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The ENDOPATH® EZ45 Endoscopic Linear Cutter is intended for transection, resection, and /or creation of anastomoses, has application in multiple open or minimally invasive surgical procedures, including radical prostatectomy, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.

All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) are identical to the design and manufacture described in 510(k) #970720.

This 510(k) submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary simply states that:

• "All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) are identical to the design and manufacture described in 510(k) #970720."
• "The technological characteristics of the ENDOPATH® EZ45 Endoscopic Linear Cutter are identical to those described in 510(k) #970720."
• "The ENDOPATH® EZ45 Endoscopic Linear Cutter performance is identical to that described in 510(k) #970720."

This means that the current device (ENDOPATH® EZ45 Endoscopic Linear Cutter) is being claimed as substantially equivalent to a previously cleared device (referenced by 510(k) #970720). Therefore, the detailed performance data and acceptance criteria would be found in the original 510(k) submission (#970720), not in this summary.

Based on the provided text, I cannot extract the requested information regarding acceptance criteria or a study. All answers to your questions would be "Not provided in this document" or "Information refers to a predicate device's submission."

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The ENDOPATH® EZ45 Endoscopic Linear Cutter [and the ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler] has application in multiple open and other minimally invasive surgical procedures for transection, resection, [and/or creation of anastomoses] and can be used with staple line or tissue buttressing materials, such as bovine pericardium.

The ENDOPATH® EZ45 Endoscopic Linear Cutter is a sterile, single patient use instrument that delivers two, double-staggered rows of staples while simultaneously dividing the tissue between rows. [The ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler is a sterile, single patient use instrument that delivers two, double-staggered rows of staples.] The instrument is designed for use in procedures that do not require insufflation. The instruments' safety lock-out feature is designed to prevent firing an unloaded instrument or prevent a used reload from being refired. The instruments have a staple line that is approximately 45 mm long and a cut line [linear cutter only] that is approximately 41 mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instrument is reloadable with a thin (vascular), white reload; a standard, blue reload; or a thick tissue, green reload. Do not reload the instrument more than seven times for a maximum of eight firings per instrument. The use of the instrument with staple line buttressing materials may reduce the number of firings.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ENDOPATH® EZ45 Endoscopic Linear Cutter and No Knife Endoscopic Linear Stapler:

This document is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance studies with detailed acceptance criteria and statistical analysis as one might find for a novel AI device.

Therefore, the information you're looking for will be limited based on the nature of this submission.

Acceptance Criteria and Reported Device Performance

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

Based on the provided text, specific numerical acceptance criteria (e.g., "sensitivity ≥ 90%") are not explicitly stated or quantified. The performance is described in a general qualitative manner.

Study Details

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

• Sample Size (Test Set): Not specified. The document only states "Pre-clinical laboratory evaluations were performed." The number of devices, firings, or tissue samples tested is not mentioned.
• Data Provenance: Not specified. It only mentions "Pre-clinical laboratory evaluations," implying a controlled lab setting rather than clinical patient data. This would typically be regarded as prospective in the sense of designing tests for the device, but not involving human subjects/retrospective patient 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. This is a mechanical surgical stapler/cutter, not an AI diagnostic device. "Ground truth" would likely be established through objective measurements of staple line integrity, tissue cutting, and functionality rather than expert consensus on diagnostic images. No experts are mentioned in this context.

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

Not applicable. This is not an AI diagnostic device requiring adjudication of interpretations.

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 is not an AI diagnostic device.

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

Not applicable. This is for a mechanical surgical device. Performance is inherently "standalone" in the sense that the device performs its function, but it is always used by a human surgeon.

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

The document does not explicitly state the "ground truth" methodology. However, given the nature of the device (stapler/cutter), the "acceptable performance" would have been assessed against engineering specifications and functional requirements such as:

• Staple formation and integrity (e.g., proper 'B' shape for staples)
• Cutting completeness
• Lack of tissue damage beyond the intended cut/staple line
• Prevention of misfires or unintended reloads (as per the "safety lock-out feature")
• Tissue-specific performance (thin, standard, thick tissue reloads)
• Performance with buttressing materials
  This would likely involve objective measurements and visual inspection in a laboratory setting.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI algorithm, so there is no "training set."

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

Not applicable. There is no training set for a mechanical device.

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