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Found 153 results
510(k) Data Aggregation
(146 days)
DXC
The radial compression device is designed to apply compression in order to achieve temporary hemostasis of the radial artery after a percutaneous transradial procedure.
The Radial Compression Device (RC-001) is designed to promote hemostasis of the radial artery post percutaneous puncture. The radial compression device is fixed on the arm and the square pad of the device is pressed against the puncture site. The square cushion is adjusted to apply pressure and temporarily compress the puncture site of the radial artery to achieve rapid hemostasis. The product is primarily composed of a plate, turn cap, screw rod, hook and loop band, tapered cushion, and square cushion. The Radial Compression Device is available in one model, RC-001.
This document describes a 510(k) premarket notification for the Ningbo DIZENGENS Medical Science Co., Ltd. Radial Compression Device (K232577). The document presents a summary of non-clinical performance testing to support the claim of substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and study results in the format requested.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance with specific metrics.
- Sample sizes used for a "test set" in the context of an algorithm's performance.
- Data provenance, number of experts, adjudication method, or ground truth details for an AI/algorithm study.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Sample size or ground truth establishment for a "training set."
The document primarily focuses on non-clinical performance testing for a physical medical device (a radial compression device), not an AI/software algorithm. The tests conducted are typical for a physical medical device.
Here's a breakdown of what is provided and what elements are missing or not applicable based on the provided text, in the context of your request for AI/algorithm study details:
1. Table of Acceptance Criteria and Reported Device Performance:
- Provided: A list of performance tests conducted. For each test, it states "All testing met the requirements and passed."
- Missing from provided text: Specific numerical acceptance criteria for each test and the corresponding numerical results obtained by the Radial Compression Device. For example, for "Bond strength testing," it doesn't state "Acceptance criteria: > X N, Result: Y N."
2. Sample size used for the test set and the data provenance:
- Not Applicable in the provided text: This question is relevant for AI/algorithm performance evaluation. The document describes tests for a physical device (e.g., visual inspections, bond strength, biocompatibility), not an AI model. Therefore, there's no "test set" of data in the context of AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the provided text: This question is relevant for AI/algorithm performance. Ground truth for a physical device's non-clinical performance tests is typically established through established engineering standards, laboratory procedures, and physicochemical measurements, not through expert consensus on images or clinical data.
4. Adjudication method for the test set:
- Not Applicable in the provided text: This is relevant for AI/algorithm performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No: The document does not mention any MRMC study, as it's for a physical device and not an AI assistant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No: The device is a physical Radial Compression Device, not an algorithm.
7. The type of ground truth used:
- Implicitly: For the physical device tests, the "ground truth" is based on engineering specifications, standardized test methods (e.g., ISO standards for biocompatibility and sterilization), and validated laboratory measurements. For instance, biocompatibility is evaluated per ISO 10993, and sterilization per ISO 11135.
- Missing from provided text: No explicit mention of ground truth in the context of expert consensus, pathology, or outcomes data, as these are typically for diagnostic AI/software.
8. The sample size for the training set:
- Not Applicable: There is no AI/algorithm training set.
9. How the ground truth for the training set was established:
- Not Applicable: There is no AI/algorithm training set.
Summary of Provided Non-Clinical Performance Testing:
The provided document lists the following non-clinical performance tests conducted for the Radial Compression Device:
- Visual inspections
- Dimensional inspections
- Bond strength testing
- Turn Cap and Screw Function
- Distribution and Packaging Tests
- Device and Packaging Aging Evaluation
- Pressure applied at puncture site (to demonstrate adequate compression)
- Biocompatibility evaluation per ISO 10993 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemolysis)
- Sterilization (EO gas, SAL of 10-6 per ISO 11135, EO/ECH residuals assessment per 10993-7)
For all of these tests, the document states: "All testing met the requirements and passed."
Conclusion:
The provided text serves as a 510(k) summary for a physical medical device. It details non-clinical performance testing for that physical device to establish substantial equivalence. It does not provide the information requested regarding acceptance criteria and studies for an AI/algorithm device, as the product is not an AI/algorithm.
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(264 days)
DXC
A surgical instrument used to occlude a blood vessel temporarily.
PICOCLAMP is Ethylene Oxide sterile single-use hemostasis clamp consisting of Polyetheretherketone (PEEK) and stainless steel (SUS series). PICOCLAMP is designed for use during surgery to temporarily occlude blood vessels during the anastomosis process. PICOCLAMP consists of three main direct patient-contacting parts, all of them are streilized; main body, axis, and spring. The body is consisting of two parts; the jaw which is used to occlude the blood vessel temporarily and the grip which functions to open and close jaws using the surgeon hand or the clamp forceps. The axis integrates the body and keep its parts intact. The spring functions to give clamping force to the jaws. Two types of clamps are provided: green color clamps used for arteries temporary occlusion and blue color clamps used for veins temporary occlusion. Both of the artery and vein clamp are having two types: single and double. PICOCLAMP is available in three different sizes; S (Small), M (Medium), and L (Large). PICOCLAMP is used for temporary occlusion of blood vessels with diameters ranging from 0.2mm to 2.0mm. The clipping power applied at the blood vessel differs depending on the size of the clamp and the pressure of the spring selected. Once the anastomosis process is complete, PICOCLAMP is removed from the patient.
This document is a 510(k) Premarket Notification from the FDA regarding the PICOCLAMP vascular clamp. It outlines the device's characteristics, indications for use, comparison with a predicate device, and the performance data submitted to demonstrate substantial equivalence.
Based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance. The document is a regulatory approval for a physical medical device (vascular clamp), not a software or AI/ML-driven device.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance using AI/ML, as the document does not pertain to such a device or study.
The performance data mentioned in the document are for:
- Sterilization & Shelf-life & Packaging Testing: This ensures the device remains sterile and functional over its shelf life and that its packaging is adequate.
- Biocompatibility Testing: This ensures the materials used in the device are safe for contact with biological tissues.
- Bench Performance Testing: This evaluates the physical performance of the clamp, such as clipping power, ability for repeated opening/closing, and resistance to dislodgement. These tests compare the proposed device (PICOCLAMP) to the predicate device to demonstrate substantial equivalence of their physical performance.
The document explicitly states:
- "Animal Performance Testing was not required to demonstrate safety and effectiveness of the device."
- "Clinical Performance Testing was not required to demonstrate the safety and effectiveness of the device."
In summary, none of the requested information regarding AI/ML acceptance criteria, test set sizes, expert ground truth, MRMC studies, standalone algorithm performance, or training set details can be extracted from this document, as it is completely unrelated to AI/ML device performance.
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(268 days)
DXC
The Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) is indicated for use to control bleeding in the pelvis, inguinal area, axilla and for pelvic fracture stabilization.
The AAJT-S device is a wedge-shaped bladder that when inflated pushes in on the body Over the target area of application. One of the target areas is the lower abdomen, over the umbilicus, compressing all the structures within, including the descending aorta, to achieve the physiological effects of aortic compression. The other two areas are over the inguinal region or the axilla. In these two areas the region is compressed with the wedge- shaped bladder including the major vasculature that runs through that area.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study to Prove |
|---|---|---|
| Pressure Maintenance: The AAJT-S must stay inflated and maintain the same pressure over the target area for at least a 4-hour period. | Confirmed successful inflation and pressure maintenance for at least a 4-hour period. | Pressure Testing |
| Component Bond Strength: The bonds of components to the hard cover must withstand normal tensile forces during clinical use. | Demonstrated ability to withstand normal tensile forces. | Force Testing |
| Biocompatibility (Cytotoxicity): No cytotoxic effects. | Passed ISO 10993-5 (in vitro cytotoxicity). | Biocompatibility Testing |
| Biocompatibility (Irritation & Skin Sensitization): No irritation or skin sensitization. | Passed ISO 10993-10 (irritation and skin sensitization). | Biocompatibility Testing |
| Wear Time (Stated Intended Use): Abdominal use: up to 1 hour; Junctional use: up to 4 hours. | Not explicitly stated as a test result, but the pressure test confirms the device maintains pressure for the maximum stated junctional use duration (4 hours). The increased wear time of 1 hour is also noted as a difference from the predicate device. | Pressure Testing implicitly supports junctional wear time. |
| Pelvic Fracture Stabilization: Indication for use. | Not explicitly stated what testing was conducted to prove this particular indication. The document refers to it as an "additional pelvic stability indication" compared to the predicate. | Not explicitly detailed in the provided text. |
Important Note: The provided text does not include specific numeric acceptance values (e.g., "maintain pressure within X mmHg of initial pressure"). It states the qualitative criteria and that the tests were performed to confirm or evaluate these criteria.
Missing Information:
- There are no explicit quantitative acceptance criteria or specific performance values reported for the pressure testing (e.g., pressure drop over time).
- Similarly, for force testing, no specific force values or deformation limits are given.
- The document doesn't detail how the "pelvic fracture stabilization" indication was specifically proven or what criteria were used for that.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify sample sizes for the performance tests (Pressure Testing, Force Testing, Biocompatibility Testing). It mentions these tests were "performed" but not the number of units or replicates used.
Data Provenance: Not applicable in the context of these non-clinical performance tests. These are laboratory tests conducted on the device itself, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. These are non-clinical performance tests conducted on the device, not clinical studies involving expert interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. This concept applies to clinical studies where experts might disagree on ground truth, requiring an adjudication process. The tests described are objective, non-clinical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The provided text describes non-clinical performance tests of the device itself (pressure, force, biocompatibility), not a clinical study involving human readers or comparative effectiveness with or without AI assistance. The device is a physical medical device (tourniquet), not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in the sense that the described tests are standalone device tests. The device's performance was evaluated independently without human-in-the-loop interaction as part of the test (beyond operating the test equipment). However, it's important to clarify that this refers to mechanical device performance, not AI algorithm performance.
7. The Type of Ground Truth Used
The "ground truth" for these non-clinical tests is based on objective physical measurements and established international standards:
- Pressure Testing: The ground truth is the measured pressure (e.g., using a pressure sensor) and its change over time.
- Force Testing: The ground truth is the applied force and the device's structural integrity under that force, measured by mechanical testing equipment.
- Biocompatibility Testing: The ground truth is determined by the results of standardized assays (e.g., cytotoxicity assays, irritation/sensitization tests) as per ISO 10993 standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is a physical device, not an AI model.
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(29 days)
DXC
VIOLA clampless proximal anastomosis sealing system is indicated for use by cardiac surgeons during coronary artery bypass grafting procedures to maintain hemostasis and facilitate the completion of proximal anastomoses to the aorta without application of an aortic clamp.
The VIOLA is a sterile, single-use device designed to maintain hemostasis and facilitate the completion of multiple proximal anastomoses during a coronary artery bypass grafting procedure, without application of an aortic clamp. The VIOLA system can be used to create up to 4 anastomoses within the same patient.
This modified version of VIOLA includes an ergonomic handle with operating button and a straight distal end.
The VIOLA is comprised of:
- A concentric 4 mm aortic punch with a detachable handle.
- A sealing assembly comprising of a sealing element (which is available in two diameters), a catheter, fixation strap and a handle.
- A silicone boundary marker stencil for marking the maximal suture line around the aortic incision.
The steps to create a sealed anastomosis hole that enables the surgeon to perform a clampless anastomosis include (1) the creation of a small "needle hole" (performed in the center of the boundary marker), (2) insertion and deployment of the sealing element, (3) creation of an anastomosis hole using the VIOLA's punch, and (4) performing the anastomosis.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) summary for a medical device called "VIOLA" and it focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions performance data in the form of "risk analysis," "bond strength testing," and "simulated use testing" that "passed successfully all acceptance criteria," but it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or their data provenance.
- Details about experts for ground truth or adjudication methods.
- Information on multi-reader multi-case studies or effect sizes.
- Details on standalone algorithm performance.
- The type of ground truth used.
- Sample size for the training set or its ground truth establishment.
The document primarily states that the modified device's technological characteristics are similar to the predicate and that performance data demonstrates it is as safe and effective.
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(166 days)
DXC
The Radial Artery Compression Tourniquet is designed for temporary hemostasis of radial artery post percutaneous puncture.
Radial Artery Compression Tourniquets
The provided document is a 510(k) clearance letter for the "Radial Artery Compression Tourniquets" and does not contain the specific information about acceptance criteria, device performance, study details, or AI-related data as requested. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but does not include the detailed technical study information you're looking for.
Therefore, I cannot provide the requested information based on the input text.
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(82 days)
DXC
GEM™ BIOVER disposable microvascular clamps are instruments which are used for all microsurgical procedures. They are used to occlude vessels during anastomosis, which is necessary as a result of vessel damage or thrombosis.
The GEM™ Biover Microvascular Clamps (Clamps) are arterial and venous clamps in both single and double clamp configurations, available in varying sizes. The clamps are sterile, disposable clamps for single use. The clamps are used in microsurgery, plastic surgery, and hand surgery for the temporary occlusion of blood vessels during an anastomosis.
The clamps are available for arteries and veins. The clamping force is higher for the arterial clamps than for the veinous clamps. The clamps are identified by a product reference code and by the color of the clamp. The clamps for veins are green, and the clamps for arteries are yellow.
The clamps are packaged individually in two Tyvek pouches (double pouched). The devices in the Tyvek pouches are gamma sterilized and are placed in cartons of 10. The clamps are used once and are disposed of after use.
This document is a 510(k) summary for the GEM™ Biover Microvascular Clamps, asserting their substantial equivalence to a previously cleared predicate device. This type of submission generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria in a robust statistical study.
Based on the provided text, the device is not an AI/ML powered device, nor is it a diagnostic device that requires high-level performance metrics, such as sensitivity, specificity, or AUC. The submission is for a physical medical device (microvascular clamps). Therefore, the information requested in the prompt regarding AI/ML performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment is not applicable to this document.
The document states:
- "The GEM Biover microvascular clamps remain unchanged from the predicate device."
- "There are no engineering or performance changes to the device or its packaging."
The "performance data" section mentions:
- "The label design change and the outer carton sales unit design change were assessed and validated in a Packaging Summative Human Factors/Usability Study."
- "Historical complaint data were reviewed and indicate no use-related concerns, thus, there are no use-related risks or complaints that trigger a need for further Human Factors validation."
This indicates that the "performance" considered for this submission relates to packaging and user interface (labeling/carton design), and the study conducted was a human factors/usability study, not a clinical performance study measuring accuracy or efficacy of a medical algorithm.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, AI/ML performance, and ground truth for a diagnostic or AI-powered device, as these details are not present and are not relevant to this type of device submission.
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(45 days)
DXC
The TR Band® is a compression device indicated to apply compression in order to achieve hemostasis while allowing the user to maintain patency of the radial artery after a transradial procedure (patent hemostasis).
The TR BAND® Radial Compression Device is a tourniquet style device consisting of a plastic belt with hook and loop adjustable fastener on each end, two compression balloons, and an injection port. The device also contains a TR Band Inflator.
After a transradial catheterization procedure, the TR Band is placed around the patient's wrist and the hook and loop strap is connected. Once the introducer sheath is removed from the patient's wrist, pressure is applied to the patient's access site by inflating the compression balloons of the TR Band. Both compression balloons are filled at the same time while air is being introduced through the air injection port.
The balloons are inflated when air is injected into the air injection port by the TR Band Inflator. The TR Band inflator is a specially designed syringe for use only with the TR Band. A valve on the air injection port assures that the air remains within the compression balloons. The volume of air can be reduced or increased by use of the TR Band Inflator (20ml syringe). This allows the physician to make fine adjustments to the pressure in the TR Band.
With the two compression balloons (large and small) the pressure is applied for efficient compression for hemostasis. The belt also has a support plate over the two compression balloons to assure that the balloons and belt conform to the contour of the wrist. The belt and compression balloons are made of clear plastic which allows the physician to view the access site during the hemostasis process.
The TR Band is a disposable device intended for single use only. This device is individually packaged and sterilized by ethylene oxide gas.
The provided text is a 510(k) Summary for the TR BAND® Radial Compression Device (K213531). It describes a submission for modifications to the Indications for Use and minor changes to the design of an existing device.
The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K152525 TR BAND® Radial Compression Device) and a reference device (K173563 ARC Adjustable Radial Cuff Compression Device).
Crucially, this submission explicitly states that it does not include data from clinical tests. Therefore, it does not describe a study that proves the device meets specific performance criteria based on clinical outcomes, nor does it establish ground truth for a test set using expert consensus, pathology, or outcomes data, as would be expected for an AI/ML medical device.
Based on the provided text, the device's acceptance is based on non-clinical performance testing and a comparison to a predicate device, not on a clinical study evaluating its effectiveness with human subjects or AI performance metrics.
Therefore, I cannot fill in most of the requested fields related to a clinical study, AI performance, or ground truth establishment. However, I can extract information regarding the non-clinical acceptance criteria and the testing done to meet them.
Here's the information that can be extracted and a clear explanation of what is not present:
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for Substantial Equivalence)
The document primarily focuses on demonstrating substantial equivalence to a predicate device by showing that the modified device has the same intended use, technology, materials, and comparable performance through non-clinical testing.
1. A table of acceptance criteria and the reported device performance:
| Parameter/Test Category | Acceptance Criteria (Implicit from Standards and General Device Requirements) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Performance Testing | Conformity to applicable external and internal standards; safety and effectiveness throughout shelf life; substantial equivalence to predicate. | "The TR BAND® Radial Compression Device tested met the predetermined acceptance criteria." "No issues of safety and effectiveness were raised with the testing performed." "The subject TR BAND® is safe and effective for its intended use." |
| Visual/Appearance | (Implicit: Device must be free of defects, meet specified appearance standards) | Met acceptance criteria. |
| Dimensional | (Implicit: Device must conform to specified dimensions) | Met acceptance criteria. |
| Functional Performance (e.g., Tensile, Torque, Shear Strength, Pressure, Leak tests) | (Implicit: Device components must perform as designed and withstand specified forces/pressures) | Met acceptance criteria. |
| Sterility | SAL 10-6 in accordance with ANSI / AAMI / ISO 11135-1 | Met acceptance criteria. (Sterilized by ethylene oxide gas, validated). |
| Material Biocompatibility | (Implicit: Biocompatible for contact with patient, as per predicate) | Materials are comparable to predicate, primarily PVC, Nylon, Polycarbonate, MABS, EPDM, Stainless Steel. |
| Shelf Life | 30 months (Same as predicate) | Device maintained performance throughout shelf life. |
| Packaging Integrity | Meet standards for sterile barrier systems and shipping (ASTM F1980-16, ASTM D4169-14, ASTM F88/F88M-15, ASTM F2825-18) | Met acceptance criteria. |
| Risk Analysis | New risks adequately captured and mitigated, no new issues of safety or effectiveness identified (ISO 14971) | "Any new risks were adequately captured and mitigated, and there were no new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific non-clinical tests. Standard engineering and quality testing typically uses a defined number of units, but this detail is not provided in a summary document like this.
- Data Provenance: The tests were conducted internally by Terumo Medical Corporation or by their contracted sterilization facility (Steris Isomedix Services Inc.). The data is from non-clinical, laboratory-based performance testing of the device prototypes/production samples. It is not patient or clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This submission relies on non-clinical engineering and performance testing against established standards and equivalence to a predicate device, not on expert-based clinical ground truth.
4. 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.
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 study was not conducted. This device is a mechanical compression device, not an AI/ML-driven diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground truth in this context is based on engineering specifications, adherence to recognized industry standards (e.g., ASTM, ISO), and direct comparison to the performance characteristics of the legally marketed predicate device. There is no "clinical ground truth" established in this submission.
8. The sample size for the training set:
- N/A. Not applicable, as this device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- N/A. Not applicable.
Summary of Study Type:
The "study" described in this 510(k) summary is a non-clinical performance and engineering validation study focused on demonstrating substantial equivalence to a predicate device. It involves:
- Bench testing: Evaluating physical and functional characteristics (e.g., tensile strength, leak tests, dimensions).
- Sterilization validation: Ensuring the device can be consistently sterilized to required levels.
- Packaging integrity testing: Verifying the packaging maintains sterility and protects the device.
- Shelf-life testing: Confirming the device retains its properties over its stated shelf life.
- Risk analysis: Identifying and mitigating potential risks associated with the device.
The statement "This 510(k) does not include data from clinical tests" (page 10) explicitly confirms that the acceptance of this medical device (based on this specific submission) is not predicated on human clinical trial data or performance in a patient population to demonstrate its effectiveness or safety. Instead, it relies on the similarity to a device already deemed safe and effective, supported by robust non-clinical testing.
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(29 days)
DXC
The SiteSeal SV is a compression device to assist hemostasis of the radial artery after a transradial procedure or the brachial artery after a transbrachial procedure.
Not Found
I am sorry, but the provided text from the FDA letter is a notification of substantial equivalence for a physical medical device (SiteSeal SV, a vascular clamp), not an AI/ML software device.
Therefore, the document does not contain any information about:
- Acceptance criteria for software performance
- Any study proving a device meets acceptance criteria via AI/ML methods
- Sample sizes for test or training sets
- Data provenance
- Number or qualifications of experts for ground truth
- Adjudication methods
- MRMC studies or human reader improvement with AI
- Standalone algorithm performance
- Types of ground truth used for AI models
- How ground truth was established for training data
Thus, I cannot fulfill your request as the necessary information regarding AI/ML device performance and testing is not present in the provided text.
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(59 days)
DXC
The MI DeTACH® is indicated for use for temporary or partial occlusion of blood vessels during cardiovascular surgical procedures.
The MI DeTACH® is comprised of a Detachable Aortic Clamp Head and a Delivery System. The MI DeTACH® Detachable Aortic Cross Clamp Head is available in three sizes: Small, Medium, and Large (55mm, and 85mm enqagement pads respectively) which are packaged and distributed separately. The Delivery System is comprised of a Delivery Device and Quick Release Device. The Delivery Device is used to deliver, clamp, deploy, unclamp, and retrieve the Clamp Head from the target occlusion site.
The MI DeTACH® Detachable Aortic Cross Clamp Head works by applying compression forces to the vessel by the padded device jaws. The top jaw is a pivot jaw allowing for parallel closure of the vessel during clamping. The amount of compression applied to the vessel for occlusion or partial occlusion is determined or adjusted by the means of the Delivery Device lever actuated jaw closure mechanism. The Clamp Head device contains ratchets that provide clamping tactile feedback to the user. A clutch mechanism prevents the user from applying excessive forces to the vessel by disengaging the lever from the device when specific force is obtained. Upon successfully clamping, the device locks and the handle is then detached leaving the clamp in the body throughout the duration of the procedure. The Delivery Device is then used to unclamp and remove the Clamp Head from the body upon procedure completion. In the event the Delivery Device becomes compromised during the course of a procedure, the Quick Release Device can be used to unclamp and remove the Clamp Head from the body.
The provided text is a 510(k) summary for the MI DeTACH® vascular clamp. This document is a regulatory submission to the FDA, demonstrating that a new device is "substantially equivalent" to legally marketed predicate devices.
It is crucial to understand that this document does NOT describe the acceptance criteria for an AI/ML device, nor does it describe a study involving AI/ML performance.
The MI DeTACH® is a physical medical device (a vascular clamp), and the "performance data" section refers to non-clinical testing for safety and functional requirements of this mechanical device, not AI/ML performance.
Therefore, I cannot extract the requested information (acceptance criteria, study details for AI/ML, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, or ground truth establishment for a training set) because this document does not pertain to an AI/ML device.
The "Performance Data" section (VII) outlines non-clinical testing performed to support the substantial equivalence of the MI DeTACH® to its legally marketed predicate devices. This includes:
- Design Verification and Validation Testing: This confirmed the product meets its requirements through:
- Vessel Occlusion Testing
- Clamping Force Distribution Testing
- Human Factors/Usability Studies
- Simulated Use Testing
- Sterilization and Shelf Life Testing: Confirmed product safety and effectiveness for both the sterile clamp head and the non-sterile delivery system, including cleaning, sterility, fatigue, and packaging/transport testing.
- Biocompatibility Testing: Conducted in accordance with FDA guidance and ISO 10993-1, including:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogen Testing
- Hemolysis
The document explicitly states that "Animal testing was not required" and "Clinical testing was not required" to demonstrate substantial equivalence.
In summary, the provided text does not contain any information relevant to the AI/ML-related questions you have asked.
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(28 days)
DXC
The V. Mueller Cosgrove™ Flex Clamps are indicated to occlude a blood vessel temporarily. Used in pulmonary and gastrointestinal procedures and can be used to clamp over indwelling catheters. Also used in minimally invasive and standard open cardiovascular procedures for temporary occlusion of a blood vessel.
Each V. Mueller Cosgrove™ Flex Clamp device consists of a ring handle, flexible shaft and jaw. The design of the flexible shaft allows the end user to bend the shaft following clamping of the blood vessel providing the user a clear field of visualization to the surgical site.
The proposed device and the predicate device have a similar design, the same materials and the same manufacturing and fabrication methods/processes. The main difference between the subject device and the predicate device is a change to the wire configuration of the cable. In addition, the cleaning and sterilization instructions in the instructions for use were updated in accordance with current guidance. These changes do not raise different questions of safety or effectiveness.
The provided text describes a 510(k) premarket notification for a medical device called "V. Mueller Cosgrove Flex Clamps." This device is a vascular clamp used to temporarily occlude blood vessels.
Based on the provided text, there is no information about a study proving the device meets acceptance criteria related to an AI or algorithm-driven system. The document, K210324, is for a physical medical device (vascular clamps) and its substantial equivalence to previously marketed predicate devices. The "Performance Data" section explicitly states: "N/A - No clinical tests were conducted for this submission." and "The results of the non-clinical tests demonstrate the V. Mueller Cosgrove™ Flex Clamps meet all performance requirements and are substantially equivalent to the predicate devices."
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/algorithm-driven device, as this document is not about such a device. The "acceptance criteria" and "performance data" discussed in the document relate to the physical properties, reusability, sterilization, and biocompatibility of the vascular clamp itself, as demonstrated by non-clinical tests.
If you intended to ask about a different document or a different type of device, please provide that information.
However, I can extract and present the existing acceptance criteria and performance data for the V. Mueller Cosgrove Flex Clamps as presented in the document, though it won't match the format for an AI/algorithm study:
Acceptance Criteria and Device Performance for V. Mueller Cosgrove Flex Clamps (K210324)
1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Characteristic) | Standard / Test / FDA Guidance | Reported Device Performance (Summary of Results) |
|---|---|---|
| Instrument strength | Strength Tests, Life Cycle Test | PASS |
| Device must be reusable | Cleaning and Sterilization Tests | PASS |
| Device is able to be cleaned and sterilized | AAMI TIR12, AAMI TIR30, ANSI AAMI ST79, ISO 11138, ISO 17664, ISO 17665 | PASS |
| Device materials are biocompatible | ISO 10993 | PASS |
Note: These criteria pertain to the physical characteristics and functionality of the vascular clamp, not to an AI or algorithm.
Regarding the other points you requested for an AI/algorithm study, they are not applicable to this document as it concerns a physical medical device:
- Sample size used for the test set and the data provenance: Not applicable. The performed tests are non-clinical (e.g., strength tests, material biocompatibility tests), not involving data sets like those for AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI validation (e.g., expert consensus on medical images) is not relevant here. Device testing would be performed by qualified engineers/technicians according to established protocols.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an AI.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, "ground truth" would be the engineering specifications and performance standards (e.g., tensile strength, sterilization efficacy), which are determined by established scientific methods and industry standards. It's not a "truth" derived from human interpretation of data in the AI sense.
- The sample size for the training set: Not applicable. This device is not an AI.
- How the ground truth for the training set was established: Not applicable. This device is not an AI.
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