Search Results
Found 19 results
510(k) Data Aggregation
(272 days)
Gelweave Vascular Prosthesis (with the exception of Valsalva variant) are indicated for the repair of damaged and diseased vessels of the thoracic and abdominal aorta in cases of aneurysm, dissection or occlusive disease. Branched configurations can also be used for debranching, i.e. reconstruction of the aortic vessels and associated Hybrid procedures. Hybrid procedures are defined as a treatment combination employing open surgical debranching with endovascular aortic repair.
Gelweave Valsalva Vascular Prosthesis are indicated for the repair or replacement of damaged and diseased thoracic aorta, such as aortic root replacement in cases of aneurysm or dissection.
Gelweave™ vascular prostheses are gelatin sealed woven polyester prostheses designed for vascular repair. The Gelweave™ polyester vascular prostheses family, which is this pre-market notification, is based on woven polyester textile technology.
The provided document describes the clearance of a medical device, the Gelweave™ Vascular Prostheses, based on substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study that proves a device meets specific performance criteria in the context of AI/ML or diagnostic performance evaluation.
Therefore, I cannot extract the requested information (performance metrics, sample sizes, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC study details) from the provided text.
The document states:
- "No clinical testing was necessary to demonstrate substantial equivalence."
- "Nonclinical testing, including bench testing, shelf-life, biocompatibility testing, chemical characterization and an animal performance study, have been conducted to demonstrate equivalency."
This indicates that the clearance was based on non-clinical data and equivalence to an existing device, rather than a study evaluating diagnostic or clinical performance against specific acceptance criteria relevant to AI/ML devices.
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(210 days)
Gelsoft™ Plus Vascular Prostheses are indicated exclusively for vascular repair of damaged and diseased vessels of the abdomen, i.e. replacement or bypass in aneurysmal and occlusive disease of abdominal arteries.
Gelsoft™ Plus vascular prostheses are gelatin sealed knitted polyester prosther repair. The Gelsoft™ Plus polyester vascular prosthesis family, which is the subject of this pre-market notification, is based on knitted polyester textile technology.
The provided text describes a 510(k) premarket notification for a medical device called Gelsoft™ Plus Vascular Prostheses. This submission is to demonstrate substantial equivalence to a legally marketed predicate device (K162803 Vascutek Gelsoft™ Plus Vascular Grafts).
The information provided does not include details about acceptance criteria, the specific study conducted, or device performance metrics as would typically be found in a study report. The document states:
"Nonclinical testing, including bench testing, shelf-life, biocompatibility testing, chemical characterization and an animal performance study, have been conducted to demonstrate equivalency. No clinical testing was necessary to demonstrate substantial equivalence."
This indicates that the assessment of substantial equivalence was based entirely on non-clinical data, and therefore, many of the requested categories in your prompt are not applicable to this type of submission.
Here's an analysis based on the information available in the provided text, addressing your points where possible:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific reported device performance metrics. Instead, it states that "nonclinical testing... have been conducted to demonstrate equivalency." This implies that the acceptance criteria would be that the new device's performance in these non-clinical tests is equivalent to, or within acceptable predefined limits compared to, the predicate device. However, these specific criteria and results are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the non-clinical tests (bench, shelf-life, biocompatibility, chemical characterization, animal study).
- Data Provenance: Not specified. The applicant is Vascutek Ltd. in the United Kingdom, so the studies likely originated from there or a related testing facility. The studies are non-clinical, not human-patient based, so terms like "retrospective" or "prospective" are not applicable in the usual sense.
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. This was a non-clinical assessment, not requiring expert consensus on clinical findings. The "ground truth" would be established by standardized testing methods and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like "2+1" are used in clinical studies where multiple human readers interpret data. This premarket notification is based on non-clinical tests.
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 vascular prosthesis and 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. This device is a vascular prosthesis, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests would be based on:
- Established physical and chemical properties measured through bench testing.
- Standardized biocompatibility assessments (e.g., cytotoxicity, irritation).
- Observed effects in an animal model (for the animal performance study).
- Chemical characterization data.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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(282 days)
Gelseal™ Vascular Prostheses: "Indicated for replacement or bypass of abdominal arteries afflicted with aneurysmal or occlusive disease."
Gelsoft™ Vascular Prostheses: "Indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries."
Gelsoft™ Plus Vascular Prostheses: "Indicated exclusively for vascular repair of damaged and diseased vessels of the abdomen, i.e. replacement or bypass in aneurysmal and occlusive disease of abdominal arteries."
Gelseal. Gelsoft and Gelsoft Plus vascular prostheses are gelatin sealed knitted polyester prostheses, designed for vascular repair.
The Vascutek Gelseal, Gelsoft and Gelsoft Plus polyester vascular prosthesis family, which is the subject of this pre-market notification, is based on knitted polyester textile technology.
This is a medical device submission for a vascular graft. The document is a 510(k) summary and FDA clearance letter. It does not describe a study involving an algorithm or AI. Instead, it describes a device (vascular grafts) and its equivalence to predicate devices based on non-clinical testing.
Therefore, many of the requested categories related to algorithm performance, ground truth, expert review, and sample sizes for AI/algorithm studies are not applicable.
Here's the information that can be extracted, with notes on what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document states: "The nonclinical testing performed, including physical and biocompatibility testing, chemical characterisation and an animal performance study, have demonstrated that the device is substantially equivalent the predicate devices."
However, specific acceptance criteria and reported numerical performance metrics for these nonclinical tests are not detailed within this document. The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance rather than presenting detailed test results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in this document for the nonclinical tests.
- Data Provenance: Not specified, but the tests were performed by the manufacturer, Vascutek Ltd., which is based in Scotland, UK. The studies would have been prospective to generate the data for this submission.
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. This device is a vascular graft, not an AI/algorithm-based diagnostic or prognostic tool requiring expert review of data for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/algorithm study requiring adjudication of expert interpretations.
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. No AI component is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No algorithm is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the nonclinical tests mentioned (physical, biocompatibility, chemical characterisation, animal performance study), the "ground truth" would be established by the defined test methodologies and objective measurements for each test, compared against predetermined specifications or predicate device performance. For example, for biocompatibility, it would be compliance with ISO standards (e.g., ISO 10993).
8. The sample size for the training set
Not applicable. There is no algorithm or AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no algorithm or AI model requiring a training set.
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(269 days)
Indicated for thoracic reconstruction procedures for replacement of the thoracic aorta in cases of aneurysm, dissection, or coarctation.
Indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.
Indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation.
Indicated for repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation.
Repair or replacement of damaged and diseased vessels of the thoracic aorta in cases of aneurysm, dissection or coarctation.
Gelweave branched vascular prostheses, including Siena™ vascular prostheses can also be used for debranching, i.e. reconstruction of the aortic vessels and associated Hybrid procedures. Hybrid procedures are defined as a treatment combination employing open surgical debranching with endovascular aortic repair.
Gelweave™ vascular prostheses are gelatin sealed woven polyester grafts, designed for vascular repair.
The Vascutek Gelweave polyester vascular graft family, which is the subject of this pre-market notification, is based on woven polyester textile technology.
The provided document is a 510(k) Summary for the Vascutek Gelweave™ Vascular Grafts. It discusses substantial equivalence to previously marketed devices and the non-clinical testing performed. However, it does not contain the specific information required to answer your request regarding acceptance criteria and performance studies of a medical device AI/ML algorithm.
The document pertains to a physical medical device (Gelweave Vascular Grafts) and its material change (new gelatin supplier), not an AI/ML system. Therefore, details like AI model performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable and not present in this document.
In summary, none of the requested information to describe the acceptance criteria and study proving device meets the acceptance criteria for an AI/ML device is available in the provided text.
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(27 days)
Gelweave™ branched vascular grafts: "Repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation".
"Gelweave™ branched vascular grafts, including Siena™ grafts can also be used for debranching i.e. reconstruction of the aortic vessels and associated Hybrid procedures".
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding the "Gelweave™ Branched Vascular Grafts with Radiopaque Markers." This document officially clears the device for marketing based on substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that would be typically found in a clinical study report or a detailed technical submission.
Therefore, I cannot provide the requested information from the given text.
The document primarily states:
- The device name and its classification (Class II, Product Code DSY).
- The indications for use (repair or replacement of damaged/diseased vessels of the abdomen and thoracic aorta, and debranching/hybrid procedures).
- That the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
- General regulatory requirements for the manufacturer.
To answer your questions, one would need to review the actual 510(k) submission document (which is typically much more extensive than this clearance letter) or a separate clinical study report from the manufacturer.
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(21 days)
Creation of subcutaneous arteriovenous conduits for blood access, bypass or reconstruction of occluded or diseased arterial blood vessels.
Not Found
The provided text is a letter from the FDA regarding the clearance of a medical device, Vascutek Maxiflo and Taperflo ePTFE Vascular Prostheses. It is a regulatory document and does not contain any information about acceptance criteria, study details, or device performance data.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from this document. My response is based solely on the provided text.
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(75 days)
"bypass or reconstruction of peripheral arterial blood vessels".
The Vascutek Cobrahood™ vascular grafts are still intended for prescription use only.
Vascuteks ePTFE vascular grafts were originally cleared by FDA in 1999 (K992832: unsealed and K993667: gelatin sealed). In 2004, Vascutek received clearance for the application of an external ePTFE wrap to the original FDA cleared ePTFE vascular graft range (K041528). As a result of development in line with design control procedures, it became possible to flare the end of a standard wrapped ePTFE graft to create the Cobrahood™ design as shown in Figures 1a and 1b of this submission. The intended use is, "bypass or reconstruction of peripheral arterial blood vessels".
All Vascutek ePTFE grafts are manufactured from virgin expanded polytetrafluoroethylene resin, including the ePTFE external wrap. Cobrahood™ ePTFE vascular grafts are not sealed, i.e. do not have an external gelatin coating. The grafts are available with or without an external support constructed of PTFE. This is identical to the support present on the predicate devices, cleared by FDA in 2005 (K041528).
All Vascutek ePTFE vascular grafts are supplied sterile. The method of sterilization is Ethylene Oxide. A shelf-life of five years has been established. All related parameters remain unchanged to the predicate grafts.
The Cobrahood™ ePTFE vascular graft range is detailed fully in Table 2 of this submission. Manufacturing drawings are provided in Attachment I.
The document provided is a 510(k) summary for the Vascutek Cobrahood™ ePTFE Vascular Grafts and the FDA's clearance letter. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance against those criteria in a typical clinical study.
Therefore, the information regarding acceptance criteria and a study proving the device meets those criteria will be interpreted in the context of a 510(k) submission, specifically focusing on bench testing for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Mechanical/Physical Properties: Tests to ensure Cobrahood™ grafts meet established standards for ePTFE vascular grafts and are comparable to predicate devices. (Specific tests or quantitative criteria are not detailed in the summary, but implied by "physical testing"). | All samples tested passed the relevant acceptance criteria. Results demonstrated that the Cobrahood™ ePTFE vascular grafts are substantially equivalent to the predicate devices (Vascutek MAXIFLO™ Wrap Grafts and IMPRA Inc. Distaflo Bypass Grafts). |
| Material Composition: Use of virgin expanded polytetrafluoroethylene resin for both graft and external wrap. | The device uses the same materials of construction (virgin expanded polytetrafluoroethylene resin, including the ePTFE external wrap) as the predicate devices. |
| Sterilization Method: Ethylene Oxide. | The device is supplied sterile via Ethylene Oxide. Method unchanged from predicate. |
| Shelf-Life: 5 years. | A shelf-life of five years has been established, and all related parameters remain unchanged to the predicate grafts. |
| Intended Use: Bypass or reconstruction of peripheral arterial blood vessels. | The intended use is "bypass or reconstruction of peripheral arterial blood vessels," identical to the predicate. |
| Technological Characteristics: No changes to materials, sterilization, packaging, or shelf life compared to predicates. | The device has the same technological characteristics as the predicates; no changes to materials of construction, sterilization, packaging, or shelf life. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "All samples tested" for bench testing, but does not provide the number of Cobrahood™ grafts or predicate grafts used.
- Data Provenance: The bench testing was conducted by Vascutek Ltd. in Scotland. It is a retrospective comparison against previously cleared predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable in the context of this 510(k) submission. The "ground truth" for demonstrating substantial equivalence against predicate devices is established through engineering and performance specifications, and comparison of physical characteristics and bench test results, rather than expert consensus on clinical outcomes or images. The "ground truth" is effectively the established performance and characteristics of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or clinical adjudication. Substantial equivalence is determined by comparing design, materials, and performance data from bench tests.
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 vascular graft, not an AI-powered diagnostic or interpretive tool. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the bench testing was primarily the engineering specifications and established performance characteristics of the predicate devices, against which the Cobrahood™ graft's physical and performance data were compared. The objective was to show that the new design (flared outflow) did not alter the safety and effectiveness, and that the performance remained unchanged, thereby achieving substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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(73 days)
Gelweave "M branched vascular graffs: "Repair of replacentent of damaged and diseased vessels of the abdomen and thoracic aorta in cases of anewrysm, dissection or courclation". Sicua TM grafts vascular with and without Gelweave radiopaque markers: "Repair or replacement of damaged and diseased vessels of the thoracie aorta in cases of anew ysm, dissection or coarctation". "Gelweave" brunched vascular grafts, including Siena" grafts can also be used for debranching i.e. reconstruction of the aortic vessels and associated Hybrid procediires".
The design and all other properties of the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers remain unchanged. The Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers function as vascular grafts manufactured from standard polyester and gelatin sealant technologies.
The provided document describes the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers. This submission (K090987) is for an expanded indication for use of existing devices, not a new device. Therefore, the "acceptance criteria" and "device performance" are focused on demonstrating that the expanded indication does not compromise the safety and effectiveness of the unchanged device.
Here's a breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an expanded indication for an existing device with no changes in design, materials, or manufacturing, the acceptance criteria are not in terms of specific performance metrics for the device itself (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria revolve around demonstrating that the device's fundamental performance characteristics (sealing properties) are maintained even with procedures related to the expanded indication.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Maintenance of Sealing Properties | The insertion and manipulation of an endovascular delivery catheter through a side branch of the graft should not alter the sealing properties of the graft or cause structural damage leading to blood leakage. This is within the context of forces and procedures that exceed those expected in an operating room. | For verification, a 26 F introducer was inserted into the 10mm side branch of 21 Gelweave grafts. The introducer and side branch were tied to allow back and forth movement. The graft was then pressurized with citrated horse blood to 120 mm/Hg. During pressurization, the delivery catheter was deliberately pushed into the main body of the Gelweave graft (i.e., forced onto the graft body wall) 10 times over a 2-minute period. This force and number of manipulations far exceeded what a surgeon would use in the operating room. Any blood lost was collected and weighed. Results showed that the insertion of the delivery catheter under these exaggerated conditions did not alter the sealing properties of the graft (i.e., did not cause damage resulting in blood leakage). |
| Clinical Equivalence to Predicates | The use of the device for debranching and hybrid procedures, as an expanded indication, should be considered standard clinical practice and not introduce new safety or effectiveness concerns compared to existing practices and predicate devices. | A comprehensive review of the literature regarding the clinical use of standard branched polyester vascular grafts for debranching and associated hybrid procedures was provided. The document states that these procedures are considered standard clinical practice and an alternative treatment option for aortic repair, especially for high-risk patients who cannot tolerate conventional open surgical repair. The submission argues that the expanded indication does not change the overall intended use or affect the safety and effectiveness of the device when used as labelled. |
| No Material/Design Changes | There should be no changes to the design, materials, packaging, sterilization, shelf life, or any other parameters of the device itself. | The submission explicitly states: "There are no other changes to the products i.e. there are no changes to the design, materials, packaging, sterilisation, shelf life or any other parameters. The only change is a request for an expanded indication for use." And "These devices have the same technological characteristics as the predicates i.e. there are no changes to the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers other than the request for an expanded indication." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 21 Gelweave grafts were used for the bench testing.
- Data Provenance: The bench testing was conducted by Vascutek Ltd. (Scotland, United Kingdom). The clinical information provided was a "comprehensive review of the literature in relation to clinical use of standard branched polyester vascular grafts," implying retrospective data from published studies and clinical opinions globally.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated as a defined number of individual experts for establishing a ground truth. Instead, the submission relies on "clinical opinion" and "available literature" for the clinical context of the expanded indications.
- Qualifications of Experts: Not specified. It refers to "clinical opinion" generally, implying established consensus within the surgical community regarding debranching and hybrid procedures.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the context of this submission. The bench testing involved objective measurement of blood leakage, not a qualitative assessment requiring adjudication. The clinical justification relied on a literature review, not individual case adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC comparative effectiveness study was not done. This submission focuses on expanding the indications for an existing physical device, not on the performance of a diagnostic algorithm or a device requiring human reader interpretation.
6. If a Standalone Study Was Done
- Yes, a standalone bench test was done to assess the physical integrity and sealing properties of the device under conditions related to the expanded indication. This test measured blood leakage after mechanical manipulation of a delivery catheter through the graft's side branch.
- The clinical justification was a standalone literature review, not a clinical study involving human subjects for this specific submission.
7. The Type of Ground Truth Used
- For the bench testing, the "ground truth" was quantifiable physical measurement (weight of blood lost) to determine if the graft's sealing properties were maintained.
- For the clinical justification, the "ground truth" was established by expert consensus and outcomes data as reflected in the "available literature and clinical opinion" regarding the standard practice of debranching and hybrid procedures with similar grafts.
8. The Sample Size for the Training Set
- Not applicable. This submission is for an expanded indication of an existing physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this is not an AI/ML algorithm submission.
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(252 days)
This device is intended to be used in axillary arterial perfusion during cardiopulmonary bypass procedures. These devices are indicated for up to 6 hours of use.
The Vascutek Cannula Graft is a modified device design. It is a combination of a Terumo Soft-Flow® Aortic Cannula (K934127) and a Vascutek SEALPTFE Wrap graft (K041528). It is intended for use in perfusion during cardiopulmonary bypass procedures. The reason for the modification is summarised as follows. Direct introduction of a cannula tip into a patient's blood vessel may cause tissue trauma during attachment of the patient to a cardiopulmonary bypass machine. Replacement of the cannula tip with a softer, SEALPTFE Wrap vascular graft, maybe less traumatic and be preferred by some surgeons. This is the design rationale for the Vascutek Cannula Graft.
There are no new materials used in the Vascutek Cannula Graft, other than the use of medical grade adhesive to create the bond between the Terumo Soft-Flow® Cannula (K934127) and Vascuteks SEALPTFE Wrap graft (K041528). Both predicate devices use materials with an extensive history of use in cardiovascular and other medical applications and have been thoroughly tested historically for their respective 510(k) clearances. All materials used in the manufacture of the Vascutek Cannula Graft are biocompatible and non-toxic.
The physical properties of the combined predicate devices i.e. the Terumo Soft-Flow® Aortic Cannula (K934127) and the Vascutek SEALPTFE Wrap graft (K041528) remain unchanged and the point of attachment of the component devices has been tested and shown to be suitable for the intended use.
The Vascutek Cannula Graft is a finished product, provided sterile for single use only.
The overall length of the Vascutek Cannula Graft is approximately 50 cm and the cannula and graft portions are both 8 mm in diameter. The Vascutek Cannula Graft is only available in a single model i.e. a CGS2008S.
The provided text is a 510(k) summary for a medical device (Vascutek Cannula Graft) and does not describe a study involving an AI/CADe device with acceptance criteria, human readers, or ground truth establishment in the way requested.
The document discusses the substantial equivalence of the Vascutek Cannula Graft to existing predicate devices based on:
- Intended Use: Axillary arterial perfusion during cardiopulmonary bypass procedures for up to 6 hours.
- Design and Materials: A combination of a Terumo Soft-Flow® Cannula and a Vascutek SEALPTFE Wrap graft, with medical grade adhesive at the attachment point.
- Performance: Studies focused on the attachment site, specifically tensile strength and leak testing.
- Principles of Operation and Technology: Used in open-heart surgery to return oxygenated blood to the patient.
Here's an attempt to answer your questions based only on the provided text, acknowledging that many details you requested (especially those related to AI/CADe studies) are not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile Strength: Strength of the attachment site | Demonstrated that the strength of the attachment of the two combined devices was greater than the tensile strength of the predicate Terumo Soft-Flow® Cannula itself (K934127). This was also demonstrated after 2 years accelerated aging. |
| Leakage: Absence of leaks at the attachment site | No leakage was observed, demonstrating equivalence to both predicate devices. This was also demonstrated after 2 years accelerated aging. |
| Biocompatibility/Non-toxicity: For new materials (adhesive) | The medical grade adhesive used at the point of attachment has undergone comprehensive biocompatibility testing, which demonstrates that it is biocompatible and non-toxic. |
| Stability: Over the product's expiry (2 years) | Testing on aged and non-aged Vascutek Cannula Grafts found the device to be stable over the expiry of the product (2 years). |
| Substantial Equivalence: In intended use, design, materials, performance, principles of operation, and technology to predicate devices. | The document concludes that the Vascutek Cannula Graft is substantially equivalent to the predicate devices. |
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 does not specify the sample size (e.g., number of devices tested) for the tensile strength, leakage, or accelerated aging tests. The provenance of the data is not explicitly mentioned (e.g., country of origin, retrospective/prospective), but the manufacturer is based in Renfrewshire, Scotland, United Kingdom.
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 a physical device, not an AI/CADe system. Therefore, the concept of "experts used to establish ground truth" related to image interpretation or diagnosis does not apply. The performance tests (tensile strength, leak testing) would have been conducted using established engineering and laboratory methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/CADe study involving subjective assessments or interpretation.
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 is a physical medical device (cannula graft), not an AI/CADe system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of AI/CADe systems. For this physical device, the "ground truth" for the performance criteria would be objective measurements from laboratory tests (e.g., force required for material failure, observation of liquid leakage, chemical analysis for biocompatibility).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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(13 days)
THIS DEVICE IS INTENDED TO BE USED AS A TEMPORARY BYPASS SHUNT IN LIMB THREATENING TRAUMA CASES WHERE THERE HAS BEEN DAMAGE TO A MAJOR BLOOD VESSEL
The Temporary Limb Salvage Shunt is a hybrid of two types of commercially available grafts, Rapidax™ (G060186) and MAXIFLO™ (K992832). The Vascutek Rapidax™ graft comprises an internal ePTFE vascular graft and an external eRTFE layer. These are identical to those used in the manufacture of the MAXIFLOTM Wrap grafts. In the Rapidax™ graft these surfaces sandwich a self-sealing elastomer membrane. Vascutek Rapidax™ and MAXIFLO™ Wrap grafts are manufactured from virgin valouter. This PTFE resin is identical to the porycollandoroun-florio (facture of Vascutek's other approved ePTFE vascular grafts. The differences associated with the Temporary Limb Salvage Shunt are summarized as: The absence of the outer ePTFE layer, The addition of a PTFE external support at both ends and middle of the TLSS, The addition of measurement markings along the surface of the TLSS. The Temporary Limb Salvage Shunt is an ePTFE vascular prosthesis which has been modified to facilitate its use as a temporary limb salvage shunt. The device includes an modified to facilitate, external support and graduated markings to allow assessment of depth of insertion. The externally supported bevelled ends facilitate the placing of the device within the severed artery. The support in the centre of the device is required if a shorter length is needed to enable the trauma surgeon to cut the device to the required length. The self-sealing membrane permits drugs to be administered directly into the lumen without loss of ooaling mombrans pormatings assist the surgeon in placement of the correct length.
The provided text is a 510(k) summary for the Vascutek Temporary Limb Salvage Shunt (TLSS). It details the device's description, intended use, and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or performance metrics in the format requested.
The 510(k) process for this type of medical device (a vascular clamp/shunt) primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific performance criteria against a predefined set of metrics through a separate study with statistical endpoints.
Therefore, many of the requested fields cannot be filled based on the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The acceptance criteria for 510(k) clearance are generally that the new device is "substantially equivalent" to predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
- Reported Device Performance: Not quantified in terms of specific performance metrics (e.g., success rates, complication rates, flow rates with statistical confidence intervals). The document states that the mechanical properties of the TLSS are "equivalent to other similar devices of this type already in commercial distribution" and that "in vitro testing and other comparisons" show it to be equivalent to current Vascutek ePTFE vascular grafts and other devices. It also mentions "Results from biocompatibility, animal and clinical studies, also demonstrate that the Vascutek Temporary Limb Salvage Shunt is biocompatible and non-toxic." However, no specific performance values or acceptance targets are provided.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "in vitro testing," "animal," and "clinical studies" but does not give sample sizes for any of these.
- Data Provenance: Not specified for the "clinical studies" mentioned. "In vitro" and "animal" studies are general categories.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of information is typically for diagnostic devices or AI algorithms that rely on expert interpretation of data. The TLSS is a surgical implant; its "ground truth" would be established through direct clinical outcomes or engineering performance.
4. Adjudication method for the test set:
- Not applicable/Not provided. This is relevant for studies involving human readers/interpreters.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No such study is mentioned or implied.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This relates to AI/diagnostic algorithms.
7. The type of ground truth used:
- Implicitly, engineering specifications, biocompatibility standards, and clinical outcomes data (from prior studies on similar devices). The document mentions "in vitro and in vivo evaluation," "biocompatibility, animal and clinical studies" that "ensure its suitability for implant." However, the specific ground truth used for each aspect is not detailed.
8. The sample size for the training set:
- Not applicable/Not provided. This relates to AI/machine learning models.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. This relates to AI/machine learning models.
Summary based on available information:
| Criterion | Device Performance/Information from Document |
|---|---|
| Acceptance Criteria | Not explicitly defined as quantifiable metrics in this document. The overarching acceptance criterion for 510(k) clearance is "substantial equivalence" to predicate devices. This implicitly means the device must meet the safety and performance characteristics demonstrated by its predicates and not raise new questions of safety or effectiveness. |
| Reported Device Performance | "The mechanical properties of the Vascutek Temporary Limb Salvage Shunt are equivalent to other similar devices of this type already in commercial distribution." "In vitro testing and other comparisons conducted on the Vascutek Temporary Limb Salvage Shunt show it to be equivalent to the current Vascutek ePTFE vascular grafts (K992832) and other devices used in the intended use application (K062474 : K052302 : K021213)." "Results from biocompatibility, animal and clinical studies, also demonstrate that the Vascutek Temporary Limb Salvage Shunt is biocompatible and non-toxic." |
| Sample size (test set) | Not specified. |
| Data Provenance | Not specified beyond "in vitro," "animal," and "human" evaluation. |
| Number of experts for ground truth & qualifications | Not applicable (device is a surgical implant, not a diagnostic algorithm). |
| Adjudication method | Not applicable. |
| MRMC comparative effectiveness study? Effect size? | No. |
| Standalone (algorithm only) performance? | Not applicable. |
| Type of ground truth used | Implicit: Engineering specifications, biocompatibility standards, and existing clinical data from predicate devices. The document refers to "in vitro and in vivo evaluation," "biocompatibility, animal and clinical studies" to ensure suitability. |
| Sample size for training set | Not applicable (not an AI/ML device). |
| How ground truth for training set was established | Not applicable. |
Conclusion:
The provided 510(k) summary focuses on establishing substantial equivalence for the Vascutek Temporary Limb Salvage Shunt. It highlights that the device is a hybrid of existing, approved technologies and has undergone biocompatibility, in vitro, animal, and clinical evaluations to demonstrate its suitability and equivalence to predicate devices (McPherson Enterprises Inc. Smithwick Carotid Shunt K062474, Boston Scientific Corp. Hemashield Platinum Woven Double Velour TAAA Graft K052302, and Boston Scientific Corp. Hemashield Platinum Woven/Microvelour K021213). However, it does not specify quantitative acceptance criteria or detailed results from studies in the format typically used for performance claims of diagnostic or AI-driven medical devices. The clearance is based on the statutory requirement of substantial equivalence, meaning the device is as safe and effective as its predicates.
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