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For Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures.

Convenience kit of laparoscopic instruments. The convenience kit contains various configurations of tools for the performance of laparoscopic procedures. These tools provide laparoscopic access, tissue dissection and manipulation, hemostasis, and specimen collection.

This is a medical device 510(k) premarket notification for a Convenience Kit for "Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures."

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain specific acceptance criteria or quantitative performance data for the "Convenience Kit" device. It is a 510(k) premarket notification for a medical device focusing on demonstrating substantial equivalence to predicate devices, not on proving performance against specific acceptance criteria.

The "PERFORMANCE DATA" section states: "Relevant clinical literature has been cited in support of the intended use of this convenience kit." This indicates the reliance on existing literature for the individual components rather than a new study for the kit itself.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable. The document does not describe a new performance study with a test set.
• Data Provenance: Not applicable. The document refers to "Relevant clinical literature" for its individual components, but does not specify the origin or type (retrospective/prospective) of this literature in detail for the kit as a whole.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There is no mention of a test set with ground truth established by experts.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication method is described.

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:

• No. This is a kit of laparoscopic instruments, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.

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

• No. This is a physical medical device kit, not an algorithm.

7. The type of ground truth used:

• Not applicable. No new ground truth for a study is mentioned. As this is a substantial equivalence submission, the "truth" is based on the safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. (See #8)

Summary of what the document does provide:

• Device: Convenience Kit of laparoscopic instruments.
• Intended Use: "Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures."
• Predicate Devices: Several previously cleared (K883018, K914753, K920599, K922123, K951589, K981941, K012539) individual laparoscopic instruments, all from the same manufacturer.
• Basis for Clearance: Substantial equivalence to these predicate devices, meaning the FDA determined the new device is as safe and effective as existing legally marketed devices.
• Performance Data Mentioned: "Relevant clinical literature has been cited in support of the intended use of this convenience kit." This implies that the safety and effectiveness of the individual components within the kit are established through existing literature and the clearance of the predicate devices. There is no new study described for the kit as a whole to meet new acceptance criteria.

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Orthopedic Kit or Tray

I am sorry, but the provided text from the 510(k) summary (Attachment 1) does not contain information about acceptance criteria, device performance, clinical studies, sample sizes, ground truth, or expert involvement.

The document primarily focuses on:

• Submitter Information: Name and address of National Healthcare Manufacturing Corp. and their general manager.
• 510(k) Summary Preparer: Information about the consultant preparing the summary.
• Date Prepared: April 1, 1997.
• Device Name/Classification: Identifying the device as an "Orthopedic Pack, Tray, or Kit" and noting the absence of a specific classification name.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text.

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The Denver® Paracentesis Needle, Paracentesis Needle with Drainage Binc, and the Denver Traracentesis Tray are indicated for use in removing from cac personed to be used for both diagnostic and therapeutic abdominal paracentesis procedures.

The Denver® Paracentesis Needle is a sterile device, for single use only. It is not to be resterilized. Components in the fluid path are non pyrogenic. This device consists of an inner two-part trocar, an outer drainage cannula, and a trocar/cannula housing. The inner two-part trocar is a rounded, closed end tube with side holes, coaxially housed within a sharp-beveled hollow needle and the outer drainage cannula. The outer drainage cannula has a beveled tip and distal side holes to facilitate drainage.

As the two-part trocar penetrates the abdominal wall, the blunt portion of the trocar is forced back within the shaft of the needle portion of the trocar, exposing the sharp-beveled needle. The trocar/cannula housing contains a red indicator which is visible when the sharp-beveled needle is exposed. When the needle encounters low resistance, such as when the abdominal cavity is entered, the blunt portion of the trocar automatically re-extends out beyond the sharp needle, thereby helping protect against inadvertent organ puncture. Once the blunt portion of the trocar re-extends beyond the needle, the red indicator is no longer visible. Proper position in an area of fluid may also be confirmed by attaching a syringe to the end of the device and attempting aspiration.

Once in the abdominal cavity, the two-part trocar is removed, leaving the outer drainage cannula and housing in place for the paracentesis procedure.

The Denver® Paracentesis Needle with Drainage Line is a sterile device intended for single use only. It is not to be resterilized. The product contains one Denver® Paracentesis Needle, one drainage tubing line, and connectors to allow attachment to wall suction or a vacuum bottle.

The Denver® Paracentesis Tray is a sterile device intended for single use only. It is not to be resterilized. The tray contains one Denver® Paracentesis Needle, one drainage tubing line, connectors to allow attachment to wall suction or a vacuum bottle, and the primary components needed for performing the paracentesis procedure.

The provided text describes a medical device, the Denver Paracentesis Needle, and its equivalency to other similar devices. It does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The document is a "Summary of Safety and Effectiveness" which is a type of submission to regulatory bodies (like the FDA, indicated by "K960456" which is likely a 510(k) premarket notification number) for medical devices. The purpose of this type of document is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics.

Therefore, the requested information cannot be extracted from the provided text for the following reasons:

1. Acceptance criteria and reported device performance (quantitative): The document does not define specific performance metrics (e.g., accuracy, sensitivity, specificity, precision) or acceptance thresholds for the Denver Paracentesis Needle. The "Performance Testing" section only mentions a comparison of "drainage rates" to a predicate device and concludes they have "similar drainage performance." This is a qualitative statement, not a reporting of specific performance values against pre-defined criteria.
2. Sample size and data provenance: No information on sample sizes for test sets or data provenance is provided.
3. Number and qualifications of experts: Not applicable as there is no mention of expert-established ground truth for a diagnostic or AI-driven device.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable as this is not an AI-assisted diagnostic or imaging device.
6. Standalone performance: Not applicable in the context of AI performance. The device's standalone performance is its mechanical function.
7. Type of ground truth: Not applicable in the context of AI/diagnostic device ground truth. The "ground truth" for this device would be its functional ability (e.g., draining fluid effectively), which is implicitly assessed by showing substantial equivalence to existing devices.
8. Sample size for training set: Not applicable as this is not an AI/machine learning device.
9. How ground truth for training set was established: Not applicable.

In summary, the provided document focuses on demonstrating substantial equivalence based on intended use and technological characteristics, along with a functional comparison (drainage rates), rather than an in-depth study of specific performance metrics with defined acceptance criteria typically seen for diagnostic devices or AI algorithms.

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