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Sterile Water and Saline Solutions are defined as an accessory to a device that is intended For Device Cleaning and Irrigation.

Automated Liquid Packaging, Inc. Sterile Water and Saline Solutions are products that have been used in the medical community for decades. The only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers.

The irrigation bottle is manufactured of 100% low density polyethylene (LDPE) and contains no color or chemical additives.

The two solutions are sterile, aseptically filled and are hermetically sealed for single use only.

The provided document is limited to a 510(k) summary for Sterile Water and Saline Bottles for Irrigation. This type of document is for a medical device and typically does not contain the detailed clinical study information such as acceptance criteria, statistical analysis, and expert adjudication that would be found in a submission for an AI/ML-driven diagnostic device.

Here's an analysis based on the lack of this information in the provided document, addressing each point:

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

   • Acceptance Criteria: Not specified in the document. For a product like sterile water and saline solutions, acceptance criteria would likely relate to sterility, chemical composition (e.g., sodium chloride concentration), pH, particulate matter, and container integrity, as well as biological compatibility with ISO 10993 standards. However, specific thresholds are not provided.
   • Reported Device Performance: The document states, "All materials used in the fabrication of Sterile Water and Saline Solutions were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." No specific performance metrics (e.g., success rates, purity levels, sterility assurance levels) or quantitative results are provided.

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

   • This information is not applicable and not present in the document. The testing described is material qualification and product performance testing (e.g., sterility, biological safety), not a clinical trial with a test set of 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 information is not applicable and not present. Ground truth, in the context of diagnostic AI/ML, refers to a definitive diagnosis or outcome. For this device, "ground truth" would relate to laboratory test results (e.g., sterility tests, chemical analysis) rather than expert clinical interpretation of patient data.

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

   • Not applicable and not present. Adjudication methods are used in clinical studies where multiple human readers or experts disagree on an outcome. The testing performed for this device would involve laboratory methods with pre-defined pass/fail criteria.

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

   • Not applicable and not present. This type of study is relevant for AI-powered diagnostic tools that assist human interpretation. The sterile water and saline solutions are not an AI device.

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

   • Not applicable and not present. This refers to the performance of an AI algorithm independently. The device in question is a physical product (sterile solutions), not an algorithm.

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

   • The "ground truth" for this device's performance would be established through laboratory testing results (e.g., microbiological cultures for sterility, chemical assays for composition, physical testing for container integrity) against established standards (e.g., USP monographs, ISO 10993 for biocompatibility). The document vaguely refers to "biological qualification safety tests as outlined in ISO 10993 Part-1" and "industry recognized test methods."

8. The sample size for the training set:

   • Not applicable and not present. Training sets are used for machine learning models. The manufacturer performed product performance and material safety testing, not AI model training.

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

   • Not applicable and not present. As there is no AI model or training set, this question is not relevant to the provided document.

Summary for the given document:

The provided 510(k) summary for Sterile Water and Saline Bottles for Irrigation, USP, describes a conventional medical device. It focuses on demonstrating substantial equivalence to a predicate device based on intended use and performance attributes. The "study" mentioned is the "Summary of testing" which involved:

• Evaluating materials through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices."
• Testing materials "in accordance with industry recognized test methods."

The objective of these tests was to confirm that the materials and the final product were "acceptable for the intended use" (device cleaning and irrigation) and met safety standards, rather than proving diagnostic accuracy or human reader improvement for an AI/ML product. The document does not provide specific data, acceptance criteria thresholds, sample sizes for these tests, or details about how the ground truth for these tests was established beyond adherence to "industry recognized test methods" and ISO 10993.

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STORE NAME Multi-Purpose Solution is indicated for use in cleaning, chemical (NOT HEAT) disinfection, and storing of soft (hydrophilic) contact leases.

A sterile isotatic, phosphate buffered saline solution containing polyoxyethylens polyoxypropylene block copolymer, preserved with 0.128% EDTA and 0.0001% Cosmocil CQ (polyhexamethylene biguanide).

Contains no chiorhaxidine or thimerosal.

Cleans, loosens and removes accurations of films, deposits and dabris from soft consist. Innissa, Destroys harmful microorganisms on the surface of the lens. Rinses, stores and rewels lenses before the lansas are placed on the eye.

Here's an analysis of the provided text regarding K980147, outlining the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Clinical Study Test Set (Eyes):
  • Test group: 491 eyes (419 completed, 72 discontinued)
  • Control (Multipurpose): 117 eyes (107 completed, 10 discontinued)
  • Control (Peroxide): 116 eyes (94 completed, 22 discontinued)
  • Total Eyes in Study (Clinical): 724 eyes
• Clinical Study Test Set (Examinations/Visits):
  • Test group: 2,990 eye examinations/scheduled visits
  • Control (Multipurpose): 750 eye examinations/scheduled visits
  • Control (Peroxide): 672 eye examinations/scheduled visits
• Data Provenance: The document does not explicitly state the country of origin. Given the FDA 510(k) submission, it is highly likely the study was conducted in the United States. The study appears to be prospective, as it involves tracking clinical outcomes and adverse events in subjects over time using the solution.
• Other Test Sets (for Chemistry, Toxicology, Microbiology): Sample sizes are not specified for these laboratory tests.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth within the clinical study. Given the nature of a clinical trial for contact lens solutions, "ground truth" would be established by the examining practitioners (e.g., ophthalmologists, optometrists, or trained study coordinators under their supervision) based on standardized clinical assessments (visual acuity tests, slit lamp examinations, patient symptom reports). No explicit "expert consensus" for specific case-by-case ground truth determination is mentioned beyond the standard clinical examination protocols.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (like 2+1, 3+1, none) for the clinical test set data. Clinical trials typically follow pre-defined protocols for data collection and assessment by trained investigators. Any disagreements or ambiguities in data interpretation would ideally be resolved according to the study protocol, but a formal adjudication process by external experts is not detailed here.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to compare the diagnostic performance of different readers (e.g., radiologists) on a set of cases, often in the context of imaging. This submission concerns a contact lens solution, and the clinical study evaluates the solution's performance in real-world use on patients, not diagnostic interpretation by multiple readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

Yes, in essence. The Chemistry, Toxicology, and Microbiology sections represent "standalone" performance evaluations of the device (the solution itself) without human-in-the-loop interaction in the context of clinical decision-making. These tests evaluate the intrinsic properties of the solution (sterility, disinfection efficacy, toxicity, etc.) in a controlled laboratory setting. The clinical study then evaluates the device's performance with human-in-the-loop (patients using the solution, and clinicians evaluating the outcomes).

7. The Type of Ground Truth Used

• Chemistry, Toxicology, Microbiology: The ground truth is established through laboratory test results against predefined chemical, biological, and safety standards (e.g., "non-cytotoxic," "passed stand-alone disinfection test," "sterile," "no acute ocular irritation").
• Clinical Studies: The ground truth is primarily based on clinical observations and patient-reported outcomes. This includes:
  • Clinical assessments: Visual acuity measurements, slit lamp findings (e.g., presence/absence of edema, staining, hyperemia), and assessment of lens cleanliness by clinicians.
  • Patient-reported data: Symptoms, problems, and complaints provided by the patients during visits.
  • Adverse events: Clinically verified adverse reactions.

8. The Sample Size for the Training Set

The document does not mention a training set. This is a 510(k) submission for a medical device (contact lens solution), not an AI/Machine Learning device or a diagnostic test where a "training set" in the computational sense would be required. The data presented is from a clinical study and laboratory evaluations conducted to demonstrate safety and efficacy.

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

As no training set (in the context of AI/ML) is mentioned or implied, this question is not applicable. The "ground truth" for the various tests (chemistry, toxicology, microbiology, and clinical outcomes) was established as described in point 7.

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This solution is indicated for use as a tracheal lavage, nasal irrigation solution or as an irrigation solution for flushing a body cavity.

Automatic Liquid Packaging, Inc. Sterile Water and Saline Solutions are products that have been used in the medical community for decades. These products have not experienced or been associated with toxic or undesirable effects that relate to the ingredients used in their production. The only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers.

The irrigation bottle is manufactured of 100% virgin low density polyethylene (LDPE) and contains no regrind, color or chemical additives.

The two solutions are sterile, aseptically filled, and are hermetically sealed for Single Use Only.

The provided text is a 510(k) summary for a medical device called "Sterile Water and Saline Bottle for Irrigation." This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a study with specific acceptance criteria and detailed performance data on a new, unproven device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in this document. The 510(k) process for this type of device typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring novel clinical studies with extensive performance metrics.

Here's an analysis based on the provided text, highlighting what can be inferred or what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. For a product like a sterile saline solution and bottle for irrigation, acceptance criteria would typically revolve around sterility, purity of ingredients, container integrity, and potentially biological safety (e.g., non-pyrogenic). However, the specific quantitative criteria and detailed performance results against those criteria are not detailed in this 510(k) summary.

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

This information is not provided. The document does not describe a clinical study or a specific test set. The focus is on the long-standing use and known properties of the product.

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

This information is not provided. No expert review or ground truth establishment process for a test set is described.

4. Adjudication Method for the Test Set

This information is not provided. No test set or adjudication process is described.

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

An MRMC comparative effectiveness study was not conducted or reported in this document. This type of study is more common for diagnostic imaging devices where human interpretation is crucial, not for a sterile irrigation solution and bottle.

6. Standalone Performance Study

A standalone performance study (algorithm only without human-in-the-loop) was not conducted or reported. This concept is not applicable to this type of medical device (a sterile solution and bottle).

7. Type of Ground Truth Used

The "ground truth" for this type of device is inherent in its composition and long history of use. The document states: "Automatic Liquid Packaging, Inc. Sterile Water and Saline Solutions are products that have been used in the medical community for decades. These products have not experienced or been associated with toxic or undesirable effects that relate to the ingredients used in their production."

Therefore, the "ground truth" or basis for safety and effectiveness relies on:

• Historical clinical use/Outcomes data: The long-standing safe use of such products.
• Chemical and material properties: The known safety and inertness of the ingredients (sterile water, sodium chloride) and the container material (100% virgin low density polyethylene).
• Manufacturing processes: Aseptic filling and hermetic sealing ensure sterility.

8. Sample Size for the Training Set

This information is not provided. There is no "training set" in the context of this device's approval process. The device is not a learning algorithm or AI.

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

This information is not provided. As no training set exists, no ground truth needed to be established for it.

In summary, the provided 510(k) summary is for a relatively simple, well-understood medical device (sterile irrigation solution and bottle). Its approval hinges on demonstrating substantial equivalence to a predicate device, relying on the known safety of its components and manufacturing processes, rather than on detailed clinical studies with the kind of metrics requested for devices like AI algorithms or complex diagnostic tools.

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