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The ORS 6000 Endoscope Holder is a single use disposable device as an accessory for ORS Solution Warmers. The ORS 6000 Endoscope Holder is designed to hold the optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece.

The ORS 6000 Endoscope Holder (figures 1) is designed to prevent fogging or wetting of the scope eyepiece by providing a hold for the scope, which keeps it above the water line of the warm solutions. The ORS 6000 Endoscope Holder is manufactured from GE VALOX thermoplastic polyester resins. The ORS Endoscope Holder is a single use disposable device. The ORS 6000 Endoscope Holder is used with ORS-2000 Solution Warmer K921633 and ORS-2000LD Solution Warmer K021289.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device efficacy with the provided text. The document describes a 510(k) premarket notification for a medical device (ORS 6000 Endoscope Holder). 510(k) submissions typically demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical studies with specific acceptance criteria as you've outlined.

Here's why the provided text doesn't contain the requested information:

• Focus on Substantial Equivalence: The document's primary purpose is to establish that the ORS 6000 Endoscope Holder is substantially equivalent to the Karl Storz KSEA Endoscope Holder (K990334). This means demonstrating that it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
• No Efficacy Study Described: There is no mention of a study designed to test the ORS 6000's performance against specific acceptance criteria for preventing fogging or wetting of the scope eyepiece. The document relies on the predicate device's established safety and effectiveness.
• Biocompatibility Testing, Not Performance Testing: While biocompatibility tests (Cytotoxicity, Systemic Injection, Intracutaneous Injection, Dermal Sensitization) are mentioned, these are safety tests related to the material, not performance tests for the device's function.
• No Performance Metrics: The document does not provide any quantitative or qualitative performance metrics for the ORS 6000's ability to prevent fogging or wetting.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance data is presented.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth... and their qualifications: No ground truth establishment process is described.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance: No standalone performance study is described.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable (no AI/machine learning component).
9. How the ground truth for the training set was established: Not applicable.

The document essentially states that the ORS 6000 performs a "similar purpose" to the predicate device and meets biocompatibility standards, thereby being "substantially equivalent." It does not present a study with performance acceptance criteria as you've requested for a device proving its own efficacy.

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