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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 pillow drape is a single-use disposable device intended for use as an accessory for ORS Solution Warmers which is designed to hold the optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece.

The following model(s) are included: ORS-400 and ORS-400N

The ORS-400N Scope Pillow™ Warmer Drape is a single-use disposable device provided non-sterile to secondary processors, who then package, label and sterilize the device. The Scope Pillow Warmer Drape is an accessory/equipment drape for use with the ORS-2057 Irrigation Solution Warming System which is designed to both protect ORS surgical fluid warmers from contamination during various procedures as well as hold the optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece.

The drape material is the identical polyurethane film that is used on all standard ORS Warmer Drapes (K021288). A soft polyurethane foam pillow is integrated within the polyurethane drape and has no direct or indirect patient contact. The pillow (endoscope holder) is designed to provide stable positioning of scope(s) during warming and prevents one or more scopes from rolling or tipping while the scope rests in the fluid warmer during the procedure (Figure 5-1).

The ORS-400 and ORS-400N model drapes are identical with the exception of how they are packaged and labeled. The ORS-400 model consists of drapes individually packaged in labeled peel pouches or header bags which are stacked inside a double poly-lined corrugate case with Instructions for Use (IFU) insert and sterilized by an Ecolab subcontractor before it is released for sale. The ORS-400N model consists of the identical drapes which are individually wrapped in a poly tie secured by a product ID label and stacked inside a double poly-lined corrugate case with IFU insert that does not get sterilized before it is released for sale to kit packer customers. The IFU insert differs between the two models in that the ORS-400N contains sterilization instructions for kit packer customers to evaluate their sterilization process as it applies to placing the product in their commercial procedure kits.

NOTE: Both device models are designed and intended to be used by clinical staff in sterile condition.

The provided text describes the acceptance criteria and study for the ORS Scope Pillow Warmer Drape. This device is an accessory designed to protect surgical fluid warmers and hold endoscope eyepieces above warm solution to prevent fogging or wetting.

Here is the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document does not explicitly state the specific sample sizes for the "test set" for each individual requirement. However, it indicates Validation & Verification (V&V) testing was performed, and the results were documented in VVR-14-0002 V&V Summary Report, Project 8 Track, and Packaging Engineering Report # REPT-18430. The nature of the tests (visual inspections, dimensional checks, simulated distribution) suggests that the testing was prospective, conducted specifically for this regulatory submission. Country of origin of the data is not specified, but the submitter is Ecolab, Inc., located in St. Paul, MN, USA.

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)

This device is an equipment cover/accessory, not a diagnostic imaging device. Therefore, the concept of "experts" establishing ground truth for performance metrics (like dimensional requirements, drape integrity, packaging, and labeling) is not applicable in the same way it would be for a medical AI device interpreting images. The assessment appears to be based on engineering specifications and visual inspections rather than expert clinical interpretation. The document does not mention the use of experts in this context.

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

Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of medical data (e.g., radiology reads) where discrepancies need to be resolved. For the performance tests described (visual inspections, dimensional requirements, packaging integrity), this type of adjudication method is not relevant. The document does not suggest any formal adjudication process was used.

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

No MRMC comparative effectiveness study was done. This device is a passive accessory and does not involve AI or human readers for interpretation.

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

No standalone algorithm performance study was done. This device is a physical accessory and does not involve any algorithms.

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

The "ground truth" for the device's performance is based on its engineering specifications and physical characteristics. For functional and packaging requirements, the ground truth is whether the device meets the predefined dimensional requirements, remains intact, has correct packaging counts, maintains fold integrity, and withstands distribution stress as per the specified methods (e.g., visual inspection, ASTM D4169-09). For labeling, the ground truth is adherence to specific label designs and content. These are objective criteria rather than subjective expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

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