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The AMPLATZER TorqVue 45°x45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart.

The AMPLATZER® TorqVue® 45°x45° Delivery Sheath is a sterile, singleuse, general-purpose sheath that is an extension of the TorqVue Delivery System product line. It is designed to provide a pathway through which a device may be delivered to the chambers of the heart. The AMPLATZER® TorqVue® 45°x45° Delivery Sheath has a usable length of 100 cm and is available in 9 Fr, 10 Fr, 12 Fr, and 13 Fr sizes (inner diameter). A dilator, which eases penetration of tissue, is packaged with each sheath. The distal end of both the sheath and dilator are curved approximately 45° in two dimensions, resulting in a three-dimensional geometry. The 10 Fr, 12 Fr, and 13 Fr sizes also include a flush adapter that facilitates connection of accessories to the proximal end of the sheath. The body of each sheath is radiopaque for visibility under fluoroscopy. The sheath is constructed of two segments of different Pebax materials to provide support for device advancement and tip flexibility for vessel engagement. The distal end of the sheath has a soft tip composed of 55-durometer Pebax® to minimize vessel trauma.

The provided text describes a 510(k) submission for the AMPLATZER® TorqVue® 45°x45° Delivery Sheath. My analysis will focus on extracting information related to acceptance criteria and the study that proves the device meets them, based on the provided document.

Acceptance Criteria and Device Performance

Note: The document explicitly states that "Bench testing of the AMPLATZER TorqVue® 45°x45° Delivery Sheath included verification of the distal curve dimensions after sterilization, distribution simulation, and six-month accelerated aging." While specific quantitative acceptance criteria values are not provided, the conclusion is that these tests demonstrated substantial equivalence, meaning the performance met the specified (though unquantified in this summary) criteria.

Study Information

1. 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 explicitly stated. The document refers to "Bench testing" without specifying the number of units tested for each criterion.
   • Data Provenance: Not specified. The testing described is "Bench testing," which typically occurs in a controlled laboratory environment. There is no information on human or animal data, country of origin, or whether it was retrospective or prospective.

2. 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. The study involved "Bench testing" of physical device characteristics, not clinical assessment requiring expert interpretation for ground truth.

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

   • Not applicable. This type of adjudication is typically used for clinical interpretation or subjective assessments, not for objective bench testing of device characteristics.

4. 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. The study performed was "Bench testing" of a medical device (delivery sheath), not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies and effect sizes for human reader improvement are not relevant.

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

   • Not applicable. This is not an algorithmic device; it is a physical medical device.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • The ground truth for the "Bench testing" was derived from predefined engineering specifications and performance standards to establish substantial equivalence with the predicate device. These standards would dictate acceptable ranges for dimensions, stability after sterilization, and aging performance.

7. The sample size for the training set

   • Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

   • Not applicable, as there is no training set for this device.

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