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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 Medline UNITE® REFLEX® Hybrid Nitinol Implants are intended to provide fixation for fractures, fusions or osteotomies of the bones of short (tarsals) and long (metatarsals, phalanges, distal tibia and fibula) bones comprising the foot and ankle such as: First metatarsal-cuneiform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, Lis-Franc arthrodesis, Scarf and Chevron osteotomies. Implants are intended for single use only.

The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® REFLEX® Hybrid Nitinol Implant. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The Medline UNITE® REFLEX® Hybrid Nitinol Implants are manufactured from nickel titanium alloy (nitinol). The implants utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. Chemical etching and passivation are common processes to create a uniform oxidation layer on the surface of the implant. The system includes implants offered in various styles, sizes, and options; each designed for specific anatomy and procedures. The implants can accommodate Ø2.7mm, Ø3.5mm, and Ø4.0mm locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots. The system also includes reusable and disposable instrumentation necessary for implantation of the REFLEX® Hybrid Nitinol Implant.

This 510(k) clearance letter is for a medical implant system, not an AI/software device, so the typical AI-related acceptance criteria and study details (like sample size for test set, experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document. The provided text describes the regulatory clearance process for a physical medical device.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, the Medline UNITE® REFLEX® Nitinol Staple System (K231885). This is achieved primarily through non-clinical (bench) testing and engineering analysis, not clinical trials or AI performance evaluations.

Here's a breakdown of the requested information based on the provided document, noting where specific AI-related questions are not applicable:

Acceptance Criteria and Device Performance (for a physical medical implant)

1. Table of Acceptance Criteria and 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)

• Sample Size for Test Set:
  • For Corrosion Susceptibility: Mentioned "not all samples," implying multiple samples were tested, but an exact number for the "test set" is not specified for the initial pass/fail.
  • For Nickel-ion Release: "three (3) samples tested over 60-days."
  • For Galvanic Corrosion: "all three (3) test samples."
• Data Provenance: The testing was non-clinical (bench testing) and performed according to ASTM standards and FDA guidance documents. There is no mention of country of origin of data as it's not human or patient data. It is inherently "prospective" in the sense that the tests were conducted specifically for this submission.

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. This is a physical medical device. Ground truth as typically defined in AI/software evaluations (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for the device's performance is established by standardized material and mechanical testing specifications (ASTM standards and FDA guidance).

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

• Not Applicable. This is a physical medical device. Adjudication methods are typically used for expert consensus on challenging cases in AI/software evaluations.

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 a physical medical device, not an AI-assisted diagnostic tool. No MRMC study was performed.

6. 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.

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

• The "ground truth" for this physical device is defined by established engineering and material science standards (ASTM F2129, ASTM F3306, ASTM F3044) and FDA guidance on biocompatibility and material safety (specifically for Nitinol implants and nickel release). Device performance is measured against these quantitative and qualitative benchmarks.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning.

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

• Not Applicable. This is a physical medical device. There is no "training set" or corresponding ground truth establishment process in the context of machine learning.

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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 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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The Medline Microdissection Needle is a monopolar electrosurgical instrument used for precision soft tissue dissection. It is a single-use device intended for cutting, dissecting, and cauterizing soft tissue. The Medline Microdissection Needle is not intended for use in the central nervous system or in the central circulatory system.

The Medline Microdissection Needle is a sterile, active electrode that is also referred to as a needle. It is designed for precision cutting, dissecting, and cauterization. The device is comprised of stainless steel, tungsten, and polyolefin heat shrink and will be offered in two different lengths, 4 cm (140936/ESE104A) and 3 cm (140937/ESE103A). The Medline Microdissection Needle is intended for connection with multiple brands of standard cautery pencils, including 510(k)-cleared Medline Cautery Pencil (K190643).

The Medline Microdissection Needle is a medical device and is not an AI/ML powered device, therefore no information about AI/ML acceptance criteria or studies is available in the provided text.

The provided document describes the 510(k) premarket notification for the Medline Microdissection Needle, comparing it to a predicate device. This submission process focuses on demonstrating substantial equivalence to a legally marketed device rather than establishing new acceptance criteria or conducting studies in the way one might for a novel AI/ML product.

Here's a breakdown of the non-clinical testing performed to demonstrate substantial equivalence, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific acceptance criteria with numerical performance targets in the way an AI/ML product might. Instead, it demonstrates equivalence through a comparison of technological characteristics and various non-clinical tests. The "Comparison Analysis" column in Table 1 serves as the "reported device performance" against the predicate device's characteristics.

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

The document primarily describes non-clinical bench testing, biocompatibility testing, electrical safety, and stability testing. It does not involve a "test set" of patient data or clinical images in the context of an AI/ML device. Therefore, a sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable as typically understood for AI/ML studies.

For bench tests, sample sizes would relate to the number of devices tested to meet statistical significance for particular tests (e.g., thermal damage, compression, dimensional measurements). These specific numbers are not detailed in the provided text.

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

Not applicable. This is not an AI/ML study involving human expert ground truth. The "ground truth" for this device's performance is established by adherence to recognized standards and validated physical/electrical performance tests.

4. Adjudication Method for the Test Set:

Not applicable. There is no human adjudication process described as this is not an AI/ML study.

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 conducted for diagnostic devices, especially those incorporating AI, to assess the impact of the device on human reader performance. The Medline Microdissection Needle is a surgical instrument.

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

Not applicable. The Medline Microdissection Needle is a physical electrosurgical instrument used by a surgeon, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the Medline Microdissection Needle is established through:

• Adherence to recognized international standards: e.g., ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 11135, ISO 11607, ASTM F1980, ANSI/AAMI ST 72, USP , IEC 60601 series.
• Physical and Electrical Performance Specifications: Demonstrated through bench testing (Thermal Damage Zone Testing, Tip/Pencil Compatibility, Appearance, Dimensional Measurements, Compression Test, Electrical Safety, EMC testing).
• Biocompatibility Testing: Evaluating potential biological responses through various ISO 10993 tests.
• Stability (Shelf Life) Testing: Demonstrating integrity over the proposed shelf life.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML product.

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

Not applicable. This is not an AI/ML product.

In summary, the provided document focuses on demonstrating that the Medline Microdissection Needle is substantially equivalent to a predicate device through comprehensive non-clinical testing against established engineering and biological standards, rather than through AI/ML specific performance metrics like accuracy, sensitivity, or human reader improvement.

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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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Medline Reusable Sterilization Wrappers are intended to be used to enclose another medical device or component that is to be sterilized by health care professionals. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Medline Reusable Sterilization Wrap is a non-sterile, reusable device, with a wash/dry/autoclave life cycle as indicated on the Wrap.

Medline Reusable Sterilization Wrappers are available in 3 different fabrics that are either single or double ply bonded sheets of cotton and polyester blends. Model Angelstat is reusable up to 50 times; Models Resistat and Ripstop are reusable up to 75 times . The Medline Reusable Sterilization Wrappers are available in Misty Green, Jade Green or Ceil Blue with configurations 12"x12" through 72"x72" and 60"x90". The Medline Reusable Sterilization Wrappers are intended to be laundered then sterilized prior to use, and examined prior to use for defects and debris.

A prevacuum steam sterilization cycle at 270 F for 4 minutes has been validated for use on textile packs, with a minimum weight of 25 pounds and 30 minute dry time.

Medline recommends following the below standards for pack configuration and assembly in sterilization facilities. · AAMI ANSI ST79 • AAMI ANSI ST65

The Medline Reusable Sterilization Wrappers are offered in bulk, non-sterile packaging. The Medline Reusable Sterilization Wrappers are available in 3 different fabrics that are either single or double ply bonded sheets of cotton and polyester blends. The Medline Reusable Sterilization Wrappers are available in Misty Green, Jade Green or Ceil Blue with configurations 12"x12" through 72"x72" and 60"x90". The Medline Reusable Sterilization Wrappers are intended to be sterilized and laundered per the instructions.

The provided text describes the acceptance criteria and the results of non-clinical testing for the Medline Reusable Sterilization Wrappers.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific sample sizes for each test listed. It mentions "Each test sample" for Cleaning Validation, implying multiple samples were tested. For other tests like Resistance to Water Penetration, Tensile Strength, and Particle Generation, it refers to "Test and Report" without specifying quantity.
The data provenance is not specified. It can be inferred that these tests were conducted by the manufacturer, Medline Industries, LP, to support their 510(k) submission.

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

This information is not provided in the document. The listed tests are non-clinical bench tests and sterilization validations, which typically rely on standardized methods and laboratory analysis rather than expert human interpretation for "ground truth" establishment in the same way, for example, medical image analysis would.

4. Adjudication method for the test set

Not applicable. The tests are objective, laboratory-based physical, chemical, and biological evaluations, not requiring human adjudication of results in the traditional sense.

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 medical accessory (sterilization wrapper) and does not involve AI or human "readers" for interpretation. Therefore, an MRMC study is not relevant.

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

Not applicable, as this device does not involve an algorithm or AI component.

7. The type of ground truth used

The ground truth for these tests is established by:

• Standardized Test Methods and Criteria: For physical and material properties (e.g., AATCC 127-2018 for water penetration, ASTM D5034-21 for tensile strength, ISO 9073-10:2004 for particle generation).
• Biological Test Outcomes: For biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity), the "ground truth" is determined by the biological response observed according to the protocols of ISO 10993 series.
• Sterilization Efficacy Indicators: For Sterilization Validation and Dry Time Validation, the "ground truth" is determined by the results of biological indicators, chemical integrators, and physical observations (e.g., moisture, weight difference) as per ST79:2017.
• Chemical Analysis: For Cleaning Validation, the "ground truth" is based on measurable chemical residuals (TOC level) and visual inspection for soil, guided by AAMI TIR30:2011.

8. The sample size for the training set

Not applicable. This device does not use an AI/ML component, so there is no "training set."

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

Not applicable, as there is no training set for this device.

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The Medline UNITE® MIS Foot Recon Screw System is indicated for the stabilization and fixation of bone reconstructions, osteotomies, joint fusions (arthrodeses), and fractures of short (tarsals) and long (metatarsals, phalanges, distal tibia and fibula) bones comprising the foot and ankle. Screws are intended for single use only.

The Medline UNITE® MIS Foot Recon Screw System includes screws manufactured from Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136 or IOS 5832-3. The screws are offered in various diameters from 2.5mm up to 4.0mm and overall lengths ranging from 14mm up to 70mm. The screws are single use and provided non-sterile intended to be cleaned and steam sterilized prior to use. The system also includes non-sterile, single use instrumentation necessary to implant the screws, e.g. drill bits and countersinks. Validated cleaning and sterilization instructions are included in the instructions for use.

The provided text is a 510(k) Summary for the Medline UNITE® MIS Foot Recon Screw System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states that no clinical testing (human or animal) was performed.

Therefore, many of the requested details, such as those related to multi-reader multi-case studies, expert adjudication for ground truth, and the use of training and test sets in the context of an AI/ML algorithm, are not applicable to this document as it does not describe an AI/ML powered device or a clinical study for device performance.

However, I can extract the acceptance criteria and performance data for the physical device based on the non-clinical testing conducted.

Here's the information that can be extracted and responses for the "not applicable" sections:

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

2. Sample size used for the test set and the data provenance

• Sample Size (Torsional Yield Strength): 6 samples (Ø2.5mm PT screws - MSCP2526)
• Data Provenance: Not specified, but given it's non-clinical lab testing of physical screws, it's likely internal lab data or from a testing facility. It is not patient data.

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

• Not Applicable. This is a physical device, and ground truth for its mechanical properties is established through standardized engineering testing (ASTM F543-23) rather than expert interpretation of medical images or clinical data.

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

• Not Applicable. See response for #3. Data is derived from objective physical testing, not subjective expert assessment.

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. No MRMC study was conducted as this is a physical medical device (bone screw), not an AI/ML diagnostic software. No human readers are involved in its primary function or assessment for regulatory clearance in this context.

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

• Not Applicable. No algorithm performance was assessed as this is a physical medical device.

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

• Ground Truth for Physical Properties: Established by the specifications of ASTM F543-23 and the FDA's Bone Screw SPBP Guidance for mechanical performance. This is an objective, quantitative ground truth based on engineering standards.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is a physical device being cleared through substantial equivalence based on non-clinical performance testing, not an AI/ML algorithm.

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

• Not Applicable. See response for #8.

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The Hudson RCI Dri-Tech Breathing Circuits are intended for pediatric and adult patients in professional healthcare environments as a conduit of breathing gas between a patient and a ventilator and to maintain the temperature of humidified inspired gas.

The Hudson RCI® Dri-Tech Breathing Circuits are intended for pediatric and adult patients in professional healthcare environments as a conduit for respiratory gas between a patient and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier (K131912). The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.

The Dri-Tech Breathing Circuits are designed to be used with various patient interfaces such as oral tracheal tubes, nasal tracheal tubes, endo-bronchial tubes, and masks (for noninvasive ventilation therapies such as CPAP, BiPAP, and Mask usage). As such, Dri-Tech Breathing Circuits are designed and will be manufactured to conform to the test requirements of ISO 5367:2014 "Anaesthetic and respiratory equipment -- Breathing sets and connectors".

The adult dual limb configuration consists of 19mm ID inspiratory limbs with 22mm connectors that are compliant to ISO 5356-1.2015 Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets. The adult circuits have a length of 1.7m on the inspiratory limb, and are kitted with the accessories described below:

• Tubing Adaptor: 22mm male to male adaptor for various connections as required.
• . Elbow Adaptor: Adaptor for connecting to the circuit wye to the patient interface to allow the circuit to exit the patient perpendicularly for optimal placement.
• . Tubing Hanger: Optional accessory for hanging the circuit to reduce pull on the patient interfaces and ventilator/humidifier connections.
• . Humidifier Limb: Required tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.

Optional Ventilator Accessory available for the Dri-Tech Dual Limb Breathing Circuit:

• . Dri-Tech Ventilator Accessory: Optional tee accessory capable of providing the 10 LPM flow required for the expiratory star lumen tubing. This ventilator accessory is comprised of male and female medical grade air DISS connectors to connect between the air hose and ventilator, a standard Christmas tree adaptor for connecting the tubing to, and an on/off valve to start and stop the flow.
  The adult single limb configuration is identical to the inspiratory limb of the dual limb configuration, however, is packaged with a different set of adaptors to facilitate connections and use with non-invasive therapies as described below:

• Humidifier Line: Optional tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.

• Exhalation Port Adaptor: Optional adaptor including an exhalation port and connector for the pressure monitoring line.

• Pressure Monitoring Line: Optional accessory tubing for use with units without an Airway Pressure Monitor.

• Pressure Monitoring Assembly: Optional accessory containing a tee and tubing for pressure monitoring on units with an Airway Pressure Monitor.

• 15mm Adaptor: Optional accessory required for connecting to certain patient interfaces.

• Male Luer: Optional accessory for required for certain setups to connect the pressure monitoring line.

• Tubing Hanger: Tubing hanger designed for single limb tubes and pressure monitoring lines to reduce pull on the patient interfaces and ventilator/humidifier connections.

• Bacterial/Viral Electrostatic Filter: Optional accessory in specific kit codes for user convenience.
  The Hudson RCI® Dri-Tech Breathing Circuits are sold non-sterile.

The provided document describes the FDA 510(k) premarket notification for the Hudson RCI Dri-Tech Breathing Circuits. This document outlines the device's characteristics, intended use, and a comparison with a predicate device, along with a summary of non-clinical testing performed to demonstrate substantial equivalence.

However, the document does not contain specific acceptance criteria in the form of numerical performance targets, nor does it detail a study that proves the device meets such criteria using a test set, expert adjudication, or MRMC/standalone performance metrics. The information provided heavily focuses on bench testing to established industry standards (e.g., ISO 5367:2014, ISO 80601-2-74:2017) and biocompatibility testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance as requested, because specific numerical acceptance criteria (e.g., a specific percentage for sensitivity or specificity) are not stated for AI/algorithm performance. The document describes a comparison to a predicate device and adherence to recognized standards, which are the basis for the FDA's substantial equivalence determination for this breathing circuit, not an AI-powered diagnostic device.

Similarly, other requested information such as sample size for the test set, data provenance, number and qualifications of experts, adjudication methods, MRMC study details, standalone performance, and ground truth establishment are not applicable to the type of device and testing described in this FDA submission. The device is a medical accessory, not an AI/ML-driven diagnostic or assistive tool.

Key takeaways from the document regarding "acceptance criteria" and "study":

• Acceptance Criteria (as implied by the regulatory submission): The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to a predicate device and meeting the requirements of recognized international standards for breathing circuits. These standards define performance characteristics such as resistance to flow, compliance, and leakage.

  • Resistance to Flow: Less than 1.8 cmH2O @ 30 LPM (per ISO 5367:2014)
  • Compliance: Less than 5 mL/cmH2O @ 60 cmH2O (per ISO 5367:2014)
  • Leakage: Less than 30 ml/min @ 60 cmH2O (per ISO 5367:2014)
  • Biocompatibility: Meeting the requirements of ISO 10993-1:2018 and ISO 18562-1:2017 for gas pathway evaluation (particulate matter, VOCs, leachables in condensate).
  • Safety: Meeting ISO 80601-2-74:2017 (Safety Testing), IEC 60601-1:2005 (Electrical Safety), and IEC 60601-1-2:2014 (EMC).
  • Useful Life: Meeting requirements for an intended 12-day useful life.

• Study That Proves the Device Meets the Criteria: The "study" described is a compilation of non-clinical bench testing.

  • Performance Testing (Bench): This included verification of features like length, leakage rate, compliance, resistance to flow (with and without bend), adaptor retention, circuit weight, ventilator accessory flow rate, expiratory star lumen tubing kink and crush resistance, moisture removal, and pressures.
  • Biocompatibility Testing: Evaluated cytotoxicity, irritation/intracutaneous reactivity, sensitization, genotoxicity, material mediated pyrogenicity, and extractables/leachables. Gas pathway evaluation included particulate matter and VOCs.
  • Electrical Safety and EMC Testing: Per IEC 60601-1 and IEC 60601-1-2.
  • Human Factors and Usability Testing: Summative testing was performed.

Therefore, I cannot populate the table or provide detailed responses to the AI/ML-specific questions as they are not relevant to the provided text.

In summary, based on the provided document:

1. A table of acceptance criteria and the reported device performance:
   • Acceptance Criteria (derived from standards):
     • Resistance to Flow:

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Rx Indications for Use: PluroGel® Antimicrobial Burn and Wound Dressing is indicated for the management of full and partial thickness wounds including surgically created wounds, dermal ulcers (pressure ulcers), leg ulcers (diabetic foot ulcers), superficial wounds, first degree burns, partial thickness burns, and donor sites. PluroGel® Antimicrobial Burn and Wound Dressing maintains a moist wound and skin environment that supports autolytic debridement of necrotic tissue.

OTC Indications for Use: PluroGel® Burn and Wound Dressing (OTC) is indicated for the management of minor cuts, minor burns, and minor lacerations. PluroGel® Burn and Wound Dressing (OTC) maintains a moist wound and skin environment.

PluroGel® Antimicrobial Burn and Wound Dressing and PluroGel® Burn and Wound Dressing (OTC) is a translucent, biocompatible, odorless, semisolid gel intended to provide and maintain a clean and moist wound environment that is conducive to healing. The dressing maintains moisture in the wound and protects the wound from desiccation to provide an optimal moist wound environment conducive to wound healing. PluroGel® Antimicrobial Burn and Wound Dressing and PluroGel® Burn and Wound Dressing (OTC) is non-cytotoxic, contains a surfactant, and is water soluble to aid in the removal of wound debris in between dressing changes.

PluroGel® is provided non-sterile and contains phenoxyethanol and potassium sorbate as antimicrobial preservative agents to inhibit the growth of microorganisms within the product during shelf storage before and after opening.

I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device that uses AI. The document discusses a 510(k) premarket notification for "PluroGel® Antimicrobial Burn and Wound Dressing" and "PluroGel® Burn and Wound Dressing (OTC)," which are wound dressings and not AI-powered devices.

Therefore, I cannot extract details about:

• A table of acceptance criteria and reported device performance for an AI device.
• Sample sizes for test sets, data provenance, or details about training sets for an AI model.
• Number of experts, their qualifications, or adjudication methods for ground truth establishment in an AI context.
• MRMC studies, effect sizes for human readers with AI assistance, or standalone algorithm performance.
• The type of ground truth (expert consensus, pathology, outcomes data) relevant to AI.

The document primarily focuses on the substantial equivalence of the wound dressing product to a predicate device based on its intended use, technological characteristics (ingredients, form, sterility), and non-clinical testing (biocompatibility, shelf life, period of use after opening, and a single animal wound healing study). It explicitly states "Summary of Clinical Testing: Not applicable," which further confirms no human clinical trials (nor AI performance studies) were conducted for this submission.

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