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The Medline Level 4 Surgical Gown with Breathable Sleeves is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Level 4 Surgical Gown with Breathable Sleeves meets the Level 4 requirements of ANSI/AAMIPB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

The Medline Level 4 Surgical Gown with Breathable Sleeves is also sold in a non-sterile version to repackagers/kitting entities, to be sterilized using the validated ethylene oxide sterilization method according to ISO 11135-1 in its final finished form, as a kit component.

The Medline Level 4 Surgical Gown with Breathable Sleeves is a single-use, sterile, disposable medical device that is provided in a variety of sizes (Large, X-Large, 3X-Large, 3X-Large and X-Long (only Sirus)) and styles (Sirus, Aurora and Eclipse). The Medline Level 4 Surgical Gown with Breathable Sleeves is constructed from nonwoven SMS (spunbond, meltblown, spunbond), a poly-fabric reinforcement on the chest front panel, and a breathable film (Polyester ether and polyester) for the sleeves. Each gown is designed with a hook and loop closure at the neck, ties at the waist, knitted cuffs at the end of the sleeves as well as a transfer tab for ease in donning. The Medline Level 4 Surgical Gown with Breathable Sleeves has been tested according to ANSI/AAMI PB70:2022 and meets AAMI Level 4 barrier level protection for a surgical gown.

This document describes the performance testing for the Medline Level 4 Surgical Gown with Breathable Sleeves (K242844), a surgical apparel device. The information provided is based on non-clinical testing only, as no clinical testing was performed for this 510(k) submission.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes non-clinical tests conducted to verify design specifications. For each test listed in the table, the "Results" column indicates a "Pass," meaning the acceptance criteria were met.

• Sample Size: The specific sample sizes for each non-clinical test (e.g., number of fabric specimens tested for ASTM F1671) are not detailed in this summary. The 510(k) summary typically provides a high-level overview, and the detailed test reports (which FDA reviews) would contain this information.
• Data Provenance: The tests are generally performed by accredited testing laboratories or the manufacturer's own qualified labs. The document does not specify the country of origin of the data. Given it's an FDA submission, the tests would typically adhere to recognized international standards like ISO and ASTM. These are prospective tests performed specifically to support the regulatory submission of this new device.

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

• Not Applicable. For this type of medical device (surgical gowns), "ground truth" is established through adherence to standardized, objective performance tests (e.g., measuring water resistance, breaking strength, biocompatibility). These are not studies that rely on expert interpretation of images or clinical outcomes to establish ground truth in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set:

• None. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or clinical endpoints, often in the context of diagnostic accuracy or clinical trials. As this is a non-clinical performance evaluation against objective standards, no adjudication method is used. The results are quantitative measurements interpreted against pre-defined thresholds.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (especially those involving image interpretation by human readers) to assess how an AI algorithm impacts reader performance. The Medline Level 4 Surgical Gown is a protective apparel, not a diagnostic device, and its performance is evaluated through physical and material property tests, not human reader studies.

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

• Not Applicable. This question typically pertains to AI/ML software as a medical device (SaMD). The Medline Level 4 Surgical Gown is a physical medical device. Its performance is inherent in its material properties and manufacturing, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established by objective, quantitative measurements against published national and international standards. This includes:

• Biocompatibility Standards: ISO 10993 series (Cytotoxicity, Irritation, Sensitization).
• Barrier Performance Standards: ASTM F1671 (blood-borne pathogens), AATCC 42 (impact penetration), AATCC 127 (hydrostatic pressure), and ANSI/AAMI PB70:2022 (overall liquid barrier performance classification).
• Material Strength Standards: ASTM D5034 (breaking strength), ASTM D5587 (tearing strength), ASTM D1683 (sewn seam failure).
• Other Performance Standards: 16 CFR 1610 (flammability), ASTM E96 (water vapor transmission/breathability).

The "ground truth" is therefore the measured physical and chemical properties of the gown, compared against the predefined acceptance criteria of these standard test methods.

8. The Sample Size for the Training Set:

• Not Applicable. The concept of a "training set" is relevant for machine learning algorithms. This device is a manufactured product, not an AI algorithm. Its design and manufacturing process would involve material selection and engineering, not machine learning training.

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

• Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

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The Medline ComfortTemp Patient Warming System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient themal comfort when conditions exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients.

The Medline ComfortTemp Patient Warming System is intended to prevent and treat hypothermia. In addition, the patient warming system provides thermal comfort when conditions exist that may cause patients to feel too warm or too cold. The patient warming system is for adult and pediatric patients. The Medline ComfortTemp Patient Warming System is used in acute care, post-acute care, operating room, and procedural rooms. The system consists of a reusable blower unit, a reusable hose, and single-patient use, disposable blankets. Replacement filters and hoses for the blower unit are additionally available as needed. All components of the ComfortTemp Patient Warming System are non-sterile. The blower unit connects to the single-patient use blanket through a reusable hose and provides forced warm air into the blanket using a PTC (positive temperature coefficient) heater, a fan/blower and a user-controlled interface. Depending on the model, the ComfortTemp blanket is placed either around, over, or underneath adult and/or pediatric patients. The blanket is comprised of two polypropylene and polyethylene layers, which allow the forced warm air to be dispersed over the patient's skin.

This document describes the FDA clearance for the Medline ComfortTemp Patient Warming System, declaring it substantially equivalent to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in terms of a digital health or AI/ML device.

The document discusses various performance tests conducted on the device, such as airflow testing, temperature verification, material strength, and biocompatibility. However, these are engineering and safety tests rather than performance evaluations against clinical acceptance criteria for an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert involvement as these details are not present in the provided text. The text does not describe an AI/ML device or a study with such methodologies.

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The Hudson RCI® TurboMist™ Nebulizer is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing.Its use is indicated when a licensed healthcare professional prescribes or administers medical aerosol to a patient using a small volume nebulizer.

The patient population includes adult and pediative (greater than 22 lbs or 10 kg) patients that are spontaneously breathing.

The product is a single patient, multi-use, non-sterile, disposable, prescriptive device intended to be used in a hospital or homecare environment.

The Hudson RCI® TurboMist™ Nebulizer System (herein referred to as "TurboMist system" or "subject device") consists of the TurboMist small volume nebulizer and a patient interface, which may include a swivel mouthpiece ors an aerosol mask and elbow adaptor. The aerosol mask is available in adult and pediatric versions. The TurboMist small volume nebulizer is a hand-held, breath-enhanced jet nebulizer designed to aerosolize liquid medications as prescribed by a physician. The nebulizer is powered by an external compressed air or oxygen source, and the aerosol is created by an internal jet located inside the nebulizer jar. The nebulizer is designed to entrain additional room air upon patient inhalation, enhancing aerosol generation and resulting in a faster nebulization rate than traditional jet nebulizers.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the Hudson RCI® TurboMist™ Nebulizer System. It details the device's indications for use, technological characteristics, comparison to predicate devices, and a summary of non-clinical testing performed to demonstrate substantial equivalence.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

• Particle Size Characterization: Not explicitly stated, but testing was performed on "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)" and "the primary predicate with a mouthpiece and aerosol mask." This implies at least one sample of each configuration for each device. The data for the secondary predicate was a "review of published test data in the 510(k) summary table."
• Shelf Life: Not explicitly stated how many samples were aged, but it was "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)."
• Useful Life: Not explicitly stated how many samples were tested, but it was "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)."
• Cleaning & Disinfection: Not explicitly stated how many samples were tested, but it was "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)."
• Biocompatibility: Not explicitly stated, but testing was performed on "the subject device as well as both proposed patient interfaces (mouthpiece and aerosol mask)."
• Gas Pathway: Not explicitly stated how many samples were tested, but it was "the subject device as well as both proposed patient interfaces (mouthpiece and aerosol mask)."

Data Provenance: The studies appear to be prospective testing conducted specifically for this 510(k) submission, with the exception of the secondary predicate's particle size data which was a retrospective review of published data. The document does not specify the country of origin for the data generation, but it is for a US FDA submission by Medline Industries LP (headquartered in Northfield, Illinois, USA), suggesting the testing was performed, overseen, or compiled for a US regulatory context.

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

This document describes non-clinical performance and safety testing of a medical device (nebulizer). It does not involve human subject data or diagnostic performance where "ground truth" would be established by experts or adjudicated. The "ground truth" for these tests is defined by established engineering and scientific standards (e.g., ISO, AAMI, FDA guidance) for physical and chemical properties, functionality, and biological safety. Therefore, this section is not applicable in the context of this 510(k) summary.

4. Adjudication Method for the Test Set:

Not applicable, as this is a non-clinical device performance and safety study, not a diagnostic study requiring expert adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. This document describes the substantial equivalence of a physical medical device (nebulizer) through non-clinical performance and safety testing, not the comparative diagnostic effectiveness of a reader-dependent system or AI.

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

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

7. The Type of Ground Truth Used:

As noted in section 3, the "ground truth" for the non-clinical tests is represented by the established scientific and engineering standards, guidance documents (e.g., FDA guidance, ISO standards, AAMI standards), and the pre-defined product specifications/acceptance criteria that the device must meet to demonstrate safe and effective performance and substantial equivalence to predicate devices. These are objective measures rather than expert consensus on a diagnostic outcome or pathology.

8. The Sample Size for the Training Set:

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

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

Not applicable. This is not an AI/machine learning device.

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The Medline Orbis Chemo Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect operating room personnel from transfer of microorganisms, body fluids, and particulate material. Additionally the gown is intended to protect healthcare personnel from exposure to chemotherapy drugs during their preparation, handling, and administration. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.

The Medline Orbis Chemo Surgical Gown meets the level 3 barrier protection requirements in accordance with ANSI/AAMI Standard PB70:2012 "Liquid Barrier Performance and Classification of Protective Apparel and Drapes intended for use in Health Care Facilities"

The Medline Orbis Chemo Surgical gown has been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-12 "Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact."

Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480 Cyclophosphamide [20 mg/ml] >480 Cytarabine Hydrochloride [100 mg/ml] >480 Dacarbazine [10 mg/ml] >480 Daunorubicin Hydrochloride [5 mg/ml] >480 Doxorubicin Hydrochloride [2 mg/ml] > 480 Etopside [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 Ifosfamide [50 mg/ml] > 480 Methotrexate [25 mg/ml] >480 Mitomycin C [0.5 mg/ml] >480 Mitoxantrone [2.0 mg/ml] >480 Paclitaxel [6 mg/ml] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/ml] >480

Gown selection should be specifically chosen for the type of chemotherapy agent used. Users are recommended to review Material Safety Data Sheets for Chemotherapy Drugs being used to determine the required level of protection.

The Medline Orbis Chemo Surgical Gown is a single-use, disposable, level 3 surgical gown available in sterile and non-sterile configurations. The multiple configurations and sizes are described in Table 1 below. The Medline Orbis Chemo Surgical Gown is manufactured using a nonwoven polypropylene spunbond. Each gown is designed with a hook and loop closure at the neck, four ties at the waist, knitted polyester cuffs at the end of the sleeves as well as a transfer tab for ease in donning.

The document describes the acceptance criteria and the performance studies for the Medline Orbis Chemo Surgical Gown. Since this is a physical medical device (surgical gown), the studies are non-clinical (laboratory testing) rather than clinical studies involving human or AI readers. Therefore, several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable in the context of this device.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

Specific Chemotherapy Drug Permeation Results (ASTM F739-12):
For the following chemotherapy drugs, the device showed no average standardized breakthrough for up to 480 minutes:

• Carmustine [3.3 mg/ml]
• Cisplatin [1.0 mg/ml]
• Cyclophosphamide [20 mg/ml]
• Cytarabine Hydrochloride [100 mg/ml]
• Dacarbazine [10 mg/ml]
• Daunorubicin Hydrochloride [5 mg/ml]
• Doxorubicin Hydrochloride [2 mg/ml]
• Etopside [20 mg/m1]
• Fluorouracil [50 mg/ml]
• Ifosfamide [50 mg/ml]
• Methotrexate [25 mg/ml]
• Mitomycin C [0.5 mg/ml]
• Mitoxantrone [2.0 mg/ml]
• Paclitaxel [6 mg/m]]
• Thiotepa [10 mg/ml]
• Vincristine Sulfate [1 mg/m]]

Additional Requested Information:

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

   • Sample Size: Not explicitly stated in terms of number of gowns, but standard testing for such products involves a specific number of samples as dictated by each ASTM/ISO/AATCC standard. The tests are laboratory-based, not based on a "test set" of patient data.
   • Data Provenance: Not specified, but generally, such non-clinical tests are performed in certified laboratories, likely within the manufacturer's operational region or by contract testing facilities. The tests are prospective in nature, as they are performed specifically to evaluate the device.

2. 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. This is a non-clinical device that relies on standardized laboratory test methods for performance evaluation, not expert-derived ground truth from human observations or medical imaging.

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

   • Not Applicable. The performance is determined by objective laboratory measurements against defined acceptance criteria, not through expert adjudication.

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:

   • Not Applicable. This is a physical medical device (surgical gown), not an AI-powered diagnostic or assistive tool for human readers.

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

   • Not Applicable. This is a physical medical device, not an algorithm.

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

   • Objective Test Standards and Criteria: The "ground truth" for this device's performance is established by the specific, objective measurement methods and acceptance criteria defined within internationally recognized standards (e.g., ISO, ASTM, AATCC, ANSI/AAMI). For example, "Pass" for cytotoxicity per ISO 10993-5 means the material did not exhibit cytotoxic effects according to that standard's defined procedure.

7. The sample size for the training set:

   • Not Applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI.

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

   • Not Applicable. As there is no training set for a physical device, this question is irrelevant.

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