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The ENTire Irrigating Pump is an accessory to the Smith & Nephew electrically powered surgical drill equipment as well as endoscopic visualization systems. It is intended to provide irrigant in conjunction with general ear, nose and throat/head & neck procedures.

This modification offers the surgeon the option of irrigating the surgical site or cleansing the lens of the endoscope during otolaryngologic/otoneurologic/head & neck/ endoscopic procedures.

The ENTire Irrigating Pump is an accessory to the Smith & Nephew electrically powered surgical drill equipment as well as endoscopic visualization systems. It is intended to provide irrigant in conjunction with general ear, nose and throat/head & neck procedures. This modification offers the surgeon the option of irrigating the surgical site or cleansing the lens of the endoscope during otolaryngologic/otoneurologic/head & neck/ endoscopic procedures.

The power instrumentation technology utilized in the system is equivalent to existing marketed devices. Power modality, intended use, and the mode of operation are substantially equivalent. The ENTire Irrigating Pump is designed to meet UL 2601-1-2 and CSA 22.2 No. 601-1.

The provided text describes a 510(k) premarket notification for the "ENTire™ Irrigating Pump." This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not applicable to this type of regulatory submission. The 510(k) process for a device like this, particularly in 1997, relied heavily on showing that the new device is as safe and effective as a legally marketed predicate device.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The primary "acceptance criteria" for a 510(k) submission are that the device is substantially equivalent to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. This is a regulatory standard, not a performance metric like sensitivity or specificity.
• Reported Device Performance: The document states that the ENTire Irrigating Pump is substantially equivalent to three predicate devices: the Essential Shaver System, the XPS Irrigator Pump, and the Endo-Scrub Lens Cleaning System. It also claims:
  • "The power instrumentation technology utilized in the system is equivalent to existing marketed devices."
  • "Power modality, intended use, and the mode of operation are substantially equivalent."
  • "Differences between the ENTire Irrigating Pump and the predicate devices should not affect the safety or effectiveness."
  • The device is designed to meet UL 2601-1-2 and CSA 22.2 No. 601-1 (safety standards for medical electrical equipment).

The table below reflects this understanding:

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 submission does not describe a clinical performance study with a test set in the conventional sense (e.g., patient data for an algorithm). The "testing" involved demonstrating compliance with general safety standards (UL, CSA) and comparing technical specifications to predicate devices.

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 in the context of expert review of performance data was established for a test set. Substantial equivalence relies on regulatory review of technical documentation and comparison to predicate devices, not expert consensus on diagnostic or treatment outcomes of the new device.

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

• Not applicable. No test set or expert adjudication related to performance was conducted or 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:

• Not applicable. This device is an irrigating pump, not an AI or diagnostic imaging device. An MRMC study is not relevant to its regulatory pathway or function.

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

• Not applicable. This device is a mechanical pump, not an algorithm.

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

• Not applicable. The "ground truth" for this 510(k) submission is the pre-existing regulatory classification and safety/effectiveness history of the predicate devices, alongside the technical specifications and safety standard compliance of the new device.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning product.

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

• Not applicable. As above, no training set or ground truth in that context was established.

In summary, the provided document is a 510(k) premarket notification that demonstrates substantial equivalence for a medical device (an irrigating pump) by comparing it to already legally marketed predicate devices and affirming compliance with relevant safety standards. It does not contain information about clinical performance studies, test sets, expert reviews, or AI-related metrics as would be found for more complex diagnostic or algorithmic devices.

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