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miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.

Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.

The color lens may enhance or alter the apparent color of the eye.

Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.

Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.

The lenses may enhance or alter the apparent color of the eye.

Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus and Miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus

• They are daily wear soft contact lens for frequent replacement
• They are in a spherical lens design with UV blocker.
• They are available in hemispherical shell.
• The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer.
• The water content is 46%.
• A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (2.31%) in the UVB range of 280-315nm and less than 50% (12.05%) in the UVA range of 316-380nm.
• The miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus" is a light blue tinted with "reactive Blue19" for handling visibility purpose.
• The Miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus is a color lens that may enhance or alter the apparent color of the eye.
• The lens is supplied in a sterile state, packaged in a buffered saline solution.

miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus and miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus

• They are daily wear soft contact lens for daily disposable
• They are in a spherical lens desing with UV blocker.
• They are available in hemispherical shell.
• The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer.
• The water content is 48%.
• A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (2.36%) in the UVB range of 280-315nm and less than 50% (13.43%) in the UVA range of 316-380nm.
• The miacare (miafilcon B) DELiGHT 1-day Contact Lens with EautraSil Plus" is a light blue tinted with "reactive Blue19" for handling visibility purpose.
• The Miacare (miafilcon B) CONFiDENCE 1-day Color Contact Lens with EautraSil Plus is a color lens that may enhance or alter the apparent color of the eye.
• The lens is supplied in a sterile state, packaged in a buffered saline solution.

The provided FDA 510(k) clearance letter and summary describe the safety and effectiveness studies for soft contact lenses, not an AI-powered medical device. Therefore, much of the requested information regarding acceptance criteria, ground truth, expert adjudication, MRMC studies, and standalone performance for an AI device is not applicable and not present in the document.

The document focuses on demonstrating substantial equivalence of the new contact lenses to legally marketed predicate devices through physiochemical studies, biocompatibility testing, and clinical wearer studies. The "acceptance criteria" discussed are primarily about demonstrating non-inferiority in terms of safety and effectiveness for the contact lenses when worn by human subjects, compared to existing, legally marketed lenses.

Here's an attempt to answer the questions based on the provided document, acknowledging where the requested information for AI devices is not relevant or available:

Acceptance Criteria and Study Details for BenQ Materials Corporation Contact Lenses (K242056)

This document describes the safety and effectiveness testing for soft contact lenses, which are physical medical devices, not AI software. As such, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" for an AI device (e.g., diagnostic accuracy, sensitivity, specificity, expert adjudication, MRMC studies) are not directly applicable. Instead, the studies aim to demonstrate the non-inferiority of the new contact lenses compared to predicate devices in terms of clinical safety and efficacy in human wearers.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a physical medical device (contact lens) and not an AI device, the "acceptance criteria" are generally framed as demonstrating non-inferiority to existing predicate devices in clinical performance. The document doesn't provide specific quantitative thresholds for "acceptance criteria" in a typical AI sense (e.g., target AUC, sensitivity). Instead, it states the overall finding of "no significant difference."

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

• miacare (miafilcon A) CONFiDENCE Color Contact Lens (vs OxyPure Color Silicone Hydrogel):

  • Enrollment: 192 subjects (96 test lenses, 96 control lenses)
  • Completed: 172 subjects (85 test group, 87 control group)
  • Data Provenance: Mainland China, multi-center, open, parallel, randomized controlled comparison study, with 90 days follow-up. (Prospective clinical study)

• miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens (vs Si-Hy (olifilcon B) Color Silicone Hydrogel):

  • Enrollment: 192 subjects (96 test lenses, 96 control lenses)
  • Completed: 192 subjects (96 test group, 96 control group)
  • Data Provenance: Mainland China, multi-center, open, parallel, randomized controlled comparison study, with 90 days follow-up. (Prospective clinical study)

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

This section is not applicable as the study involved clinical performance trials of physical contact lenses on human subjects, not an AI device requiring expert consensus for ground truth on imaging or diagnostic tasks. The "ground truth" here is the observed clinical outcome (e.g., adverse events, visual acuity, slit lamp findings) directly measured from the study participants by eye care professionals involved in the study. The document does not specify the number or qualifications of these eye care professionals, beyond stating the studies were conducted in "3 hospitals."

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in AI studies for resolving discrepancies in ground truth labeling by multiple experts. This concept is not applicable here. Clinical outcomes were presumably recorded by the investigators at different sites. The summary states "No statistic significant difference between test lens and control lens with respect to safety data," implying statistical comparison of observed clinical metrics between groups.

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. MRMC studies are specific to evaluating human reader performance with and without AI assistance for tasks like medical image interpretation. This document describes a clinical trial evaluating the performance of contact lenses for vision correction and eye health.

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

This question is not applicable. "Standalone performance" refers to the algorithm's performance without human interaction for AI devices. The devices in this submission are contact lenses, which are inherently used by humans.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in these clinical studies primarily consists of:

• Clinical Outcomes Data: Direct observations and assessments from study participants during the 90-day follow-up. This includes:
  • Adverse events reported and observed.
  • Slit lamp findings (examinations of the eye's anterior segment).
  • Symptoms/problems/complications reported by subjects.
  • Keratometry (K) readings (corneal curvature).
  • Refractive changes (absolute value).
  • Visual acuity (VA) data.
  • Average wearing time (AWT).
  • Discontinuation reasons and lens replacement data.
• Visual Acuity: The ability of the CVA (Corrected Visual Acuity) to reach "equal or higher than 1.0" (presumably 20/20 or better).
• Aesthetic Effect: The color lens's ability to "enhance or alter the apparent color of the eye."

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train an AI model. This document describes clinical trials for physical medical devices (contact lenses), not the development of an AI algorithm.

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

This question is not applicable for the same reasons as #8. There is no AI training set in this submission.

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SIMO System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of excess exudate and infectious materials.

SIMO System is suitable for use in both hospital and homecare setting and is indicated for the following wound types:

• Chronic wounds
• Acute wounds
• Traumatic wounds
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or pressure)
• Flaps and grafts
• Closed surgical incisions

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System including non-sterilized SIMO Pump and sterilized SIMO Dressing. Patient is able to carry the SIMO Pump easily in the pocket or a belt holder (additional accessory). Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is also called "SIMO System" in the following description.

SIMO System has 3 types of model variants including "2 SIMO Dressings and 1 SIMO Pump", "2 SIMO Dressings and 1 SIMO Pump with 1 holder" and "3 SIMO Dressings". Each type has 4 models, and each modelcontains 4 different sizes of SIMO dressing separately.

SIMO System is for single person use only. SIMO Pump could use for 30 days. The SIMO Dressing is sterilized by Ethylene Oxide and single-use.

SIMO System including non-sterilized negative pump and sterilize dressing. The negative pressure wound therapy is provided by a pump (-125±15mmHg) up to 30 days by manual and may promote wound healing via the removal of exudate. The negative pressure is provided by the SIMO Pump, and the exudates of wound bed is managed by the dressing. SIMO Dressing is applied to the wound. It should be changed in line with standard wound management guidelines, typically every 3-4 days up to 7 days. More frequent dressing changes may be required depending on the level of exudates, condition of the dressing, wound type/size, orientation of dressing, environmental considerations and/or other patient the considerations.

The provided text describes a 510(k) premarket notification for a medical device (Anscare SIMO Negative Pressure Wound Therapy (NPWT) System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance and safety testing. It does not present a study proving the device meets acceptance criteria in the format of a clinical trial or a machine learning model's performance evaluation against specific metrics.

Therefore, I cannot extract the information required to answer your request in the specified format, as the document details bench testing, biocompatibility, and sterilization, but not a study designed to evaluate performance against the kind of "acceptance criteria" you've outlined (e.g., accuracy, sensitivity, specificity, or human improvement with AI assistance).

The provided text details the following:

• Device: Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
• Intended Use: Promotes wound healing via removal of excess exudate and infectious materials. Suitable for hospital and homecare settings for various wound types (chronic, acute, traumatic, subacute/dehisced, partial-thickness burns, ulcers, flaps/grafts, closed surgical incisions).
• Predicate Device: SNaP® Wound Care System (K151710) and Reference Device: PICO Single Use Negative Pressure Wound Therapy System (K151436).
• Testing Performed:
  • Bench Testing: Tubing Tensile Strength Test, Adhesive test, Function Test after Drop Testing, Life Time for 30 Days Test (pump performance over 150 presses), Simulation Test (performance with low/moderate exudate, pressure stability, exudate management, fluid reflux rate), HFE/UE Report (Human Factors and Usability Engineering).
  • Biocompatibility Testing: In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Skin irritation, Acute Intravenous Systemic Toxicity, Acute Intraperitoneal Systemic Toxicity, Pyrogen Test, Subacute/subchronic toxicity, Implantation study, Phthalate leachables study.
  • Sterilization Testing: Verification of Ethylene Oxide (EO) sterilization process and residual testing per ISO standards.

This documentation serves to demonstrate that the device is as safe and effective as a legally marketed predecessor, not to provide statistical performance metrics typically seen in AI/ML device submissions or clinical trials.

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AnsCare ChitoClot Pad is indicated for use of bleeding wound management. It promotes rapid control of wound bleeding and exudates absorption.

AnsCare ChitoClot Pad is indicated for use in wound management and to provide barrier to bacteria.

It is indicated for the following wounds, including lacerations, abrasions, hemodialysis wound and puncture sites for vascular procedures.

AnsCare ChitoClot Pad is made from cross-linked chitosan with glutaraldehyde. It works as a topical wound dressing intended to promote hemostasis when in contact with a bleeding wound. AnsCare ChitoClot Pad is made from chitosan whose hemostatic effect is independent of anticoagulant. Chitosan has a long clinical history of safety and effectiveness.

The provided text describes the AnsCare ChitoClot Pad, a wound dressing intended to promote hemostasis and provide a bacterial barrier.

Here's an analysis of the acceptance criteria and study information:

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

The document states, "All the test results demonstrate that AnsCare ChitoClot Pad meet the requirements of its pre-defined acceptance criteria and intended uses." However, it does not explicitly list specific numerical or qualitative acceptance criteria for each test performed. It only lists the tests themselves. Therefore, a table comparing acceptance criteria to reported performance cannot be fully constructed from the provided text.

The reported device performance, in a general sense, is that it "meet[s] the requirements of its pre-defined acceptance criteria and intended uses."

Table of Tests Performed and General Performance:

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for any of the non-clinical tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these tests. The animal studies mentioned (white rabbits, guinea pigs, mice) imply laboratory conditions, but no further details are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests described are primarily non-clinical (biocompatibility and bench performance) and do not typically involve human expert interpretation for ground truth establishment in the way clinical studies with image analysis or diagnostics would.

4. Adjudication method for the test set

This information is not applicable/not provided. The listed tests are laboratory-based and generally have objective endpoints rather than requiring adjudication methods like those used in clinical trials with human readers.

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

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers in the context of this device. The device is a wound dressing, 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. The device is a physical wound dressing and does not involve an algorithm.

7. The type of ground truth used

For the non-clinical biocompatibility and bench performance tests, the "ground truth" would be established by the standard scientific and regulatory protocols for each specific test (e.g., cell viability assays for cytotoxicity, physiological responses for irritation, specific absorption measurements for absorbency, microbial growth inhibition for barrier to bacteria). These are objective measurements rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical wound dressing, not a machine learning model, so there is no concept of a "training set."

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

This information is not applicable/not provided, as there is no training set for this type of device.

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AnsCare ChitoClot Gauze (prescription use): For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations.

AnsCare ChitoClot Gauze (over-the-counter use): To control bleeding of lacerations, minor cuts and abrasions.

The AnsCare ChitoClot Gauze is made of a non-woven fabric derived from chitosan fibers. The device is made of 100% chitosan - it is not coated or impregnated with chitosan granules. Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the AnsCare ChitoClot Gauze will turn into a gel-like condition to absorb the blood and seal the wound. The AnsCare ChitoClot Gauze also contains acetic acid as an acidity regulator and Polysorbate 20 as a surfactant.

The provided text does not contain information about acceptance criteria for a device's performance that would typically be described with metrics like accuracy, sensitivity, or specificity, nor does it include a study that proves the device meets such criteria.

The document discusses the regulatory approval (510(k)) of the "AnsCare ChitoClot Gauze" device, asserting its substantial equivalence to predicate devices based on non-clinical testing. The non-clinical testing included biocompatibility tests, bench performance tests, and animal testing. However, the exact acceptance criteria for these tests and their numerical results are not provided.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: The document lists types of tests conducted but does not provide specific criteria or performance metrics in a quantifiable way.
2. Sample size used for the test set and the data provenance: No details about sample sizes for the "test set" (which here refers to non-clinical testing as opposed to a clinical AI model test set) or data provenance are given.
3. Number of experts used to establish the ground truth... and their qualifications: This information is not relevant to the type of non-clinical testing described.
4. Adjudication method: Not relevant to the non-clinical testing described.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: This type of study is used for diagnostic algorithms or medical imaging devices involving human readers and AI performance, which is not applicable to the "AnsCare ChitoClot Gauze" as described.
6. Standalone (i.e. algorithm only without human-in-the loop performance) study: Again, this is for AI algorithms, not the type of medical device described.
7. The type of ground truth used: The "ground truth" in the context of this device's testing would be the measured outcomes of the non-clinical tests (e.g., cytotoxicity, pH, hemostasis in animal models). No specific ground truth definition is stated beyond the test results themselves.
8. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence for regulatory purposes, primarily through comparisons of intended use, materials, design, and general safety/performance claims with already cleared predicate devices.

Information that can be extracted related to testing:

Non-clinical Testing Conducted (listed in Section 5.8):

• Biocompatibility testing:
  • Cytotoxicity Test
  • Skin Irritation Test
  • Skin Sensitization Test (Closed-patch Method)
  • Acute Systemic Toxicity (intraperitoneal and intravenous)
  • Hemolysis Test Report
  • Pyrogen, Protein content and Residual solvent Testing Report
• Bench performance testing:
  • Absorb Test
  • pH
  • Tensile Strength (wet and dry)
  • Platelet Aggregation
  • Extreme Environmental Conditions Test
  • Competitor analysis
• Animal Testing:
  • In-vivo Hemostasis Test

The conclusion states: "All the test results demonstrate that AnsCare ChitoClot meet the requirements of its pre-defined acceptance criteria and intended uses." However, the specific acceptance criteria and the detailed test results are not enumerated in this document.

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