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510(k) Data Aggregation
(287 days)
Amsino International Inc.
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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(249 days)
Amsino International, Inc.
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).
| Test | Method | Acceptance Criteria | Conclusion |
|---|---|---|---|
| Physical Performance test | |||
| Leakage Test | ISO8536-4 | ISO8536-4 | Pass |
| Luer adapter connection | ISO80369-7 | ISO80369-7 | Pass |
| Free Flow rate | ISO8536-4 | ISO8536-4 | Pass |
| Particulate contamination | ISO8536-4 | ISO8536-4 | Pass |
| Chemical performance test | |||
| Reducing matter | ISO8536-4 | ISO8536-4 | Pass |
| Metal ions | ISO8536-4 | ISO8536-4 | Pass |
| Titration acidity or alkalinity | ISO8536-4 | ISO8536-4 | Pass |
| Residue on evaporation | ISO8536-4 | ISO8536-4 | Pass |
| UV absorption of extract solution | ISO8536-4 | ISO8536-4 | Pass |
| EO residual test | ISO10993-7 | ≤10µg/g | Pass |
| Biological performance test | |||
| Sterility test | ISO8536-4 | ISO8536-4 | Pass |
| Pyrogenicity | ISO8536-4 | ISO8536-4 | Pass |
| Biocompatibility test | |||
| In vitro cytotoxicity test | ISO10993-5 | ISO10993-5 | Pass |
| Skin sensitization test 0.9% sodium chloride injection extract | ISO10993-10 | ISO10993-10 | Pass |
| Skin sensitization test sesame oil extract | ISO10993-10 | ISO10993-10 | Pass |
| Intracutaneous reactivity test 0.9% sodium chloride injection extract | ISO10993-10 | ISO10993-10 | Pass |
| Acute systemic toxicity test sesame oil extract | ISO10993-11 | ISO10993-11 | Pass |
| Pyrogen test 0.9% sodium chloride injection extract rabbit | ISO10993-11 | ISO10993-11 | Pass |
| Bacteria endotoxins test Gel-Clot technique | USP 43-NF | USP 43-NF | Pass |
| Subchronic systemic toxicity test | ISO10993-11 | ISO10993-11 | Pass |
| In Vitro hemolytic properties test | ISO10993-4 | ISO10993-4 | Pass |
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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(139 days)
Amsino International, Inc.
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.
| ID# | Test | Method | Acceptance Criteria | Conclusion |
|---|---|---|---|---|
| 1 | Physical testing of syringe | ISO7886-1 ISO80369-7 | ISO7886-1 ISO80369-7 | Pass |
| Integrity test of package | ASTM F2338-09 | No leakage | Pass | |
| Dimension test | ISO80369-7 | ISO80369-7 | Pass | |
| Lubricant of syringe test | ISO7886-1 | ISO7886-1 | Pass | |
| Dead space test | ISO7886-1 | ISO7886-1 | Pass | |
| Limits of acidity or alkalinity of syringe | ISO7886-1 | ISO7886-1 | Pass | |
| 2 | Sodium Chloride Injection, USP Testing | |||
| pH value | USP | PH: 4.5-7.0 | Pass | |
| Chemical Identification Tests | USP | USP | Pass | |
| 0.9% normal saline content test | USP6-466 | 0.86% -- 0.94% | Pass | |
| Oxidizable substance test | USP6-471 | USP6-471 | Pass | |
| Iron test | USP | USP | ||
| Calcium | USP | USP | Pass | |
| Carbonate | USP | USP | Pass | |
| Sulfate | USP | USP | Pass | |
| Total organic carbon | USP | USP | Pass | |
| Limits of extractable metals | USP USP | USP USP | Pass | |
| 3 | Particulate matter | USP | ≥10um, ≤6000 ≥25um, ≤600 | Pass |
| 4 | Biocompatibility testing | |||
| Bacterial endotoxins test | USP | Bacterial endotoxins≤0.5EU/mL | Pass | |
| Acute systemic toxicity | ISO10993-11 | No systemic toxicity | Pass | |
| Intracutaneous reactivity | ISO10993-10 | Non-irritant | Pass | |
| Pyrogen test | ISO10993-11 | Non-pyrogen | Pass | |
| Skin sensitization | ISO10993-10 | Non-sensitizer | Pass | |
| In vitro cytotoxicity | ISO10993-5 | Non-cytotoxic | Pass | |
| In vitro hemolysis properties | ASTM F756-17 | Non-hemolytic | Pass |
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, USP, USP6-466, USP6-471, USP, USP, USP, USP.
- 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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(259 days)
Amsino International Inc.
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
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance (as stated in the document) |
|---|---|
| Software Verification & Validation per FDA Guidances | Software verification and validation were successfully performed for a Major Level of Concern, in accordance with FDA Guidance for "Content of Premarket Submissions for Software Contained in Medical Devices" and "Infusion Pump Total Product Life Cycle." |
| Cybersecurity Evaluation per FDA Guidances | Cybersecurity was evaluated, and the risk associated with cybersecurity-related hazards was determined to be low, following FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." |
| Electrical Safety per IEC 60601-1 | Electrical Safety testing was successfully completed in accordance with IEC 60601-1:2005 AAMI ES 60601-1:2005. |
| EMC per IEC 60601-1-2:2014 | Electromagnetic compatibility evaluation was successfully performed against IEC 60601-1-2:2014. |
| Administration Set Compatibility | Verification of essential pump performance was completed with the indicated administration sets. |
| Essential Performance Requirements (e.g., Flow Rate Accuracy, Occlusion Detection, Alarms) | The essential performance requirements (including feeding sets) were verified through performance testing in accordance with the intended use and FDA Guidance "Infusion Pumps Total Product Life Cycle." This included: System V&V, Performance testing of essential attributes, Stability testing of feeding set, Flow Rate Accuracy testing across all operating conditions, Downstream Occlusion Detection, Pump Alarms (Air presence, upstream/downstream occlusions, set dislodged, rotor stuck, cassette error). |
| The device's flow rate accuracy is +/- 5%. (Compared to predicate's +/-5% or 0.5 mL/h according to IEC standard 60601-2-24, where the subject device confirmed +/-5% for "all flow rates" not just those in the standard). | |
| The maximum occlusion pressure is 16 psi (110 kPa), and the device has a more sensitive detection of occlusions and raises an alarm in a shorter period compared to the predicate's 20 psi (138 kPa). | |
| Battery Safety per IEC 62133 | NiMH battery safety was successfully tested per IEC 62133. |
| Human Factors per FDA Guidance | Human factors studies were conducted with the intended user population, use environment, and scenarios to simulate clinical conditions. The results demonstrate validation of the device per its intended use, in accordance with FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." |
| Reprocessing/Cleaning per AAMI TIR30 | Compliance with AAMI TIR30:2011/R 2016 for cleaning reusable medical devices. (Implies successful verification). |
| Biocompatibility per ISO-10993 (FDA Guidance) | Biocompatibility testing demonstrated the biological safety of parts of the medical device that may indirectly contact the patient, as outlined in FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'." |
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.
Ask a specific question about this device
(210 days)
Amsino International, Inc.
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.
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
| ID# | Test | Method | Acceptance Criteria | Reported Device Performance (Result/Conclusion) |
|---|---|---|---|---|
| 1 | Plastic syringe | ISO7886-2017 | ISO7886-2017 | Conforms/Pass |
| Sodium Chloride Injection, USP Testing | ||||
| 2 | pH value | USP40 | pH: 4.5 – 7.0 | Pass |
| Limits of extractable metals of saline solution | USP, | USP, | Pass | |
| Chemical Identification Tests | USP | USP | Pass | |
| 0.9% normal saline content test | VP200 | 0.86% -- 0.94% | Pass | |
| Oxidizable substance test | VP200 | VP200 | Pass | |
| Iron test | USP40 | USP40 | ||
| Calcium | USP40 | USP40 | Pass | |
| Carbonate | USP40 | USP40 | Pass | |
| Sulfate | USP40 | USP40 | Pass | |
| Particulate matter | USP 40 | ≥10um, ≤6000; ≥25um, ≤600. | Pass | |
| 3 | Biocompatibility testing | |||
| Bacterial endotoxins test | USP40 | Bacterial endotoxins ≤ 0.25 EU/mL | Pass | |
| Acute system toxicity | ISO10993-11 | The device extracts did not elicit a systemic response | Pass | |
| Irritation / Intracutaneous reactivity | ISO10993-10 | Non-irritant | Pass | |
| Material-mediated pyrogenicity | ISO10993-11 | Non-pyrogenic response | Pass | |
| Sensitization | ISO10993-10 | Non-sensitizer | Pass | |
| Cytotoxicity | ISO10993-5 | Non-cytotoxic | Pass | |
| Hemolysis | ISO10993-4 (ASTM F756) | Non-hemolytic | Pass | |
| Chemical characterization | USP, USP | Acceptable extractable / leachable profile | Pass | |
| 4 | Blister package integrity | |||
| Seal strength test | ASTM F88/F88M-15 | Should not be less than 2 N/inch | Pass | |
| Dye integrity test | ASTM F1929-15 | ASTM F1929-15 | Pass |
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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(122 days)
Amsino International Inc.
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.
| SN | Test items (Acceptance Criteria) | Reported Device Performance (Summary) |
|---|---|---|
| 1 | Packaging inspection | Conducted |
| 2 | Appearance inspection | Conducted |
| 3 | Leakage | Conducted |
| 4 | Kink resistance | Conducted |
| 5 | Strength test | Conducted |
| 6 | Connector security | Conducted |
| 7 | Flow test | Conducted |
| 8 | Friction value | Conducted |
| 9 | Chemical performance: Reducing matter | Conducted |
| 10 | Chemical performance: pH value | Conducted |
| 11 | Chemical performance: Metal ions | Conducted |
| 12 | Chemical performance: EO residue | Conducted |
| 13 | Biological performance: Sterility | Conducted |
| 14 | Physical performance: Water sachet | Conducted |
| 15 | Chemical performance: sterile water | Conducted |
| 16 | Aging (shelf life/stability testing) | Conducted |
| 17 | Human factor testing | Conducted |
| Biocompatibility | Cytotoxicity, Sensitization, and Irritation | Demonstrated biological safety per ISO 10993-5 and ISO 10993-10 for direct contact with patients. |
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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(99 days)
Amsino International Inc.
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. 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)
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Biocompatibility | Biological safety for direct/indirect patient contact (ISO10993 standard) | Demonstrated as non-cytotoxic, non-irritating, and non-sensitizing. |
| Performance | Meet USP requirements for sterile saline and sterile water. | Demonstrated that proposed devices meet the standard on USP Sterile Saline and USP Sterile Water. |
| Stability | Maintain properties after accelerated aging. | Evaluated properties after accelerated aging in support of the labeling; results shown to pass acceptance criteria. |
Study Details (Information Not Available or Applicable for this type of device)
- 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.
- 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), not expert clinical review of images or data.
- 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.
- 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.
- 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.
- 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 for chemical composition and sterility, and ISO10993 for biocompatibility.
- The sample size for the training set: Not applicable. There is no training set as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
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(280 days)
Amsino International, Inc.
The AMSafe® Sure-Lok™ Needle-Free Connector is an accessory to an Intra-vascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein.
The AMSafe® Sure-Lok™ Needle-Free Connector is a Needle-Free connector intended for single patient use, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids used as an accessory to an Intravascular administration set without the use of a needle, thus eliminating the risk of needlestick injuries. The AMSafe® Sure-Lok™ Needle-Free Connector is a closed, Luer activated device that allows for negative fluid displacement. The AMSafe® Sure-Lok™ Needle-Free Connector individually packaged is supplied as a sterile, non-pyrogenic, single use, disposable device.
The provided text is a 510(k) Summary for the AMSafe® Sure-Lok™ Needle-Free Connector, a medical device. This document describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness in comparison to a predicate device.
Here's an analysis of the acceptance criteria and study information, organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Items | Test Criteria (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Visual inspection | Conform with the internal criteria | Met the acceptance criterion |
| Leakage test | Conform with ISO 8536-4 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed [Including: Amendment 1 (2013)]; Conform with ISO 8536-8: 2015 Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus | Met the acceptance criterion |
| Compatible with MLL fitting | Section 3: Dimensions and tolerances in ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings) | Met the acceptance criterion |
| Sealing performance | Section 4.2: leakage in ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings) | Met the acceptance criterion |
| Free Flow Rate | Conform with ISO 8536-4:2010 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed [Including: Amendment 1 (2013) | Met the acceptance criterion |
| Liquid leakage | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Air leakage | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Separation force | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Stress cracking | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Unscrewing torque | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Ease of assembly | Section 5.6: Ease of assembly in ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings) | Met the acceptance criterion |
| Resistance to overriding | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Weld strength test | Conform with the internal criteria | Met the acceptance criterion |
| Cytotoxicity | ISO 10993-5: 2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | Met the acceptance criterion |
| Sensitization | ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization | Met the acceptance criterion |
| Intracutaneous Reactivity Test | ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization | Met the acceptance criterion |
| Acute systemic toxicity | ISO 10993-11: 2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Met the acceptance criterion |
| Haemolysis | ASTM F 756-13: Standard Practice for Assessment of Hemolytic Properties of Materials | Met the acceptance criterion |
| Pyrogenicity | ISO 10993-11: 2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Met the acceptance criterion |
| Subchronic Toxicity | ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Met the acceptance criterion |
| Sterility | ISO 11135:2007, Sterilization of Health Care Products-Ethylene Oxide; ISO 10993-7: 1995 and 2008, Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide sterilization residuals. | Assessed in accordance with standards and met acceptance criteria. Based on the conclusion, it implies that the device is sterile after processing. |
| Microbial ingress testing | Internal standard | Met the acceptance criterion |
| Biocompatibility (Overall Assessment) | ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (for "External communicating device, Blood path, indirect (>24 hours to 30 days)") | Assessed in accordance with the standard. Results from Cytotoxicity, Sensitization, Intracutaneous Reactivity Test, Acute systemic toxicity, Haemolysis, Pyrogenicity, and Subchronic Toxicity demonstrate no new issues of safety and efficacy. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that "Bench testing of the proposed devices is performed," and tests were conducted according to various ISO and ASTM standards. However, the specific sample sizes used for each individual test or for a comprehensive "test set" are not mentioned. The document does not specify data provenance (country of origin) or if the data was retrospective or prospective, as these are bench tests rather than clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the described studies are bench tests (physical and chemical testing of the device) rather than clinical studies requiring expert interpretation or ground truth establishment based on clinical observations or diagnoses.
4. Adjudication Method for the Test Set
This section is not applicable for the same reason as point 3. Bench testing adherence to standards usually relies on measurement and observation against pre-defined criteria, not expert adjudication of subjective findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench testing and biocompatibility assessments, not comparative effectiveness studies with human readers or clinical outcomes. The goal was to demonstrate substantial equivalence to a predicate device through engineering and biological testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the device is a physical medical connector, not an AI algorithm.
7. The Type of Ground Truth Used
For the bench testing, the "ground truth" is defined by the specific requirements and limits set forth in the referenced international standards (ISO, ASTM) and the manufacturer's own internal criteria. For example, for a leakage test, the ground truth is "no leakage" or leakage within a specified limit according to the standard. For biocompatibility tests, the ground truth is a lack of cytotoxic, sensitizing, or toxic effects as defined by the respective ISO standards.
8. The Sample Size for the Training Set
This question is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set for a physical medical device.
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(57 days)
Amsino International, Inc.
Pre-filled Syringe for Balloon Inflation with Sterile Water is intended to be used in inflating foley catheter balloon.
The AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water is a 3cc, 5cc, 10cc and 30cc syringe pre-filled with USP purified water and gamma irradiated. The syringe is produced using polypropylene for the device barrel and plunger and pharmaceutical grade latex free rubber for both the plunger gasket and syringe tip cover. The shelf life of AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water is 3 years.
The provided document describes the AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water, which is a pre-filled syringe intended for inflating foley catheter balloons. The document is a 510(k) Premarket Notification, which aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute safety and effectiveness through extensive clinical trials.
Therefore, the information regarding acceptance criteria and study details is presented in the context of demonstrating substantial equivalence rather than a detailed clinical effectiveness study of a novel AI device.
Here's the information as requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that the AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water underwent performance testing to establish substantial equivalence. It does not provide specific quantitative acceptance criteria or detailed performance metrics in the way a clinical study report for an AI device might. Instead, it refers to conformity with established standards.
| Acceptance Criteria (General Description from Text) | Reported Device Performance (General Description from Text) |
|---|---|
| Functional Criteria | Meets acceptance criterion for all functional criteria. |
| Sterility Criteria | Meets acceptance criterion for all sterility criteria. |
| Biocompatibility Criteria | Meets acceptance criterion for all biocompatibility criteria. |
| Other Performance Criteria | Meets acceptance criterion for all other performance criteria. |
| Conformity with ISO7886-1, ISO 80369-7, USP 40 | Conforms with these standards. |
| Conformity with ISO 10993-5, ISO 10993-10 requirements | Conforms with these standards. |
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 the performance tests, nor does it provide details on the data provenance (country of origin, retrospective/prospective). The tests mentioned are laboratory/bench tests, not typically clinical studies involving 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 type of information is not applicable to this 510(k) submission. The "ground truth" for this device's evaluation is based on established engineering specifications, material science, and regulatory standards for medical devices, not expert human interpretation of medical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The evaluation relies on standardized test methods and conformity to norms, not on expert adjudication of medical 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. This device is a pre-filled syringe, not an AI or diagnostic imaging device that would typically undergo an MRMC study.
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 a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for evaluating this device's performance is based on established engineering specifications, material standards, and regulatory requirements (e.g., ISO, USP standards) for syringe functionality, sterility, and biocompatibility.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm.
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(282 days)
Amsino International, Inc.
The AMSure® Enteral Feeding Syringe with ENFit Tip is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral 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 adults only.
The AMSure® Enteral Feeding Syringes with ENFit Tip are standard piston style syringes consisting of a syringe barrel with ENFit syringe nozzle, syringe plunger, syringe stopper and protective cap. The devices are made with polypropylene and polyisoprene rubber. The plunger can be linearly pulled and pushed along the inside wall of the barrel, allowing the syringe to take in and expel fluid through the nozzle at the front end of the barrel. The integral syringe nozzle has a female ENFit connector designed to be compatible only with enteral access devices or accessories having ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids. The Enteral Feeding Syringes with ENFit Tip have a capacity of 60mL for single-use. The devices are provided either sterilized by EtO or non-sterile.
The provided document is a 510(k) premarket notification for a medical device, specifically an "AMSure® Enteral Feeding Syringe with ENFit Tip." This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing studies and acceptance criteria for a novel AI/software device.
Therefore, the specific information requested, such as acceptance criteria table with reported device performance for an algorithm, sample sizes for test/training sets for an AI model, data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training sets, are not applicable to this type of medical device submission.
The "studies" and "acceptance criteria" discussed in this document refer to traditional medical device testing, primarily non-clinical, to ensure the physical and biological safety and performance of the syringe itself.
However, I can extract the information that is present concerning the non-clinical testing performed on the AMSure® Enteral Feeding Syringe with ENFit Tip, which serves a similar purpose to demonstrating a device meets its intended performance.
Here's the relevant information based on the provided text, re-interpreting "acceptance criteria" and "study" in the context of a physical medical device submission:
1. A table of acceptance criteria and the reported device performance
The document lists various performance characteristics that were tested. For a 510(k) submission, "acceptance criteria" typically refers to established standards (e.g., ISO standards) or pre-defined thresholds that the device must meet to be considered safe and effective and substantially equivalent to its predicate. The document states a general conclusion that the device "passed all acceptance criteria" without specifying the exact numerical criteria or individual results for each test.
| Test Category | Specific Test (where listed) | Acceptance Criteria (General, based on passing relevant standards) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Meets ISO 10993-5 standards | Passed |
| Sensitization | Meets ISO 10993-10 standards | Passed | |
| Irritation | Meets ISO 10993-10 standards | Passed | |
| Syringe Tip (ENFIT) per ISO 80369-3 | Dimensional analysis | Meets ISO 80369-3 standards | Passed |
| Enteral Connector Misconnection assessment | Prevents misconnection as per ISO 80369-3 | Passed | |
| Fluid leakage | Within acceptable limits as per ISO 80369-3 | Passed | |
| Stress Cracking | Meets ISO 80369-3 standards | Passed | |
| Resistance to separation from axial load | Meets ISO 80369-3 standards | Passed | |
| Resistance to separation from unscrewing | Meets ISO 80369-3 standards | Passed | |
| Resistance to overriding | Meets ISO 80369-3 standards | Passed | |
| Disconnection by unscrewing | Meets ISO 80369-3 standards | Passed | |
| Dose accuracy | Meets ISO 80369-3 standards | Passed | |
| Syringe per ISO 7886-1 | Appearance performance | Meets ISO 7886-1 standards | Passed |
| Capacity Tolerance | Meets ISO 7886-1 standards | Passed | |
| Graduated Scale | Meets ISO 7886-1 standards | Passed | |
| Critical Dimension | Meets ISO 7886-1 standards | Passed | |
| Freedom from air and liquid leakage | Meets ISO 7886-1 standards | Passed | |
| Tolerance on graduated capacity | Meets ISO 7886-1 standards | Passed | |
| Dead space | Meets ISO 7886-1 standards | Passed | |
| Piston/plunger assembly (Piston sliding, Piston Fit in Barrel) | Meets ISO 7886-1 standards | Passed | |
| Silicone oil quantity | Meets ISO 7886-1 standards | Passed | |
| Chemical (Limits for acidity or alkalinity, Limits for extractable metals) | Meets ISO 7886-1 standards | Passed | |
| Ink adhesion | Meets ISO 7886-1 standards | Passed | |
| Additional Testing | Stability testing | Ensures performance over time | Passed |
| Sterilization validation | Meets sterilization standards (e.g., EtO efficacy) | Passed | |
| Package testing | Ensures package integrity and sterility | Passed | |
| Dose accuracy testing (additional) | Confirms accurate fluid delivery | Passed | |
| Risk management | Demonstrates identified risks are mitigated | Passed | |
| Usability testing (for cleaning instructions) | Confirms clear and effective cleaning instructions | Passed | |
| Cleaning validation for reprocessing | Validates cleaning procedure per FDA guidance for 8 uses/washes | Passed | |
| Performance testing following 8 uses and washes within 24 hours | Maintains performance after reprocessing | Passed |
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 for the non-clinical tests. Sample sizes for physical device testing typically refer to the number of physical devices subjected to each test. The provenance would be the manufacturing site (Amsino International Inc. in Pomona, CA). The tests are prospective in nature, as they are performed on new devices to demonstrate compliance.
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 the device is a physical enteral feeding syringe, not an AI/software device requiring expert ground truth for image interpretation or similar tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the device is a physical enteral feeding syringe, not an AI/software device requiring expert 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 as the device is a physical enteral feeding syringe, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical enteral feeding syringe, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For manufacturing quality and performance testing of a physical device, the "ground truth" is typically defined by established engineering specifications, recognized national/international standards (e.g., ISO, ASTM), and regulatory guidance documents (e.g., FDA guidance). Device performance is measured against these objective criteria.
8. The sample size for the training set
This is not applicable as the device is a physical enteral feeding syringe, not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical enteral feeding syringe, not an AI/software device that requires a training set and associated ground truth.
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