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Getinge Series Warming Cabinet (models 5524, 5618, 5624) are designed for the heating and storage of irrieation solutions and/or blankets used in the care of patients in areas such as surgery, recovery, OB/GYN, ICU or ER.

The Getinge Series Warming Cabinets are designed for warm storage of solutions and blankets used for patient care in healthcare facilities. The model designations include 5618, 5624, and 5524. The Getinge Series Warming cabinet is not intended for the storage of injectable fluids, blood or blood products.

The provided text describes a 510(k) premarket notification for the Getinge Series Warming Cabinet. This document primarily focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study of acceptance criteria and performance as might be seen for more complex medical devices like those involving AI.

Therefore, many of the requested categories for the description of "acceptance criteria and the study that proves the device meets the acceptance criteria" are not fully applicable or are not explicitly detailed in this type of submission.

Here's a breakdown of the available information:

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

The document does not present a formal table of acceptance criteria and reported device performance in the way a clinical trial or performance study for a high-risk device might. Instead, it summarizes "performance testing" and compares features to a predicate device.

However, based on the "Summary of Performance Testing" and the comparison table, we can infer some criteria and reported performance:

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

• Sample Size: The document states, "All tests were conducted on current production units." It doesn't specify the number of units tested.
• Data Provenance: The tests appear to be internal performance verification conducted by Getinge Sourcing LLC, based in Rochester, New York, USA. The testing is prospective for the purpose of this submission. It is not patient or clinical data.

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 is not applicable. The device is a warming cabinet, and its performance criteria are primarily engineering and safety standards, not clinical diagnostic accuracy. "Ground truth" in the clinical sense (e.g., confirmed disease diagnosis) is not relevant here. The "ground truth" for this device's performance would be derived from physical measurements and adherence to specified design parameters and referenced safety standards.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers interpret data, often with disagreements that need resolution (e.g., in medical image analysis). For a warming cabinet's functional and safety testing, the "ground truth" is established by physical measurement equipment and compliance with engineering specifications, not by expert consensus on subjective interpretation.

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

This is not applicable. The Getinge Series Warming Cabinet is a physical device for heating and storing solutions/blankets, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and analysis of AI-assisted human reader improvement are entirely irrelevant to this device.

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

This is not applicable. As stated above, this is a warming cabinet, not an algorithm or AI system.

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

The "ground truth" for the performance testing of this device is based on:

• Engineering specifications and measurements: For temperature control, heat-up times, and adherence to design parameters.
• Compliance with recognized standards: Such as IEC 61010-1, 61010-2-010, and 61326-1 for electrical safety and electromagnetic compatibility (EMC).
  The measurements and verification against these standards serve as the "ground truth."

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device that requires a training set.

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

This is not applicable as this is not an AI/machine learning device.

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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 IntraTemp Solution Warmer (ITW6L) is designed to warm and maintain the temperature of surgical solutions prior to their use.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the "IntraTemp™ Solution Warmer, Model ITW6L." This document establishes that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

However, the provided text does not contain the specific information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. These details are typically found in the manufacturer's 510(k) submission summary, which is a separate document detailing the technical and performance data used to support the substantial equivalence claim.

Therefore, I cannot populate the table or answer the specific questions because the necessary information is not present in the provided FDA letter. The letter is an approval notification, not a technical performance report.

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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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The ORS drape is a single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.

The Non-Sterile ORS Warming and Slush Drapes are single-use equipment covers intended for use during various surgeries where warm irrigation, slush and/or cold solution is required. These equipment drapes consist of a polyurethane film base material manufactured to protect ORS surgical fluid warmers and slush machines from contamination during various procedures throughout the clinical setting.

These equipment drapes come in a variety of sizes and shapes to allow the device to properly fit ORS surgical fluid warmers and slush machines.

The provided text describes a 510(k) summary for "Non-Sterile ORS Warming and Slush Drapes." This submission is for a medical device (equipment cover) and not an AI/ML-driven device. Therefore, many of the requested elements pertaining to AI model performance, expert review, training sets, and statistical studies are not applicable.

However, I can extract the acceptance criteria and performance data as presented for this medical device from the "Performance Data Summary" table (Table 5-2).

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information, they are not applicable as this is a traditional medical device, not an AI/ML product:

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 mentions "Representative drapes were chosen to cover all drape types" for functional testing. It also refers to "VVR-14-0002 V&V Summary Report, Project 8 Track" and "PKG 001F" and "REPT-18430" which suggests internal validation and verification testing. Specific sample sizes for each test are not provided in this summary. Data provenance (country of origin, retrospective/prospective) is not mentioned, but is likely internal testing by the manufacturer.

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. The "ground truth" for this device is based on physical specifications, visual inspection according to engineering drawings and internal reports, and adherence to ASTM standards for packaging. There is no indication of expert interpretation, as would be required for diagnostic AI devices.

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

• Not applicable. The tests involve objective measurements, visual inspections, and adherence to specifications, not subjective expert reviews requiring adjudication.

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 device is an equipment cover, not a diagnostic AI tool.

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

• Not applicable. This is not an algorithm-based device.

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

• The ground truth for this device's performance relies on adherence to engineering drawings, visual inspection criteria, and industry-standard physical testing methods (e.g., ASTM D4169-09 for distribution testing).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device where a training set is used.

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

• Not applicable. There is no training set for this device.

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The IntraTemp™ Solution Warmer (TCT-6LW) is designed to warm and maintain the temperature of surgical solutions prior to their use.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the IntraTemp™ Solution Warmer. It confirms the device's substantial equivalence to previously marketed devices and outlines regulatory responsibilities. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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These warming cabinets are designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use.

These devices are 120 or 220 V Ac powered warming cabinets designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use. The particular cabinet configuration can be deduced from its model number: SWC = Single Warming Cabinet. DWC = Dual Warming Cabinet. G = Glass Door The temperature ranges and capacities vary according to model but all have: Adjustable Temperature Range Digital Control Dual Display Push Button Operation Rapid Warm Time High Accuracy.

The provided document is a 510(k) summary for warming cabinets (SWC/DWC Various Models) and does not contain information about acceptance criteria for a device evaluated with a study (like an AI/ML device). Instead, it's a notification to the FDA to market a medical device, demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them, as the document does not describe such a study or criteria for this type of medical device (warming cabinets).

The document focuses on:

• Device Name: SWC/DWC (Various Models) Warming Cabinets
• Regulation Number and Name: 21 CFR 890.5950, Powered Heating Unit
• Product Code: LHC
• Indications for Use: To store, warm, and maintain the recommended temperature of irrigation solutions prior to use.
• Predicate Device: K993797, Enthermics Medical Systems Fluid Warming Cabinet
• Conclusion: Based on bench and standards testing, the device is deemed as safe and effective as the predicate device, with few technological differences and no new indications for use, thus substantially equivalent.

There is no mention of an algorithm or AI component, nor any study involving a test set, ground truth, or expert review, as would be relevant for an AI/ML device. The "testing" referred to is "bench and standards testing," which typically involves engineering and performance validation against industry standards for warming cabinets, not a clinical or AI performance study.

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The Integrity Spine Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) mav be implanted:

• bi-laterally in pairs via a posterior (PLIF) approach;
• as a single device via an oblique (OLIF) approach: a
• as a single device via a transforaminal (TLIF) approach: or -
• as as a single device via an anterior or anterolateral (ALIF) approach.
  The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
  The implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

Since the extracted text refers to a 510(k) summary for a medical device (Integrity Spine Lumbar Interbody Fusion System), the "acceptance criteria" and "device performance" would typically relate to comparisons to predicate devices based on non-clinical testing, rather than explicit numerical performance metrics like sensitivity or specificity often seen in AI/diagnostic device contexts. Also, there's no mention of a "study that proves the device meets the acceptance criteria" in terms of clinical trials or AI performance evaluations with ground truth. The summary focuses on substantiating substantial equivalence through non-clinical testing.

Here's an attempt to answer your questions based solely on the provided text, acknowledging that many of your points are not directly addressed due to the nature of this particular 510(k) summary:

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

Based on the provided text, the "acceptance criteria" for this device are primarily met by demonstrating substantial equivalence to predicate devices through non-clinical testing. The "reported device performance" is the successful completion of these tests with results deemed equivalent. There are no explicit numerical acceptance criteria for performance provided in the document in the way one might see for diagnostic AI (e.g., sensitivity > X%, specificity > Y%).

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 describes non-clinical mechanical testing rather than testing on patient data. Therefore, the concept of "test set" in terms of patient data, data provenance, or retrospective/prospective studies does not apply here. The "samples" used were physical devices subjected to the specified ASTM tests. The sample sizes for these specific mechanical tests are not detailed in this summary.

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 question is not applicable to the provided document. The ground truth for this device's evaluation (substantial equivalence) is established through adherence to recognized international standards for mechanical testing (ASTM standards) and comparison to legally marketed predicate devices, not through human expert interpretation of clinical data in a diagnostic context.

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

This question is not applicable to the provided document, as it pertains to clinical data interpretation and not mechanical device testing.

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

There is no mention of a multi-reader multi-case (MRMC) study. This document describes a medical device (spinal implant) and its substantial equivalence determination, not an AI or diagnostic tool that would involve human readers or AI assistance.

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

This question is not applicable. The device is a physical spinal implant, not an algorithm.

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

For the non-clinical testing, the "ground truth" is established by the specified ASTM (American Society for Testing and Materials) standards for mechanical performance (e.g., F2077-11 for static and dynamic testing, F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion). The performance of the predicate devices under these same standards also serves as a comparative benchmark.

8. The sample size for the training set

This question is not applicable to the provided document. There is no concept of a "training set" for a physical medical device like a spinal implant in the context of this 510(k) summary.

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

This question is not applicable to the provided document for the same reasons as point 8.

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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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