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The AMO® Prestige® Day Pack supports the irrigation fluid path for replenishing intraocular fluid removed during cataract extraction. The tubing pack also supports the aspiration fluid path for removing fluid and nuclear fragments during cataract surgery.

The AMO® Prestige® Day Pack has been designed for single patient use or multiple reuse and is used with the AMO® Prestige® Advanced Cataract Extraction™ System. The Day Pack is comprised of the AMO® Prestige® Disposable Cartridge Assembly, the AMO® Prestige® Disposable UA Tubing Assembly and the AMO® Prestige® Drip Spike Assembly, all of which are provided to the customer in a sterile configuration. The AMO® Prestige® Day Pack provides a conduit for the irrigation fluid used to replenish the intraocular fluid removed during cataract extraction. The tubing pack also provides a conduit for the aspiration fluid that contains the aspirated fluid and nuclear fragments removed during cataract surgery.

The provided text describes a 510(k) summary for the AMO® Prestige® Day Pack, a device used in phacoemulsification procedures. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a device meets specific clinical performance metrics with acceptance criteria and a detailed study.

Therefore, many of the requested categories for performance evaluation, such as "acceptance criteria," "reported device performance," "sample size for test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established," are not applicable or extractable from this 510(k) summary.

The document describes nonclinical tests to demonstrate substantial equivalence, focusing on the device's functional integrity and compatibility.

Here's the information that can be extracted, along with an explanation for the non-applicable sections:

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

  • Not Applicable. This document does not provide specific quantitative acceptance criteria or detailed reported device performance in the manner requested (e.g., sensitivity, specificity, accuracy). It states that the "results of these tests indicate that the AMO® Prestige® Day Pack is substantially equivalent to the currently marketed predicate devices and is compatible for use with the AMO® Prestige® Advanced Cataract Extraction™ System."
  • The tests conducted were:
    • Durability Tests
    • Worst Case Sterilization
    • Aspiration Obstruction
    • Chamber Maintenance

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

  • Not Applicable. This information is not detailed in the provided 510(k) summary. The document describes "nonclinical tests" which typically involve laboratory or bench testing rather than clinical data from a "test set" from patients.

• 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 pertains to clinical studies and ground truth establishment, which are not described in this 510(k) document for nonclinical performance testing.

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

  • Not Applicable. This pertains to clinical studies and ground truth establishment, which are not described in this 510(k) document.

• 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 summary describes a medical device (tubing pack) for cataract surgery, not an AI software or a device that would typically involve human "readers" or AI assistance.

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

  • Not Applicable. This summary describes a medical device (tubing pack), not an algorithm or AI.

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

  • Not Applicable. For the nonclinical tests described, the "ground truth" would likely be engineering specifications or performance baselines derived from the predicate devices. This document does not specify the method for establishing "ground truth" for the nonclinical tests.

• 8. The sample size for the training set

  • Not Applicable. This device is hardware for a surgical procedure; there is no "training set" in the context of machine learning or algorithms.

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

  • Not Applicable. As above, there is no "training set" for this type of device.

Study Description (Based on "Brief summary of nonclinical tests and results"):

The study conducted was a series of nonclinical performance tests designed to demonstrate the substantial equivalence of the AMO® Prestige® Day Pack to its predicate devices.

• Tests Performed:

  • Durability Tests (details not provided)
  • Worst Case Sterilization (details not provided)
  • Aspiration Obstruction (details not provided)
  • Chamber Maintenance (details not provided)

• Purpose: To confirm that the new device performs as intended and is compatible with the AMO® Prestige® Advanced Cataract Extraction™ System, similar to the predicate devices.

• Conclusion: The results indicated that the AMO® Prestige® Day Pack is substantially equivalent to the currently marketed predicate devices and is compatible for use with the AMO® Prestige® Advanced Cataract Extraction™ System.

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