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Intended to add moisture to breathing gases for administration to pediatric through adult patients weighing ≥ 10 kg >1 month in homecare, hospital, extended care and hospice.

There are two models of the Hudson RCI Disposable Humidifier. Both models have identical intended uses and modes of operation. One model has a 4 PSI pressure relief valve (referred to as model 3230) and the other has a 6 PSI pressure relief valve (referred to as model 3260). Regardless of device model, the disposable humidifier delivers humidified gases to the patient. Both models of the non-prefilled disposable humidity in water vapor form to respiratory gases delivered to patients to make the gases more comfortable to breathe. The disposable humidifier incorporates a pressure relief valve with an audible alarm at 4 psi or 6 psi. depending on the model selected.

In both models, air is channeled through the water-containing bottle where it becomes humidified before exiting the device and being administered to the patient.

The patient can influence the use of these devices by occluding or loosening secure connections. In cases where the patient is also the user, over or under filling the device and selection of incorrect oxygen percent concentration and gas input pressures may influence the use of the device.

This is a 510(k) premarket notification for the "Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve" and "Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve". The document asserts substantial equivalence to the predicate device "Salter Labs Bubble Humidifier (K161719)".

However, the provided text does not contain a study that proves the device meets specific acceptance criteria in the format requested. Instead, it summarizes non-clinical testing performed to demonstrate safety based on industry standards and establish substantial equivalence to a predicate device.

The document lists various tests performed and standards utilized, but it does not provide:

• A table of acceptance criteria with reported device performance values against those criteria.
• Sample sizes used for test sets.
• Information about ground truth establishment, experts, or adjudication methods.
• Details about MRMC studies or effect sizes for AI assistance.
• Information on standalone algorithm performance or training set details.

The document provides a "Summary of Non-Clinical Testing" and then lists specific types of tests, such as "Humidification Output," "Flow Rate," "Alarm," and "Pull Test." While it states that the results of these tests indicate substantial equivalence, it does not detail the acceptance criteria for each test or the specific reported performance values that met those criteria.

Therefore, I cannot populate the requested table or provide the detailed information about study design, ground truth, and sample sizes that would typically be found in a study demonstrating device performance against acceptance criteria.

The information that is available regarding acceptance criteria and performance is very high-level and can be inferred from the "Comparison of Technological Characteristics" table and the "SUMMARY OF NON-CLINICAL TESTING" section:

Inferred Information from the Document:

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

The document does not provide information for the following points as they are typically associated with clinical studies or more detailed performance reports, which are not present here:

2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a device performance summary focusing on non-clinical engineering and biocompatibility tests, not diagnostic accuracy requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this is a device performance summary focusing on non-clinical engineering and biocompatibility tests. For these tests, the "ground truth" would be established by the defined test methods and measurement standards (e.g., a specific method to measure humidification output).
8. The sample size for the training set: Not applicable, as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable, as this is not a machine learning device.

Conclusion from the document:
The document concludes that "Based on the testing performed, including humidification output and additional gas pathway biocompatibility testing according to ISO 18562, it can be concluded that the subject devices do not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed Hudson RCI Bubble Humidifiers are assessed to be substantially equivalent to the predicate devices." This statement implies that all the non-clinical tests were successfully completed and the devices met the performance expectations for substantial equivalence.

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The Medline UNITE® Ankle Fusion Plating System is indicated for use in arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodesis, in conjunction with stabilization of fresh fractures, revision procedures, and reconstruction of bones in the feet and ankles.

The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® Ankle Fusion Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device. The system can be used in both adult and pediatric (adolescent and child) patients.

Medline UNITE® Ankle Fusion Plates and Screws used for the surgical treatment of pediatric patients should not cross an active growth plate as this may impede bone growth and development in skeletally immature patients. Implanted Medline UNITE® Ankle Fusion Plates and Screws which span an active growth plate in a pediatric patient. should be considered for hardware removal after primary arthrodesis or bone healing has been achieved.

The Medline UNITE® Ankle Fusion Plating System Plates and Screws are manufactured from Titanium Alloy (Ti-6A1-4V ELI). The system includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 4.5mm and 5.5mm diameter locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots included in the plates. Additionally, several plates in the system can accommodate 3.5mm and 4.0mm locking and non-locking cortical screws. Previously cleared 3.5mm (K151235) and 4.0mm locking and non-locking cortical screws, ranging from 16-40mm will be included in the tray with the Medline UNITE® Ankle Fusion Plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drills, drill guides, tissue protectors, targeting guides, targeting guide sleeves, and a tray.

I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) premarket notification for a medical device (Medline UNITE® Ankle Fusion Plating System) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical (bench) testing.

The document explicitly states:

• "This section does not apply. No animal testing was performed."
• "This section does not apply. No clinical testing was performed."
• "Summary of Clinical Testing: Not applicable."

Therefore, there is no information regarding:

• Acceptance criteria and reported device performance related to a clinical study.
• Sample size used for the test set or its data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical study.
• Sample size for the training set.
• How ground truth for the training set was established.

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The Medline Sure-Snap Safety Syringe is intended for use in the aspiration and injection of fluids for medical purposes. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

The Medline Sure-Snap Safety Needle is intended for use with a luer-lock syringe for aspiration and injection of fluids for medical purposes. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

The Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe comprises hypodermic single lumen luer-lock safety needles alone (Identified in this submission as Medline Sure-Snap Safety Needles) and a combination of hypodermic single lumen luer-lock safety needles with luer-lock piston syringes (identified in this submission as Medline Sure-Snap Safety Syringes).

The provided text describes a 510(k) premarket notification for the Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe. This type of submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a clinical efficacy study. Therefore, much of the requested information regarding clinical study design (sample size, expert ground truth, MRMC studies, training set details) is not applicable or explicitly stated in this document because the regulatory pathway chosen focuses on device characteristics and bench testing.

However, based on the document, here's what can be extracted regarding acceptance criteria and the study performed, focusing on the "Performance Testing (Bench)" and "Usability Testing" sections as these are the closest to performance evaluation.

Acceptance Criteria and Device Performance (Summary based on available information)

The primary "acceptance criteria" from a regulatory perspective for this 510(k) submission is to demonstrate substantial equivalence to predicate devices. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. Performance is evaluated through a series of bench tests and a simulated clinical use study as recommended by FDA guidance.

Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence and non-clinical testing, explicit numerical "acceptance criteria" and "reported device performance" are presented as compliance with established standards and successful outcomes of specific tests, rather than clinical efficacy metrics.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Simulated Clinical Use Study for Sharps Injury Prevention): 1,000 safety needles were tested (500 per "safety needle type" – though the document details multiple configurations, it doesn't specify if "safety needle type" refers to Sure-Snap Safety Needle vs. Sure-Snap Safety Syringe types or different gauge sizes).
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission, the studies would typically be conducted prospectively as part of the premarket submission process, and are likely to be conducted under a quality system by the manufacturer (Medline Industries, Inc. in Northfield, Illinois, USA).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For the simulated clinical use study (usability testing), "Participating healthcare professionals assessed the function of the safety needle with a pass/fail criteria and provided feedback." The specific number of professionals or their detailed qualifications (e.g., years of experience, specific role like nurse, phlebotomist) are not specified in the document.

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

   • The document implies a direct "pass/fail criteria" assessed by the participating healthcare professionals during the simulated clinical use study. It does not mention any formal adjudication method (like 2+1 or 3+1 consensus) for the results, suggesting a direct observation of the device's functional activation.

4. 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. This is a medical device (syringe and needle) and not an AI/imaging device. Therefore, an MRMC comparative effectiveness study is not applicable and was not conducted.

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

   • Not applicable. This device is a physical medical instrument, not an algorithm. Bench tests evaluate the physical properties and functional aspects of the device itself (e.g., needle sharpness, sheath activation), which could be considered a form of "standalone" performance testing for a physical object.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • For the simulated clinical use study, the "ground truth" for the device's safety feature activation was based on direct observation of its functional activation against pre-defined pass/fail criteria by "participating healthcare professionals." It's a performance truth based on observed mechanical function in a simulated setting, rather than a diagnostic truth like pathology or outcome data.
   • For other performance tests (e.g., biocompatibility, functional performance under ISO standards), the "ground truth" is defined by the requirements and test methods specified in the cited international consensus standards. Compliance with these standards indicates the device performs as expected for its class.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set" for an algorithm. All listed tests are for device verification/validation.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for an AI model.

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The Hudson RCI Triflo II Incentive Deep Breathing Exerciser is intended as an inspiratory deep breathing positive exerciser for adult and pediatric (above 5 years) patients.

Intended for single-patient, multi-use in a hospital or home care setting.

The Hudson RCI Triflo II Incentive Deep Breathing Exerciser. The device is a non-diagnostic, therapeutic spirometer (inspiratory deep-breathing exerciser) designed for a maximum flow rate of approximately 1200 cc/sec. It is supplied in clean, sanitary condition, ready for use. It is designed for single patient use and discarded when no longer needed by the patient to whom assigned. By sequentially lifting the balls that are inside every chamber it provides an exercise incentive to patients who require sustained maximal inspiration (SMI), or similar maneuvers.

The provided document is a 510(k) premarket notification for a medical device, specifically an Incentive Spirometer. It contains information about the device, its intended use, comparison with predicate devices, and performance data.

However, the document does not describe a study involving:

• An AI/algorithm-based device.
• Establishment of ground truth by experts.
• Sample sizes for test sets or training sets in the context of an AI study.
• Multi-reader multi-case (MRMC) studies.
• The effect size of human readers improving with AI assistance.
• Standalone algorithm performance.

The "Performance Data" section (Section VII) details bench testing for the physical device (biocompatibility, cleaning validation, and various physical performance tests like flow accuracy, useful life, drop testing, packaging). These are standard engineering and safety tests for a physical medical device, not a study evaluating an AI algorithm's diagnostic or predictive performance.

Therefore, based on the provided text, I cannot extract the information required to answer your prompt about acceptance criteria and a study proving an AI device meets acceptance criteria. The document describes a traditional medical device (an incentive spirometer) and its associated regulatory clearance process.

If you can provide a document that discusses the development and validation of an AI-powered medical device, I would be happy to analyze it against your specified criteria.

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The Medline General Surgery Tray contains a single-use sterile surgical drape intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is packaged and sterilized with disposable devices intended for professional use/used by licensed physicians in preparing the operating environment for, and performing procedures and surgeries. The intended products assembled in these kits will not be changed from the manufacturer's original intended use.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Medline General Surgery Tray" does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) letter is a regulatory document indicating that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory requirements, classification, and general controls, rather than detailed performance study results or acceptance criteria.

The "Indications for Use" section describes how the device is intended to be used (as a single-use sterile surgical drape to isolate a surgical site) but does not provide details of any studies or performance metrics.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, adjudication methods for test sets.
3. Information on MRMC studies or human reader improvement.
4. Stand-alone algorithm performance.
5. Type of ground truth used.
6. Sample size for the training set or how ground truth was established for the training set.

This type of information is typically found in the full 510(k) submission, not in the public clearance letter.

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Medline's Smoke Evacuation Shroud is a single use, sterile product. Its intended use is as an electrosurgical accessory to attach to a standard cautery pencil. The shroud removes surgical procedures. The product is used inside the sterile field.

Medline's Smoke Evacuation Shroud is a single use, sterile product.

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Medline Smoke Evacuation Shroud" does not contain the information necessary to answer your request about acceptance criteria and a study proving device performance as it relates to AI/machine learning devices.

The document is a standard FDA 510(k) clearance letter for a Class II medical device (a smoke evacuation shroud, which is a physical accessory for electrosurgical pencils) and primarily addresses regulatory compliance and substantial equivalence to predicate devices. It does not discuss:

• Acceptance criteria for an AI/ML algorithm.
• Performance studies involving AI/ML.
• Sample sizes for test or training sets.
• Expert involvement in establishing ground truth.
• Adjudication methods.
• MRMC studies or effect sizes for human readers.
• Stand-alone algorithm performance.
• Types of ground truth.

Therefore, I cannot populate the table or provide any of the requested details based on the given input. This document is not relevant to the kind of AI/ML device performance study you are asking about.

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The Medline UNITE® REFLEX™ Dynamic Discs are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Discs are intended for single use only.

The Medline UNITE® REFLEX™ Dynamic Discs are manufactured from nickel titanium alloy (nitinol). The discs utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. The discs are offered in various diameters and thicknesses to be used in conjunction with screws of various diameters.

The provided text is related to a 510(k) premarket notification for a medical device (Medline UNITE® REFLEX™ Dynamic Discs). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria via a clinical or comparative effectiveness study as would be seen for an AI/ML medical device.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in a clinical or AI/ML context. It focuses instead on non-clinical (bench) testing to support material and design equivalency.

Here's why the requested information cannot be extracted from this document:

• No AI/ML Component: The device described (Dynamic Discs) is a metallic bone fixation appliance, not an AI/ML-driven diagnostic or analytical tool. Therefore, there are no AI/ML performance metrics, acceptance criteria, or studies (like MRMC or standalone performance) to report.
• Focus on Substantial Equivalence: The 510(k) pathway is primarily about demonstrating that a new device is "substantially equivalent" to a predicate device already on the market. This often relies on comparing technological characteristics, intended use, and performing non-clinical (bench) tests to ensure safety and performance are comparable, rather than conducting large-scale clinical trials with specific performance endpoints and expert ground truth establishment.
• Non-Clinical Testing Only: The "Summary of Non-Clinical Testing" section describes tests like transformation temperature (ASTM F2004), galvanic corrosion (ASTM F3044), and corrosion susceptibility (ASTM F2129). These are material and safety tests, not performance studies in a clinical setting determining diagnostic accuracy or human reader improvement.
• "Summary of Clinical Testing: Not applicable.": This explicitly states that clinical testing was not performed or required for this submission, further reinforcing that there won't be data on human reader improvement or standalone diagnostic performance.

In summary, none of the specific bullet points regarding acceptance criteria, study details (sample sizes, data provenance, expert adjudication, MRMC, standalone performance, ground truth), or training set information are applicable or present in this 510(k) submission for the Medline UNITE® REFLEX™ Dynamic Discs.

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The Medline Cardiovascular Procedure Kit contains a single-use sterile surgical drape intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is packaged and sterilized with disposable devices intended for professional use/used by licensed physicians in preparing the operating environment for, and performing cardiovascular procedures and surgeries. The intended use of the medical products assembled in these kits will not be changed from the manufacturer's original intended use.

The Medline Cardiovascular Procedure Kit is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits are assembled for customer convenience using Medline and other manufacturer's currently manufactured/marketed components. Customers specify the kit contents, quantity, and placement of individual components in the kit. A component listing is provided within this submission, which includes the name and regulatory status of components that can be selected for placement in various configurations of the final Medline Cardiovascular Kits. The BOM provides the corresponding FDA product codes, and reference to respective marketing clearances (as applicable). These included components are standard for cardiovascular procedures.

The intended use of the products assembled in the final Medline Cardiovascular Procedure Kit will not be changed. These components are all legally marketed drug products, and/or medical devices that are either: (1) pre-amendment devices; (2) 510(k)-cleared devices; or (3) 510(k) exempt devices. Commodity products, not regulated by FDA, are additionally included in the proposed kit. The customer may also specify a certain brand of similar items or minor variations of items. If additional components and/or manufacturers must be added to this list, we certify the regulatory compliance of the added components and maintain the information in our internal Device Master Record.

This document is a 510(k) Premarket Notification for a Medline Cardiovascular Procedure Kit. It is a regulatory submission to the FDA, and as such, it does not contain a study that proves the device meets acceptance criteria in the way described in the request (e.g., performance metrics, sample sizes for test sets, expert adjudication methods).

Instead, this submission is built on the principle of Substantial Equivalence (SE) to a legally marketed predicate device. The core argument is that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate.

Here's a breakdown based on your request, explicitly stating when the information is not present in the document:

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

   • Not applicable in the provided document for this type of device. This document is for a "convenience kit" which is essentially a collection of existing, already-cleared medical devices (and some non-regulated items) bundled together for convenience. The performance of the individual components is assumed to be established by their original clearances or regulatory status (e.g., pre-amendment devices).
   • The "acceptance criteria" for a 510(k) for a convenience kit revolve around demonstrating that the kit itself does not alter the intended use or safety/effectiveness of its components, and that the chosen sterilization method is appropriate.

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

   • Not applicable. No test set with patient data (e.g., images for AI) was used or described. The "testing" primarily refers to non-clinical evaluations related to biocompatibility and sterilization of the kit assembly.

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. No external experts were used to establish ground truth in the context of device performance testing in this submission.

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

   • Not applicable. No test set with adjudication was performed.

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 a surgical procedure kit, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

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

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

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

   • Not applicable in the context of performance testing. The "ground truth" for this submission concerns the regulatory status and intended use of the individual components within the kit, and the validation of the sterilization process.

8. The sample size for the training set

   • Not applicable. There is no training set mentioned as this is not an AI/ML device.

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

   • Not applicable.

Information that is present in the document relevant to a regulatory acceptance:

• Predicate Device: K962826 - Medline Radiology-Diagnostic Kits. This is the primary "proof" for substantial equivalence.
• Non-Clinical Testing: The safety and performance evaluation was conducted based on a risk assessment and evaluated in accordance with applicable recognized standards and FDA guidance documents. These include:
  • ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process
  • AAMI/ANSI/ISO 10993-7, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals.
  • FDA's Convenience Kits, Interim Regulatory Guidance: 20 May 1997
  • FDA's Sterilized Convenience Kits for Clinical and Surgical Use: 7 January 2002
• Sterilization: The kit is terminally sterilized by ethylene oxide (EO) to deliver a minimum sterility assurance level of 10-6. Medline ensures sterility of components and no adverse impact from sterilization on functionality.
• Components: The device consists of legally marketed drug products and/or medical devices that are either pre-amendment, 510(k)-cleared, or 510(k) exempt devices, along with commodity products not regulated by FDA. The intended use of these products is not changed.

In summary, this document is a regulatory submission for a convenience kit, not a performance study for a novel diagnostic or therapeutic device. The "acceptance criteria" are interpreted by the FDA as meeting the requirements for Substantial Equivalence to the predicate device, primarily through demonstrating similar intended use, technological characteristics, and compliance with relevant non-clinical and sterilization standards.

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These devices are indicated for use as a barrier accessory to digital thermometers while taking rectal, oral or axillary temperature measurements. These sheaths are non-sterile and intended for single use only. This accessory is contraindicated for use with broken skin.

The Medline Digital Thermometer Non-Lubricated Probe Sheath is an accessory to a clinical electronic thermometer, which is intended to measure body temperature. The Medline Digital Thermometer Non-Lubricated Probe Sheath is a flexible plastic sheath that is used to cover the transducer of clinical electronic thermometers while taking body temperature measurements from the oral, axillary, or rectal measurement sites and acts as a barrier to prevent possible contamination of the device during temperature measurement. The sheath is an over-the-counter (OTC), disposable, single use, nonlubricated, and non-sterile device that is compatible with most digital stick thermometers.

The Medline Digital Thermometer Non-Lubricated Probe Sheath is an accessionary to a clinical electronic thermometer. This device aims to prevent contamination of the thermometer during temperature measurement by acting as a barrier. The device is non-sterile and intended for single use only. This accessory is contraindicated for use with broken skin.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not explicitly state the sample sizes used for the non-clinical performance and biocompatibility testing. It only mentions that testing was conducted to demonstrate safety and effectiveness. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

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

Not applicable. This device is a physical accessory and does not involve AI or human interpretation for diagnosis, thus no experts were used to establish ground truth in the context of clinical interpretation. Ground truth for its performance is established through adherence to engineering and biological safety standards.

4. Adjudication Method for the Test Set:

Not applicable. As no human interpretation for diagnosis or AI performance evaluation is involved, no adjudication method was used. Performance was assessed directly against pre-defined engineering and biological standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. A MRMC comparative effectiveness study was not done as this is a non-AI medical device accessory.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. This device is a physical accessory and does not involve an algorithm. Performance testing was purely on the physical properties and biological safety of the device.

7. Type of Ground Truth Used:

The ground truth for evaluating the device's performance relies on established engineering standards (ASTM E1104-98 and ASTM E1112 for compatibility and leakage, and general tensile strength properties) and biological safety standards (ISO 10993 series for cytotoxicity, skin sensitization, and skin irritation).

8. Sample Size for the Training Set:

Not applicable. As this is a physical medical device accessory and not an AI algorithm, there is no training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set.

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The surgeon's glove is a disposable device made of synthetic rubber latex intended to be worn by surgeon's and or operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The surgeon's glove is a disposable device made of synthetic rubber latex.

This document describes the FDA clearance for the "SensiCare PI Ortho LT Surgical Glove." The primary study referenced is for the glove's permeation resistance to chemotherapy drugs.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, which the device was tested against. While specific thresholds for "acceptance" are not explicitly stated in this document (e.g., minimum acceptable breakthrough time), the results report the breakthrough detection time for each drug. The interpretation is that a longer breakthrough time indicates better performance.

Note: The document includes a "Warning: Do not use with Carmustine" and "Caution: Testing showed a minimum breakthrough time of 34.6 minutes with Thiotepa," indicating that for these specific drugs, the performance may not meet an assumed universal acceptance criterion for all chemotherapy drugs, or at least warrants specific precautions.

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

• Sample Size: The exact sample size (number of gloves or individual test replicates for each drug) is not explicitly stated in the provided text. However, for Carmustine and Thiotepa, three individual breakthrough times are listed, suggesting at least three replicates for these specific drug tests (e.g., 25.8, 34.1, 35.4 minutes for Carmustine; 37.5, 37.8, 34.6 minutes for Thiotepa). For drugs with ">240 minutes", it's implied that the test continued for at least 240 minutes without breakthrough for all tested samples.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a report on device testing results.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This study involves material testing (chemical permeation through a glove), not interpretation of medical images or patient data that would require expert consensus for ground truth. The "ground truth" here is the physical breakthrough detection time measured by laboratory equipment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is a material science test, not a subjective assessment requiring adjudication. The method is likely standardized within ASTM D6978.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, this was not an MRMC comparative effectiveness study. This type of study is for evaluating diagnostic or screening performance of an AI system, often involving human readers. The current study is an objective material property test.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, this is a "standalone" performance test, but not in the context of an AI algorithm. It's a test of the physical characteristics of the surgical glove itself, without human intervention in the measurement of permeation. The device (glove) functions independently of human interpretation regarding its barrier properties.

7. The Type of Ground Truth Used

The ground truth used is objective laboratory measurement (breakthrough detection time) in accordance with the specified standard (ASTM D6978). This is analogous to pathology or outcomes data in a clinical context, as it's a definitive, measurable characteristic of the device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set" in the conventional sense. The glove's design and manufacturing process would be informed by material science and engineering principles, not an algorithmic training process on data.

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

Not applicable, as there is no training set for an AI algorithm.

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