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Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses, as recommended by your eye care practitioner.

Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is a sterile, buffered solution containing 3% hydrogen peroxide which contains a phosphonic acid stabilizer, potassium chloride, propylene glycol, carbamide (Urea), a citrate/phosphate buffer system, and poloxamer 181. A special lens case containing a platinum coated neutralizing disc is provided with the OCD04 Cleaning and Disinfecting Solution. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.

The provided text describes the acceptance criteria and the studies conducted for the Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution. This device is a contact lens care product, and the studies performed are primarily in vitro and pre-clinical, along with a clinical evaluation, rather than focusing on AI/human-in-the-loop performance.

Here's the breakdown of the information requested:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated in a quantified manner with pass/fail thresholds for each test. Instead, the document states that the device "meets the criteria for disinfection and preservative efficacy" and "was substantially equivalent to the predicate device."

Study Details

Given that this is a submission for a contact lens cleaning and disinfecting solution, the "test set" and "training set" concepts as typically applied to AI/ML models are not directly applicable in the same way. The studies are pre-clinical (in vitro) and clinical, focusing on the chemical and biological efficacy and safety of the product.

2. Sample Size and Data Provenance for Test Sets:

• Biocompatibility Studies: Not explicitly stated, but performed "in accordance with FDA Guidance for Contact Lens Solutions and Accessory Products, May 1997, as well as referencing several recognized testing Standards" under Good Laboratory Practice (GLP) regulations. These are typically controlled laboratory experiments.
• Microbiology Studies: Not explicitly stated, but followed EN ISO 14729:2001/AMD.1:2010(E) and EN ISO 14730:2000(E), and the ISO-FDA Regimen Procedure. Nine lens materials were tested for disinfection. These are in vitro laboratory studies.
• Lens Compatibility Studies: Not explicitly stated, but confirm compatibility with "soft contact lenses including, silicone hydrogel contact lenses and rigid gas permeable lenses." These are likely in vitro laboratory studies.
• Residual Peroxide and Area Under Curve: Cases cycled for 35 cycles (recommended use period) and a safety margin out to 50 cycles. This is an in vitro laboratory study.
• In-Vitro Protein Removal and Cleaning Efficacy: Evaluated using seven contact lens materials (FDA groups I and IV and silicone hydrogel materials). This is an in vitro laboratory study.
• Clinical Evaluation: Not explicitly stated, but described as a "three-month multicenter, randomized, masked, parallel, bilateral clinical trial." Subject recruitment included "currently adapted wearers of both soft and RGP lenses." The number of subjects is not given in this summary. Data provenance would be multi-center clinical data (presumably within the US or compliant with international clinical trial standards). This is a prospective study.

3. Number of Experts and Qualifications for Ground Truth:

• For the in vitro and pre-clinical studies (Biocompatibility, Microbiology, Lens Compatibility, Residual Peroxide, In-Vitro Protein Removal, Cleaning Efficacy), the "ground truth" is established by the standardized methods themselves (e.g., ISO standards, FDA guidance). The "experts" are the laboratory personnel conducting these GLP-compliant tests, who are qualified to perform such scientific evaluations.
• For the clinical evaluation, the "ground truth" for patient comfort and safety endpoints is based on patient self-reported outcomes and investigator observations. The "experts" are the investigators (likely ophthalmologists or optometrists) involved in the multicenter clinical trial. Their qualifications are not specified but would include medical licensure and experience in eye care.

4. Adjudication Method for Test Set:

• For in vitro and pre-clinical studies, adjudication methods (like 2+1 or 3+1) are not typically relevant as the results are based on objective measurements and adherence to standardized protocols. Replicate testing and statistical analysis ensure data reliability.
• For the clinical evaluation, the study was "multicenter, randomized, masked, parallel, bilateral." This design inherently builds in robustness against bias. Adjudication refers more to agreement on specific endpoints or readings, which is not described as a separate process here beyond the study design (e.g., masking helps prevent bias, and "investigators evaluated the lenses").

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

This information is not applicable as the device is a contact lens solution, not an AI-assisted diagnostic or imaging device. There is no "human reader" in the context of interpreting images or medical cases with or without AI assistance. The clinical study does compare the new solution to a predicate solution in terms of human experience (comfort) and safety.

6. Standalone (Algorithm Only) Performance:

This information is not applicable as the device is a contact lens solution, not an algorithm.

7. Type of Ground Truth Used:

• For in vitro and pre-clinical studies: The ground truth is established by objective measurements against defined standards and protocols (e.g., microbial counts, chemical concentrations, physical compatibility, protein removal quantification).
• For the clinical evaluation: The ground truth is based on patient-reported outcomes (e.g., comfort levels) and investigator observations (e.g., lens wetting, fitting characteristics, safety assessments).

8. Sample Size for Training Set:

This information is not applicable as there is no "training set" in the context of an AI/ML model for this type of device. The formulation development and optimization would involve internal testing, but not in the sense of a machine learning training set described here.

9. How Ground Truth for Training Set Was Established:

This information is not applicable for the reasons stated above.

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