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Vascular Clamps are indicated for use for temporary or partial occlusion of blood vessels during open surgical procedures.

HEBUmedical Vascular Clamps are reusable stainless steel ring-handled clamps provided in a wide variety of shapes, sizes and lengths to accommodate the individual needs of the surgeon and the procedure. based on the anatomy of the site and type of occlusion. The length and angles are design features that can be important to keep the handles and shanks out of the field of vision of the operative site. The handle is provided with a ratchet closure, which permits the surgeon to adjust the amount of tension applied to the vessel. The device is provided non-sterile for sterilization by the user.

The provided 510(k) summary for HEBUmedical GmbH's Vascular Clamps does not describe a study involving an AI/software device, clinical data analysis, or a comparison with human readers. Instead, it describes a medical device (vascular clamps) that is a physical instrument, and its performance evaluation is based on bench testing.

Therefore, most of the requested information (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth for training/test sets, effect size of human improvement with AI) is not applicable to this submission.

However, I can extract the information relevant to the provided text regarding the device and its performance relative to acceptance criteria.

Analysis of Acceptance Criteria and Device Performance for HEBUmedical Vascular Clamps

The 510(k) summary for the HEBUmedical Vascular Clamps focuses on demonstrating substantial equivalence to predicate devices through technological and performance characteristics, primarily assessed via bench testing. The "acceptance criteria" here are implicitly defined by the similar performance of the predicate devices in the described characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are not quantitative thresholds but rather qualitative comparisons to existing predicates, demonstrating similar characteristics to establish substantial equivalence.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of a "test set" for data or images. The evaluation was based on bench testing of the physical vascular clamps. The number of clamps tested (sample size for bench testing) is not specified.
• Data Provenance: The data provenance is from bench testing performed by the manufacturer, HEBUmedical GmbH, in Germany. This is an engineering/physical performance evaluation, not clinical data from patients. It is implicitly a prospective evaluation in the sense that the new device's performance was tested.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This submission is for a physical medical device (vascular clamp) and relies on bench testing for performance evaluation, not expert-labeled clinical data or images. Ground truth was established through physical measurements of clamp force and occlusion during bench testing.

4. Adjudication Method for the Test Set

• Not Applicable. As no clinical image or data review requiring human expert interpretation was performed, there was no need for an adjudication method. Bench test results are typically objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study was not conducted as this device is a physical surgical instrument, not an AI/software product, and its evaluation did not involve human readers interpreting clinical cases.

6. Standalone Performance (Algorithm Only)

• Not Applicable. This is a physical device, not an algorithm or software. Its "standalone performance" refers to its physical characteristics and functionality, which were assessed via bench testing for clamp force and occlusion.

7. Type of Ground Truth Used

• Objective Bench Testing Measurements. The ground truth for evaluating the device's performance was derived from objective measurements obtained during bench testing of the physical clamp force and occlusion capabilities, compared against the characteristics of predicate devices.

8. Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of this physical device's evaluation. The device itself is manufactured, not "trained."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set, this question is not relevant.

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K2 Medical Vascular Clamps are devices intended for temporary or partial occlusion of blood vessels during vascular surgical procedures.

The K2 Medical Vascular Clamps are reusable surgical instruments. To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows: - Some have ring handles with a ratchet closure to adjust the amount of tension applied to . the vessel for occlusion or partial occlusion. - Bulldog style Vascular Clamps are another type of vascular cross clamp that use a spring or cross . action mechanism to apply tension to the vessel for occlusion. - The choice of iaw style depends on the surgeon's preference, based on the type and delicacy of . the vessel to be occluded. The surgeon chooses the vascular clamp based on the anatomy of the site and the type of occlusion desired, based on the type and size of the blood vessels, and surgical techniques. Clamps are either fully or partially occluding an artery or vein with correct tension to produce minimal trauma to vessels. Full occlusion clamps stops blood flow entirely by covering the full vessel. Partial occlusion clamps are placed on part of the vessel to isolate the area to be worked on while allowing blood flow to continue in the rest of the vessel. K2 Medical vascular clamps are made of the following standardized materials Stainless Steel ASTM F 899-07 or Titanium Alloy. The instruments are offered in non-sterile condition.

The provided text describes a 510(k) summary for the K2 Medical Vascular Clamp, which is a reusable surgical instrument. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving specific acceptance criteria for a novel device or AI algorithm.

Therefore, many of the requested categories related to proving device meets acceptance criteria through a study (especially those concerning AI, ground truth, expert readers, and specific performance metrics like sensitivity/specificity) are not applicable to this document.

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

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

The document does not specify quantitative acceptance criteria or a direct performance study with numerical results. Instead, it relies on demonstrating substantial equivalence to an existing predicate device. The "performance" assessment is qualitative, stating:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes a 510(k) submission for a physical medical device (vascular clamp) and relies on bench testing and comparison to a predicate device, not a "test set" of clinical data in the context of an AI or diagnostic device.

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)

Not applicable. "Ground truth" in this context would likely refer to engineering specifications or material standards, rather than expert interpretation of medical data.

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 surgical instrument, not an AI or diagnostic imaging device.

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)

For a device like a vascular clamp, the "ground truth" for performance would be established through engineering standards, material specifications (e.g., Stainless Steel ASTM F 899-07 or Titanium Alloy), and bench testing against established performance parameters for temporary occlusion of blood vessels. It is not externally defined clinical ground truth.

8. The sample size for the training set

Not applicable.

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

Not applicable.

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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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INSTRUMED Vascular Clamps are devices intended for temporary or partial occlusion of blood vessels during vascular surgical procedures.

The Instrumed Vascular Clamps are reusable surgical instruments. To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows:

• . Some have ring handles with a ratchet closure to adjust the amount of tension applied to the vessel for occlusion or partial occlusion.
• Bulldog style Vascular Clamps are another type of vascular cross clamp that use a spring or cross – action mechanism to apply tension to the vessel for occlusion.
• The choice of jaw style depends on the surgeon's preference, based on the type and delicacy of ↓ the vessel to be occluded.
  The surgeon chooses the vascular clamp based on the anatomy of the site and the type of occlusion desired, based on the type and size of the blood vessels, and surgical techniques. Clamps are either fully or partially occluding an artery or vein with correct tension to produce minimal trauma to vessels. Full occlusion clamps stops blood flow entirely by covering the full vessel. Partial occlusion clamps are placed on part of the vessel to isolate the area to be worked on while allowing blood flow to continue in the rest of the vessel.
  Instrumed vascular clamps are made of the following standardized materials Stainless Steel ASTM F 899-07 or Titanium Alloy,
  The instruments are offered in non-sterile condition.

This is a 510(k) premarket notification for the Instrumed Vascular Clamp, a reusable surgical instrument. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria or quantitative performance metrics are provided in the document for the Instrumed Vascular Clamps. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The reported device performance is qualitative, asserting that the new device is "completely comparable" to the predicate devices.

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

The document states that "non-clinical and bench testing" was conducted. However, it does not specify the sample size used for the test set.

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) submission for a surgical instrument, the non-clinical and bench testing would generally be prospective testing conducted by the manufacturer.

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

This information is not provided in the document. For a physical device like a vascular clamp, "ground truth" would likely be established through standardized engineering tests and material analyses, not through expert consensus in the typical sense of image-based or diagnostic devices.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation appears to be based on direct testing and comparison to predicate devices' specifications, not on expert adjudication of ambiguous cases.

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 typically conducted for diagnostic devices where human interpretation is a key component, not for surgical instruments like vascular clamps.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the performance of the vascular clamps would be based on:

• Engineering Specifications/Standards: Performance criteria related to material strength, clamping force, corrosion resistance, sterilization effectiveness, and biocompatibility, as defined by relevant industry standards (e.g., ASTM F 899-07 for Stainless Steel).
• Predicate Device Performance: The established performance characteristics and safety profile of the legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not provided and is generally not relevant for this type of device submission. There is no "training set" in the context of a physical surgical instrument; it's not a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no "training set" for this device.

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These titanium clamps are used for temporarily occlusion of blood vessels during surgery.

Vitalcor Featherweight clamps are made from Grade 5 titanium, Vitalcor Featherweight clamps are calibrated to have a clamping pressure that will minimize the possibility of vessel damage. As a guide, the following Vitalcor Featherweight sizes should be used for the vessels size range indicated.
VA079-06 0.4mm-1.0mm .
. VA115−09 0.6mm−1.5mm
VA140-09 1mm-2mm .
VA240-18 1.5mm-3mm .
VA300-24 2mm-4mm .
VA375-30 3mm-5mm .

The provided text describes a 510(k) submission for the Vitalcor Featherweight Vascular Clamps. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it does not contain information about a study proving the device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

The document focuses on establishing substantial equivalence through a comparison of physical characteristics, indications for use, and bench testing, rather than a clinical trial or performance study against pre-defined acceptance criteria in the way one might evaluate an AI-powered diagnostic device.

Therefore, for aspects of your request related to acceptance criteria for algorithmic performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies, the provided text does not contain the necessary information.

However, I can extract the relevant information from the document related to the comparison with the predicate device and the non-clinical testing performed.

Here's an attempt to answer your questions based solely on the provided text, acknowledging the limitations:

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

Based on the 510(k) summary, the device's "performance" is primarily assessed against the characteristics of the predicate device to establish substantial equivalence, rather than against explicit numerical acceptance criteria for clinical outcomes or diagnostic performance. The key performance characteristic mentioned is clamping pressure.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "non-clinical and bench testing data." It does not specify sample sizes for these tests, nor does it describe data provenance in terms of country of origin or retrospective/prospective nature. These tests are typically performed on the device itself (e.g., mechanical testing) rather than clinical data.

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

The document does not mention the use of experts to establish ground truth for performance data in the context of a clinical or retrospective study. The "ground truth" for this device's evaluation is primarily its adherence to established engineering principles and comparison to a legally marketed predicate device's characteristics and performance.

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

Not applicable. There is no mention of a test set requiring adjudication in the context of clinical or image-based assessment as described in your request.

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 MRMC comparative effectiveness study was reported. This type of study is not relevant for the evaluation of a mechanical vascular clamp. The submission focuses on substantial equivalence to a predicate device.

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

Not applicable. This device is a surgical instrument, not an algorithm. Therefore, "standalone algorithm-only performance" is not relevant.

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

For this type of device, the "ground truth" for safety and effectiveness is established through:

• Bench Testing: Verifying mechanical properties such as clamping pressure, material integrity, and sterility.
• Biocompatibility Testing: Ensuring the material is safe for contact with human tissue.
• Comparison to Predicate Device: Demonstrating that the new device shares fundamental technological characteristics and performance with an already legally marketed device that has a known safety and effectiveness profile.

The document states, "The results of non-clinical and bench testing indicates that the new device is completely comparable to the predicate devices. Biocompatibility and sterilization studies were successfully completed."

8. The sample size for the training set

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

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To temporarily occlude an artery or vein with correct tension to produce minimal trauma to vessels. The different sizes and models are designed according to the type and size of the blood vessels, anatomical sites, and surgical techniques. Bulldog clamps are self-closing and are used for small vessels. The closing pressure of the GLOVER clamps can be adjusted using a nut and spring.

Applying forceps are used to apply bulldog clamps in deep surgical wounds.

To secure vascular occlusion of small vessels during surgery and to secure vascular occlusion during pediatric surgery.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer for "Vascular Clamps." This type of document is an approval based on substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating the performance of the device against specific acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, and multi-reader comparative effectiveness studies is not present in this document.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...".

Therefore, I cannot provide the requested information based on the provided text.

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The Koala Vascular Clamps and Inserts are reusable, ring-handled stainless steel clamps for clamping delicate vessels during surgery. They are radiopaque, visualized under fluoroscopy. Designed for tip-first closure to prevent vessel roll-out. Applications include pulmonary, gastrointestinal procedures, peripheral clamping, thoracic procedures such as occlusion of the aorta and vena cave, cross-clamping of the aorta and aortic aneurysms, etc.

The Boss Instrument Koala Vascular Clamps and inserts are reusable, ring-handled stainless steel instruments which have inserts which reduce trauma to the tissue being clamped.

The provided text describes a 510(k) submission for the "Koala Vascular Clamps and Inserts," demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and a detailed performance evaluation of the device itself.

Therefore, many of the requested details, such as specific acceptance criteria and a study proving those criteria were met, are not available in the provided document. The document focuses on comparing the new device to an existing predicate device to establish substantial equivalence for regulatory approval.

Here's a breakdown based on the available information:

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

This information is not present in the provided document. The document asserts substantial equivalence to a predicate device based on attributes such as indicated use, design, packaging, and materials.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided document. The document describes a comparison to a predicate device, not a performance study of the Koala Vascular Clamps and Inserts with a test set.

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 information is not present in the provided document.

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

This information is not present in the provided document.

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 present in the provided document. This type of study is more relevant for diagnostic AI devices, not for surgical instruments like vascular clamps.

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

This information is not present in the provided document. This is not applicable to a physical surgical instrument.

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

This information is not present in the provided document. The basis for comparison is the characteristics and intended use of the legally marketed predicate device.

8. The sample size for the training set

This information is not present in the provided document. This is not applicable to a physical surgical instrument.

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

This information is not present in the provided document. This is not applicable to a physical surgical instrument.

Summary of what is available:

The document is a "Non-Confidential Summary of Safety and Effectiveness" for a 510(k) premarket notification. It aims to demonstrate that the "Koala Vascular Clamps and Inserts" are substantially equivalent to a legally marketed predicate device.

Predicate Device: Baxter V. Mueller - Fogarty Hydragrip Clamps and Inserts - K951413

Comparison to Predicate Devices (which serves as the "study" for substantial equivalence):

Differences between Other Legally Marketed Predicate Devices:
"The clamps are manufactured and supplied by the same manufacturer. The inserts are manufactured by different companies, but the base material is exactly the same. Therefore there are no significant differences between the intended device and the predicate - Baxter - V. Mueller - Fogarty -Hydragrip Vascular Clamps and inserts approved under K951413."

Conclusion of the FDA:
The FDA reviewed the 510(k) and determined that "the device is substantially equivalent... to legally marketed predicate devices."

This document does not provide a study with acceptance criteria for the Koala Vascular Clamps and Inserts themselves, but rather provides evidence for substantial equivalence to a known device, which is the basis for its regulatory clearance.

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