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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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