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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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The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush® machine. This is a single use product supplied sterile. This device is intended for use during various surgeries where slush and/or cold solution is required.

The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush® machine. This is a single use product supplied sterile.

The provided document is a 510(k) premarket notification letter from the FDA to OR Solutions, Inc. regarding their ORS-3000LD Equipment Cover. This document focuses on regulatory approval and classification, not on the technical performance specifications or clinical study results of the device itself.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Information about a standalone performance study.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This is a regulatory approval letter, indicating the device's classification and its substantial equivalence to a predicate device, allowing it to be marketed. It does not delve into the detailed technical performance data or clinical studies that would typically define acceptance criteria or demonstrate meeting them.

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The ORS-1075LD is designed to cool surgical irrigation solutions and/or create slush.

Not Found

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a 510(k) clearance letter from the FDA for a device called "1075LD Hush-Slush®," primarily addressing its substantial equivalence to predicate devices and outlining regulatory obligations.

Therefore, I cannot provide the requested table or answer the questions regarding study details, sample sizes, expert qualifications, or ground truth establishment.

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The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile. This device is intended for use during various surgeries where warm irrigation solution is required.

The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile.

This document is a 510(k) clearance letter for the ORS-1000LD Leak Detection Drape. It asserts substantial equivalence to a predicate device and outlines regulatory compliance, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested table and information as these details are not present in the provided text. The letter is a regulatory approval document, not a performance study report.

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The ORS-2000LD is designed to warm and maintain the temperature of surgical solutions prior to their use.

Not Found

The provided text is related to a 510(k) clearance letter for the "Warmer 2000LD" device, which is a "Powered Heating Unit" designed to warm and maintain the temperature of surgical solutions.

However, the document does not contain any information regarding acceptance criteria, device performance metrics, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

The letter is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to general controls and regulations but does not delve into the specific performance studies that would be required to establish acceptance criteria and device performance.

Therefore, I cannot provide the requested table and study details based on the given input.

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Ask a specific question about this device