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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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