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"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

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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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:

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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The SwirlGraft™ Bypass Graft is intended for bypass or reconstruction of occluded or diseased peripheral arterial blood vessels.

The SwirlGraft™ Vascular Access Graft is intended for use as a subcutaneous arteriovenous conduit for vascular access.

The SwirlGraft™ Bypass and Vascular Access Grafts are 6 mm diameter expanded polytetraflouro-ethylene (ePTFE) vascular grafts that are manufactured with a small amplitude helical geometry along their length. The SwirlGraft™ Bypass Graft has a thin wall ePTFE construction and a full ePTFE external support. The SwirlGraft™ Vascular Access Graft is a standard wall ePTFE construction with no external support.

The provided text refers to a 510(k) summary for a vascular graft device, not an AI/ML device. Therefore, the questions regarding acceptance criteria, study details, and AI/ML specific performance metrics like MRMC studies, standalone algorithm performance, or ground truth for training/test sets are not applicable to the information contained in this document.

The document indicates that the device's safety and effectiveness were demonstrated through:

• Bench testing: This refers to in-vitro experiments performed in a laboratory setting.
• Animal data: This refers to in-vivo studies conducted on animal subjects.

The core of the submission relies on demonstrating substantial equivalence to a predicate device (Sulzer Medica's Sulzer Vascutek ePTFE Vascular Prosthesis, K992832). This means that the technological characteristics, performance, and principle of operation of the SwirlGraft™ were found to be similar enough to the predicate device, which is already legally marketed.

Therefore, the specific quantitative acceptance criteria or detailed study results that would typically be reported for an AI/ML device are not present in this 510(k) summary. The summary states:

"Comparative testing of the SwirlGraft™ Bypass and Vascular Access Grafts with the predicate device found that the technological characteristics, performance and principle of operation were substantially equivalent."

And:

"Bench testing and animal data demonstrated that the safety and effectiveness of the SwirlGraft™ Bypass and Vascular Access Grafts is equivalent to the predicate devices."

Without further documentation, it is not possible to provide answers to the specific questions laid out in the prompt as they pertain to AI/ML device evaluation.

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