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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 to be used during various surgeries where slush and/or cold 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 device is intended for use during various surgeries where warm irrigation solution is required.

The ORS Fluid Warming and Slush Drapes are sterile, single-use equipment covers intended for use during various surgeries where warm irrigation, slush and/or cold solution is required. The ORS Fluid Warming drapes consist of a polyurethane film base material manufactured to protect ORS surgical fluid warming consoles. The ORS Surgical Slush drapes consist of a polyurethane film base secured to a polycarbonate disc or plate manufactured to protect ORS surgical slush machines from contamination during various procedures throughout the clinical setting.

The ORS Fluid Warming and Slush Drapes come in a variety of sizes and shapes specifically designed for safe use and proper fit on ORS Fluid Warming Consoles and Slush Machines.

Here's a breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text.

Important Note: The provided document is a 510(k) Pre-market Notification for a medical device (ORS Fluid Warming and Slush Drapes). It focuses on demonstrating substantial equivalence to predicate devices, particularly regarding a change in packaging. This means the study described is primarily focused on validating the packaging change and its impact on the device's performance, rather than a de novo validation of device performance itself. It does not contain information typically found in studies for AI/algorithm-based medical devices (e.g., MRMC studies, ground truth establishment by experts for AI, training set details). Therefore, many of the requested points related to AI/algorithm performance (e.g., effect size for human readers with AI assistance, independent algorithm performance, expert qualifications for ground truth) are not applicable to this document.

1. Table of Acceptance Criteria and Reported Device Performance

This table summarizes the design verification testing results presented in Table 5-2 of the document.

Note on Temperature Failures: The document explains that although the temperature results for pre-conditioning and gas dwell did not strictly meet the protocol's acceptance criteria, it was determined the criteria were inappropriate for the assessment. The performance was deemed acceptable because temperature penetration into the new packaging was comparable to the incumbent packaging, avoiding an adverse impact on sterility assurance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set:

  • EO Residuals: ORS-321 (flat pack; 24/case) - Implies testing on a representative sample from this lot size.
  • Seal Strength (various tests): 15 samples for each of the "Pre Seal Current," "Post Seal Current," "Pre Seal New," and "Post Seal New" tests.
  • Sterilization Cycle Comparison: ORS-321 (file pack; 24/case) - Implies representative samples.
  • ISO 11607-1 Transport Challenge & Package Integrity Testing (ORS-301): 3 samples for the initial transport challenge, and 22 samples for each of the dye penetration, bubble emission, and seal strength tests.
  • ISO 11607-1 Transport Challenge & Package Integrity Testing (ORS-321): 3 samples for the initial transport challenge, and 22 samples for each of the dye penetration, bubble emission, and seal strength tests.
  • Packaging Shelf Life Assessment: POU708 & POU709 Header Bags (assessment, not direct testing on specific number of samples for results).
  • Biocompatibility Assessment: POU708 Header Bag (assessment, not direct testing on specific number of samples for results).

• Data Provenance: The document does not specify the country of origin for the data. The testing appears to be internal verification and validation testing performed by Ecolab, Inc., for a 510(k) submission to the FDA (USA). The studies are inherently prospective in nature, as they involve testing conducted specifically to validate a manufacturing or design change (changing the packaging configuration).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This document describes design verification and validation testing for a physical medical device (equipment covers) and a change in its packaging. It does not involve an AI/algorithm where "ground truth" related to expert interpretations (e.g., radiology reads) would be established. Therefore, this section is Not Applicable.

4. Adjudication Method for the Test Set

This document describes physical and chemical testing (tensile strength, dye penetration, sterilization cycle parameters, etc.). "Adjudication methods" like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers for diagnostic interpretation. Therefore, this section is Not Applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was Not Applicable and therefore not done. This type of study is relevant for AI-powered diagnostic devices where human readers' performance with and without AI assistance is evaluated. This document pertains to sterile equipment covers.

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

This document does not involve an algorithm. Therefore, this section is Not Applicable.

7. The Type of Ground Truth Used

For this device and the tests performed, the "ground truth" is established by:

• Engineering specifications and standards: e.g., minimum seal strength, maximum EO residuals, temperature/RH requirements for sterilization, and compliance with ASTM and ISO standards (e.g., ISO 14971, ISO 10993-7, ISO 11607-1, ASTM D4169-14, ASTM F3039-13, ASTM F1929-12, ASTM F2096-11, ASTM F88-09).
• Laboratory measurements and observations: The quantitative results from the tests (e.g., 2.9 mg EO, 15 of 15 passes for seal strength, observed lack of dye penetration).
• Prior predicate device performance: The basis for demonstrating substantial equivalence is that the new packaging performs comparably to the previously cleared packaging, without raising new questions of safety or effectiveness.

This is not a clinical "ground truth" derived from expert consensus, pathology, or outcomes data in the sense used for diagnostic algorithms.

8. The Sample Size for the Training Set

This document does not describe the development or testing of an AI/algorithm, and thus there is no "training set" in this context. Therefore, this section is Not Applicable.

9. How the Ground Truth for the Training Set was Established

As explained above, there is no AI/algorithm and no training set involved. Therefore, this section is Not Applicable.

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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.

Ask a specific question about this device