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Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device.

The Medline Bag Decanter is a non-pyrogenic, single use, disposable device, which is supplied sterile. The device comprises of a one-piece transfer device with protective flexible caps at either end. The device is an injection molded hollow tube with a spiked end used to access the source container and withdraw fluid. The spike component is designed with a built-in splash guard. The device is designed for use in transferring IV fluids/medication from a bag to an IV fluid administration device.

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Hudson RCI® Comfort Flo Nasal Cannulas Premature, Infant:
Hudson RCI® Comfort Flo Nasal Cannulas Premature, Infant are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

It is indicated for single use by premature and infant (birth to 2 years) patients in professional healthcare environments.

Hudson RCI® Comfort Flo® Plus Cannulas and Comfort Flo® Soft Plus Cannulas Extra Small:
Hudson RCI® Comfort Flo® Plus Cannulas and Comfort Flo® Soft Plus Cannulas Extra Small are intended to be used in conjunction with the Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

It is indicated for single use by adult and pediatric (12 years and above) patients in professional healthcare environments.

Hudson RCI® Comfort Flo Nasal Cannulas Premature, Infant
Hudson RCI® Comfort Flo Plus Cannulas Extra Small
Hudson RCI® Comfort Flo Soft Plus Cannulas Extra Small

This is a 510(k) clearance letter for a medical device (nasal cannula), not an AI/ML-driven device. Therefore, the information typically requested for AI/ML device validation (such as expert consensus, MRMC studies, or training/test set details) is not applicable.

The document describes the device, its intended use, and a summary of non-clinical testing performed to demonstrate substantial equivalence to predicate devices. It clearly states that no clinical testing was performed.

Here's a breakdown of the requested information based on the provided document, highlighting why many points are not applicable for this type of device clearance:

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

   • The document lists various non-clinical performance tests but does not provide a table of specific acceptance criteria with corresponding reported device performance values. Instead, it generally states that testing was conducted "to demonstrate substantial equivalence." For example, it lists "Relevant Humidity Output testing" but doesn't state the specific humidity output range considered acceptable or the measured output. This is typical for a 510(k) submission where broad equivalence is the goal rather than meeting precise performance thresholds for novel functionality.

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

   • Not applicable. This is a physical medical device. Testing involved bench tests on manufactured units, not data sets in the AI/ML sense. Data provenance, retrospective/prospective, and sample sizes for test sets (in the context of patient data) are not relevant as no human or clinical data was used for validation.

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 "ground truth" was established by experts in the context of diagnostic performance, image interpretation, or similar AI/ML applications, as this is a physical medical device.

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

   • Not applicable. There was no test set requiring expert adjudication for performance evaluation.

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 is not an AI-assisted device, and no MRMC study was conducted. The document explicitly states "No clinical testing was performed."

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)

   • Not applicable. The concept of "ground truth" as it applies to AI/ML model validation is not relevant here. The device's performance was evaluated against engineering specifications and industry standards for physical device functionality (e.g., flow rates, material compatibility, strength).

8. The sample size for the training set

   • Not applicable. There is no AI/ML model, and thus no training set.

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

   • Not applicable. There is no AI/ML model, and thus no training set or ground truth establishment for it.

In summary, the provided document is a 510(k) clearance for a physical medical device, not an AI/ML-driven product. Therefore, most of the requested information related to AI/ML validation (ground truth, expert studies, training/test sets) is irrelevant to this submission.

The acceptance criteria for this device focus on:

• Biocompatibility: Meeting ISO standards (e.g., ISO 10993 series, ISO 18562 series) to ensure the materials are safe for patient contact and breathing gas pathways. The document lists the specific ISO standards used.
• Performance Bench Testing: Covering aspects like visual inspection, humidity output, thermal overshoot, connection strength, leak testing, headgear testing, shelf life, and useful life. While the specific numerical acceptance criteria for each test (e.g., "humidity output must be within X amount") are not explicitly listed in this summary, the document indicates these tests were performed and implicitly met the company's internal acceptance criteria for demonstrating substantial equivalence.
• Substantial Equivalence: The overarching acceptance criterion for a 510(k) is demonstrating that the device is "as safe and as effective" as a legally marketed predicate device, based on the non-clinical testing performed.

The "Study that proves the device meets the acceptance criteria" for this product consists of the various Non-Clinical Testing described on pages 16-17, primarily Biocompatibility Testing and Performance Testing (Bench), which were conducted to support the claim of substantial equivalence to the predicate devices.

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The Hudson RCI Comfort Flo® CubCannula™ is a single use nasal cannula intended to administer respiratory gas to a spontaneously breathing patient through both nostrils delivering flow rates ranging from 1 to 25 LPM.

CubCannula™ is a patient interface used to deliver heated and humidified gas to the following populations:

• · Neonates, birth to 1 month of age
• · Infants, 1 month to 2 years of age
• · Children, 2 to 12 years of age

CubCannula™ is designed for use in professional healthcare environments and must be prescribed by a physician.
CubCannula is used in conjunction with the Humidification System intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

The Comfort Flo® CubCannula™ is a single patient use nasal cannula containing two-prongs intended to administer gas to a spontaneously breathing patient through both nostrils. CubCannula™ is a patient interface used as a conduit to deliver heated and humidified gas to the following pediations: neonates, infants, children. The nasal cannula incorporates soft prongs, a soft, silicone, kink and crush resistant lariat, in addition to a color-coded bolo for easy size identification. The CubCannulas will be available in five sizes: Extra Small (XS), Small (XS), Small (XS), Small (XS), Medium (M), Large (L), and Extra Large (XL). The nasal cannula will be secured to the patient's face via use of Hydrocolloid pads (CubPads™) to assist with easy positioning and change out of the cannula during use.

The CubCannula™ will be individually packaged with a pair (2) of CubPad™ replacements will be available in a separate package.

Based on the provided text, the device in question is the Hudson RCI Comfort Flo® CubCannula™, a nasal cannula. The document is a 510(k) Premarket Notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study as might be done for a novel device or pre-market approval (PMA) pathway.

Therefore, the information regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with pre-defined primary and secondary endpoints is not explicitly present for this 510(k) submission. Instead, the focus is on demonstrating equivalence through non-clinical testing (biocompatibility and bench testing).

Here's an analysis of the provided information relative to your questions, with specific callouts where information is not available due to the nature of a 510(k) substantial equivalence submission:

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

The document does not present a formal table of acceptance criteria with corresponding performance results in the way a clinical study report would. Instead, it lists the non-clinical tests performed and states that they revealed "passing results" or that "emissions are well below the health-based thresholds." The "acceptance criteria" are implied by the standards cited and the statement of compliance.

Implied Acceptance (Compliance) and Reported Performance (Statement of Passing):

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

This information is not provided in the document as it pertains to a 510(k) submission based on non-clinical (bench) testing, not a clinical study. The "test set" would refer to the physical units of the device tested in the lab, but the number of units is not specified. There is no patient data or country of origin for the data as no clinical testing was performed ("No clinical testing was performed").

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 as there was no clinical study, no patient data, and therefore no "ground truth" established by experts in the context of clinical interpretation or outcomes. The ground truth for the non-clinical tests would be the established performance standards set by the cited ISO and ASTM documents.

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

This is not applicable as there was no clinical study or expert review for 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

This is not applicable. The device is a physical medical device (nasal cannula), not an AI-powered diagnostic or assistive tool.

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

This is not applicable, as it is not an algorithm-based device.

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

Since no clinical study comparing the new device's performance against a "ground truth" in patients was conducted per the document ("No clinical testing was performed"), the concept of "ground truth" in a clinical sense is not applicable. For the non-clinical testing, the "ground truth" is adherence to the specified performance characteristics and safety profiles as measured against the requirements of the cited ISO and ASTM standards. These standards define the acceptable range for each test parameter (e.g., cytotoxicity, leachable substances thresholds, connection strength, leak rates).

8. The sample size for the training set

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

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

This is not applicable for the reasons stated in point 8.

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Hudson RCI® Comfort Flo nasal cannulas are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

It is indicated for single use by adult and pediatic (2 years and above) patients in professional healthcare environments.

Hudson RCI® Comfort Flo® Plus cannulas are intended to be used in conjunction with the Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

It is indicated for single use by adult and pediative (12 years and above) patients in professional healthcare environments.

Hudson RCI® Comfort Flo Nasal Cannulas:
Comfort Flo nasal cannulas are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated humidified air to spontaneously breathing patients. Sizes available include adult and pediatric.

Hudson RCI® Comfort Flo Plus Cannulas:
Cannula tube is assembled with other components to create a product named Comfort Flo® Plus Cannula with/ without Chin Strap. The Comfort Flo Plus cannulas are intended to be used in conjunction with the Humidification system intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients. It allows for the safe and effective delivery of heated, humidified oxygen therapy to the patients.

The Comfort Flo Plus Cannulas are available in small, medium and large configurations. The chin strap is also offered individually.

Hudson RCI® Comfort Flo Plus Cannulas:
Comfort Flo Soft Plus cannulas are the same as Comfort Flo Plus cannulas except for head strap. These have a soft/cushioned head strap for patient comfort.

It is used as an alternative to oxygen face mask and allows the patient to continue to talk, eat and drink while receiving the therapy.

Hudson RCI® Tracheostomy Adaptor:
The Hudson RCI® Tracheostomy Adapters are intended to be used in conjunction with tracheostomies in order to provide a secure connection to spontaneously breathing tracheostomy patients for oxygen therapy. It allows for the safe and effective delivery of oxygen therapy to the patient's trachea.

The Tracheostomy Adaptor consists of 15mm (female) connector with cap deflector which enables it to be attached to 15M conical connector of tracheostomy tube/ patient connector port and swivel connector (15F/22M) at another end in order to connect with breathing circuit/ humidification system.

It is indicated for single use by adult and pediatric (12 years and above) patients in professional healthcare environments.

The provided text is related to a 510(k) premarket notification for a medical device (nasal cannulas) and does NOT contain information about acceptance criteria or a study proving that the device meets specific performance criteria, especially not in the context of an AI/ML-driven medical device.

The document describes the device, its intended use, comparison to predicate devices, and a summary of non-clinical (bench) performance testing and biocompatibility testing. However, it explicitly states "This section does not apply. No animal testing was performed" and "This section does not apply. No clinical testing was performed" under "Performance Testing (Animal)" and "Performance Testing (Clinical)" respectively.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance from a test set, sample sizes for test/training sets, data provenance, expert numbers/qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device.

The document discusses tests like:

• Post aging Visual Inspection
• Relevant Humidity Output testing
• Thermal Overshoot testing
• Gas path and headgear joint and connection strength testing
• Flow Leak Test/ Gas path leak testing
• Head Gear Testing
• Shelf Life Testing
• Useful Life Testing
• Transportation simulation
• ISO gauging

These are all bench tests for a mechanical/physical device (nasal cannula), not studies that would involve AI/ML performance metrics like sensitivity, specificity, AUC, or the involvement of human readers/experts for ground truth.

In summary, the provided document does not contain the information required to answer your request about acceptance criteria and study details for an AI/ML medical device.

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The Medline Orbis LVL 3 Surgical Gown is intended to be worn by healthcare professionals during surgical procedures to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter. The Medline Orbis LVL 3 Surgical Gown is a single use, disposable medical device provided both sterile and nonsterile.

The Medline Orbis LVL 3 Surgical Gown meets the Level 3 requirements of ANSI/AAMIPB70:2012 Liquid barrier and performance classification of protective apparel and drapes intended for use in healthcare facilities.

Non-sterile gowns are to be sold 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 the end users after EtO sterilization validation to ISO 11135-1.

The Medline Orbis LVL 3 Surgical Gown is a single use, disposable medical device provided both sterile and nonsterile.

The provided text is a 510(k) clearance letter from the FDA for a surgical gown (Medline Orbis LVL 3 Surgical Gown). It states the device's indications for use and confirms its substantial equivalence to a predicate device.

However, the document does NOT contain information regarding:

• Acceptance criteria for device performance based on a study. (The text only mentions meeting Level 3 requirements of ANSI/AAMI PB70:2012 for liquid barrier and performance, which is a standard, not specific acceptance criteria from a study).
• Reported device performance from a specific study.
• Sample size used for a test set or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• 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).
• Sample size for a training set.
• How ground truth for a training set was established.

The document is a regulatory clearance letter, not a clinical or performance study report. Therefore, I cannot extract the detailed information requested about acceptance criteria and a study proving those criteria are met.

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