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The Pilling Weck Secondary Flexible Sleeve with Cap and Trocar are manual surgical instruments used to support a cut down ( has approach) on secondary puncture placement.

The Trocar is used in Endoscopic Surgery (Gmecologic, general and other laparoscopic procedures and thoracic) for incision and peritoneal access for positioning of the hollow flexible sleeve.

Once the Trocar is removed, the port of entry provided by the sleeve through the cap, is used with manual instruments, laproscopes, and probes.

The device consists of Trocar and Sleeves, with integral and separately available Single Use Disposable Caps. The Sterile Disposable Cap Assembly consists of a universal adapter seal, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.

The Optional Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch.

The Trocar, sizes 3mm .- 15mm .. is constructed with a polymer hub and shaft with stainless steel tip and is available in pyramidal style.

The Sleeve, proportionally sized, is made of polymer and comes with or accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.

This 510(k) summary (K971334) for the Pilling Weck Secondary Flexible Sleeve and Trocar does not contain the detailed information necessary to describe acceptance criteria and a study proving the device meets those criteria.

510(k) summaries for Class II devices primarily focus on establishing substantial equivalence to legally marketed predicate devices, rather than presenting de novo clinical study results against specific performance acceptance criteria.

The provided document describes:

• The device and its intended use.
• The predicate devices to which it claims substantial equivalence.
• General technological characteristics of the device and how they compare to predicates.
• The FDA's determination of substantial equivalence.

Therefore, I cannot extract the following requested information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria or provide performance data.
2. Sample size used for the test set and the data provenance: No test set or study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method for the test set: No test set or adjudication is mentioned.
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: This is a physical medical device (trocar and sleeve), not an AI/software device, so an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is a physical device, so "standalone algorithm performance" is not applicable.
7. The type of ground truth used: No ground truth is mentioned.
8. The sample size for the training set: No training set is mentioned as this is a physical device.
9. How the ground truth for the training set was established: No training set or ground truth is mentioned.

In summary, the provided 510(k) document is a regulatory submission focused on substantial equivalence, not a clinical study report detailing performance against pre-defined acceptance criteria.

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