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The SureClip Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.

The SureClip Clip Applier ("SureClip") is comprised of a cartridge ("SureClip Clip Applier Cartridge" or "SureClip Cartridge") (5mm or 10mm) (Class II) and a handle (Class I). Each cartridge is pre-loaded with 17 implantable titanium clips. The SureClip Clip Applier is intended to apply implantable, medium/large, titanium clips. The clips are manufactured from unalloyed implant grade titanium (ASTM F67 Grade 1 Titanium, UNS R50250). The cartridge must be assembled and locked into the handle. The handle includes a pistol grip trigger and a rotation knob for 360° rotation in either direction. The jaws, which are located at the distal end of the SureClip Cartridge, form each clip as the trigger is actuated.

The provided text does not contain information about acceptance criteria for a device's performance that can be presented in a table with reported device performance. It also does not describe a study that proves a device meets such acceptance criteria in the way requested (e.g., sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness study results).

The document is a 510(k) summary for the ConMed SureClip Clip Applier, primarily focused on establishing substantial equivalence to a predicate device. It mentions "Non-clinical Performance Testing" and "Performance testing" but does not provide specific metrics or acceptance criteria for those tests in a format suitable for the requested table.

Here's an analysis of what is available in the document regarding testing:

Key Information from the Document:

• Device Name: ConMed SureClip Clip Applier
• Intended Use / Indications for Use: The SureClip Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.
• Predicate Device: LIGAMAX™ 5 Clip Applier (K110699) by Ethicon Endo-Surgery. Reference devices: LIGAMAX™ 10-M/L (K864102, K830503, and K812291)
• Testing Conducted:
  • Non-clinical bench and simulated use testing
  • Clip burst testing
  • Clip retention testing
  • Animal testing (implantation) per Good Laboratory Practice 21 CFR Part 58.
  • Material analysis and biocompatibility testing (complying with ANSI/AAMI/ISO 10993-1:2009(R)/2013)
• Outcomes of Testing:
  • "demonstrate the SureClip Clip Applier is substantially equivalent to the predicate with regard to intended use, materials, technology, and performance."
  • "Results of product performance testing confirm that devices comply with design specifications and applicable sections of ISO 11135:2014, AAMI/ANSI ST67:2011, ISO 10993-7:2008, ISO 14971:2007, ASTM F67-13:2013, and ASTM F2503-13:2013."
  • "Product performance and animal testing demonstrate the safe and effective application of the new design features for the same intended use as the predicate device."
  • "Comparison of device features and side-by-side comparison testing conducted for clip applier performance demonstrate that SureClip Clip Applier is substantially equivalent to Ethicon's Clip Applier for both the 5mm and 10mm regarding intended use/indications for use, technology, and performance specifications."

Missing Information (required by your request):

1. Table of Acceptance Criteria and Reported Device Performance: Not provided explicitly. The document states compliance with design specifications and standards but doesn't list specific performance metrics (e.g., minimum burst strength, maximum clip retention force) or the exact values achieved by the device.
2. Sample sizes used for the test set and data provenance: No specific sample sizes for bench, simulated, or animal testing are mentioned, nor is the data provenance (country, retrospective/prospective) described.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable/not mentioned, as these are primarily engineering performance tests, not clinical evaluations requiring human expert interpretation in the way AI/diagnostic devices do.
4. Adjudication method: Not applicable/not mentioned.
5. MRMC comparative effectiveness study: Not conducted. This is an engineering/performance substantial equivalence claim, not an AI or diagnostic effectiveness study.
6. Standalone (algorithm only) performance: Not applicable. This is a mechanical device, not an algorithm.
7. Type of ground truth used: For the physical performance tests (burst, retention), the "ground truth" would be the measured physical properties themselves, established through standardized testing methodologies. For biocompatibility, it's compliance with established ISO standards. For animal testing, it's observation of biological response in live subjects.
8. Sample size for the training set: Not applicable. This is not a machine learning/AI device.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the document focuses on demonstrating substantial equivalence through compliance with recognized standards and comparison to a predicate device, rather than presenting a detailed "acceptance criteria vs. performance" table with specifics on sample sizes, expert ground truth, or MRMC studies as typically requested for diagnostic or AI-based devices.

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