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The AMSure® Enteral Feeding Pump is intended to work with the disposable enteral feeding sets to deliver nutritional formula to the gastrointestinal system of adult patients who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing.

Only intended for adult patients, not for pediatric use.

The AMSure® Enteral feeding pump is intended to be used in healthcare facilities by licensed healthcare professional users only.

The AMSure® Enteral feeding pump is for use only with Amsino AMSure® feeding sets.

The AMSure® enteral feeding pump is intended to work with the disposable enteral feeding sets that deliver formula via rotary peristaltic pumping system to provide nutrition for those who do not have the ability to orally ingest food

The provided text does not contain information about an AI/ML-driven medical device, an acceptance criteria table with reported device performance for such a device, or a study that proves a device meets specific acceptance criteria using AI/ML technology.

The document is a 510(k) Premarket Notification for a non-AI/ML medical device, specifically an AMSure® Enteral Feeding Pump and Feeding Set. It details the device's indications for use, technological characteristics, and compares it to a predicate device (SENTINEL Enteral Feeding pump K011587) to demonstrate substantial equivalence.

While the document mentions "custom software designed to allow the user to set feed rates and volumes as well as other feeding options" and "2 separate MCUs, and each MCU embeds a specific software in order to secure the pump's running," this refers to basic embedded software for controlling the pump's mechanical functions and not an AI/ML algorithm that requires a test set, ground truth experts, or MRMC studies.

Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance for an AI/ML device, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, training set details, or ground truth establishment) because the document describes a traditional medical device without AI/ML components.

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The AMSafe® NeuFloTM Needleless Connector are intended to use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

AMSafe® NeuFlo™ Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set.

The provided text is a 510(k) summary for the AMSafe® NeuFlo™ Needleless Connector. This document outlines the device's characteristics, its comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.

However, the provided text does not describe a study involving an AI/Machine Learning device, nor does it detail a study that proves a device meets acceptance criteria in the context of AI/ML performance metrics like sensitivity, specificity, or reader studies.

Instead, it details the acceptance criteria and results for a physical medical device. The criteria are based on compliance with established ISO standards and other tests to confirm physical, chemical, and biological performance. The "performance" described refers to the functionality and safety of the needleless connector itself, not AI model performance.

Therefore, I cannot fulfill the request as it pertains to AI/Machine Learning evaluation criteria, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, or training set ground truth establishment in the context of an AI/ML device.

The document speaks to the following for the physical medical device:

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

The document provides a table under "g) Summary of Non-clinical testing (Bench)" listing tests, methods, acceptance criteria, and conclusions (Pass/Fail).

For the other points (2-9), as explained, the document pertains to a physical medical device and its compliance with standards, not an AI/ML device performance study. Thus, no information is available regarding:

• Sample size used for the test set and data provenance (in an AI/ML context).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc. for an AI/ML model).
• Sample size for the training set.
• How the ground truth for the training set was established.

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The AMSafe® Pre-Filled Normal Saline Flush Syringe, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

AMSafe® Pre-Filled Normal Saline Flush Syringe is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap.

This document describes the premarket notification (510(k)) for the AMSafe® Pre-Filled Normal Saline Flush Syringe. The information provided outlines the device's technical characteristics, intended use, and comparison to a legally marketed predicate device (K183473). The study performed is a non-clinical bench testing study, not an AI/ML-based clinical study, therefore, many of the requested elements for an AI/ML study (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are detailed in "Table 5-2" on page 6 of the document.

Additionally, shelf life was evaluated:

• Test: Shelf life
• Method: ASTM F1980-16
• Acceptance Criteria/Conclusion: Verify that the device will remain within specification during the prescribed shelf life when stored under labeled conditions. (Implied Pass, as per overall conclusion).

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

The document describes non-clinical bench testing of manufacturing characteristics and chemical composition, not an AI/ML-based study with a "test set" composed of patient data. Therefore, the concept of sample size for a test set (e.g., number of images, patient records) and data provenance (country of origin, retrospective/prospective) as typically understood for AI/ML studies are not applicable. The tests were performed on samples of the device itself. The specific number of units tested for each criterion is not provided, but it would typically be a predetermined number based on the statistical requirements of the specific test methods (e.g., ISO, ASTM, USP standards).

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

Not Applicable. This was a bench study, not an AI/ML study requiring expert labeling of data. The "ground truth" for these tests are the established physical, chemical, and biological standards and methodologies outlined in the referenced ISO, ASTM, and USP documents.

4. Adjudication Method for the Test Set

Not Applicable. This was a bench study; there was no human-in-the-loop expert adjudication process as would be typical for AI/ML algorithm evaluation.

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

No, an MRMC study was not done. This is a review of a physical medical device (pre-filled syringe), not an AI/ML diagnostic or assistive tool where human reader performance would be a relevant metric.

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

Not Applicable. This document describes the performance of a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established industry standards and pharmacopeial specifications. This includes:

• Physical Properties: Standards like ISO7886-1, ISO80369-7, ASTM F2338-09.
• Chemical Composition: United States Pharmacopeia (USP) monographs such as USP<791>, USP<191>, USP6-466, USP6-471, USP<241>, USP<643>, USP<233>, USP<232>.
• Biocompatibility: ISO10993 series (ISO10993-11, ISO10993-10, ISO10993-5) and ASTM F756-17.
• Sterility Assurance: The mention of 10-6 SAL (Sterility Assurance Level) indicates adherence to established sterilization standards.

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not Applicable. As there is no training set for a physical device, there is no ground truth establishment process in that context.

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For use in moistening and lubricating absorbent wound dressings for cuts, bruises and minor burns prior to removal from the wound area

The subject AMSure® Single Use Saline Topical Solution device is normal saline 0.9% w/v Sodium Chloride. It is used in moistening and lubricating absorbent wound dressings for cuts, bruises, and minor burns prior to removal from the wound area. They are intended to be used in clinical and should only be used by clinicians familiar with the treatment of possible complications.

The subject device of normal saline topical solution 0.9% w/v is a unit-dose low density polyethylene (LDPE) vial contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives. The subject device is using blow fill seal technology. The devices are offered in 15mL, 35mL, 50mL.

The provided text is a 510(k) Premarket Notification summary for a medical device called "AMSure® Single Use Saline Topical Solution". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance-based acceptance criteria through an independent study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, specifically:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, ground truth establishment, expert involvement, or adjudication methods.
• Information about MRMC effectiveness studies or standalone algorithm performance.
• Details on training set sample size or how its ground truth was established.

Instead, the document details:

• Device Name: AMSure® Single Use Saline Topical Solution
• Regulatory Class: Unclassified
• Product Code: FRO
• Intended Use: For use in moistening and lubricating absorbent wound dressings for cuts, bruises, and minor burns prior to removal from the wound area.
• Predicate Device: K993969 SALJET single dose sterile saline topical solution.
• Substantial Equivalence Discussion: The document argues that the subject device is substantially equivalent to the predicate device based on:
  • Similar Technological Characteristics: Both are 0.9% w/v Sodium Chloride solutions in LDPE vials. The principle of operation is the mechanical action of fluid for removing foreign objects.
  • Similar Intended Use: Both are used for moistening and lubricating wound dressings.
  • Difference in Sterility: The subject device uses aseptic blow-fill-seal technology, while the predicate is terminally sterilized. The submission argues this difference does not affect safety or effectiveness due to aseptic process validation and biocompatibility testing.
• Nonclinical Testing (Bench):
  • Design Verification Testing: Tests performed to ensure predetermined acceptance criteria were met for:
    • Identify Assay % NaCl
    • pH
    • Endotoxin
    • Sterility
    • Leak Testing
    • Net Fill Volume
    • (Note: Specific acceptance criteria values and reported performance values are NOT provided in this summary.)
  • Biocompatibility Testing: Conducted in accordance with ISO 10993-1, including:
    • In Vitro Cytotoxicity (ISO 10993-5)
    • Acute Systemic Toxicity (ISO 10993-11)
    • Intracutaneous Reactivity (ISO 10993-10)
    • Skin Sensitization (ISO 10993-10)
    • Material-mediated pyrogenicity (USP <151>)
    • Chemical characterization and toxicological risk assessment.

In summary, this document is a regulatory submission for a medical device demonstrating substantial equivalence, not a clinical study report or a detailed performance validation study with specific acceptance criteria and results. The "performance testing" mentioned is bench testing for design verification and biocompatibility, not a clinical study involving human patients, algorithms, or expert readers.

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The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to deliver nutritional formula to the gastrointestinal system of a patient age infant and older who is physically unable to eat and swallow. Not for use with neonates. The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to be used in clinical or home care settings by users ranging from laypersons to physicians. The PUGGLE® Enteral Feeding Pump and Feeding Set shall be used together only.

The PUGGLE® Enteral Feeding Pump and Feeding Set consists of an enteral feeding pump and disposable enteral feeding sets that deliver formula via rotary peristaltic pumping system to provide nutrition for those who do not have the ability to orally ingest food. The pump incorporates a graphical interface that walks the users through the PUGGLE® Enteral Feeding Pump and Feeding Set setup feed rates and volumes as well as other feeding options. The PUGGLE® Enteral Feeding Pump and Feeding Set come with three different connector types: standard, ENFit®, and ENFit® with Transition Connector.

The provided text is a 510(k) summary for the PUGGLE® Enteral Feeding Pump and Feeding Set. It outlines the device's technical characteristics and how it compares to a predicate device (Kangaroo™ Connect Enteral Feeding Pump and Set K143263). The document primarily focuses on demonstrating substantial equivalence to the predicate, rather than detailing a specific clinical study with acceptance criteria and device performance in the way a traditional clinical trial report would.

However, based on the Performance Testing section, we can extract information regarding acceptance criteria in the form of standards and general performance attributes, and the "reported device performance" is indicated by the statement that the device was verified and validated to meet these requirements.

Here's an attempt to structure the information based on your request, acknowledging that some fields may not be directly available in the provided document:

1. Table of Acceptance Criteria (based on standards and essential performance) and an indication of Device Performance

The study that proves the device meets the acceptance criteria is detailed under the "Performance Testing" section within the 510(k) summary. It describes a "safety assurance case" approach.

Detailed Information about the Study:

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: The document does not specify a numerical sample size for individual performance tests (e.g., how many pumps or feeding sets were tested). It refers to "performance testing of essential performance attributes" and "stability testing of feeding set" but doesn't give a number of units tested.
• Data Provenance: Not specified in the document. It does not mention country of origin or whether the data was retrospective or prospective, as these are typically not relevant for bench performance testing of this nature.

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 question is Not Applicable (N/A) in this context. The testing described is primarily bench and engineering validation (e.g., electrical safety, EMC, flow rate accuracy). "Ground truth" established by experts, as in clinical image interpretation, is not relevant here. The "ground truth" for these tests would be the measured physical parameters against defined engineering specifications and regulatory standards.

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

• N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving expert interpretation of medical images. For engineering performance testing, the results are typically objectively measured against pre-defined specifications.

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

• N/A. This is an enteral feeding pump, not an AI-assisted diagnostic device. Therefore, MRMC studies or human reader improvement with AI are not applicable.

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

• This question is partially applicable in the sense that the device's technical functions (e.g., pump mechanism, sensors, alarms) were tested in isolation (standalone performance) against technical specifications. The "Performance Testing" section confirms that the "essential performance requirements of the device (including feeding sets) were verified through performance testing". This implies testing the device's inherent functionality. However, this is not "algorithm only" in the context of AI but rather the entire device's automated functions.

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

• The "ground truth" for these tests is based on established engineering specifications, national and international standards (e.g., IEC standards), and regulatory guidance documents (e.g., FDA guidance for Infusion Pumps). For example, flow rate accuracy is measured against a defined percentage deviation. Occlusion detection is measured against specified pressure thresholds and response times.

8. The sample size for the training set

• N/A. As an enteral feeding pump, there is no "training set" in the context of machine learning or AI that would require a data sample for training. The device operates based on programmed logic and hardware, not a learned model from a dataset.

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

• N/A. Since there is no training set, this question is not applicable.

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The AMSafe® 0.9% Sodium Chloride Pre-Filled Normal Saline Flush Syringe, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

AMSafe® Pre-Filled Normal Saline Flush Syringe is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene cap. The device will be terminally sterilized by gamma radiation sterilization. The device will be marketed as a 12mL syringe with a 3mL, 5mL, or 10mL fill volume, and a 20mL syringe with 20mL fill volume. The products are in two different packages, one is poly blister package and the entire packaged device are gamma radiation sterilized for sterile delivery to a sterile field; another is PP wrapper as a dust cover for non-sterile field. The solution is sterile normal saline for injection and meets the requirements of USP<40>.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the AMSafe® Pre-Filled Normal Saline Flush Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study of an AI-powered diagnostic device. Therefore, much of the requested information regarding acceptance criteria and study design for an AI device is not applicable to this document.

However, I can extract information related to the device's acceptance criteria for performance (bench testing) and the testing done to prove it meets those criteria.

Here's an attempt to answer your questions based only on the provided text, recognizing its limitations for an "AI-powered diagnostic device":

Device: AMSafe® Pre-Filled Normal Saline Flush Syringe

Type of Device: Prefilled plastic piston syringe with 0.9% sodium chloride for injection, USP, intended for flushing intravenous administration sets and indwelling intravenous access devices. This is a medical device, not an AI-powered diagnostic device.

Study Type: Non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device. No clinical study with human subjects, AI assistance, or MRMC design was conducted.

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 for Test Set: The document describes "non-clinical testing" and lists various tests, each presumably with its own sample size of syringes or solution, but these specific sample sizes are not detailed in the provided text.
• Data Provenance: The tests are standard industry bench tests (e.g., ISO, USP, ASTM standards). The country of origin for the data is not explicitly stated within the context of the testing, but the company is Amsino International Inc., based in Pomona, CA, USA, suggesting testing likely occurred in or for a US regulatory submission. The data is from prospective bench testing, not retrospective or prospective clinical data.

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

• This device is not an AI diagnostic, so there is no concept of "ground truth" derived from expert consensus of images/data in the way it applies to AI devices. The "ground truth" for the performance tests (e.g., pH, chemical content, sterility) is established by the specified reference standards (USP, ISO, ASTM) and the inherent measurable properties of the device and its contents. The results are objective, quantitative measurements following validated methods, not subjective interpretations by experts.

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

• Not applicable as this is not an AI diagnostic device requiring human expert adjudication of diagnostic outcomes. The results are objective measurements against pre-defined criteria.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a pre-filled saline syringe, not an AI-powered diagnostic. This type of study is irrelevant to its purpose and regulatory pathway.

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

• Not applicable. This device is not an algorithm or AI. The tests performed are standalone bench tests of the physical and chemical properties of the syringe and its contents.

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

• The "ground truth" for these tests is based on established scientific and engineering standards and methods (e.g., USP monographs for chemical purity and content, ISO standards for device properties, ASTM for packaging). It is a direct measurement against defined physical, chemical, and biological specifications, not a diagnostic ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device; therefore, there is no concept of a "training set."

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

• Not applicable. As there is no training set for this type of device, no ground truth needed to be established for it.

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The LIASYS 600 Electrolyte Measurement System is intended for the quantitative determination of sodium, chloride, and potassium in human serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of hormone aldosterone), diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The LIASYS 600 creatinine reagent is intended for the quantitative determination of creatinine in human serum. Packaged for the ease of use with LIASYS 600. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

The LIASYS 600 is a random access, computer controlled, standalone clinical analyzer intended for the in-vitro determination of analytes in human serum.

The LIASYS 600 is a random access, computer controlled, standalone clinical analyzer intended for the in-vitro determination of analytes in human serum.

This FDA document describes the clearance of the LIASYS 600 Electrolyte Measurement System and LIASYS 600 Creatinine reagent. It does not contain information about acceptance criteria or specific study results that proves the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices for the specified indications for use.

Therefore, I cannot provide the requested information based on the provided text. The document is a 510(k) clearance letter, which affirms substantial equivalence rather than detailing performance acceptance criteria and study findings.

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Amsel Endo Occluder device is an endoscopic ligating clips, which is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.

Amsel Endo Occluder device is an endoscopic ligating clip applier that is pre-loaded with four sterile ligating clips. Amsel Endo Occluder device is intended to be used during endoscopic procedures (such as Laparoscopic procedures), for permanent secure occlusion of blood vessels and ductal structures. The device is a mechanical occlusion clip that when deployed transfixes the target vessel while clamping it shut. Amsel Endo Occluder contains two main components: Ligating (Occluder) Clips and Applier (device delivery).

Here's a summary of the acceptance criteria and study information for the Amsel Endo Occluder device based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner for specific device functions. Instead, it states that the device was tested to demonstrate compliance with international and FDA-recognized consensus standards and FDA guidance documents, and that it "Meets the acceptance criteria and is adequate for its intended use and specifications."

The provided information focuses on the type of tests conducted rather than specific numerical acceptance criteria and performance outcomes.

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

The document states that "Preclinical in-vivo tests, including acute and chronic tests, were conducted." However:

• Specific sample sizes for these in-vivo tests are not provided in the summary.
• Data provenance (e.g., country of origin, retrospective or prospective) for the test set is not specified.

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

This information is not provided in the document. The summary focuses on preclinical testing and does not mention the involvement of experts for establishing ground truth as typically seen in clinical device evaluations involving human diagnosis or interpretation.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here for the preclinical tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, Amsel Endo Occluder device did not require clinical studies to support equivalence." Biomedical devices like ligating clips are often cleared based on non-clinical performance and substantial equivalence to predicate devices, rather than comparative clinical efficacy studies with human readers.

6. Standalone Performance Study (Algorithm Only):

This section is not applicable as the Amsel Endo Occluder device is a mechanical medical device (ligating clip applier and clips), not an AI/algorithm-driven device.

7. Type of Ground Truth Used:

For the preclinical in-vivo tests, the ground truth was based on demonstrating the safety and effectiveness of occlusion performance. This would likely involve direct observation, measurement, and pathological analysis of the ligated vessels/structures in animal models or cadaveric tissue.

8. Sample Size for the Training Set:

This information is not applicable as the device is not an AI/algorithm that requires a training set. The "training set" concept is typically for machine learning models.

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

This information is not applicable for the same reason as above (not an AI/algorithm).

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INTENDED USE:

The AMSure® Hydrophilic Intermittent Catheter is inserted into the patient's bladder and indicated for intermittent use for the purpose of drainage of urine from the bladder. The catheter does not contain a balloon on its tip. An optional Water sachet is included to activate the hydrophilic-coated surface prior to use. The target populations for the subject device are Adults and Pediatrics.

The AMSure® Hydrophilic Intermittent Catheter is a urethral catheter intended to be passed through the urethra during urinary catheterization and into the bladder to drain urine. It is hydrophilic and lubricous coated flexible tube owns a hydrophilic polymer in the surface which makes the catheter highly lubricious and good adhesion upon contact with water, saline solution, body fluids. The catheter and gripper is manufactured with medical grade PVC, the surface is coated with a hydrophilic lowfriction coating (polyvinyl pyrrolidone, or PVP), the water sachet is with USP grade sterile water. Each catheter is provided in sterile, single-use packages, intended to be used by adults and pediatrics.

The provided document is a 510(k) summary for the AMSure® Hydrophilic Intermittent Catheter. This document details the regulatory pathway for a medical device and typically does not include the specifics of a standalone algorithm study, MRMC comparative effectiveness study, or details like the number and qualifications of experts for ground truth establishment, which are more common for AI/ML-based device submissions.

Based on the provided text, here's a summary of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Test items" under "Performance Testing" which serve as the acceptance criteria for the device. The reported performance is that these tests were conducted and demonstrate the device's substantial equivalence. Specific quantitative performance metrics (e.g., specific friction values, flow rates, or strength measurements) that would constitute "acceptance criteria" are not reported in this summary, only the tests performed.

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

The document does not specify the sample size used for performance testing (test set) for any of the listed items (e.g., number of catheters tested for leakage, kink resistance, etc.). The data provenance (country of origin, retrospective/prospective) is also not mentioned.

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 and is not provided in the document. The device is a physical urological catheter, not an AI/ML diagnostic device requiring expert interpretation for ground truth.

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

This information is not applicable and is not provided in the document, as it relates to expert review for diagnostic devices, not performance testing of a physical medical 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

No MRMC comparative effectiveness study was performed or mentioned. This type of study is relevant for AI-powered diagnostic devices, which this catheter is not.

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

A standalone algorithm performance study was not performed. The device is a physical medical device (catheter) and does not involve an algorithm.

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

The "ground truth" for the performance tests would be based on the established standards for each physical and chemical test (e.g., passing a specific leakage pressure, meeting a defined friction value, demonstrating sterility). For biocompatibility, the ground truth is generally adherence to ISO 10993 standards and the absence of adverse biological reactions. It's not a diagnostic "ground truth" in the AI/ML sense.

8. The sample size for the training set

This information is not applicable. The device is a physical catheter, not an AI/ML model that requires a training set.

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

This information is not applicable. The device is a physical catheter and does not involve a training set.

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AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush

• For over the-counter use: For moistening absorbent wound dressing and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
• For prescription use: For moistening absorbent wound dressing and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile Water and sterile normal saline for wound flush are intended to be used in clinical or home care and should only be used by clinicians familiar with the treatment of possible complications.
The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP<40>. The bottle and cap are made by HDPE, the inner induction sealed film is foil. The devices are offered in 100mL bottles.

The provided text is an FDA 510(k) summary for a medical device: "AMSure Sterile Water, and Sterile Normal Saline for Wound Flush." This document outlines the manufacturer's claim that their device is substantially equivalent to legally marketed predicate devices.

However, the document does NOT contain information about an AI/algorithm-driven device, nor does it present data from a "study that proves the device meets the acceptance criteria" in the way one would for an AI-powered diagnostic tool.

The acceptance criteria mentioned are related to:

• Biocompatibility: Ensuring the materials are safe for patient contact.
• Performance: Meeting USP standards for sterile saline and sterile water.
• Stability: Maintaining properties after accelerated aging.

The "studies" are described as "Nonclinical Testing (Bench)" and include:

• Biocompatibility testing: Demonstrated biological safety.
• Performance testing: Demonstrated meeting USP standards.
• Stability testing: Evaluated properties after accelerated aging.

The conclusion is that the device "passed all acceptance criteria."

Given this, I cannot provide the detailed information requested in the prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) because this information is not present in the provided text. The device in question is a simple medical product (sterile water/saline for wound flush), not a complex AI diagnostic system.

Therefore, the table and other detailed points will reflect the lack of this information from the provided document.

Acceptance Criteria and Device Performance (Based on provided document)

Study Details (Information Not Available or Applicable for this type of device)

1. Sample size used for the test set and the data provenance: Not applicable. The "tests" were benchtop performance, biocompatibility, and stability testing on the product itself, not a clinical study on patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a wound flush solution is based on chemical composition and sterility standards (USP<40>), not expert clinical review of images or data.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a study requiring adjudication of clinical findings.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is sterile water/saline, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or AI component to this device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth was based on established industry standards and regulations for medical devices, specifically USP<40> for chemical composition and sterility, and ISO10993 for biocompatibility.
7. The sample size for the training set: Not applicable. There is no training set as this is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable.

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