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The non-prefilled nebulizer is indicated for use when humidity needs to the air flow going to a patient in the form of an aerosol. The large volume nebulizer also allows for the provision of humidified oxygen at select oxygen concentrations from 28% to 98%. This product is for single patient use and is designed to be used in hospital, nursing homes, extended care facilities, outpatient clinics as prescribed by a healthcare professional.

The large volume nebulizer is a non-prefilled reservoir nebulizer for supplying humidity for inhalation therapy. The device features a wing nut style connector that fits standard flow metered medical gas sources and includes a 500mL capacity jar with minimum and maximum fill lines. Large volume nebulize an internal venturi nozzle to draw the solution up from the jar through a small plastic pickup tube and into the gas stream to be aerosolized. A rotating collar sets the delivered oxygen concentration by controlling the size of the room air opening around the venturi. A bull-nose style output connector is used to connect 22mm aerosol tubing for delivery to the patient.

This document is a 510(k) Summary for the Hudson RCI Variable Concentration Large Volume Nebulizer, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria for a new and innovative AI-powered product.

Therefore, the requested information categories related to AI/algorithm performance, such as sample size for test sets and training sets, number of experts for ground truth, adjudication methods, MRMC studies, and standalone algorithm performance, are not applicable to this document. This document describes a traditional medical device, not an AI/ML-driven one.

Here's a response tailored to the provided document:

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

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance values in the manner typically seen for novel AI systems with quantitative metrics for accuracy, sensitivity, specificity, etc. Instead, it states that tests were performed to demonstrate safety based on current industry standards and concludes that the device is substantially equivalent to predicate devices. The "performance" here refers to meeting established safety and functional requirements rather than predictive accuracy.

Here's an interpretation based on the provided text, outlining the tests performed and the general "acceptance" that they indicate substantial equivalence:

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 typically found in detailed study reports or clinical trial summaries, which are not part of this 510(k) Summary. The document describes pre-clinical (bench) testing, not human subject data. Therefore, concepts like "test set," "data provenance," "country of origin," and "retrospective/prospective" studies as they apply to clinical data are not present. The "tests were performed" implies an internal engineering and quality assurance process.

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. "Ground truth" in the context of expert consensus is relevant for diagnostic algorithms or subjective assessments. For a physical device like a nebulizer, the "ground truth" is typically established by objective measurements against engineering specifications and validated test methods overseen by qualified engineers and technicians. The document does not specify the number or qualifications of individuals involved in setting or verifying these engineering standards or conducting the tests.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image analysis). For the physical and chemical testing of a nebulizer, the "adjudication" is through meeting predefined analytical standards and specifications, not through expert consensus on subjective findings.

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. MRMC studies are specific to evaluating diagnostic technologies, often AI-driven, where human readers interpret cases. This document is for a physical medical device (nebulizer) and does not involve human "readers" or an AI component.

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

Not applicable. This device is not an algorithm and does not have a "standalone" or "human-in-the-loop" mode for performance evaluation in the context of AI. It is a mechanical device that delivers aerosolized humidity.

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

For this type of device, the "ground truth" is based on:

• Engineering specifications and standards: Performance metrics like oxygen entrainment percentages, humidity output, and mechanical integrity are objectively measured against predefined engineering targets.
• Material compatibility standards: Biocompatibility is assessed against ISO 10993 series standards.
• Safety standards: General device safety is evaluated against recognized industry standards and regulatory requirements.

8. The sample size for the training set

Not applicable. There is no "training set" as this device is not an AI/ML model that undergoes a training process.

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

Not applicable. As there is no AI/ML model, there is no "training set" or ground truth established for it. The standards and specifications are established through medical device development processes and regulatory requirements.

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Medline's Smoke Evacuation Pencil is designed for general electrosurgical applications including cutting and coagulating, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

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The provided document is a 510(k) premarket notification letter from the FDA for a medical device (Medline Smoke Evacuation Pencil). It does not contain any information about acceptance criteria, device performance studies, or the methodologies used to establish ground truth or train AI models.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing ground truth for the training set.

The document focuses on the regulatory clearance process for a relatively low-tech electrosurgical device, not on the validation of an AI/ML-based medical device.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) are single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, light blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.

This document is a 510(k) summary for the Medline Powder-Free Light Blue Nitrile Exam Gloves, which have been tested for use with chemotherapy drugs. It is a report from Medline Industries, Inc. to the U.S. Food & Drug Administration (FDA) dated September 18, 2020. The purpose of this summary is to demonstrate substantial equivalence to a legally marketed predicate device (K172525).

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

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

The document provides performance data for resistance to permeation by chemotherapy drugs, evaluated per ASTM D6978-05 (Reapproved 2019). The "acceptance criteria" can be inferred from the "≥ 240 Minutes" value for most drugs, indicating that a barrier of at least 240 minutes is considered acceptable for practical use, though specific quantitative acceptance criteria are not explicitly stated for all tests. For Carmustine and Thio-Tepa, specific (lower) breakthrough times are reported, along with cautions/warnings.

Notes on Biocompatibility: The "Cytotoxic / Non-Toxic" entry under the proposed device's biocompatibility in the table (page 5) is contradictory. Under the "Summary of Non-Clinical Testing" (page 8), it explicitly states that ISO 10993-05: Cytotoxicity was performed. However, the result in the comparison table is listed as "Cytotoxic / Non-Toxic." Assuming the test was conducted and the device is intended for medical use, it should generally be "Non-Toxic." For this response, I've noted the apparent contradiction.

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

The document does not specify the sample sizes for the various tests (e.g., number of gloves tested for chemotherapy permeation, physical properties, or biocompatibility). It only states that the tests were performed "per ASTM D6978-05 (Reapproved 2019)" and other standards.

The provenance (country of origin, retrospective/prospective) of the data is not mentioned. It is implied to be prospective testing conducted for the purpose of this 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 applicable to this type of device and study. The "ground truth" here is established through standardized laboratory testing (ASTM standards) of physical and chemical properties, not through expert human interpretation of medical images or clinical observations. Therefore, there are no medical experts establishing ground truth in the context of this submission. The "experts" would be the accredited laboratories and technicians conducting the ASTM tests.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where there is subjective interpretation of data (e.g., medical images) by multiple human readers, and a consensus needs to be reached. For standardized laboratory tests of physical properties, the results are quantitative and objective, and thus adjudication is not necessary.

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 information is not applicable. This submission is for medical gloves, which are a physical device, and does not involve AI or human readers for diagnostic or interpretive tasks.

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

This information is not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used

The ground truth for the device's performance is established by standardized laboratory test methods and their defined parameters. Specifically:

• Chemotherapy Permeation: ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The "ground truth" is the breakthrough time measured according to this standard.
• Physical Properties: ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application. The "ground truth" is the measured tensile strength, elongation, dimensions, etc., according to this standard.
• Freedom from Holes: ASTM D5151-06 (Reapproved 2011) Standard Test Method for Detection of Holes in Medical Gloves.
• Residual Powder: ASTM D6124-06 (Reapproved 2011) Standard Test Method for Residual Powder on Medical Gloves.
• Biocompatibility: ISO 10993-10 (Primary Skin Irritation, Dermal Sensitization), and ISO 10993-05 (Cytotoxicity). The "ground truth" is the biological response observed according to these standards.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of laboratory testing of a physical medical device. This term typically refers to machine learning algorithms.

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

This information is not applicable for the same reason as point 8.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy drugs) are nonsterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are dark blue, powder free, nitrile ambidextrous gloves with a beaded cuff. The gloves are offered in sizes small, medium, large, and extra extra extra large packaged in a chipboard box.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Medline Nitrile Powder Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs).

This document outlines the substantial equivalence review for a medical device (examination gloves), not an AI/ML powered device. Therefore, many of the requested categories related to AI performance, such as sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies, are not applicable.

The core of the acceptance criteria and study in this submission revolves around the physical properties and barrier efficacy of the gloves, particularly against chemotherapy drugs.

1. Table of Acceptance Criteria and Reported Device Performance

• Cyclophosphamide: >240 minutes
• Dacarbazine: >240 minutes
• Doxorubicin HCl: >240 minutes
• Etoposide: >240 minutes
• Fluorouracil: >240 minutes
• Methotrexate: >240 minutes
• Mitomycin C: >240 minutes
• Paclitaxel: >240 minutes
• ThioTepa: 27.4 minutes
• Vincristine Sulfate: >240 minutes
  Labeling restriction: Do Not Use with Carmustine or Thiotepa |

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

The document does not specify the exact sample sizes (number of gloves) used for each individual test (e.g., tensile strength, hole detection, each chemotherapy drug). It references adherence to ASTM standards, which would dictate the sample sizes and testing methodologies. The data provenance is implied to be from laboratory testing conducted on the manufactured gloves. It is prospective in the sense that the testing was performed specifically for this submission on the device being reviewed. The country of origin of the data is not specified, but the testing standards (ASTM, ISO) are international/US-based.

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

Not applicable. The "ground truth" for glove performance is established by standardized laboratory testing methods (ASTM, ISO). Expert interpretation of images or clinical data is not relevant here.

4. Adjudication method for the test set

Not applicable. This concept is typically relevant for studies involving human interpretation or subjective assessments, not for objective laboratory physical and chemical barrier testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device for physical protection, not an AI/ML diagnostic or assistive tool.

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

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

7. The type of ground truth used

The "ground truth" is defined by the objective measurements obtained through standardized laboratory tests (e.g., physical dimensions, strength, and chemical permeation) as dictated by the referenced ASTM and ISO standards. For chemotherapy permeation, the "breakthrough time" measured according to ASTM D6978-05 served as the direct performance metric.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in the machine learning sense.

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

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

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The Medline UNITE® Jones Fracture Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion and repair and fixation of mal-unions, acute fractures, avulsion fractures, and repetitive stress fractures for bones appropriate for the size of the device including the fifth metatarsal (Jones fracture). Screws are intended for single use only.

The Medline UNITE® Jones Fracture Screws are manufactured from titanium alloy. The screws are offered in various diameters ranging from 4.5mm up to 6.0mm and overall lengths ranging from 34mm up to 65mm with consistent thread lengths.

This document is a 510(k) premarket notification for the Medline UNITE Jones Fracture Screw System. This type of FDA submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through extensive clinical trials as typically seen for novel drugs or high-risk devices. Therefore, the information provided does not directly align with a study designed to meet specific acceptance criteria in the manner you described for an AI/CADe device.

Here's an analysis based on the provided text, addressing your questions to the extent possible, and highlighting where the information is not applicable due to the nature of a 510(k) submission for a bone fixation screw:

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

The document does not present acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, accuracy, or reader agreement that would be typical for an AI/CADe device. Instead, the "acceptance criteria" for a 510(k) for a bone fixation screw relate to demonstrating substantial equivalence to a predicate device through mechanical testing and design comparisons.

Therefore, a table cannot be constructed as requested for an AI/CADe device. The reported "performance" is based on the results of non-clinical mechanical testing and engineering analysis to show that the new device is comparable to the predicate.

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

This information is not applicable as there was no test set in the context of clinical data for an AI/CADe device. The testing involved mechanical testing of the screws, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable as there was no clinical test set requiring expert ground truth for an AI/CADe device. The review of the device's design and mechanical testing would be conducted by engineers and regulatory experts.

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

This information is not applicable as there was no clinical test set with human readers to adjudicate for an AI/CADe device.

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 information is not applicable. An MRMC study is relevant for AI/CADe devices that assist human readers in image interpretation. This submission is for a physical medical device (bone fixation screws) and does not involve AI or image reading.

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

This information is not applicable. This device is a bone fixation screw, not an algorithm.

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

This information is not applicable as there was no clinical ground truth established for patient data in the context of an AI/CADe device. The "ground truth" for this submission would be established by engineering standards and mechanical test results demonstrating the screw's physical properties are suitable for its intended use and comparable to the predicate.

8. The sample size for the training set

This information is not applicable as there was no training set for an AI model.

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

This information is not applicable as there was no training set for an AI model.

Summary of what was done based on the provided text:

The submission for the Medline UNITE Jones Fracture Screw System (K201319) is a Special 510(k), indicating minor changes to an already cleared device. The "study" refers to non-clinical testing and engineering analysis to demonstrate substantial equivalence to a predicate device, not clinical efficacy or AI performance.

• Non-Clinical Testing: ASTM F543 testing was performed, including:
  • Insertion torque testing
  • Torsional strength testing
  • Axial pullout strength testing
• Engineering Analysis: Used to compare screw mechanical performance, fixation performance, and usability.
• Comparison to Predicate (Medline Cannulated Screw - K130319):
  • Intended Use: Identical.
  • Indications for Use: Similar, with the new device having more specific indications consistent with other screws cleared under 21 CFR 888.3040, but still falling under fracture fixation.
  • Materials: Identical (titanium alloy per ASTM F136).
  • Geometry and Size: Similar. The new device's diameters (4.5mm, 5.5mm, 6.0mm) and lengths (34mm - 65mm) are within the range of the predicate (2.0mm to 7.5mm diameter, 10mm to 130mm length).
  • Design Feature: Similar, but with a key difference: the Jones Fracture Screws are solid core and only self-drilling to reduce the risk of bi-cortical fixation in the 5th metatarsal, whereas the predicate is cannulated and self-drilling/self-tapping. Both feature a torx drive mechanism.

The conclusion is that the Medline UNITE® Jones Fracture Screws are substantially equivalent to the predicate device based on these non-clinical comparisons and testing. Clinical testing was not applicable for this submission.

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