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Aqua Naina Plus Sterile Saline Solution: The Aqua Naina Plus Sterile Saline Solution for single use is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion. This solution may be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses. The Aqua Naina Plus Sterile Saline Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner.

Aqua Naina Sterile Saline Solution: The Aqua Naina Sterile Saline Solution is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion and following proper lens disinfection as recommended by the eye care practitioner. The Aqua Naina Sterile Saline Solution may be used as needed throughout the day to rinse contact lenses and contact lens cases.

Aqua Naina Plus Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear (colorless) aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Plus Sterile Saline Solution has pH of 7.00 to 7.40 and Osmolality of 290 to 320 mOsmol/kg. The Sterile Saline Solution is packed in single dose 1 fl oz (30 ml) high density polyethylene (HDPE) container with a tamper evident seal. Aqua Naina Plus Sterile Saline Solution is for single use only.

Aqua Naina Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear (colorless) aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Sterile Saline Solution has pH of 7.00 to 7.40 and Osmolality of 290 to 320 mOsmol/kg. The Sterile Saline Solution is packed in a multidose 4 fl oz (118ml) high density polyethylene (HDPE) container with a tamper evident seal.

The provided text is a 510(k) summary for a medical device (Aqua Naina Sterile Saline Solution and Aqua Naina Plus Sterile Saline Solution). This document outlines the device's characteristics and its substantial equivalence to existing predicate devices, but it does not contain information about acceptance criteria or specific performance studies as would be typically found for AI/ML-based diagnostic devices.

The relevant section, "VII. PERFORMANCE DATA," explicitly states:
"The package volume change was validated using the same methods identified in K193441. No other performance data (clinical or non-clinical) are required for this special 510(k) submission."

This indicates that for this specific type of device (saline solution), comprehensive performance studies with acceptance criteria, sample sizes, ground truth establishment, expert reviews, and MRMC studies, as typically requested for AI/ML medical devices, were not required by the FDA for this submission. The submission relies on establishing substantial equivalence to previously cleared predicate devices based on chemical composition, intended use, and production methods, rather than demonstrating performance against specific clinical metrics.

Therefore, I cannot provide the requested information in the format of acceptance criteria and study details because such data is not present in the provided document.

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Aqua Naina Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and disinfection before use.

Aqua Naina Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear colorless aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Sterile Saline Solution has pH of 6.30 to 7.80 and Osmolality of 280 to 320 mOsmol/kg The Sterile Saline Solution is packed in 4 fl oz (118ml) high density polyethylene (HDPE) container with a tamper evident seal.

The provided text describes the 510(k) Premarket Notification for Aqua Naina Sterile Saline Solution and its substantial equivalence to predicate devices. It focuses on the chemical composition, intended use, and various safety tests (sterility, biocompatibility, ocular irritation, cytotoxicity).

However, this document does not describe acceptance criteria, performance data, or study details relevant to a machine learning or AI device. The device in question is a sterile saline solution, which is a chemical product, not a medical imaging or AI diagnostic device. Therefore, the requested information about test sets, data provenance, expert consensus, MRMC studies, or training sets is not applicable to this submission.

The "study that proves the device meets the acceptance criteria" in this context refers to a series of chemical and biological tests conducted on the saline solution to demonstrate its safety and performance, as outlined in section (7) "PERFORMANCE STSTANDARDS APPLIED".

Here's a breakdown of what is provided and why it doesn't fit the typical AI/ML device study format:

• Device: Aqua Naina Sterile Saline Solution (a chemical product for contact lens care).

• Acceptance Criteria & Reported Performance: These are presented implicitly through the successful completion of various tests against established standards for saline solutions.

  • Sterility: USP
  • Bacteriostasis: USP
  • Ocular irritation: Tested per ISO 10993-10:2010
  • Cytotoxicity (Direct contact test & MEM Elution test): Tested per ISO 10993-5:2009
  • Biocompatibility: Tested per ISO 10993-1:2009
  • pH: 6.30 to 7.80 (reported in description)
  • Osmolality: 280 to 320 mOsmol/kg (reported in description)
    The document states: "Results of all testing demonstrate the solution is non-toxic, is comparable to other currently marketed soft contact lens solution and is substantially equivalent to legally marketed predicates." This is the reported device performance meeting the acceptance criteria set by these standards.

• Sample Size for Test Set and Data Provenance: Not applicable. This refers to chemical and biological samples, not image datasets. The tests are laboratory-based, not based on patient data in the sense of AI/ML.

• Number of Experts, Qualifications, Adjudication Method: Not applicable. These relate to human interpretation of diagnostic data, which is not relevant for testing a saline solution.

• MRMC Comparative Effectiveness Study: Not applicable. This is for evaluating AI assistance in diagnostic tasks.

• Standalone Performance (algorithm only): Not applicable, as there is no algorithm.

• Type of Ground Truth: Not applicable in the AI/ML sense. Ground truth here is established by laboratory measurements and biological assays, comparing results against defined pass/fail criteria from recognized standards (e.g., USP, ISO).

• Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. There is no machine learning model involved, therefore no training set. The "training" of the product is its formulation and manufacturing process, and its "ground truth" is its chemical and physical properties verified through standard laboratory testing.

In summary, the provided document details the regulatory clearance of a contact lens saline solution, not an AI/ML-based medical device. Therefore, the questions posed regarding AI/ML device acceptance criteria and study methodology cannot be answered from this information.

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The LensGiene™ Sterile Saline Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The LensGiene™ Sterile Saline Solution is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.

The LensGiene™ Sterile Saline Solution is a sterile, preservative-free, aqueous solution of sodium chloride, boric acid, and sodium borate provided in single does, carry-on size 10 ml bottles. The sterile saline solution has a pH 7.2-7.8 and a tonicity of 290-320 mOsm/kg. It rinses loose debris and cleaning solution off soft (hydrophilic), rigid gas permeable (RGP) and hard contact lenses prior to insertion. The rinsing solution removes debris and bacteria following proper disinfection as recommended by the eye care practitioner. The sterile saline solution can be used to rinse contact lens cases, rinse lenses as needed throughout the day and to fill the concave posterior surface of scleral lenses prior to insertion to provide a more natural environment than currently approved multipurpose solutions which contain preservatives and osmolarity agents that are not designed to be held against the cornea for extended periods of time.

The LensGiene™ Sterile Saline Solution is a clear solution and should not be used if cloudy or discolored. The individual 10 ml bottle should be discarded after opening and use and should not be used after its labeled expiry date.

This document describes the 510(k) summary for the LensGiene™ Sterile Saline Solution. It is a submission for a medical device and, as such, there are no acceptance criteria or studies to prove the device meets acceptance criteria in the way you've outlined for an AI/algorithm-based device.

The document states that non-clinical and clinical data were unnecessary because the solution was previously submitted and cleared under 510(k) K110221. This means the current submission is relying on prior approvals and established equivalence to predicate devices, rather than new performance studies with specific acceptance criteria.

Therefore, for the information you've requested, the answer is that these criteria and studies were not conducted for this 510(k) submission. However, I can still extract details that relate to the device's characteristics and the basis for its clearance, if reinterpreted for this context:

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

Since this is a submission for a sterile saline solution and not an AI or algorithm, there aren't "acceptance criteria" in the traditional sense of performance metrics for an algorithm. Instead, the "performance" is based on its composition and how it compares to predicate devices. The closest equivalent is the comparison table to predicate devices.

2. Sample size used for the test set and the data provenance: Not applicable. No new test set was used for this 510(k) submission as the device's performance relies on previously cleared data and substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment was performed for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new adjudication was performed.

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-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this submission. The "ground truth" for saline solutions generally pertains to sterility, biocompatibility, and chemical composition, which would have been established during the studies for the predicate devices (K110221 specifically).

8. The sample size for the training set: Not applicable. No training set for an algorithm was used.

9. How the ground truth for the training set was established: Not applicable. No training set was used.

Summary of the basis for clearance for this specific submission (K161622):

The LensGiene™ Sterile Saline Solution received 510(k) clearance based on its substantial equivalence to two predicate devices:

• Menicon Co., Ltd. Saline Rinse Solution (K151768)
• Optics Laboratory, Inc. EyeCept™ Sterile Saline Solution (K110221)

The key justification was that the LensGiene™ solution has a similar composition (sterile, preservative-free aqueous solution of sodium chloride, boric acid, and sodium borate with specific pH and tonicity) and intended use as the predicate devices. The submission explicitly states: "Non-clinical tests were unnecessary for this application because this testing was previously submitted for this solution under cleared 510(k) K110221." and "Clinical studies were unnecessary for this application because this solution was previously cleared for rinsing soft (hydrophilic) contact lenses under K110221." This means that the original safety and effectiveness data for a very similar product (EyeCept™ Sterile Saline Solution, K110221) was leveraged for this new submission.

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Eye-Cept® Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and for wetting soft contact lenses after disinfection before use.

Eye-Cept® Sterile Saline Solution is provided in single use, carry-on size bottles that are preservative free. It rinses loose debris and cleaning solution off soft (hydrophilic) contact lenses. It is only for use to rinse and wet soft contact lenses (a) after cleaning before disinfection and (b) after disinfection before using. It is not a disinfectant nor should it be used as eye drops. It is a clear solution and should not be used, if cloudy or discolored. The individual 10 ml bottle should not be kept once used; it should be discarded after opening. It should not be used after its labeled expiry date.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Eye-Cept® Sterile Saline Solution.

Important Note: The provided document is a 510(k) Summary for a contact lens care product, not a medical device in the typical sense of AI/CADe systems that require clinical studies with human readers. Therefore, many of the requested elements (like sample sizes for test sets, number of experts, MRMC studies, standalone performance for AI, etc.) are not applicable to this type of submission. The "study" here refers to pre-clinical and laboratory testing to demonstrate safety and effectiveness for a chemical solution.

Acceptance Criteria and Reported Device Performance for Eye-Cept® Sterile Saline Solution

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for "Eye-Cept® Sterile Saline Solution" are primarily based on demonstrating substantial equivalence to predicate devices and conformance to specified physicochemical properties and safety/effectiveness standards outlined in FDA guidance documents for contact lens care products.

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

• Sample Size: The document does not specify exact sample sizes for the in vitro cytotoxicity, acute ocular irritation, or antibacterial effectiveness tests. For these types of tests, sample sizes are typically determined by established laboratory protocols and standards for chemical testing, rather than patient-based test sets used for AI/CADe.
• Data Provenance: The studies were conducted by Optics Laboratory, Inc. to support their 510(k) submission. The data is internal to the manufacturer, as is standard for pre-market submissions of this nature. The country of origin for the data is implicitly the USA, where the sponsor is located and where the FDA operates. The studies are described as having been completed "to demonstrate the substantial equivalence," implying they were specifically conducted for this submission (prospective in that sense, but not a prospective clinical trial).

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

• This question is not applicable to this type of device. "Ground truth" in the context of diagnostic devices typically refers to expert consensus, pathology, or clinical outcomes for patient data. For a sterile saline solution, the "ground truth" is established by laboratory measurements (e.g., pH meters, osmometers, cytotoxicity assays) and standardized animal or in vitro tests for irritation and antimicrobial properties. These are measured by laboratory technicians and scientists following established protocols, rather than medical experts forming a consensus.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple human readers interpret medical images or perform clinical assessments, and disagreement needs to be resolved. For laboratory-based chemical and safety testing, the results are typically quantitative measurements or qualitative observations directly interpreted by trained laboratory personnel.

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 question is not applicable. An MRMC study is relevant for AI/CADe diagnostic devices that assist human readers in interpreting medical data. The Eye-Cept® Sterile Saline Solution is a chemical solution, not an AI-powered diagnostic tool.

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

• This question is not applicable. This device is a chemical solution, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established through:
  • Physicochemical Measurements: Direct measurements of properties like pH (7.2-7.8) and tonicity (290-320 mOsm/kg).
  • In vitro Laboratory Assays: Tests for cytotoxicity (evaluating non-toxicity of the solution and container).
  • Animal Testing: Acute ocular irritation studies (demonstrating no irritation).
  • Microbiological Testing: Antibacterial effectiveness (to ensure it does not promote microbial growth, though it is not a disinfectant).
  • Substantial Equivalence: Demonstrating that its characteristics and performance are comparable to legally marketed predicate devices.

8. The Sample Size for the Training Set

• This question is not applicable. The concept of a "training set" and "test set" applies to machine learning algorithms. For a chemical solution, there is no "training set" in this context. The manufacturing process is developed and validated, but this is distinct from training a machine learning model.

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

• This question is not applicable for the same reasons above.

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Sterile Saline Solution is indicated for rinsing and wetting of soft (hydrophilic) contact lenses.

Sterile Saline Solution is a sterile, preservative free, buffered, isotonic, clear, colourless aqueous solution containing Sodium Chloride, Sodium Borate, Boric Acid and Nitrogen as Propellant. The solution is packaged in lacquered aluminum spray containers with caps. Each container is sealed with a tamper evident hologram seal at the junction of the container and the cap.

Acceptance Criteria and Study Details for Cachet Pharmaceuticals Pvt. Ltd. Sterile Saline Solution

This document describes the acceptance criteria and related study details for the Cachet Pharmaceuticals Pvt. Ltd. Sterile Saline Solution, based on the provided 510(K) premarket submission.

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new performance criteria. Therefore, the "acceptance criteria" are primarily framed around demonstrating equivalence in key characteristics and safety.

Note: The acceptance criteria are implicitly met by demonstrating that the Cachet Sterile Saline Solution is substantially equivalent to the predicate device in all critical aspects and adheres to relevant guidance documents.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated as numerical sample sizes for individual tests. The studies are described as "a series of studies" and "a bacteriostasis study."
• Data Provenance: Not explicitly stated in terms of country of origin for the specific test data. The submitter is Cachet Pharmaceuticals Pvt. Ltd. from India. The studies were conducted in accordance with FDA guidance documents. The studies appear to be prospective in nature, as they were conducted to support the premarket submission.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The studies were conducted in accordance with "Micro Appendix C of the Premarket Notification 510 (K) Guidance Document for Contact Lens Care Products" and "FDA's May 1, 1997 Guidance for Industry, Premarket Notification 510 (K) Guidance Document for Contact Lens Care products," implying that relevant scientific and regulatory expertise was involved in designing and interpreting these tests, but specific expert qualifications are not detailed.

4. Adjudication Method

Not applicable. This submission is for a medical device (saline solution) and not an AI or diagnostic device that would typically involve expert adjudication of results. The "adjudication" is implicitly done through laboratory testing and comparison to established standards and predicate device characteristics.

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

Not applicable. This is not a study comparing human reader performance with and without AI assistance, but rather a submission for a sterile saline solution.

6. Standalone Performance Study

Yes, a standalone performance was done in the sense that the device's performance was evaluated independently through a series of tests (toxicity, bacteriostasis) to demonstrate its safety and functionality compared to regulatory requirements and the predicate device. These tests evaluated the algorithm (the saline solution's formulation and properties) without human interpretation as a primary output.

7. Type of Ground Truth Used

• Toxicity: The ground truth for toxicity was established through in vitro (cytotoxicity) and in vivo (eye irritation) studies, where the outcome (e.g., cell viability, irritation levels) was measured and compared against established safety benchmarks and the predicate device's expected non-toxic profile.
• Bacteriostasis: The ground truth for bacteriostasis was established by controlled laboratory experiments where the survival and growth of specific microorganisms (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, and Aspergillus niger) in the saline solution were directly measured and compared against acceptance criteria outlined in the relevant guidance document (Micro Appendix C).

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for such a device would be the extensive research and development that led to its formulation, which is not quantified in terms of a "training set" sample size in this context.

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

Not applicable, as there is no "training set" in the context of this device. The ground truth for the device's properties (formulation, sterility, safety) is established through standard laboratory testing and adherence to regulatory guidance as detailed in section 7.

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Sterile Saline Solution is indicated for rinsing & wetting of soft (hydrophilic) contact lenses.

Sterile Saline Solution is a sterile, preservative free, buffered, isotonic, clear, colourless aqueous solution containing Sodium Chloride, Sodium Borate and Boric Acid. The solution is packaged in plastic sterile single use twist open pods, reusable bottles with dropper tips and caps. Each bottle is closed with tamper resistant cap with a breakable ring, which must be broken in order to open the bottle.

This document describes the premarket submission for Cachet Pharmaceuticals Pvt. Ltd.'s Sterile Saline Solution.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are primarily focused on demonstrating substantial equivalence to existing legally marketed predicate devices and meeting specific safety and performance standards for contact lens care products.

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

• Sample Size for Test Set: The document does not explicitly state the sample sizes used for the cytotoxicity, eye irritation, or bacteriostasis studies.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the submitter is based in India, it is possible the studies were conducted there. The studies are described in a way that suggests they were prospectively conducted for the submission.

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

This type of information is not applicable or not provided for this device. The Sterile Saline Solution is a chemical solution, not an imaging or diagnostic AI device that requires expert ground truth establishment for a test set. The "ground truth" for this device relates to established scientific and regulatory standards for sterility, non-toxicity, and inhibition of microbial growth, as determined by laboratory testing and specified protocols rather than expert consensus on interpretations of complex data like medical images.

4. Adjudication Method for the Test Set

This is not applicable or not provided. As explained above, the assessment criteria are based on objective laboratory tests against pre-defined thresholds, not on subjective interpretations requiring 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. The device is a sterile saline solution, not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

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

This is not applicable. The device is a physical product (saline solution), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on:

• Laboratory-based scientific testing: This includes cytotoxicity studies, eye irritation studies, and bacteriostasis studies conducted according to established protocols (e.g., Micro Appendix C of FDA Guidance).
• Regulatory standards and guidance: Compliance with the FDA's "Guidance for Industry, Premarket Notification 510 (K) Guidance Document for Contact Lens Care products."
• Chemical and physical properties: Assessed through the formulation details (components, preservative status, sterility claim).

8. The Sample Size for the Training Set

This is not applicable. As a physical product, there is no "training set" in the context of machine learning or AI algorithms. The development of the solution would involve formulation studies and pilot testing, but these are not considered "training sets" in the AI sense.

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

This is not applicable for the same reasons as point 8. The "ground truth" for the development of the saline solution would have been established through a combination of pharmaceutical formulation science, existing knowledge of safe and effective ingredients for ophthalmic use, and preliminary laboratory testing to optimize the solution's properties.

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ACU-PAK Sterile Saline Solution 0.9% / Sterile Water are used in health care facilities for the irrigation of general medical devices. It is used as a lubricant for suction catheters.

ACU-PAK Sterile Saline Solution 0.9% and Sterile Water are used for the irrigation of medical devices. The device consists of 100ml of Saline Solution at a concentration of 0.9% or Water contained within a 100cc polyethylene wide mouthed bottle. The closure is a 38/400 white polypropylene cap fitted with an F 217 liner. A printed tamper-evident band is placed over the top of the bottle. Each bottle contains a product label displaying a lot code and expiration date.

The provided text is a 510(k) summary for a medical device: ACU-PAK Sterile Saline Solution 0.9% and Sterile Water. This document is a premarket notification for a Class II medical device, indicating that the manufacturer believes it is substantially equivalent to legally marketed predicate devices.

The information provided does not include a study that proves the device meets specific acceptance criteria in the way described in your request (e.g., performance metrics, statistical analysis, or clinical trial results). This is because the 510(k) process for devices like sterile saline or water for irrigation typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical performance studies with specific acceptance criteria that need to be met by the new device itself.

Instead, the submission focuses on demonstrating that the ACU-PAK product has the same intended use and technological characteristics as predicate devices. The "performance" in this context refers to its similarity to already approved products.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a traditional performance study, nor can I provide information about sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance. These types of studies are typically required for more novel or higher-risk devices where substantial equivalence cannot be solely established through technological comparison.

However, I can extract the relevant information from the provided text demonstrating how the device meets the criteria for substantial equivalence based on its comparison to predicate devices.

Summary of Acceptance Criteria and Device Performance (as per 510(k) submission for Substantial Equivalence):

This 510(k) submission relies on demonstrating substantial equivalence to predicate devices rather than meeting new, unique performance criteria through a standalone study. The "acceptance criteria" here are the characteristics and intended use that must match or be equivalent to already approved devices.

Information Regarding Study and Ground Truth (for Substantial Equivalence):

1. Sample size used for the test set and the data provenance: Not applicable. This 510(k) relies on a comparison of device characteristics to predicate devices, not a test set of data. The "data provenance" is the existence of legally marketed predicate devices.

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 test set is not established in this type of submission. The "ground truth" for substantial equivalence is that the predicate devices are legally marketed and safe/effective. The FDA regulatory reviewers eventually make the determination of substantial equivalence.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no test set or adjudication process as typically understood in performance studies.

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 a sterile solution, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a sterile solution, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices as determined by their prior clearance by the FDA. The new device demonstrates substantial equivalence to these predicate devices. The manufacturer states, "ACU-PAK Sterile Saline Solution 0.9% and Sterile Water is identical to predicate devices."

7. The sample size for the training set: Not applicable. No training set is used for this type of device submission.

8. How the ground truth for the training set was established: Not applicable. No training set is used.

Conclusion:

The ACU-PAK Sterile Saline Solution 0.9% and Sterile Water device meets its "acceptance criteria" by demonstrating that it is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and manufacturing processes. The "study" proving this is the 510(k) submission itself, which provides a detailed comparison of the new device to the predicate devices. The FDA's clearance (letter dated AUG 18 1998) confirms this finding of substantial equivalence.

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