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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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The Pilling Weck 2-Piece Take-Apart Instrumentation is designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.

The Pilling Weck 2-Piece Take-Apart Instrumentation are endoscopic instruments, which have jaws designed to cut, grasp, dissect, retract, and manipulate. The reusable handles are offered in both insulated and noninsulated actuating rings that adapt to various interchangeable jaw configurations with integral shafts. The shaft of the jaws fits into the handle and can be taken apart for cleaning. The jaws are rotated by turning the knob on the handle. The devices have reusable handles that accommodate inserts, that can be rotated 360 Degrees during use. Both devices include insulated and noninsulated handles, and accommodating shafts. In the Pilling Weck device there is included a flushing port to facilitate cleaning. All Pilling Weck device handles adapt the interchangeable working ends by inserting them through the inner diameter of the shaft that is an integral part of the handle. The fit is secured by a detented proximal end that locks securely in place by encapsulation with the actuation of a push button.

I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies or acceptance criteria for the new device.

The document mainly describes:

• The submitter's information.
• The device's name and classification.
• The predicate device.
• A description of the Pilling Weck 2-Piece Take-Apart Instruments.
• The intended use of the device.
• A comparison of the technological characteristics of the new device to the predicate device to establish substantial equivalence.

Therefore, I cannot fill out the requested table or answer the questions related to studies, sample sizes, expert qualifications, or ground truth.

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The Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down(lap approach). The secondary trocar is used in Endoscopic Surgery(Abdominal and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve.

Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry.

The device consists of a Secondary Trocar and Sleeve with Insufflation Port with mounted cap. The cap consists of a universal adapter seal with reducer, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.

The Secondary Trocar is constructed with a stainless steel tip and is available in pyramidal style and has a polymer handle and upper shaft.

The Sleeve, proportionally sized, is made of polymer, threaded and contains an insufflation port . There is a mounted cap assembly, which has a universal adapter seal with guiding port and reducer.

The provided text is a 510(k) summary for a medical device (Secondary Trocar and Sleeve with Insufflation Port). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo performance studies with defined acceptance criteria. The summary states: "The usage of this product is identical to previous devices, which have the same technological characteristics" and "The following technological characteristics are the same or equivalent as predicate devices."

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them based on the provided text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance. The concept of a "test set" for performance evaluation against acceptance criteria is not present here.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone (algorithm only) performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is purely a regulatory submission claiming equivalence based on design and intended use, not a performance study report.

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The Reusable Trocars and Cannula with Insufflation Ports are manual surgical instruments used to support a cut down(lap approach). The trocar is used in Endoscopic Surgery(Gynecologic, general and other laparoscopic procedures and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve. Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry.

The device consists of Reusable Trocars and Cannula with Insufflation Port with available Single Use Disposable Caps. The 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 Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch. The Reusable Trocars are constructed with a stainless steel shaft and are available in pyramidal style. The Reusable Shielded Trocar is available with a conical or pyramidal tip. The Sleeve, proportionally sized, is made of polymer and accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.

This document is a 510(k) summary for a medical device (reusable trocars and cannula with insufflation port). It focuses on establishing substantial equivalence to predicate devices, not on proving device performance against specific acceptance criteria through a study.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth cannot be extracted from this document because such a study is not described.

This 510(k) is a premarket submission to demonstrate that the device is as safe and effective as a legally marketed device (predicate device). It relies on technological characteristics being substantially equivalent, rather than presenting a performance study with defined acceptance criteria and statistical outcomes.

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The Reusable Trocar and Sleeve are manual surgical instruments used to support a cut down(lap approach) on secondary puncture placement. The trocar is used in Endoscopic Surgery(Abdominal and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve.

Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry.

The device consists of Reusable Trocars and Sleeves, with available Single Use Disposable Caps. The 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 Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch.

The Reusable Trocar, sizes 3mm -11mm. , is constructed with a stainless steel shaft and is available in pyramidal style.

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

This document is a 510(k) summary for a medical device (Reusable Trocar and Sleeve). It focuses on establishing substantial equivalence to previously marketed devices rather than detailing a specific study to demonstrate performance against predefined acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not provided in this document.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria nor explicit reported device performance against such criteria. The entire purpose of this 510(k) submission is to demonstrate "substantial equivalence" to predicate devices, meaning the new device is as safe and effective as existing legally marketed ones. The "performance" is implicitly deemed acceptable if it's equivalent to the predicates.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

There is no mention of a "test set" or specific sample sizes for performance testing. The claim of equivalence is based on the device's design, materials, and intended use being similar to predicate devices. This type of submission relies on design comparisons rather than clinical trial data.

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. No "ground truth" establishment by experts for a test set is described in this document.

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

Not applicable. No test set or adjudication method 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

Not applicable. This document is about a surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is irrelevant.

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

Not applicable. This device is a manual surgical instrument, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The document does not describe the establishment of a "ground truth" in the context of performance testing. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI or machine learning device.

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

Not applicable. There is no mention of a training set or its ground truth establishment.

Summary based on the document:

The provided text from the 510(k) summary focuses entirely on demonstrating the "substantial equivalence" of the Pilling Weck Reusable Trocar and Sleeve to legally marketed predicate devices (Core Dynamics Entree II, Apple Medical Hunt Reich Secondary Trocar, and Access Surgical Access Single Use Trocar and Sleeve). This regulatory pathway typically relies on comparisons of technological characteristics, intended use, and materials rather than extensive de novo clinical performance studies with predefined acceptance criteria. Therefore, the document does not contain the detailed information requested about specific performance studies, sample sizes, expert involvement, or ground truth establishment as would be found for a novel device or an AI/ML product.

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