Search Results

Over-the-Counter Use: For moistening absorbent wound dreaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin. Prescription Use: For moistening absorbent wound dressing and for moistening, debriding, and cleaning acute and chronic dernal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second-degree burns, cuts, abrasions, and minor skin irritations and for device irrigation.

The subject device Sterile Water USP, and Sterile 0.9% Normal Saline USP is a colorless, transparent solution with no preservatives or antimicrobial agents added. It is used only for external irrigation, and not for injection purposes and it is a single use device. The subject device is packaged in clear, polypropylene (PP) bottles capped with PP Screw cap and filled with a sterile, preservative-free, clear, colorless aqueous solution and sealed with a PP/PET aluminum induction seal. The aqueous solution composition is either sterile 0.9% normal saline, both which meet their respective USP monograph criteria and contain no additives. The container and closure system for the 250mL, and 1000mL sizes include PP bottles with a PP screw cap with a PP/PET aluminum induction seal and a tamper evident plastic shrink wrap. The container and closure system for the 100mL size includes a PP bottle with a PP screw cap and a PP/PET aluminum induction seal. These single-use devices are labeled for device irrigation and wound debridement and are not intended for injection. The subject device will function by the mechanical action associated with applying and moving an aqueous solution across a wound or device surface, which facilitates the moisturizing, debridement and irrigation of these surfaces.

The provided text is a 510(k) summary for a medical device clearance, specifically for "Sterile Water USP and Sterile 0.9% Normal Saline USP" for use as sterile irrigation solutions. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/software device.

Therefore, the information required to answer your prompt, which is tailored for an AI/software medical device's performance evaluation (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details), is not present in the provided document.

The document discusses performance testing, but these are primarily bench tests, biocompatibility tests, and packaging tests for the physical product (sterile water/saline solution and its container), not performance metrics for an AI/software algorithm.

Here's a breakdown of why each point in your prompt cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document does not define "acceptance criteria" in the context of an AI/software's performance (e.g., accuracy, sensitivity, specificity). It lists various tests (biocompatibility, packaging, non-clinical bench tests for chemical properties and sterility) and reports that the device "complies with the criteria" or "successfully withstood" them. These are not performance metrics for a diagnostic or AI device.

2. Sample sized used for the test set and the data provenance: Not applicable. There is no AI/software test set. The tests mentioned are for physical product characteristics (e.g., "no bottles exhibited leakage," "containers remained undamaged").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for an AI/software test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no test set in the context of AI/software performance.

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 sterile water/saline, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the AI/software sense is not relevant here. The "truth" for this product is its chemical composition, sterility, and physical integrity, which are verified through standard laboratory tests.

8. The sample size for the training set: Not applicable. There is no training set for an AI/software.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA 510(k) summary pertains to a physical medical device (sterile water/saline solution) and its substantial equivalence to a predicate device. It does not contain information about the development, validation, or performance of an AI/software medical device, which would typically involve the type of acceptance criteria and study details you have requested.

Ask a specific question about this device

Sterile Water for Inhalation, USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional and non-institutional care settings.

Sterile Water for Inhalation, USP is a sterile, single-dose medical device provided in durable Polypropylene (PP) bottles, which are resistant to breakage and designed for safe and easy handling. The bottles are available with two types of closures:

• A 36 mm PP screw cap with a PP/PET aluminium induction seal .
• A 28mm bromobutyl stopper with an aluminium seal .
  The bottles are available in the following volume configurations:
• . 1000mL PP bottles with either a bromobutyl stopper and aluminium seal, or a PP/PET aluminium induction seal, PP screw cap, and tamper-evident plastic shrink wrap.
• 500mL PP bottles with a PP/PET aluminium induction seal, PP screw cap, and tamper-. evident plastic shrink wrap.
  Sterile Water for Inhalation, USP is not for parenteral administration or irrigation. The product is For Inhalation Therapy Only. It is supplied sterile and intended for single use only. Discard any unused portion.

The provided text describes a 510(k) summary for a medical device called "Laboratorios Biogalenic Sterile Water for Inhalation, USP." This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

It's important to note that this document does not describe a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device performance evaluation. Instead, it's a regulatory submission demonstrating the substantial equivalence of a general medical device (sterile water for inhalation) to an existing one. The "acceptance criteria" here refer to regulatory requirements for substantial equivalence, not performance metrics like sensitivity, specificity, or AUC as seen in AI/ML device evaluations.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to the information provided in this document as it relates to an AI/ML device.

However, I can extract information related to the "performance testing" conducted for this non-AI/ML device to demonstrate its substantial equivalence to the predicate device.

Summary of Acceptance Criteria and Device Performance (Non-AI/ML Device)

The "Laboratorios Biogalenic Sterile Water for Inhalation, USP" is a non-AI/ML medical device. Its acceptance criteria and performance are assessed through physicochemical, biological, packaging, and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify a distinct "test set" in the context of an AI/ML algorithm. The tests described are laboratory-based validation tests performed on samples of the manufactured device.
• The provenance of the data (e.g., country of origin, retrospective/prospective) is not detailed for these specific tests. These are standard validation tests for manufacturing processes and product integrity.

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

• This concept is not applicable as there is no "ground truth" derived from expert consensus for a diagnostic medical device in this context. The validity of the tests (e.g., sterility, leak resistance) is determined by established scientific methods and standards (USP, ASTM, ISO).

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

• Not applicable. The tests are laboratory-based with objective outcomes against defined standards.

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, as this is not an AI/ML device.

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

• Not applicable, as this is not an AI/ML device.

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

• The "ground truth" for this device's performance is established by scientific standards and analytical methods defined in regulations and industry standards (e.g., USP for sterility, ASTM for packaging, ISO for biocompatibility and sterilization). It's not based on expert consensus, pathology, or outcomes data in the way it would be for a diagnostic AI/ML device.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device. There is no training set for an algorithm.

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

• Not applicable, as this is not an AI/ML device.

Ask a specific question about this device

The Sterile Water for Inhalation Flexoval® Bottle is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional care settings by qualified staff. The Sterile Water for Inhalation is intented for use in all patient populations including adults, pediatrics, infants and neonates.

The Sterile Water for Inhalation is provided in a Flexoval® bottle which is a flexible plastic bottle with a spikeable cap at the base and is pre-filled with sterile water. The bottle is 1 liter in volume and is made of Low-Density Polyethylene (LDPE). The bottle has one administration port (cap) which is clear and natural in color. The bottle has one standard hanger that is integrated at the base of the bottle also has a multi-color adhesive label affixed by an automatic labeler. The product is sterilized by heat in an autoclave. The device is sold sterile and cannot be re-used: it is discarded after use. The device is intended for use by qualified staff.

This document is a 510(k) Premarket Notification from Hometa Inc. for their "Sterile Water for Inhalation in 1L Flexoval® Bottles." It focuses on demonstrating substantial equivalence to a predicate device, "Sterile Water for Inhalation Flex Bag, USP" by Cardinal Health Inc.

The document does not describe an AI/ML-driven medical device evaluation. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details for an AI/ML device, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

The study described in this document is primarily focused on non-clinical testing to ensure the new device (Sterile Water for Inhalation in Flexoval Bottles) performs equivalently to the existing predicate device (Sterile Water for Inhalation Flex Bag). The testing includes:

• Functional Testing (per ISO 15747): Resistance to temperature, pressure, and leakage; penetration ability of the insertion point; adhesion strength and impermeability of the insertion point; transparency; resistance to dropping; and hanger integrity.
• Physicochemical and Biological Testing (per USP methods and internal validated methods): Total Organic Carbon, Conductivity, Oxidizable Substances, Process Bioburden, Sterility, and Bacterial Endotoxins.
• Sterilization Validation (per ISO 17665): Moist heat sterilization to achieve a Sterility Assurance Level (SAL) of 10^-6, using Geobacillus stearothermophilus as a biological indicator.
• Biocompatibility Testing (per ISO 10993 series): Extractable/leachables testing, toxicological risk assessment, cytotoxicity, sensitization testing, intracutaneous reactivity test, and material-mediated pyrogenicity.

The "acceptance criteria" discussed in this document are the standards and requirements for these non-clinical tests to demonstrate that the new device is safe and effective and performs as intended, similar to the predicate. The reported "performance" is that the device met these standards.

Therefore, I cannot provide the requested table or details related to AI/ML device evaluation. The information in the provided text pertains to the substantial equivalence of a medical consumable (sterile water) based on physical, chemical, and biological properties, not an AI/ML algorithm.

Ask a specific question about this device

The AquaFlate Pre-filled Sterile Water Syringe is intended to be used for inflating a Foley catheter balloon.

The proposed device, AquaFlate Pre-Filled Sterile Water Syringe 10mL (REF 250-400), is a 10mL syringe prefilled with USP purified water and sterilized via gamma irradiation. The syringe consists of a polypropylene barrel and plunger and latex free rubber for both the plunger gasket and syringe tip cap.

The AquaFlate Pre-Filled Water Syringe 10mL is intended for inflating an indwelling. urethral Foley catheter balloon. In accordance with CDC Guidelines, healthcare facility protocols, and the Foley catheter manufacturer's instructions for use, prior to catheterization, the syringe cap of the AquaFlate Pre-Filled Sterile Water Syringe 10mL is removed and the luer tip of the syringe is connected to the inflation port of the catheter. Once the catheter is inserted into the bladder, the entire contents of the syringe are dispensed to inflate the catheter balloon to ensure the catheter does not slide out. After balloon inflation, the syringe is disconnected from the catheter inflation port and discarded.

The AquaFlate Pre-Filled Sterile Water Syringe 10mL is not intended for injection and is for single use only.

The shelf life of the AquaFlate Pre-Filled Sterile Water Syringe 10mL is one (1) year.

HR Pharmaceuticals does not intend to market this device with accessories or as part of a system.

The provided text describes the 510(k) summary for the AquaFlate Pre-Filled Sterile Water Syringe 10mL. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets a specific set of acceptance criteria for a new and novel AI/ML-driven medical device. Therefore, much of the requested information regarding acceptance criteria, specific study design for AI/ML performance, ground truth establishment, expert involvement, and statistical comparisons is not applicable to this type of regulatory submission.

However, I can extract the information relevant to the performance data and equivalence claims made for this product.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of AI/ML performance metrics, the "acceptance criteria" here refer to conformance with established industry standards and regulations for medical devices of this type. The reported device performance is its successful adherence to these standards.

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

• Sample Size: The document does not specify exact sample sizes for each of the testing protocols (e.g., how many syringes were tested for sterility, or how many materials were tested for biocompatibility). It broadly states that "performance testing conducted per HR Pharmaceuticals' protocols" and that validation was performed. These are not "test sets" in the AI/ML context, but rather samples used for engineering and quality control validation.
• Data Provenance: Not applicable in the context of typical AI/ML data provenance (e.g., country of origin, retrospective/prospective). The data comes from internal testing and validation activities by the manufacturer and third-party labs according to recognized consensus standards.

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

• Not Applicable. This device is a pre-filled sterile water syringe, not an AI/ML diagnostic or therapeutic device. Ground truth, in the AI/ML sense, is not established by human experts for basic device functionality and safety testing like biocompatibility or sterility. Conformance to standards is the "ground truth" here.

4. Adjudication Method for the Test Set

• Not Applicable. As this is not an AI/ML device, there's no diagnostic output requiring adjudication. Test results (e.g., pass/fail for a sterility test) are objective and determined by the methodology of the standard.

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

• Not Applicable. This is not an AI/ML device. No human reader studies or comparative effectiveness studies with AI assistance were performed or are relevant.

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

• Not Applicable. This is not an AI/ML device. No algorithm-only performance testing was conducted.

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

• The "ground truth" for this device's performance, safety, and effectiveness is established by conformance to recognized consensus standards and regulations (e.g., ISO for connectors, USP for sterility, ISO for biocompatibility, ASTM/ISTA for packaging). These standards define acceptable limits and methodologies.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device; therefore, there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

Ask a specific question about this device

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)

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), 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 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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor burns, superficial abrasions and minor irritations of the skin.

For Prescription Use: For moistening absorbent wound dressings and for mostening acute and chronic dernal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

The subject devices are 100 mL, 250 mL or 500 mL sterile normal saline (0.9% Sodium Chloride). The design of these single-use devices incorporates clear, high density polyethylene (HDPE) bottles filled and sealed with a sterile, preservative-free, clear, colorless, aqueous solution, as labeled for device irrigation and wound debridement (not for injection). The subject device will function by means of mechanical action; specifically, by the mechanical mechanism of action associated with applying and moving an aqueous solution across a wound or device surface, which facilitates the moisturizing, debridement and irrigation of these surfaces.

The chemical composition of its aqueous solution is either sterile saline (0.9% Sodium Chloride in sterile water) for irrigation, which have been substantiated to each meet their respective USP monograph criteria, and its formulation contains no additives. The components of the subject device's container and closure system, made from polyethylene (PE) resins and an induction-heat seal and liner, meet the requirements of the Agency's food additive regulations.

The provided text is a 510(k) Premarket Notification for Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP. This document asserts substantial equivalence to a predicate device (Nurse Assist Wound Flush, Sterile Water and Sterile Normal Saline, K083042) rather than proving device performance against specific acceptance criteria through a clinical study.

Therefore, the requested information regarding "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established" is not available in this document.

The document explicitly states: "Summary of Clinical Testing: Not applicable. No clinical testing was done on the proposed device." (Page 9)

Instead, the submission relies on non-clinical testing (bench testing) and a comparison of technological characteristics to demonstrate substantial equivalence to a legally marketed predicate device.

Here's the relevant information provided:

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

• This document does not present acceptance criteria for a clinical study or a table of reported device performance from such a study. It focuses on demonstrating equivalence through non-clinical means.
• The "Comparison of Proposed and Predicate Devices" (Table 1 on page 6) lists characteristics like product name, K number, product owner, product code, indications for use, regulation number, technological characteristics, chemical composition, design configurations, and performance specifications. The "Comparison Analysis" column for most entries is "Same" or "Similar," indicating that the proposed device matches the predicate in these aspects.

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

• Not applicable, as no clinical test set was used.

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

• Not applicable, as no clinical test set with human ground truth was established.

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

• Not applicable.

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 not an AI-assisted diagnostic tool.

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

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

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

• Not applicable. The "ground truth" for this 510(k) submission is demonstrated through adherence to USP monographs for sterile water and saline, and safety standards for medical device materials, as assessed through bench testing and comparison to a predicate device.

8. The sample size for the training set:

• Not applicable, as there was no training set for an algorithm.

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

• Not applicable.

Summary of Non-Clinical Testing provided:

• Biocompatibility Evaluation: Conducted according to ANSI/AAMI/ISO 10993-1:2009. The device is classified as a surface device with limited contact ( Pyrogen Test Procedure, Material-Mediated Rabbit Pyrogen Testing
• Shelf Life and Sterilization:
  • Sterilized by gamma radiation in accordance with AAMI TIR33 (Sterilization of healthcare products - Radiation - Substantiation of a selected sterilization dose - Method VDmax) to achieve a Sterility Assurance Level (SAL) of 10^-6.
  • Aging studies conducted in accordance with ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems for Medical Devices) to verify shelf life and maintained sterility.
• Performance Testing (Bench): Mentioned generally as being conducted to evaluate safety, performance, and functionality, demonstrating overall safety. Specific details of these bench tests are not provided in this summary.

In conclusion, this 510(k) submission establishes substantial equivalence through non-clinical testing and comparison to a predicate device, as permitted for certain low-to-moderate risk medical devices. It explicitly states that no clinical (human) testing was performed.

Ask a specific question about this device

For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.

For Prescription Use: For moistening absorbent wound dressings and for moistening, debriding and cleaning acute and chronic dermal lesions, such as stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

The Sterile Water and Sterile Normal Saline devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP. The devices are offered in 100mL, 250mL, and 500mL bottles, and 120mL cups.

The provided document describes a 510(k) premarket notification for the "Anexa Wound Flush, Sterile Water and Sterile Normal Saline" device. This is a medical device clearance, not an AI/ML device approval, therefore, many of the requested criteria related to AI/ML device evaluation are not applicable.

Based on the information provided in the document:

1. Table of acceptance criteria and the reported device performance:

The document concludes that "Sterile Water and Sterile Normal Saline perform at least as well as the predicates' devices" and are "substantially equivalent" based on these comparisons and tests.

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

This document does not specify a "test set" in the context of an AI/ML algorithm. The tests conducted (biocompatibility, sterility, etc.) are standard material and device performance tests, not AI model evaluations. Therefore, information about sample size, country of origin, or retrospective/prospective nature of data for an AI/ML test set is not provided.

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

Not applicable. This device is not an AI/ML algorithm that requires expert-established ground truth for a test set.

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

Not applicable. This device is not an AI/ML algorithm that requires an adjudication method for a test set.

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 wound flush solution, not an AI system.

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

Not applicable. This device is a wound flush solution, not an AI algorithm.

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

Not applicable. The "ground truth" for this device would be its chemical composition, sterility, and biocompatibility, which are verified through laboratory testing against established physical, chemical, and biological standards (e.g., USP , ISO 10993 standards). This is not equivalent to ground truth in the context of AI/ML.

8. The sample size for the training set:

Not applicable. This device is a wound flush solution, 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 an AI/ML algorithm, no ground truth needs to be established for it.

Ask a specific question about this device

OTC: For moistening absorbent wound dressings and cleaning minor burns, superficial abrasions and minor irritations of the skins. Not for injection.

Rx: For moistening absorbent wound dressings and for moistening, debriding and cleaning acute and chronic dermal lesions, such as stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation. Not for injection.

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline device is a wound and device cleansing solution that is intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile saline for irrigation and meets all of the associated requirements defined in the USP. The subject device is offered in various bottle and cup sizes.

The provided text is a 510(k) summary for a medical device called "Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline." This device is a wound and device cleansing solution. The summary details information typically found in a regulatory submission rather than a clinical study report. Therefore, much of the requested information regarding a study proving acceptance criteria (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, or training set details) is not present.

However, I can extract information related to the acceptance criteria and the types of testing performed to demonstrate conformance.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on conformance to USP (United States Pharmacopeia) monographs for "Water for Irrigation" and "Sodium Chloride," and demonstrating sterility. The device's performance is reported by stating its compliance with these standards.

Details of the Study/Testing (as provided in the document):

The document describes laboratory testing to demonstrate chemical and sterility conformance against established standards (USP monographs and industry sterilization practices). It does not describe a clinical study or a comparative effectiveness study involving human interpretation or AI.

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

   • Sample Size: Not explicitly stated for each test, but the document mentions "a summary of all lots tested can be found in summary tables on page 14-3 and 14-4." These pages are not included in the provided text.
   • Data Provenance: The testing was performed on the product itself ("Sterile Water for Irrigation" and "sodium chloride used in the Sterile Normal Saline"). No external data from specific countries or populations are mentioned. The testing is analytical/laboratory-based rather than a retrospective or prospective clinical study.

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

   • Not applicable. The ground truth for this device (chemical purity, sterility) is established by adherence to recognized pharmacopeial standards (USP monographs) and sterilization validation protocols, not by expert consensus on interpretations of complex data like medical images.

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

   • Not applicable. Adjudication methods are typically employed in studies where human readers are making subjective assessments that need to be aggregated or confirmed (e.g., radiology reads). The testing here is objective, analytical, and laboratory-based.

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:

   • No. This device is a sterile solution for wound irrigation. It is not an AI-assisted diagnostic or therapeutic device, and therefore, an MRMC comparative effectiveness study is not relevant or described.

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

   • No. This is not an algorithm-based device. The testing described is for the chemical and physical properties and sterility of the solution.

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

   • The ground truth is established by conformance to recognized industry and regulatory standards, specifically USP monographs for "Water for Irrigation" and "Sodium Chloride," and validated sterilization parameters.

7. The sample size for the training set:

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

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

   • Not applicable. No training set is used for this device.

Ask a specific question about this device

For moistening of absorbent wound dressings and irrigation to remove loose debris and dirt from the wound.

The Wound Flush, Sterile Water & Sterile Normal Saline device can be used 1) for moistening a dry sterile dressing for wound cleansing and 2) irrigation to remove loose debris and dirt from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of loose foreign material such as dirt and debris. The product has a shelf life of 2-years.

The solution is available as sterile saline for irrigation and is gamma sterilized. The subject device is offered in various bottle sizes of 100ml, 250ml, and 500ml and cup sizes of 120ml.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Anexa Wound Flush, Sterile Water & Sterile Normal Saline device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of "acceptance criteria" in the traditional sense of performance metrics for a medical device (e.g., sensitivity, specificity, accuracy). Instead, it describes a substantial equivalence (SE) determination based on a comparison to a predicate device and a series of non-clinical tests. The "performance" is demonstrated by passing these tests and showing similarity to the predicate.

• Same Regulatory Product Code (FRO)
• Same Classification (Pre-amendment)
• Similar Indications for Use
• Similar Principle of Operation (mechanical action removing foreign objects)
• Same Chemical Composition (0.9% Sterile Saline or Sterile Water; no additives)
• Uses same materials and container designs
• Same method of sterilization (gamma) |
  | Biocompatibility Testing | Anexa conducted and passed the following biocompatibility tests:
• Cytotoxicity
• Dermal Sensitization
• Intracutaneous test (direct injection)
• Acute Systemic Toxicity
• Bacterial Endotoxin Test |
  | Compliance with Recognized Standards (Non-Clinical Testing) | Anexa conducted and passed tests according to the following standards:
• ASTM F1980-07 (Reapproved 2011)
• AAMI/ANSI/ISO 11607-1:2006/(R)2010
• AAMI/ANSI/ISO 11607-2:2006/(R)2010
• AAMI / ANSI / ISO 11137-1:2006/(R)2010
• AAMI / ANSI / ISO 11137-2:2013
• AAMI / ANSI / ISO 11737-1:2006 (R)2011
• AAMI / ANSI / ISO 11737-2:2009/(R)2014
• AAMI/ANSI/ISO 10993-1:2009/(R) 2013
• AAMI / ANSI/ISO 10993-5:2009/(R) 2014
• ISO 10993-10 Third Edition 2010-08-01
• AAMI/ANSI/ISO 10993-11:2006/(R)2010
• AAMI TIR 22:2007
• AAMI TIR 33:2005
• AAMI/ANSI/ISO TIR 13004:2013 |
  | Device Stability / Shelf-life | Product has a shelf life of 2-years. This implies successful testing to demonstrate this. |

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

The document describes non-clinical testing and a comparison to a predicate device, not a "test set" in the context of clinical performance evaluation (e.g., for an AI algorithm). The sample sizes for the specific non-clinical tests (biocompatibility, shelf-life, etc.) are not provided in this summary. The data provenance is also not explicitly stated beyond being part of Anexa Biomedical, Inc.'s internal testing records.

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

This information is not applicable as the document describes non-clinical testing for a wound flush solution, not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical setting.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a wound flush solution, not an AI-powered diagnostic tool. An MRMC study is explicitly designed for evaluating the impact of AI on human reader performance.

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

This information is not applicable. The device is a wound flush solution, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests (biocompatibility, sterility, shelf-life), the "ground truth" would be established by:

• Reference Standards/Controls: For biocompatibility, comparisons are made to established safe materials and adverse reactions are assessed.
• Scientific Methods and Measurements: For sterility, microbiological testing to confirm absence of microorganisms. For shelf-life, stability studies measuring chemical and physical properties over time.
• Compliance with Recognized Standards: Meeting the pass/fail criteria outlined in the referenced ASTM, AAMI/ANSI/ISO standards.

For the substantial equivalence claim, the "ground truth" is the legally marketed predicate device and its established safety and effectiveness profile.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI algorithm requiring a training set.

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

This information is not applicable for the same reasons as #8.

Ask a specific question about this device