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The ASSISTO® Universal Applicator Clamping Device is indicated for use as an accessory for HDR or PDR brachytherapy treatment. Specifically, it is intended to hold dedicated applicator holding devices by Varian Medical Systems in place during cancer treatment of the vaginal stump, rectum, cervix, uterus and endometrium using HDR or PDR brachytherapy.

The ASSISTO® Universal Applicator Clamping Device is a self-retaining device that consists of a stainless steel tubular, articulated arm connected to a vertical stand. The arm is freely adjustable within the articulating radius. A screw clamp mounted on the distal end of the device serves to hold dedicated applicator holding devices by Varian Medical Systems in place during cancer treatment of the vagina, vaginal stump, rectum, cervix, uterus and endometrium using HDR or PDR brachytherapy. Two accessories, a stainless steel clamp socket and a base plate manufactured of thermoplastic and stainless steel, are provided to table-mount the device during clinical use. The ASSISTO® Universal Applicator Clamping Device and the clamp socket are reusable and provided non-sterile for cleaning and sterilization by the user before use. The non-sterile, reusable base plate is intended for cleaning and disinfection by the user before use.

The provided text describes a 510(k) premarket notification for the ASSISTO® Universal Applicator Clamping Device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of diagnostic accuracy or clinical effectiveness with human subjects.

Therefore, many of the requested points regarding diagnostic performance studies (sample size, expert qualifications, ground truth, MRMC studies, standalone performance) are not applicable to this submission, as the device is an accessory for brachytherapy and its performance is evaluated based on engineering and functional testing.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated as this is not a clinical study involving human cases or diagnostic imaging. The "test set" here refers to the number of Varian Medical Systems applicator holding devices used for verification, and potentially the number of reprocessing cycles for validation. These numbers are not provided in the summary.
• Data Provenance: Not applicable in the context of clinical data. The tests are engineering verification and validation tests, likely performed in a lab setting by the manufacturer, Geomed Medizin-Technik GmbH & Co. KG, located in Germany.

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

• Not applicable. The ground truth for engineering performance measures (like securely holding an object or effective reprocessing) is established through technical specifications, engineering principles, and validated testing protocols, not by expert medical opinion on clinical cases.

4. Adjudication method for the test set

• Not applicable. There's no clinical "ground truth" to adjudicate. Test results are likely objectively measured against predefined engineering specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The ASSISTO® is a physical accessory for brachytherapy.

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

• Not applicable. The device is a physical mechanical accessory, not an AI algorithm. Its function is to physically hold other devices.

7. The type of ground truth used

• The "ground truth" for this device's performance is based on engineering specifications and functional requirements. For example, the ability to physically secure an applicator holding device without slippage or failure, and the effectiveness of specified cleaning/sterilization protocols.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm, so there is no "training set."

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

• Not applicable. As there is no training set for an AI algorithm.

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Geomed Vascular Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.

Vascular Dilators are reusable stainless-steel surgical instruments that are used by qualified surgeons to enlarge or calibrate vessels. They are provided in two basic models and various sizes to accommodate individual needs, based on the anatomy of the site and the type of surgical procedure. The device is provided non-sterile for steam sterilization by the user.

This document is a 510(k) summary for the Geomed Vascular Dilators, a surgical instrument. It is NOT for an AI/ML powered device, therefore most of the requested information regarding AI/ML studies is not applicable.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons) are not detailed in this summary. The summary states that "Acceptance criteria were met for all tests performed," implying that the device successfully passed these tests.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes for the individual tests (tensile strength, dimensional verification, cleaning, sterilization, drying time). The data provenance is not explicitly mentioned but can be inferred as internal testing performed by the manufacturer, Geomed Medizin-Technik GmbH & Co. KG, as part of their 510(k) submission. These are device performance tests, not clinical studies with human data.

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

This information is not applicable as this is not a study involving human interpretation of data or a clinical study. The "ground truth" for these tests would be established by engineering specifications, validated cleaning protocols, and sterilization standards.

4. Adjudication method for the test set

This information is not applicable for device performance testing. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in observations or diagnoses.

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

This information is not applicable. The device is a physical surgical instrument (vascular dilator), not an AI-powered diagnostic or assistive tool.

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

This information is not applicable. The device is a physical surgical instrument, not an algorithm.

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

For the device performance tests, the "ground truth" is based on:

• Engineering specifications and standards: For tensile strength and device dimensions.
• FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (03/17/2015): For cleaning and sterilization validation.
• Established industry standards for sterilization and drying: For sterilization and drying time validation.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML model being trained.

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

This information is not applicable. There is no "training set" for this type of device submission.

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GEOMED Vascular Clamps are intended for use for temporary occlusion of blood vessels during surgical procedures.

The GEOMED Vascular Clamps are reusable devices and provided non sterile. They must be thoroughly cleaned and sterilized before use. GEOMED Vascular Clamps are made of Stainless Steel (following ASTM F 899-07). They are provided with ring handles and ratchet closures to adjust the amount of tension applied to the vessel for occlusion or partial occlusion. The GEOMED Vascular Clamps are available in a wide variety of shapes, sizes and lengths to accomodate to the individual needs of the surgeon. Based on the anatomy of the site, the surgical technique chosen, the size and type of blood vessel and occlusion desired, the surgeon decides which clamp to use. During surgery the handles and shanks need to be out of the field of vision of the operative site and therefore a wide variety of instrument figures and sizes is necessary. The Vascular Clamps occlude the arteries or veins with a tension that intends to produce minimal trauma to the vessels. They cover the vessel and stop the blood flow.

The provided text is a 510(k) Summary for the GEOMED Vascular Clamps, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving effectiveness through extensive clinical trials or performance studies with acceptance criteria in the way a new drug or novel medical software would.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, and AI-related studies is not present in this document. The document primarily focuses on demonstrating that the GEOMED Vascular Clamps are substantially equivalent to existing, legally marketed vascular clamps.

Here's a breakdown of why this information isn't available in the provided text, and what is discussed:

1. A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the vascular clamps in the way that would be done for a diagnostic device or AI algorithm. The "performance" assessment is based on the device's physical properties and intended use mirroring existing devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, in the context of performance metrics for an AI or diagnostic device, is mentioned or used. The "testing" referred to is for cleaning and sterilization procedures, not for clinical performance.

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): This is not applicable. There is no "ground truth" to establish for this type of mechanical device in the same way there would be for an AI diagnostic.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 mechanical surgical instrument, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

What the document does state regarding "Design Verification Performance":

• Design Verification Performance: "Tests for Cleaning and Sterilization are provided." This indicates that the device underwent testing to ensure it can be properly cleaned and sterilized for reuse, which is a critical safety and functionality aspect for reusable surgical instruments. However, the details of these tests (e.g., number of cycles, specific protocols, acceptance criteria for sterility/cleanliness) are not included in this summary.

In summary, the provided document is a 510(k) summary for a mechanical surgical device (Vascular Clamps) and, as such, does not contain the detailed performance study information typically required for devices involving complex algorithms, diagnostics, or AI. The substantial equivalence claim is based on similar design, materials, and intended use compared to predicate devices.

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ASSISTO® Arm Systems consist of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 2.7mm to 10mm during general diagnostic and therapeutic procedures. The device is also intended for use by qualified surgeons for holding endoscopes during diagnostic and therapeutic neurologic procedures.

Table-mounted self-retaining endoscope holder system consisting of stainless steel tubular, articulated arms that are connected to a vertical stand and are freely adjustable within the articulating radius according to the requirements of the particular surgical procedure. Accessories include endoscope holders for 2.7mm to 10mm scopes. The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.

The provided text is a 510(k) summary for the ASSISTO® Arm Systems, describing its substantial equivalence to predicate devices. It does not contain information about specific acceptance criteria or a study that quantitatively measures the device's performance against such criteria using a test set of data with ground truth. Instead, it focuses on demonstrating equivalence through design analysis and verification testing.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be extracted from this document, as they pertain to performance studies typically involving AI/software devices evaluated against ground truth. This document describes a mechanical device.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

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

Explanation: The document states that verification testing confirms "basic functional characteristics" and "substantial equivalence." It does not provide specific, measurable acceptance criteria (e.g., accuracy thresholds, sensitivity, specificity) that would be relevant for a software or AI device. The device is a mechanical arm system, and its "performance" is assessed through engineering analysis and confirmation of functional equivalence to existing devices.

2. Sample sized used for the test set and the data provenance

• Sample size: Not specified. The verification testing mentioned likely refers to engineering tests on the physical device, not a test set of data.
• Data provenance: Not applicable, as there's no "data" in the sense of medical images or patient records being analyzed by the device.

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

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

Explanation: Ground truth, in the context of AI regulatory submissions, typically refers to expert labels or confirmed diagnoses used to evaluate an algorithm's performance. This type of "ground truth" is not relevant for a mechanical device like the ASSISTO® Arm System.

4. Adjudication method for the test set

• Not applicable, as there is no "test set" or "ground truth" in the context of an AI/software performance study.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or decision-making systems, not for a mechanical endoscope holder.

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

• Not applicable. The device is a mechanical system, not an algorithm.

7. The type of ground truth used

• Not applicable. There is no ground truth in the sense of expert consensus, pathology, or outcomes data, as this is a mechanical device. The "ground truth" equivalent for such a device is likely compliance with design specifications and functional requirements through engineering tests.

8. The sample size for the training set

• Not applicable. The device is not an AI/ML algorithm that requires a training set.

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

• Not applicable.

Summary for the ASSISTO® Arm Systems based on the provided text:

The ASSISTO® Arm Systems is a mechanical device, an endoscope holder, and therefore the regulatory submission (510(k)) focuses on demonstrating substantial equivalence to predicate mechanical devices. This involves design analysis and verification testing to confirm its basic functional characteristics and safety, rather than performance metrics against a data-driven ground truth that would be relevant for AI or software devices. The document explicitly states: "Design analysis and comparison as well as verification testing confirm that basic functional characteristics are substantially equivalent to the predicate devices cited and raise no new issues of safety and effectiveness." This statement serves as the "proof" that the device meets the implied "acceptance criteria" of being functionally equivalent and safe.

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