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The CardioVations Retractor has application for use in the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in surgical procedures requiring dissection and retraction of tissue.

The CardioVations Retractor is a single patient use device for dissection and retraction of soft tissue to maintain space while under endoscope visualization. For example, like the predicate device, the retractor will be used to dissect and retract tissue surrounding a vessel to allow for instrument passage beneath the shaft of the retractor in vessel harvesting procedures. The blunt, spoon (hood) distal tip functions to dissect and create a working cavity for instrument passage. The wide shaft provides for retraction and maintenance of the operative working space. The transparent tip allows visualization during insertion, tunneling and dissection. A vein retractor feature has been added. The device is compatible with the CardioVations Optical Bipolar Device (included in the vessel harvesting package tray).

This document describes a 510(k) submission for the CardioVations Retractor, a medical device for tissue dissection and retraction. The submission focuses on demonstrating substantial equivalence to a predicate device, the CardioVations Ultra-Retractor, rather than presenting a detailed study with specific acceptance criteria and performance metrics typically seen for AI/ML-based devices.

Therefore, many of the requested sections are not applicable or cannot be extracted from the provided text.

Here is an attempt to address the points based on the available information, noting where information is absent:

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

The provided text does not specify numerical acceptance criteria or detailed quantitative performance metrics for the CardioVations Retractor. The submission states: "Results of verification testing indicates that the product meets the established performance requirements." However, what those established performance requirements are (e.g., force limits, dissection speed, tissue damage scores) and the specific results of the verification testing are not detailed.

Being a physical retractor device, the "performance" here relates to its mechanical and functional integrity to perform its intended surgical tasks safely and effectively.

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

This information is not provided. The submission refers to "verification testing" but does not detail the sample size, type of testing (e.g., benchtop, animal, human cadaver), or data provenance.

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)

This information is not applicable and not provided. For a physical surgical retractor, "ground truth" as it applies to AI/ML or diagnostic devices is not relevant. The performance evaluation would likely involve engineering tests, biocompatibility tests, and potentially simulated use or animal studies, where expert opinion might guide the study but not establish a "ground truth" in the same way.

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

This information is not applicable and not provided. Adjudication methods are typically used in studies involving subjective interpretation (e.g., image reading) where multiple experts assess the same data. This is not relevant for a mechanical device like a retractor.

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 information is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation of data (e.g., radiographs, pathology slides), often with AI assistance. The CardioVations Retractor is a surgical tool, not a diagnostic or AI-assisted device.

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

This information is not applicable. This question is pertinent to AI/ML devices. The CardioVations Retractor is a mechanical surgical tool.

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

This information is not applicable in the traditional sense for a physical medical device. The "ground truth" for a surgical retractor is its ability to mechanically dissect and retract tissue as intended without causing undue harm or failing during use. This is typically assessed through engineering specifications, biocompatibility, sterilization validation, and potentially simulated or animal use studies. The document does not specify these methods in detail.

8. The sample size for the training set

This information is not applicable. Training sets are used for AI/ML algorithms, which are not involved in this device.

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

This information is not applicable. Training sets and their associated ground truth are relevant for AI/ML algorithms, which are not involved in this device.

Summary of the Study (Based on Substantial Equivalence Claim):

The provided 510(k) summary for the CardioVations Retractor indicates that the device's acceptance criteria and proof of meeting them are primarily based on demonstrating substantial equivalence to a predicate device, the CardioVations Ultra-Retractor.

• Acceptance Criteria (Implied): The implied acceptance criteria are that the modified device (CardioVations Retractor) performs its intended functions safely and effectively, and is as safe and effective as its predicate device. This is supported by the statement "Results of verification testing indicates that the product meets the established performance requirements."
• Study That Proves the Device Meets the Criteria: The "study" is the overall 510(k) submission itself, where the manufacturer provides evidence of substantial equivalence. This includes:
  • Device Description: Highlighting that the CardioVations Retractor is a single patient use device for dissection and retraction of soft tissue, similar to the predicate. It notes the addition of a "vein retractor feature."
  • Intended Use/Indications for Use: Stating that the device is for creating and maintaining operative cavities in extraperitoneal spaces, requiring tissue dissection and retraction, which is identical to the listed predicate's use.
  • Technological Characteristics Comparison: Explicitly stating, "The modified device has the same technological characteristics as the predicate device. The form, fit, function and method of operation are similar." This is a crucial element in demonstrating substantial equivalence.
  • Performance Data: A general statement confirms: "Results of verification testing indicates that the product meets the established performance requirements." While specific data is not included in this summary, the FDA review would have relied on this data to make its determination. This "verification testing" would likely include mechanical performance tests, material compatibility, sterilization validation, and other bench-top or simulated use tests relevant to a physical surgical instrument.

Conclusion from the Document:

The FDA's decision to clear the device (K031847) confirms that, based on the provided information, they determined the CardioVations Retractor to be substantially equivalent to the predicate device. This means the FDA found the device to be as safe and effective as a legally marketed device that does not require premarket approval.

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