Search Results

REFRESH® RELIEVA™ FOR CONTACTS is indicated to lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to the application on the eye.

REFRESH® RELIEVA™ FOR CONTACTS is a sterile, buffered, isotonic, preserved solution. This aqueous formulation includes carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, magnesium chloride hexahydrate, potassium chloride, purified water, sodium borate decahydrate, sodium citrate dihydrate, sodium hyaluronate and the preservative PURITE® (stabilized oxychloro complex 0.01%). The solution may also contain hydrochloric acid and/or sodium hydroxide to adjust pH. All ingredients except for Purite are compendial grade (USP/NF/Ph Eur). The product is supplied in a teal colored, low density polyethylene (LDPE) multi-dose bottle and tip with a teal colored high impact polystyrene (HIPS) cap. The bottles are further packaged in paper cartons with a patient information insert.

This document is a 510(k) Summary for the REFRESH® RELIEVA™ FOR CONTACTS device. It describes the device, compares it to predicate devices, and summarizes testing performed to support its substantial equivalence. The document is a regulatory submission for a medical device and does not inherently describe a study that uses AI, nor does it provide detailed acceptance criteria related to AI performance.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable as this document pertains to a medical device (contact lens solution), not an AI/ML powered device.

However, I can extract the information relevant to the performance of the device as described in this document.

Device Name: REFRESH® RELIEVA™ FOR CONTACTS

Device Description: A sterile, buffered, isotonic, preserved solution containing carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, magnesium chloride hexahydrate, potassium chloride, purified water, sodium borate decahydrate, sodium citrate dihydrate, sodium hyaluronate and the preservative PURITE® (stabilized oxychloro complex 0.01%).

Indications for Use: To lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to the application on the eye.

Predicate Devices:

• REFRESH® Contacts Lubricating and Rewetting Drops (K992028)
• REFRESH OPTIVE CONTACTS Lubricating and Rewetting Drops (K083812)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for performance in the typical sense of numerical thresholds for sensitivity, specificity, or similar metrics for an AI/ML device. Instead, the "acceptance criteria" are implied by the requirement for "substantial equivalence" to predicate devices, which the studies aimed to demonstrate. The performance is reported in terms of safety and efficacy.

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

• Sample Size for Test Set:

  • Clinical Study: The document states "A 3-month clinical study was conducted... in contact lens wearers." However, the exact number of participants (sample size) in this clinical study is not provided in the available text.
  • Biocompatibility/Stability: Not applicable as these are bench/lab tests, not human test sets.

• Data Provenance: Not explicitly stated (e.g., country of origin). The clinical study was conducted to evaluate the device against a marketed predicate, implying a controlled clinical trial setting. The studies are prospective as they were specifically performed to support the 510(k) submission.

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

This section is not applicable as the described studies are for a contact lens solution, not an AI/ML powered device where expert readers typically establish ground truth. Clinical endpoints in this context would likely be based on participant reporting of symptoms and potentially objective ophthalmological assessments, not "expert ground truth" for image interpretation.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. Clinical study endpoints would be collected and analyzed, but "adjudication" in the sense of resolving discrepancies between expert interpretations of data (as typically seen in AI/ML performance studies) is not relevant here.

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 section is not applicable. This document describes the safety and effectiveness testing for a contact lens comfort solution, not an AI/ML diagnostic or assistive device. There are no "human readers" interpreting images with or without AI assistance in this context.

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

This section is not applicable. The device is a physical product (contact lens solution), not an algorithm.

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

For the clinical study, the "ground truth" or primary endpoints would likely be based on:

• Patient-reported outcomes (PROs): Subjective relief of dryness, discomfort, and irritation; comfort upon lens insertion.
• Clinical assessments: Potentially objective measures of ocular surface health or lens-eye interaction, as assessed by an optometrist or ophthalmologist, though specific measures are not detailed in this summary.
• The study aimed to demonstrate substantial equivalence in safety and efficacy compared to a predicate device, meaning its performance was judged against the established acceptable performance of the predicate.

For biocompatibility, the ground truth involves adherence to and successful completion of established test methods (e.g., cytotoxicity, irritation, sensitization) as per FDA guidance.

For stability, the ground truth involves chemical, physical, and microbiological specifications being met over time.

8. The sample size for the training set

This section is not applicable. The device is a contact lens solution, not an AI/ML model that requires a training set.

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

This section is not applicable for the reasons stated above.

Ask a specific question about this device

The XEN Glaucoma Treatment System is indicated for the management of refractory glaucomas, including cases where previous surgical treatment has failed, cases of primary open angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.

The XEN Glaucoma Treatment System consists of the XEN45 Gel Stent preloaded into the XEN Injector. The XEN45 Gel Stent is composed of a gelatin derived from porcine dermis, formed into a tube, and then cross-linked with glutaraldehyde. The inside diameter of the tube is approximately 45 um, its outside diameter is approximately 150 um, and it has a length of approximately 6 mm. The XEN45 Gel Stent creates a permanent channel through the sclera allowing aqueous flow from the anterior chamber to the subconjunctival space.

The XEN45 Gel Stent is preloaded into an injector designed to place the XEN45 Gel Stent in the intended position. The injector with the preloaded implant is sterilized via gamma irradiation and is provided sterile. The injector is discarded after a one-time use.

The document provided is a 510(k) summary for a medical device (XEN Glaucoma Treatment System) and details the performance data used to demonstrate substantial equivalence to predicate devices, rather than formally outlining acceptance criteria for AI/ML-based device performance and a study proving it meets those.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test/training, training set build) are not applicable or cannot be extracted from this document, as they relate to AI/ML device validation, which is not the subject of this 510(k) summary.

However, I can extract information related to the clinical effectiveness and safety evaluation of the XEN Glaucoma Treatment System, which serves as its "performance data" in this context.

Here's an attempt to structure the available information relevant to "acceptance criteria" and "device performance" as per the document provided, interpreting "acceptance criteria" as the measures of effectiveness and safety used to demonstrate equivalence.

Device: XEN Glaucoma Treatment System

Study Type: K161457 510(k) Premarket Notification - demonstrating substantial equivalence to predicate devices.

Interpretation of "Acceptance Criteria" for this device: For this type of medical device (an aqueous shunt), acceptance criteria are primarily demonstrated through clinical effectiveness in lowering intraocular pressure (IOP) and an acceptable safety profile, comparable to legally marketed predicate devices. The "performance data" presented is the evidence that these clinical objectives were met.

1. Table of "Acceptance Criteria" (Effectiveness and Safety Measures) and Reported Device Performance

Ask a specific question about this device

The Natrelle® 133 Plus Tissue Expanders can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The Natrelle® 133 Plus Tissue Expanders are designed to develop tissue flaps as part of 2stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of an expansion envelope with a BIOCELL® textured surface, an orientation line, three suture tabs (optional), a MAGNA-SITE® integrated injection site, and a stable base to enable outward expansion. The tissue expanders are available in multiple styles and sizes to meet diverse surgical needs.

The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expanded, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. The injection site is self-sealing and includes a titanium needle guard to prevent inadvertent puncture through the base of the injection site.

The provided text is a 510(k) summary for the Natrelle® 133 Plus Tissue Expander, a medical device. This type of document is filed with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove a device meets specific acceptance criteria based on a clinical study for AI or diagnostic performance. Instead, it focuses on non-clinical performance data and technological characteristics.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) is not applicable to this document. This document does not describe a study proving a device meets acceptance criteria related to AI or diagnostic performance.

Explanation based on the provided text:

• Type of device: The Natrelle® 133 Plus Tissue Expander is a physical medical device (tissue expander made of silicone elastomer) used for breast reconstruction, scar revision, and tissue defect procedures. It is not an AI or diagnostic software/device.
• Purpose of the 510(k) submission: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. This means it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety or effectiveness.
• Performance Data mentioned: The document states: "Non-clinical performance data were submitted to support the substantial equivalence of the Natrelle® 133 Plus Tissue Expander to the predicate device. These data included biocompatibility data and mechanical testing data. Where appropriate, testing was conducted according to methods prescribed by relevant ASTM and/or ISO standards. All pre-established acceptance criteria were met."

This refers to engineering and material testing (e.g., strength, durability, biocompatibility), not clinical diagnostic accuracy or AI performance. The "acceptance criteria" here would be specific thresholds for these physical properties and material safety, not metrics like sensitivity, specificity, or AUC for an AI model.

In summary, as this document pertains to a physical medical device and a 510(k) submission focused on substantial equivalence through non-clinical testing, the requested information about AI/diagnostic study setup is not present.

Ask a specific question about this device

Use REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops to lubricate and rewet soft and rigid gas permeable (RGP) contact lenses, to help relieve dryness, discomfort, and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to insertion on the eye.

REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops is a sterile, buffered, isotonic, preserved solution. This aqueous formulation includes carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, levocarnitine, magnesium chloride hexahydrate, potassium chloride, purified water, PURITE® (stabilized oxychloro complex), sodium borate decahydrate, and sodium citrate dihydrate. This formula does not contain chlorhexidine, thimerosal, or any other mercury-containing ingredients.

The provided text describes REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops and its 510(k) submission (K083812). However, it does not contain details about specific acceptance criteria, a corresponding study, or the performance metrics that would typically be found in an Acceptance Criteria table.

Instead, the document focuses on:

• Substantial Equivalence: The primary claim is substantial equivalence to a predicate device (Allergan REFRESH® Contacts Lubricating and Rewetting Drops).
• Testing Performed: It mentions that the sponsor performed "stability, compatibility, toxicology and microbiology testing and a clinical study" to support the claim of substantial equivalence.
• Indication for Use: The main application of the device is to lubricate and rewet soft and rigid gas permeable (RGP) contact lenses to relieve dryness, discomfort, and irritation.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor can I answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. These types of details are usually found in comprehensive clinical study reports or detailed performance data sections of a 510(k) submission, which are not present in this summary.

The document states: "The sponsor performed stability, compatibility, toxicology and microbiology testing and a clinical study with this formulation to support the claim of substantial equivalence." This is a high-level statement that a clinical study was done, but no details about the study design, acceptance criteria, or results are provided.

In summary, the provided text lacks the detailed information required to answer your request.

Ask a specific question about this device

The Signal Amplifier for BOTOX® is intended to aid in the guidance of injections into the muscles.

Not Found

I am sorry, but the provided text from the FDA 510(k) letter for "Signal Amplifier for BOTOX®" (K051852) does not contain the information necessary to answer your request regarding acceptance criteria and the study proving the device meets those criteria.

The 510(k) letter is a premarket notification that determines substantial equivalence to a predicate device. It indicates that the device can be legally marketed, subject to general controls. It does not typically detail the specific performance studies, acceptance criteria, or ground truth methodologies that would be part of a robust clinical trial report.

Here's what the provided text does contain:

• Trade/Device Name: Signal Amplifier for BOTOX®
• Regulation Number/Name: 21 CFR 882.1835, Physiological signal amplifier
• Regulatory Class: II
• Product Code: GWL
• Indications for Use: "The Signal Amplifier for BOTOX® is intended to aid in the guidance of injections into the muscles."

To answer your questions, I would need access to the actual 510(k) submission document, any associated clinical study reports, or other performance data presented to the FDA for review, which are not included in the provided text.

Ask a specific question about this device

TRADE NAME Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to:

• Chemically (NOT HEAT) Disinfect
• Clean
• Rinse
• Store
• Remove Protein

TRADE NAME Multipurpose Solution is a sterile, isotonic, buffered, aqueous solution containing sodium chloride, potassium chloride, phosphate buffer, edetate disodium, and Poloxamer 237 with polyhexamethylene biguanide 0.0001% as a preservative. As with COMPLETE® brand Multi-Purpose Solution, this product is a clear, coloriess solution, packaged in the same plastic bottles with controlled dropper tips.

Acceptance Criteria and Study for Allergan TRADE NAME Multipurpose Solution

The provided document describes the acceptance criteria and supporting studies for Allergan's "TRADE NAME Multipurpose Solution," which is a soft (hydrophilic) contact lens care product. The submission is a 510(k) premarket notification, seeking substantial equivalence to predicate devices (COMPLETE® brand Multi-Purpose Solution, K003252 and K013479). The key change in the new product is the removal of the lubricant HPMC, leading to the deletion of the "conditioning" claim. Therefore, the studies primarily focus on demonstrating that removing HPMC does not negatively impact the remaining indicated uses and that the new formulation is comparable to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a non-clinical device (not an AI/ML medical device as would typically have performance metrics like sensitivity/specificity), the "acceptance criteria" are based on demonstrating equivalence to the predicate device. The performance is assessed through various nonclinical studies.

2. Sample Size and Data Provenance

The document does not specify exact sample sizes for each study, but provides the following details:

• Solution Compatibility: Used FDA Group I and IV soft contact lenses for 30 cycles.
• Cleaning Studies: Used Group I and IV lenses over a 30-day/30-cycle period.
• Toxicological Studies (In-vivo): A 21-day rabbit study was performed.
• Data Provenance: The studies were conducted by Allergan, presumably in the USA. Given the submission date (2002), these are retrospective studies on the newly formulated product.

3. Number of Experts and Qualifications for Ground Truth

This type of product (contact lens solution) does not typically involve human expert adjudication for ground truth in the way a diagnostic AI/ML device would. The "ground truth" for the non-clinical studies is based on objective measurements and established laboratory protocols.

• Solution Compatibility/Cleaning: Assessment of lens parameters (diameter, power, basecurve), integrity, visual appearance, and presence of deposits would be performed by lab technicians or scientists following standardized procedures.
• Microbiological Studies: Efficacy against microorganisms assessed via standardized microbiological assays.
• Toxicological Studies: In-vitro cytotoxicity assessed by laboratory techniques. In-vivo rabbit study would involve veterinarians or toxicologists assessing ocular effects, but the document doesn't specify a "number of experts" or their specific qualifications beyond what implied for such studies.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this submission concerns non-clinical performance of a contact lens solution, not an AI/ML diagnostic system requiring human adjudication of results. The results are based on objective laboratory measurements and observations.

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

Not applicable. This is not an AI/ML device, and no human reader performance is being evaluated or compared with or without AI assistance. The studies assess the intrinsic properties and performance of the contact lens solution itself.

6. Standalone (Algorithm Only) Performance

Not applicable. This is not an algorithm based device. The "device" is a chemical solution. The studies describe the standalone performance of the solution as a product.

7. Type of Ground Truth Used

The ground truth for these studies is based on:

• Objective measurements: E.g., lens diameter, power, basecurve changes, protein removal percentages, cytotoxicity levels.
• Standardized protocols and assays: E.g., for microbiological efficacy, cleaning effectiveness.
• Veterinary/Toxicological observations: For the in-vivo rabbit study regarding ocular effects.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The "formulation" is the "design" of the product, which is then tested.

9. How Ground Truth for the Training Set Was Established

Not applicable, for the same reason as point 8.

Ask a specific question about this device

COMPLETE® brand Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to:

• Chemically (NOT HEAT) Disinfect
• Clean
• Rinse
• Store
• Remove Protein
• Condition

There are no formulation or other changes in the device description.

The provided document describes the 510(k) summary for Allergan's COMPLETE® brand Multi-Purpose Solution. It details a clinical study conducted to demonstrate the substantial equivalence of a modified cleaning regimen with the existing standard regimen.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The device (COMPLETE® brand Multi-Purpose Solution with modified cleaning regimen) was evaluated for its non-inferiority compared to the standard regimen. The primary acceptability criterion was the mean change from baseline in lens comfort score.

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

• Sample Size (Clinical Study): 157 subjects were enrolled. 151 subjects completed the study.
• Data Provenance: The document does not explicitly state the country of origin. However, Allergan is based in Irvine, California, USA, and the submission is to the US FDA, which implies the study was likely conducted within the USA or aligned with US regulatory standards. The study was prospective, as it involved enrolling subjects and randomizing them to different regimens over a three-month period.

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

The document does not specify the number of experts or their qualifications for establishing ground truth within the clinical study. However, it mentions that nine investigators enrolled the subjects. It's implied that these investigators, likely eye care professionals, were responsible for evaluating lens comfort, symptoms of discomfort, and performing slit lamp examinations which contributed to the clinical ground truth. Their specific qualifications (e.g., ophthalmologist, optometrist, years of experience) are not detailed.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (such as 2+1 or 3+1 for resolving discrepancies). The clinical data likely rely on the assessments made by the individual investigators at each study site, potentially with standardized protocols for evaluation.

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 conducted as described in the provided text. This study was a clinical trial comparing two active treatment regimens (standard vs. modified) of the same product, rather than comparing human readers' performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This study relates to a contact lens care solution, a physical product used by humans, not an algorithm or AI. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this submission. The effectiveness of the solution is inherently tied to human use. The microbiological and cleaning effectiveness studies could be considered "standalone" in that they evaluate the product's intrinsic properties without human physiological interaction, but this is distinct from AI/algorithm standalone performance.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on a combination of:

• Expert Clinical Assessment: Mean change from baseline in lens comfort score, symptoms of discomfort, slit lamp examination findings (e.g., edema, neovascularization, hyperemia), visual acuity, and other ocular parameters assessed by the investigators.
• Subjective Patient Reporting: Subject ratings of comfort, vision quality, and self-reported symptoms.
• Laboratory Analysis: For cleaning effectiveness (surface deposits and general condition of lenses returned to Allergan).
• Standardized Microbiological and Toxicological Testing: As per FDA and USP guidelines.

8. The Sample Size for the Training Set

The document describes a single clinical study of 157 subjects (151 completed) that serves as the basis for the 510(k) submission. It does not mention a separate "training set" in the context of device development or machine learning. This study is the primary evidence for the modified regimen.

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

As no separate "training set" is described in the context of machine learning, this question is not applicable to the provided information. The ground truth for the clinical study was established as described in point 7.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device