected to the BRAVOS Afterloader System and GammaMedeplus iX series afterloader.
• Suitable for patient contact for a period of less than 30 days

This document is a 510(k) Premarket Notification for the Titanium Flexible Geometry FSD Applicator Set (GM11013400). It does not describe an AI/ML powered device. The information provided focuses on the substantial equivalence to a predicate device through non-clinical performance testing. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, standalone algorithm performance, AI training/test sets, expert ground truth establishment, etc.) are not applicable to this submission.

Here is the information that can be extracted relevant to the performance and acceptance criteria for this medical device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This submission concerns a physical medical device (applicator set), not an AI/ML model for data-driven analysis. Performance testing likely involved physical prototypes or units, but specific "sample sizes" in the context of data analysis are not presented.
• Data Provenance: Not applicable in the context of clinical data used for AI/ML development. The testing described is non-clinical (biocompatibility, MR compatibility, cleaning/sterilization, mechanical, human factors).

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

• Not applicable. Ground truth as typically defined for AI/ML (e.g., expert labels on medical images) is not relevant for the type of device and testing described. The "ground truth" for this device's performance is established by objective engineering and safety standards.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication is typically for resolving discrepancies in expert labels for AI/ML ground truth.

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

• No. This is not an AI-powered device.

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

• No. This is not an AI-powered device.

7. The Type of Ground Truth Used

• The ground truth for this device's performance is based on objective engineering standards, regulatory requirements, and validated test methods. This includes:
  • Compliance with ISO 10993 for biocompatibility.
  • Compliance with ASTM standards for MR compatibility.
  • Demonstrated effectiveness for cleaning, disinfection, and sterilization.
  • Usability verification through human factors studies (IEC 62366).
  • Verification and validation against design specifications and risk management (21 CFR §820, ISO 13485, ISO 14971).

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.

Ask a specific question about this device

The Mould Probe MR Safe is intended for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy. IORT = Intraoperative Radiation Therapy.

The Mould Probe MR Safe is a Brachytherapy applicator. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.

The Mould Probe MR Safe is intended for HDR or PDR brachytherapy and the key performance characteristics are as follows:

• Suitable for intraoperative, intraluminal, and interstitial brachytherapy.
• Can be used for surface treatments in combination with the suitable Varian flap.
• Equipped with stabilizing mandrins for easy insertion.
• MR Safe, if used without mandrins.
• CT compatible, if used without mandrins.
• Elastomer material construction provides increased flexibility for easy placement as well as luminal rigidity, which prevents kinks.
• Steam sterilizable.
• Suitable for patient contact for up to 24 hours. The stainless steel mandrins are not intended to have patient contact.

The provided text is a 510(k) premarket notification summary for the "Mould Probe MR Safe" device. It describes the device, its intended use, and its comparison to a predicate device. However, this document does not contain information about the acceptance criteria and performance study outcomes related to an AI/ML device.

The document states:

• "Software Verification and Validation Testing: This item is not applicable to the subject device. The devices do not contain or consist of software/firmware. No software verification and validation testing have been included in this submission in support of the substantial equivalence determination."

Therefore, I cannot extract the requested information about acceptance criteria and study that proves the device meets the acceptance criteria for an AI/ML device from the provided text. The device in question is a physical medical instrument (brachytherapy applicator), not one that relies on AI/ML for its function.

Ask a specific question about this device

The Intraluminal Applicator Set is intended for intraluminal brachytherapy treatments including endobronchial treatments and treatments on body sites such as the bile duct using HDR brachytherapy.

The Intraluminal Applicator Set is intended for intrapy treatments including endobronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy.

The Intraluminal Applicator Set acts to guide the radioactive source to the correct location for treatment.

Key performance characteristics are as follows:

• . Suitable for treating body sites allowing insertion of a catheter.
• CT compatible. ●
• MR Compatibility: Safe. ●
• Fits a 2 mm diameter bronchoscope biopsy channel allowing for easy insertion.
• Elastomer construction provides increased flexibility for easy placement and luminal rigidity to avoid kinks. ●
• Nylon monofil adds luminal stability during catheter insertion and manipulation. ●
• Comes with 2.8 mm spacing tubes, which minimize surface dose. .
• . Spacing tubes enable secure placement during treatment.
• The bronchial catheter and monofil are supplied sterile, and for single use.
• . The guide tubes, the bronchial catheter, the bite catheters are intended for continuous use for less than 24 hours of contact with patients.

The provided document is a 510(k) Premarket Notification for a medical device called the "Intraluminal Applicator Set." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting effectiveness studies with explicit acceptance criteria and performance metrics.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria for device performance, the specific study design to prove those criteria (like sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance), or the type of ground truth used.

Instead, the document details non-clinical testing performed to establish the device's safety and effectiveness in comparison to its predicate. The "Summary of Performance Testing (Non-Clinical Testing)" section outlines the types of tests conducted:

• Biocompatibility Testing: Confirms the compatibility of skin-contact components with requirements as per ISO 10993-1. Specific tests included Hypersensitivity, Material Mediated Pyrogen, and Acute Systemic Toxicity.
• Cleaning, Disinfection, and Sterilization Testing: Verifies that components can be effectively sterilized and reused for the specified number of times.
• Human Factors Validation Study: Conducted according to IEC 62366 to ensure the device is safe and effective for intended users, uses, and environments.
• Mechanical and Acoustic Testing: Formal design validation testing to demonstrate the device performs as intended.
• Magnetic Resonance Testing (MR): Confirms the device is MR Safe, complying with ASTM F2503-23.
• Electromagnetic Compatibility (EMC) Testing: Assessed against IEC 60601-2-17 to demonstrate compatibility in an electromagnetic setting.

The "Determination of Substantial Equivalence to the Predicate" section states: "The results of verification as well as conformance to relevant safety standards demonstrate that the safety and performance criteria." This implies that the 'acceptance criteria' for this submission are met when the device successfully passes these non-clinical tests and conforms to the listed standards.

Without the specific details of a clinical performance study with acceptance criteria, I cannot complete the requested tables and information as described in the prompt. The document is a regulatory submission for substantial equivalence based on technical and safety characteristics, not a clinical efficacy trial.

Ask a specific question about this device

The Esophageal Brachytherapy Applicator is intended for use with commercially available afterloader during brachytherapy. The purpose of the device is for delivery of radioactive source to the esophagus. This device is sterile, disposable and single-use.

[BKMI2001]
The device has 6 independently balloons. Each balloon corresponds to a specified needle free connector (valve). The #1 valve is connected to the most distal balloon and the #6 valve corresponds with the proximal balloon. There is an indication balloon on each valve unit, which can indicate the inflated balloon. The distance between first marker printed on the main catheter and the distal tip is 19.8 cm. This device is disposable and designed for sterile and single use.

[BKMI2002]
The device has 8 independently balloons. Each balloon corresponds to a specified needle free connector (valve). The #1 valve is connected to the most distal balloon and the #8 valve corresponds with the proximal balloon. The distance between first marker printed on the main catheter and the distal tip is 40 cm. This device is disposable and designed for sterile and single use.

The provided text is a 510(k) summary for the "BRAXX" Esophageal Brachytherapy Applicator. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, the document does not describe a study involving an AI/software device that requires acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance improvement.

The "Performance Testing" section refers to mechanical tests for the physical device (Balloon Burst, Balloon Fatigue, Balloon Diameter and Volume, Leakage, Tensile Strength). These are not related to an AI algorithm's performance on a test set of data.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study proving device meets criteria for an AI/software device. The provided text is solely for a physical medical device.

To answer your request, if this were an AI/software device, the information would typically be found in a section detailing clinical performance studies or algorithm validation studies.

Ask a specific question about this device

The Titanium Fletcher-style Applicator Set - Defined Geometry is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina using HDR or PDR brachytherapy.

The Smit Cervical Sleeves are indicated for use where any intrauterine tandem is used for HDR or PDR brachytherapy.

The Titanium Fletcher-style Applicator Set – Defined Geometry is intended for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina when performing HDR or PDR brachytherapy.

The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization.

The Titanium Fletcher-Style Applicator Set Defined Geometry includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Titanium Fletcher-Style Applicator Set Defined Geometry is intended to be used in a healthcare or treatment facility by trained and qualified personnel.

This 510(k) submission is also inclusive of the Smit Cervical Sleeve which is an optional component that may be used with the Titanium Fletcher Style Applicator Set Defined Geometry but is not required to successfully perform the intended use.

The provided text describes a 510(k) premarket notification for a medical device, the "Titanium Fletcher-Style Applicator Set Defined Geometry" and "Smit Cervical Sleeves" by Varian Medical Systems, Inc. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that a new AI/software-based device meets specific acceptance criteria through a clinical study.

The acceptance criteria and study information requested in your prompt (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, ground truth types for training/test sets) are highly relevant for AI-powered medical devices (software as a medical device - SaMD). However, this 510(k) submission is for a physical medical device used in brachytherapy, not an AI or software device.

Therefore, many of the specific questions in your prompt are not applicable to this non-AI medical device submission. The document details the device's technical specifications, intended use, indications for use, and a comparison to a predicate device to argue for substantial equivalence. The "performance testing" mentioned is primarily non-clinical (biocompatibility, MR compatibility, cleaning/sterilization, human factors, mechanical/acoustic testing), focusing on the device's physical properties and safety, not its diagnostic or therapeutic performance in a statistical sense that would require large clinical studies with ground truth derived from experts or pathology.

Here's a breakdown based on the provided text, addressing the points where information is available and noting where it's not applicable:

Acceptance Criteria and Device Performance (for a non-AI physical device)

The concept of "acceptance criteria" for this type of physical device is framed around demonstrating that its design and performance characteristics are equivalent to or do not raise new questions of safety and effectiveness compared to a legally marketed predicate device. The "performance" is primarily assessed through non-clinical laboratory testing to ensure physical integrity, material compatibility, and functionality within its intended use.

Table of Acceptance Criteria and Reported Device Performance (as inferred for a non-AI device through a 510(k))

Study Information (as applicable to a non-AI physical device 510(k) submission):

1. Sample size used for the test set and the data provenance:

   • N/A (for clinical performance data): This is a submission for a physical device, not an AI/software device requiring a clinical test set for performance evaluation (e.g., diagnostic accuracy). The "testing" refers to non-clinical lab tests (biocompatibility, MR, mechanical, sterilization, human factors).
   • For the non-clinical tests (e.g., sterilization cycles, human factors study), the sample size would be determined by the specific ISO/ASTM standards referenced, but typically isn't a large "test set" in the sense of clinical cases. The document does not specify these sample sizes.
   • Data Provenance: Not applicable in the context of clinical data for a physical device. Testing is conducted in a laboratory environment, not on patient data from specific countries.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A: Ground truth established by medical experts is not listed as a component of this non-AI device's performance testing for 510(k) clearance. The device's "performance" is assessed through engineering testing against physical and safety standards and comparison to a predicate.

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

   • N/A: Not applicable as there is no clinical test set requiring expert adjudication for accuracy or performance.

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:

   • No: This is not an AI-powered device, so an MRMC study comparing human performance with and without AI assistance was not conducted.

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

   • N/A: This is a physical medical device, not an algorithm.

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

   • N/A: "Ground truth" in the sense of clinical reference standards (pathology, expert consensus) is not applied to this type of 510(k) submission for a non-AI physical device. The "truth" or reference is established by engineering specifications, material standards, and functional test results (e.g., "does it sterilize correctly?", "is it MR compatible?").

7. The sample size for the training set:

   • N/A: This is not a machine learning/AI device, so there is no training set in the AI sense.

8. How the ground truth for the training set was established:

   • N/A: Not applicable.

In summary: The provided document is a 510(k) letter for a physical brachytherapy applicator set, demonstrating substantial equivalence to a predicate device. The regulatory pathway for such devices involves rigorous non-clinical testing (e.g., material testing, mechanical testing, sterilization validation) and a comparison of technical characteristics to a predicate, rather than large-scale clinical performance studies or AI-specific validation methods outlined in your prompt.

Ask a specific question about this device

The Catheter Surface Flap Applicator Set is intended for use for skin cancer treatment using HDR or PDR brachytherapy.

The Catheter Surface Flap Applicator Set is an applicator for Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.

The key performance characteristics of this applicator set are as follows:

• Surface applicator intended for the treatment of skin cancers.
• A 10mm thick flap allowing for up to 38 channels spaced at 5 mm allows for a large uniform treatment.
• Hollow pattern design and semi translucent material provides good visibility of the treatment area.
• The material high flexibility allows the applicator to conform closely to complex patient anatomies such as when treating nose or ear lesions.
• Silicone material gives excellent biocompatibility and durability.
• Single patient multiple use.
• The Catheter Surface Flap is MR and CT compatible.
• Patient-contacting parts constructed of silicone and Polyvinylchloride; suitably for patient contact for a period up to 24 hours.

The fixation buttons are used for locking the mould probes in place after insertion in the catheter surface flap. Some of these are supplied in the fixation button kits but they are also available to be purchased separately as spares. As spares, they are packed in sterile pouches, with 10 pieces per pouch and sold as pack of 10 pouches respectively.

The provided text is a 510(k) summary for a medical device called the "Catheter Surface Flap Applicator Set (GM11011830)". This document is not a study proving a device meets acceptance criteria for an AI/ML algorithm. Instead, it's a submission to the FDA to demonstrate substantial equivalence to a predicate device, primarily focusing on materials, design, and intended use as an applicator for brachytherapy.

Therefore, I cannot extract the requested information because the document does not contain details about:

• Acceptance criteria for an AI/ML device's performance.
• A study involving a test set, training set, ground truth experts, or MRMC studies for an AI/ML algorithm.
• Any mention of AI or machine learning.

The document discusses non-clinical performance testing for a physical medical device, including biocompatibility, cleaning/disinfection/sterilization, human factors validation, and mechanical/acoustic testing. These are typical tests for a physical medical device, not an AI/ML software device.

Ask a specific question about this device

The Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy.

The Heyman Packing Applicator Set consists of various sized Heyman-capsules which may be connected to compatible brachytherapy afterloaders via guide tubes. The set also includes a number of associated accessories for sterilization (Cleaning Cap, Leak Stop Button, and Leak Stop Channel Marker Sets). The Heyman Packing Applicator Set is an applicator for intracavitary Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment. The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization. The Heyman Packing Applicator Set includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel.

The provided text describes a 510(k) premarket notification for a medical device called the "Heyman Packing Applicator Set (GM11004580)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through a separate study with specific performance metrics (like accuracy, sensitivity, specificity, etc.) that would typically apply to AI-driven or diagnostic devices.

Instead, the "acceptance criteria" here refer to the device's conformance to established engineering standards, biocompatibility, and safety, as well as its functional characteristics. The "study that proves the device meets the acceptance criteria" is primarily a series of non-clinical performance tests and adherence to consensus standards.

Here's a breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is a physical medical device and not an AI or diagnostic software, the "acceptance criteria" are not reported as statistical performance metrics like sensitivity or specificity. Instead, they relate to functional and safety attributes. The "reported device performance" refers to the confirmed characteristics after testing.

Ask a specific question about this device

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.

Ask a specific question about this device