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Zynergy Loc-Sure Single Pass Drainage Assembly is a minimally invasive device for percutaneous drainage of cysts, abcesses and fluid collections such as:

• Renal cysts .
• Renal, hepatic and other abcesses .
• Pleural effusions .
• Ascitic collections .
• Thoracic collections .
• Nephrostomies .

The Zynergy Loc-Sure Single Pass Drainage Set comprised of four components:

1. A radiopaque, semi-coiled, drainage catheter. The distal segment of the catheter has drainage holes on the inside radius to facilitate the draining of fluid from the selected body cavity.
2. The proximal connector cannula flange is comprised of a standard male luer lock. This is inserted into the catheter tubing and is used as an insertion guide for a trocar stylet and may be attached directly to ancillary drainage devices.
3. The trocar stylet is a needle used as a puncture trocar for placing the drainage catheter in the precise location required for the drainage procedure.
4. A suture button is included which may be sutured to the skin for safe extended drainage.

The provided text describes a medical device, the "Zynergy Loc-Sure Single Pass Drainage Set," and its clearance by the FDA based on substantial equivalence to predicate devices. However, the document does not contain any information about acceptance criteria, device performance studies (beyond basic certifications and biocompatibility), training sets, test sets, expert consensus, or any metrics typically associated with AI/algorithm performance studies.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed performance study with acceptance criteria in the context of an AI/algorithm.

Therefore, I cannot fulfill your request for the specific points related to AI/algorithm performance. I can only extract information related to the device itself and its regulatory clearance process as present in the provided text.

Here's what can be extracted from the document:

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

• No acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, etc.) are present in this document. The document primarily focuses on demonstrating that the device is "substantially equivalent" to predicate devices and has successfully completed standard certifications and biocompatibility testing.

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

• Not applicable. This document does not describe a performance study with a test set.

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. This document does not describe a performance study with a ground truth established by experts.

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

• Not applicable. This document does not describe a performance study with adjudication.

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 does not mention an MRMC study or any AI component.

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

• Not applicable. This document describes a physical medical device, not an algorithm.

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

• Not applicable. This document does not describe a performance study requiring ground truth.

8. The sample size for the training set

• Not applicable. This document does not describe an algorithm or a training set.

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

• Not applicable. This document does not describe an algorithm or a training set.

Additional information from the document regarding device validation/testing:

• Sterilization: Qualified based on the overkill method with a sterility assurance level of 10^-6. ETO sterilized in accordance with ANSI/AAMI/ISO 11135, EN550:1994, EN556:1994. ETO residuals are within ISO10993-7 guidelines.
• Pyrogenicity: LAL testing done for each sterilization lot to assure non-pyrogenicity.
• Performance Testing: Successfully completed per BS/EN1617:1997.
• Biocompatibility Testing: Successfully completed per ISO10993 and FDA guidelines, including cytotoxicity, systemic injection, intracutaneous injection, pyrogenicity, sensitization, and implantation.

Study described to meet acceptance criteria:

The "study" referenced in this document is primarily the demonstration of substantial equivalence to existing predicate devices (ELECATH One-Step Fluid Drain Assembly and Cook Dawson-Mueller Drainage Catheter with Slip-Coat Hydrophilic Coating). The manufacturer compared the design, composition, and function of the Zynergy Loc-Sure Single Pass Drainage Set to these predicates. The successful completion of standard certification tests (sterilization, biocompatibility, performance) supports this claim of equivalence. The FDA letter confirms that the device was deemed "substantially equivalent" for its stated indications for use.

In summary, this document is a regulatory submission for a physical medical device and does not contain the kind of detailed performance study information you would expect for an AI/algorithm-based device as outlined in your request.

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