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Monoject Syringes with Luer tip are intended for single use by health care professionals for general purpose fluid aspiration and and/or injection.

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The provided FDA 510(k) clearance letter pertains to Monoject™ Syringes, which are physical medical devices (piston syringes) and not an AI/ML software device. Therefore, the concepts of acceptance criteria for algorithm performance, study methodology for AI models, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this document.

The letter indicates that the device has received substantial equivalence to legally marketed predicate devices, meaning it meets the safety and effectiveness requirements for its intended use, which is general purpose fluid aspiration and/or injection by healthcare professionals.

To answer your request, if this were an AI/ML device, the information would typically be found in the 510(k) submission summary or a separate clinical study report, neither of which is present in the provided FDA clearance letter. The letter itself is a notice of clearance, not a detailed technical report of the studies performed.

Therefore, I cannot extract the requested information from the provided document as it does not contain details about an AI/ML study or its performance criteria.

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The Monoject™ Enteral Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids, either orally or enterally, into the gastrointestinal system of a patient. The orallenteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

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This document is an FDA 510(k) clearance letter for the Monoject™ Enteral Syringe with ENFit Connector. It does not contain any information regarding acceptance criteria or a study proving that a device meets those criteria for software or AI/ML-enabled devices.

The letter is a regulatory document indicating that the FDA has determined the device to be substantially equivalent to a legally marketed predicate device. This process primarily focuses on comparing the new device's intended use, technological characteristics, and safety and effectiveness to an existing, legally marketed device.

Therefore, I cannot provide the requested information from this document. The document discusses regulatory aspects like:

• Trade/Device Name
• Regulation Number and Name
• Regulatory Class
• Product Code
• Indications for Use
• General controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling, misbranding, adulteration)
• Quality System (QS) regulation requirements
• Unique Device Identification System (UDI Rule)
• Medical Device Reporting (MDR)
• Contact information for the FDA.

However, none of these sections detail acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications as typically provided for AI/ML device submissions.

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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. These gloves were tested for use with chemotherapy drugs per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

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This document is a 510(k) clearance letter for Cardinal Health Nitrile Exam Gloves. While it confirms the device is substantially equivalent to legally marketed predicate devices, it does not contain information about acceptance criteria or a study design in the typical format of an AI/ML device submission.

This type of device (nitrile exam gloves) is a physical medical device, not a software device or an AI/ML product. The "acceptance criteria" and "study" described in the input prompt are typically associated with the evaluation of performance claims for AI/ML algorithms, which involve metrics like accuracy, sensitivity, specificity, and rigorous testing on curated datasets.

Here's what can be extracted and inferred from the provided text, acknowledging that it doesn't align with the detailed AI/ML study request:

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

The closest information provided is the permeation resistance to chemotherapy drugs as tested per ASTM D6978. This acts as a performance standard for this specific "indication for use."

Note: The "acceptance criteria" here are implied by the testing standard ASTM D6978 and the explicit warnings for drugs with low permeation times. For most drugs, " >240 minutes" appears to be the desired performance, and the device meets this for the majority. For Carmustine and Thiotepa, where performance is lower, specific warnings are issued.

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

• Sample Size: Not specified in the provided text. The ASTM D6978 standard would dictate the number of gloves tested.
• Data Provenance: Not specified, but generally for such testing, it would be laboratory testing conducted according to the ASTM standard. It's not "country of origin of data" in the sense of patient data, nor is it retrospective or prospective as it's a materials performance test.

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

• Not applicable. This is not a diagnostic device requiring expert interpretation of medical images or data. The "ground truth" here is the physical permeation time measured by laboratory equipment following the ASTM D6978 standard.

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

• Not applicable. This refers to consensus building among experts for tasks like image labeling or diagnosis, which is not relevant for glove permeation 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. The device is a physical medical glove, not an AI/ML diagnostic aid.

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

• Not applicable. The device is a physical medical glove, not an AI/ML algorithm.

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

• The ground truth is the measured breakthrough detection time for each chemotherapy drug, obtained through standardized laboratory testing (ASTM D6978).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device.

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Cardinal Health™ SMARTGOWN™ Surgical Gown with ASSIST™ Instrument Pockets is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The gowns meet the barrier protection requirements of AAMI Level 4 per ANSI/ AAMI PB70 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. The Cardinal Health™ SMARTGOWN™ Surgical Gown with ASSIST™ Instrument Pockets is a single use, disposable medical device provided sterile and non-sterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user

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This FDA 510(k) clearance letter pertains to a surgical gown, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not present in the provided text.

The document discusses the regulatory clearance of a physical medical device: Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets.

Here's what the document does provide regarding the device and its compliance:

• Regulation Number: 21 CFR 878.4040
• Regulation Name: Surgical Apparel
• Regulatory Class: Class II
• Product Code: FYA
• Intended Use: To be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
• Performance Standard: The gowns meet the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. This reference to AAMI Level 4 and ANSI/AAMI PB70 is the primary "acceptance criterion" mentioned, indicating the device's barrier performance.

Since this is a traditional medical device, not an AI/ML product, the questions related to AI/ML specific criteria (sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable here.

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Cardinal Health™ Level 1 Surgical Mask with Anti-fog Hydrogel are intended to be worn by operating room personnel and other general healthcare workers to protect both the patients and the healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 1 Surgical Mask with Anti-fog Hydrogel are single use, disposable devices provided non-sterile.

Cardinal Health™ Level 3 Surgical Mask with Anti-fog Hydrogel are intended to be worn by operating room personnel and other general healthcare workers to protect both the patients and the healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 3 Surgical Mask with Anti-fog Hydrogel are single use, disposable devices provided non-sterile.

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The provided document is a 510(k) clearance letter for Cardinal Health Surgical Masks. This type of document does not contain the detailed technical study information requested in your prompt.

510(k) clearances are primarily concerned with demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through novel studies in the way an AI/ML device would. The FDA typically relies on existing standards (e.g., ASTM standards for medical masks) for performance evaluation in these cases.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report for an AI/ML device.

Therefore, I cannot provide the requested information based on the provided text.

If this were an AI/ML device, the information would typically be found in sections detailing performance data, clinical validation, or technical specifications.

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Monoject Magellan Insulin Safety Syringes are intended for delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.

The Monoject™ Magellan™ Insulin Safety Syringe consists of a piston syringe with a permanently attached needle, and safety shield designed to extend, fully cover, and permanently lock over the needle when activated by a fingertip or thumb to reduce the occurrence of accidental needle sticks. The device is provided sterile and is intended for single use only. An orange needle cap indicates for use with insulin. The barrel of the syringe is graduated for measuring a prescribed dose. The syringe is intended for use immediately after filling and is not intended to contain or store insulin for extended periods of time.

The provided text is a 510(k) summary for a medical device (Monoject Magellan Insulin Safety Syringe). It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

However, this document does not contain any information about an AI/ML-driven device or its acceptance criteria and study results. The device described is a physical medical device (syringe), not a software or AI/ML product.

Therefore, I cannot fulfill the request to describe acceptance criteria and associated study results for an AI/ML device based on the provided text. The questions posed (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set data) are relevant to the evaluation of AI/ML models, but the provided document is not about such a device.

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Intended Use

The Kendall SCD SmartFlow Compression system (hereby referenced as "Kendall SCD SmartFlow") is designed to apply Intermittent Pneumatic Compression (IPC) to increase venous blood flow in atrisk patients in order to help vein thrombosis and pulmonary embolism. The system, additionally, will enhance circulation and treats venous stasis, addressing associated symptoms such as pain and swelling. The system consists of the tubing assemblies (provided with the controller) and single-patient use garments (purchased separately from this controller).

The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression cycle, the controller measures the time it takes for the limbs to refill with blood and adjusts the compression frequency to maximize flow rate.

The system may be used for all ages of adults and children when indicated to apply intermittent pneumatic compression. System is also designed to increase venous blood flow in at-risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism. The system is intended for use in a clinical setting by health care professionals.

Indications

Leg Compression

The use of the Kendall SCD SmartFlow Compression System with Sequential, Gradient, Circumferential (SGC) compression is indicated for:

• · Deep Vein Thrombosis and Pulmonary Embolism Prophylaxis.
• · Treatment of pain and swelling related to venous stasis
• · Circulation enhancement

The use of the Kendall SCD SmartFlow Compression System with uniform, posterior compression is indicated for:

· Deep Vein Thrombosis Prophylaxis.

Foot Compression

The use of the Kendall SCD SmartFlow Compression System with foot compression is indicated for:

• · Circulation Enhancement
• · Deep Vein Thrombosis Prophylaxis
• · Edema Acute
• · Edema Chronic
• · Extremity Pain Incident to Trauma or Surgery
• · Leg Ulcers
• · Venous Stasis

The Kendall SCD SmartFlow Compression system (hereby referenced as "Kendall SCD SmartFlow") is designed to apply Intermittent Pneumatic Compression (IPC) to increase venous blood flow in atrisk patients in order to help vein thrombosis and pulmonary embolism. The system, additionally, will enhance circulation and treats venous stasis, addressing associated symptoms such as pain and swelling. The system consists of the tubing assemblies (provided with the controller) and single-patient use garments (purchased separately from this controller).

The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression cycle, the controller measures the time it takes for the limbs to refill with blood and adjusts the compression frequency to maximize flow rate.

The system may be used for all ages of adults and children when indicated to apply intermittent pneumatic compression. System is also designed to increase venous blood flow in at-risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism. The system is intended for use in a clinical setting by health care professionals.

This document is an FDA 510(k) clearance letter for the Kendall SCD SmartFlow Controller and related components. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The letter explicitly states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...""
• "Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

Therefore, I cannot extract the requested information from the provided text. The document is a regulatory approval letter, not a device performance study report.

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Intended for delivery of enteral fluids, including nutritional fluids and/or water to the gastrointestinal system via nasogastric, orogastric, nasojejunal, gastrostomy, and jejunostomy tubes. Not for use with neonates. Intended for any patients ages infant, child/adolescent and adult who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. Intended to be used in hospital and acute care settings, as well as long term and home care settings by users ranging from clinicians to laypersons and patients. Some patients may need a caregiver to support using the device. It is intended to be used in both stationary and ambulatory conditions including ground and air transport while using backpack accessory.

The Kangaroo OMNI™ Enteral Feeding Pump and Feeding Set are intended to be used together as a system. Kangaroo OMNI™ Enteral Feeding Sets for administration of standard formula are able to be connected to access devices of all sizes that are ENFit™ compatible. The Kangaroo OMNI™ Thick Formula Feeding Sets for administration of thick formula can be used with access devices 8 Fr size or greater that are ENFit™ compatible.

The Kangaroo OMNI™ Enteral Feeding Pump, Kangaroo OMNI™ Feeding Sets and Kangaroo™ Accessories consist of an enteral feeding pump and disposable enteral feeding sets along with accessories that deliver fluids via rotary peristaltic tension loop pumping to provide hydration and nutrition for those who do not have the ability to orally ingest food or drinks.

This document is a 510(k) Summary for the Kangaroo OMNI™ Enteral Feeding Pump and related accessories. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, this document does not contain information about a study that proves the device meets specific acceptance criteria based on AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment.

The "Performance Testing" section primarily focuses on engineering and regulatory compliance tests for the physical device, not software performance related to AI or diagnostic accuracy. It mentions software verification and validation but within the context of general medical device software guidance, not AI-specific performance metrics like sensitivity, specificity, or accuracy for a diagnostic task.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI-powered device using the provided text. The document describes a traditional medical device (an enteral feeding pump) and its associated accessories, and the testing outlined is typical for such a device (electrical safety, EMC, human factors, biocompatibility, battery testing, and essential performance requirements like flow rate accuracy and alarm detection).

Specifically, the document does not contain the following information relevant to AI device studies:

• A table of acceptance criteria and reported device performance (for an AI component): While there's a table comparing features, it lists physical and operational characteristics of the pump, not AI performance metrics.
• Sample size used for the test set and data provenance: Not applicable as it's not an AI test set.
• Number of experts used to establish ground truth and qualifications: Not applicable.
• Adjudication method for the test set: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or mentioned.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document states "Clinical Testing: Not Applicable," further indicating that this submission does not involve clinical performance data for a diagnostic or AI-driven device.

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The Salem Sump™ Silicone Dual Lumen Stomach Tube with ENFit™ Connection is intended for gastric decompression and administration of nutrition, fluids, and medication. The device is intended for patients with age of two and older.

The proposed Salem Sump™ Silicone Dual Lumen Stomach Tube with ENFit™ Connection is a dual lumen gastrointestinal enteral access tube made of medical grade silicone. The dual lumen design allows for decompression and administration of fluids within the larger (main) lumen while simultaneously allowing air to enter the secondary (vent) lumen during suctioning. This prevents invagination of the stomach wall into the tube eyelets during gastric decompression. During the period that decompression is needed, delivery of nutritional fluids such as formula, hydration or medication may be delivered through the main catheter lumen. The Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection contains an ISO 80369-3 compliant connector tethered to the Y-Shaft of the device. When nutritional fluid delivery is required, the male ENFit connector is inserted into the main lumen. The ENFit connector contains a female cap which helps the connector act as a lumen capping system when feeding or decompression is no longer required. Capping the lumen ends with the ENFit connector and the vent lumen cap helps aid in the prevention of gastric content leakage.

This document pertains to a 510(k) premarket notification for a medical device: the "Salem Sump™ Silicone Dual Lumen Stomach Tube with ENFit™ Connection." It does not describe an AI/ML medical device or any study that proves a device meets acceptance criteria related to AI/ML performance metrics (such as sensitivity, specificity, or human reader improvement with AI assistance).

The document is a submission to the FDA for a physical medical device, specifically a gastrointestinal tube. The acceptance criteria and "study" described are for non-clinical performance testing of this physical device, not for the performance of an algorithm or AI system.

Therefore, I cannot provide the information requested in your prompt because it is designed for an AI/ML device, and this document does not contain that type of information.

To elaborate on why the requested information cannot be found:

• Acceptance Criteria/Reported Performance (Table): The document lists various non-clinical tests (e.g., Functional Verification, Occlusion Verification, Tensile Strength, Biocompatibility). It states that the "results of the testing demonstrate that the proposed device continues to meet the requirements of the product specifications" but does not provide specific numerical acceptance criteria or reported performance values in a table format.
• Sample Size/Data Provenance/Experts/Adjudication/MRMC/Standalone Performance/Ground Truth/Training Set Details: These questions are entirely relevant to AI/ML device studies. This document explicitly states: "Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence." This means there was no clinical study, human reader study, or AI algorithm involved that would require the establishment of ground truth by experts, adjudication, or training/test sets as understood in the context of AI/ML.

The "study" referenced in this document is a series of laboratory tests on the physical properties and performance of the gastrointestinal tube.

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Cardinal Health™ RoyalSilk™ Surgical Gown is a single use, disposable medical device intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70).

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I am sorry, but based on the provided text, there is no information about a medical device that uses AI or machine learning, nor any details about a study to prove its performance or acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to Cardinal Health LLC regarding their RoyalSilk Surgical Gown and RoyalSilk Scrub Nurse Gown. It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

The content focuses on regulatory information, such as:

• The trade/device name and regulation number
• General controls provisions of the Act
• Requirements for registration, listing, labeling, and medical device reporting
• Information about the regulation entitled "Misbranding by reference to premarket notification"
• Links to FDA resources for medical devices
• Indications for Use for the surgical gowns, specifically stating that the Cardinal Health RoyalSilk Surgical Gown meets the requirements of AAMI Level 3 barrier protection per ANSI/AAMI PB70:2012.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, or AI performance, as these topics are not present in the provided text.

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