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510(k) Data Aggregation
(194 days)
The Miru 1day UpSide (midafilcon A) SPHERICAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myperopia) in aphakic and non-aphakic people with disease free eyes who may have 1.50 diopter (D) or less of astigmatism.
The Miru 1day UpSide (midafilcon A) TORIC Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic people with disease free eyes with 3.00 diopter (D) or less of refractive astigmatism.
The Miru 1day UpSide (midafilcon A) MULTIFOCAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia) and emmetropia with presbyopia in aphakic and non-aphakic people with disease free eyes who may require a reading addition of 3.00 diopter (D) or less and who may have 1.50 diopter (D) or less of astigmatism.
The Miru 1day UpSide (midafilcon A) should only be worn once and then discarded at the end of each wearing period on a daily basis. The patient should start the next wearing period with fresh lenses should not be cleaned or disinfected and should be discarded after a single use.
The Miru 1day UpSide (midafilcon A) is a hydrophilic contact lens which is available as a spherical, toric and multifocal lens. The lens is indicated for daily wear disposable single use.
The non-ionic lens material (midafilcon A) is a random co-polymer containing polydimethyl siloxane macromonomer. It consists of 46% midafilcon A and 54% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibility handling tint.
The lens contains a benzotriazole UV absorbing monomer which is used to block UV radiation. The transmittance characteristics for the lens (-3.00D) are less than 5% of UVB radiation and less than 50% of UVA radiation.
This document, K193399, is a 510(k) Premarket Notification for the Miru 1day UpSide (midafilcon A) contact lens. It describes the device, its indications for use, and the data supporting its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a tabular format for an AI/ML device. Instead, it presents the results of non-clinical and clinical studies to demonstrate the safety and effectiveness of the contact lens, comparing it to predicate devices. The implicit acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device.
For a contact lens, performance is typically assessed based on:
- Material Properties: Water content, refractive index, oxygen permeability (Dk), UV blocking.
- Physical Characteristics: Powers, diameter, base curve, manufacturing method, sterilization, packaging.
- Clinical Performance: Visual acuity, comfort, adverse event rates, biocompatibility.
Here's an inferred table based on the "Comparison of Characteristics" and "Performance Data" sections:
| Feature/Metric | Acceptance Criteria (Implied by Predicate/Standards) | Miru 1day UpSide (midafilcon A) Performance | Notes |
|---|---|---|---|
| Non-Clinical Data | |||
| Biocompatibility | Non-toxic, non-irritating, non-sensitizing | Non-toxic, non-irritating, non-sensitizing | "The results of the non-clinical testing and evaluation demonstrate that the lens material/extracts are non-toxic, non-irritating and non-sensitizing under the experimental conditions." |
| Material Properties | Consistent with predicate lenses | Consistent with predicate lenses | "and the material properties are consistent with the predicate lens." (The specific material properties are detailed in the comparison table below). |
| UV Blocking Transmittance | <5% UVB, <50% UVA (for -3.00D lens) | <5% UVB, <50% UVA (for -3.00D lens) | "The transmittance characteristics for the lens (-3.00D) are less than 5% of UVB radiation and less than 50% of UVA radiation." |
| Light Transmittance | Similar to predicate (>92-96%) | > 92 % | Compared to Visco Si-Hy (94%) and MyDay (96%). |
| Water Content | Similar to predicate (47-54%) | 54% | Compared to Visco Si-Hy (47%) and MyDay (54%). |
| Refractive Index | Similar to predicate (1.401-1.410) | 1.403 | Compared to Visco Si-Hy (1.410) and MyDay (1.401). |
| Dk (Oxygen Permeability) | Similar to predicate (80-120) | 64 | This is lower than the predicates (Visco Si-Hy: 120, MyDay: 80), but the overall conclusion is still "as safe, as effective and performs as well as the predicate devices," implying this Dk value is acceptable for the intended daily wear, single-use modality. The FDA's determination of substantial equivalence takes into account all factors. |
| Clinical Data | |||
| Efficacy | Lens visual acuity comparable to control lenses | Substantially equivalent to control | "The efficacy outcome measures were lens visual acuity comparisons between the test and the control contact lenses." This suggests the visual performance was not inferior to the control. |
| Safety | Acceptable adverse event rates, biomicroscopy, subjective acceptance | Substantially equivalent to control | "The safety outcome measures included adverse event rates, biomicroscopy and subjective acceptance." This implies that the rates of adverse events, ocular health assessments (biomicroscopy), and patient comfort/satisfaction were comparable to the control. |
| Overall Conclusion | As safe, as effective, performs as well as predicates | "as safe, as effective and performs as well as the predicate devices." | This is the ultimate acceptance criterion for a 510(k) submission. |
2. Sample Size and Data Provenance for the Test Set:
- Sample Size: 148 subjects (male and female) were randomized and dispensed lenses. This implies a test set of approximately 74 subjects for the investigational device (assuming a 1:1 ratio into test and control groups).
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "three-month randomized controlled clinical study." Since the applicant is Menicon Co., Ltd. in Japan, and the submission is to the U.S. FDA, the study could have been conducted in Japan, the US, or other regions. It was a prospective clinical study.
3. Number of Experts and Qualifications for Ground Truth:
- This is a medical device (contact lens) safety and efficacy study, not an AI/ML algorithm study requiring expert consensus for image annotation or diagnosis. Therefore, the concept of "experts establishing ground truth" in the same way as for AI image analysis (e.g., radiologists interpreting images) is not directly applicable.
- Clinical Efficacy/Safety Assessment: The evaluations were likely performed by ophthalmologists or optometrists who are qualified to assess visual acuity, conduct biomicroscopy examinations, and monitor adverse events related to contact lens wear. Their qualifications are not specified beyond being "qualified investigators."
4. Adjudication Method for the Test Set:
- Not applicable in the context of an AI/ML algorithm's ground truth establishment.
- For clinical trials, independent data monitoring committees (DMCS) or clinical event committees (CECs) might be used to adjudicate serious adverse events, but the document doesn't detail this for the study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This was a clinical trial comparing a new contact lens to a control contact lens, not an AI-assisted diagnostic system. Therefore, MRMC studies and the concept of "human readers improving with AI vs. without AI assistance" are irrelevant to this submission.
6. Standalone (Algorithm Only) Performance:
- No. This is a physical medical device (contact lens), not an AI/ML algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. Type of Ground Truth Used:
- The "ground truth" for this study was established through direct clinical measurements and observations in human subjects, compared against a control (predicate) lens. This includes:
- Objective measures: Visual acuity measurements (e.g., Snellen chart, other standardized tests), biomicroscopy findings (e.g., assessing corneal health, conjunctiva).
- Subjective measures: Patient-reported acceptance and comfort, reporting of symptoms and adverse events.
- Biomaterial properties: In-vitro lab testing of Dk, water content, UV blocking, etc.
- In essence, the "ground truth" for a contact lens is its direct impact on a patient's vision, ocular health, and comfort during wear, as assessed by clinical professionals and the patients themselves.
8. Sample Size for the Training Set:
- This is a clinical study for a physical device, not an AI/ML algorithm. Therefore, there is no discrete "training set" in the AI/ML sense. Data for device development and optimization (analogous to a training set) would come from extensive R&D, material science experiments, and possibly earlier pilot clinical studies, none of which are explicitly detailed as a 'training set' sample size in this regulatory summary.
9. How Ground Truth for the Training Set Was Established:
- As there is no "training set" in the AI/ML sense, this question is not applicable. The development of the contact lens material and design would have been based on established optometric and material science principles, biocompatibility testing, and iterative design processes.
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(234 days)
Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for use in cleaning, daily protein removal, disinfection, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, as recommended by your eye care professional.
The Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution system consists of: Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution and the special lens case. The lens case consists of a transparent cup and a lens holder-lens case cap assembly with a neutralizer catalyst disk. Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution and the special lens case must always be used together.
The preservative free, aqueous Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution contains: hydrogen peroxide 3%, phosphonic acid compound (stabilizer), citric acid, polyethylene glycol, sodium chloride, sodium hydroxide, and phosphate (buffer system).
The provided document describes the FDA 510(k) clearance for Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution. Here's a breakdown of the requested information based on the text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical "acceptance criteria" for performance metrics in a table. Instead, it states that tests were conducted according to established guidance and protocols, and the results "demonstrated" effectiveness or compatibility. The general acceptance criterion for most tests appears to be "similar to the predicate device" or "effective/compatible."
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Lens Compatibility | Compatible with various commercially available hydrogel, silicone hydrogel, and RGP lenses. | "Results demonstrated that the Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution was compatible with the test contact lenses." |
| Neutralization Profile | Similar neutralization profile to the predicate device; neutralizer catalyst disk stability. | "The Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution showed a similar neutralization profile to the predicate device. In addition, stability of the neutralizer catalyst disk was confirmed for 90-cycles treatments." |
| Disinfecting Efficacy | Harmful microorganisms reduced to an ISO level at specified time points. | "Results demonstrated that harmful microorganisms were effectively reduced to an ISO level at 6 and 24 hours and 7 days after neutralization." |
| Preservative Efficacy | Ensure 3-month open bottle discard date. | "Preservative Efficacy test was conducted to ensure 3-month open bottle discard date of the Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution." |
| Cleaning Efficacy | Similar performance to the predicate device in protein and lipid removal. | "Results suggested that both solutions performed similarly in the removal of lens deposition." |
| Toxicology/Biocompatibility | Non-toxic and non-irritating for the neutralized solution, lens case, and catalyst. | "Results demonstrated that the neutralized solution, the lens case materials and the neutralizer catalyst were non-toxic and nonirritating under the experimental conditions." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (e.g., number of lenses, microorganisms, or test runs) for each non-clinical test. It mentions testing with:
- Lens Compatibility: Six commercially available hydrogel/silicone hydrogel soft contact lenses and two commercially available RGP lenses.
- The data provenance (country of origin, retrospective/prospective) and specific details about the laboratories conducting these non-clinical tests are not provided in this summary.
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 device is a cleaning and disinfecting solution, not an AI or diagnostic imaging device that requires human expert review for "ground truth." The "ground truth" for its performance is established through objective laboratory tests and scientific protocols that measure chemical properties, microbiological reduction, and material compatibility. Therefore, the concept of "experts establishing ground truth" in the way it applies to AI diagnostic studies is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI diagnostic evaluations where human readers interpret data. This is a non-clinical, laboratory-based performance study for a chemical solution. Therefore, such adjudication methods are not applicable and not mentioned.
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
No MRMC comparative effectiveness study was done. This is a chemical cleaning solution, not an AI-assisted diagnostic device, so comparison with human readers is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an algorithm's performance. As the device is a chemical solution, this concept is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of this device is established through:
- Scientific Protocols and Laboratory Measurements: For lens compatibility, neutralization profiles (residual hydrogen peroxide levels), disinfecting efficacy (microbial reduction counts against ISO standards), preservative efficacy, cleaning efficacy (quantification of protein/lipid removal), and toxicology (in-vitro and in-vivo biocompatibility tests based on GLP regulations). This is essentially objective, measurable data generated by laboratory instruments and techniques following validated methods.
8. The sample size for the training set
This device is not an AI algorithm requiring a "training set." Therefore, the concept of a training set sample size is not applicable. The performance studies are validation tests, not machine learning model training.
9. How the ground truth for the training set was established
As there is no training set for an AI algorithm, this question is not applicable.
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(48 days)
One Day Flat Pack (hioxifilcon A) Spherical Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes who may have 1.00 diopter (D) or less of astigmatism that does not interfere with visual acuity.
One Day Flat Pack (hioxifilcon A) Multifocal Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have 1.00 D or less of astigmatism that does not interfere with visual acuity.
One Day Flat Pack (hioxifilcon A) Spherical and Multifocal Lenses are intended to be worn once and then discarded at the end of each wearing period on a daily basis. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
The One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lenses are daily wear disposable soft contact lenses available as spherical and multifocal lens designs. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The One Day Flat Pack Daily Disposable Contact Lens packaging system is designed to reduce lens handling by always presenting the lens anterior side up upon opening, which ensures correct lens orientation for proper insertion. The non-ionic lens material. (hioxifilcon A) is a random copolymer of 2- hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 43 % hioxifilcon A and 57 % water by weight when immersed in a buffered saline solution. The lens is available with a blue visibility-handling tint, color additive Reactive Blue # 19, 21 CFR part 73.3121.
This document describes a 510(k) premarket notification for a new soft contact lens, the Menicon One Day Flat Pack (hioxifilcon A) Multifocal Daily Disposable Soft Contact Lens. The information largely focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study proving performance against explicit acceptance criteria for the new multifocal design.
Based on the provided text, the device meets acceptance criteria primarily by demonstrating substantial equivalence to predicate devices based on material, manufacturing process, and performance characteristics.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with specific numerical thresholds for the new multifocal lens beyond what is inherent in demonstrating substantial equivalence. Instead, it relies on a comparison of characteristics to predicate devices. The implicit acceptance criteria are that the new device should perform as safely and effectively as the predicate devices.
| Characteristic | Acceptance Criteria (Implicit for Substantial Equivalence to Predicates) | Reported Device Performance (One Day Flat Pack Multifocal) |
|---|---|---|
| Material/Composition | Same as predicate hioxifilcon A lenses (e.g., K080632, K102895) | hioxifilcon A |
| Manufacturing Process | Similar to predicate devices | Same material, similar manufacturing processes as predicates |
| Intended Use (for Spherical) | Daily wear, single use, correction of refractive ametropia (myopia/hyperopia) in aphakic/non-aphakic persons with non-diseased eyes, <=1.00 D astigmatism not interfering with acuity. | Same as predicate (One Day Flat Pack Spherical) |
| Intended Use (for Multifocal) | Daily wear, single use, correction of refractive ametropia (myopia/hyperopia) and/or presbyopia in aphakic/non-aphakic persons with non-diseased eyes, <=3.00 D reading addition, <=1.00 D astigmatism. | Explicitly stated (see Indications for Use) |
| Oxygen Permeability | Comparable to predicate hioxifilcon A lenses | 25.38 x 10^-11 (cm²/sec) (mL 0₂/(mL x mm Hg)) |
| Water Content | Comparable to predicate hioxifilcon A lenses | 57% (at 20°C) |
| Refractive Index | Comparable to predicate hioxifilcon A lenses | 1.409 (at 20°C) |
| Light Transmittance | Comparable to predicate lenses (e.g., >94% or >95%) | >94 % |
| Biocompatibility | No new issues of safety and effectiveness related to material. | No additional biocompatibility testing required due to known material. |
| Clinical Safety/Effectiveness | As safe and effective as predicate devices. | No clinical studies were deemed necessary. |
2. Sample Size Used for the Test Set and Data Provenance
- Test set for the new multifocal lens: No specific test set or clinical study was conducted for the new multifocal lens design to assess its direct performance against new acceptance criteria. The document explicitly states: "Clinical studies were unnecessary for this application."
- Data Provenance: The device relies on existing data from predicate devices and the known properties of the hioxifilcon A material. This would be retrospective in the sense of leveraging historical data. The origin of this historical data (e.g., country of origin) is not specified in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. No new clinical trials or specific test sets requiring expert ground truth establishment for the new device's performance are described. The evaluation relies on the known safety and effectiveness of the material and previous designs.
4. Adjudication Method for the Test Set
Not applicable. As no specific test set or clinical study was performed for the new multifocal device, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study was not conducted as no clinical studies were deemed necessary for this application.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical medical device (contact lens), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" implicitly used for demonstrating substantial equivalence is the established safety and effectiveness of the predicate devices and the hioxifilcon A material, which has been reviewed in multiple prior 510(k) applications (1998-2016). This relies on prior clinical data (from the predicates) and material characterization data.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
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(51 days)
The Menicon ASRB (asmofilcon A) SPHERICAL Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes who may have 1.50 D or less of astigmatism.
The Menicon ASRB (asmofilcon A) TORIC Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes with 3.00 D or less of refractive astigmatism.
The Menicon ASRB (asmofilcon A) MULTIFOCAL Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have 1.50 D or less of astigmatism.
The Menicon ASRB (asmofilcon A) MULTIFOCAL TORIC Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia with astigmatism) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have up to approximately 3.00 D or less of refractive astigmatism.
The Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is a frequent replacement lens. The lenses are intended to be worn on a daily wear basis with removal for cleaning and chemical disinfection (not heat) prior to reinsertion, as recommended by the eye care practitioner.
The Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is a hydrophilic contact lens which is available as a spherical/aspherical, toric, multifocal and multifocal toric lens. This soft contact lens is indicated for daily wear frequent replacement.
The non-ionic lens material (asmofilcon A) is a random co-polymer containing polydimethyl siloxane macromonomer. It consists of 60% asmofilcon A and 40% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibility handling tint, C.I. Reactive Blue 246.
The hydrophilic material characteristics allow aqueous solutions to enter the lens. In its fully hydrated state, the lens is approximately 40% water by weight.
The provided document is a 510(k) premarket notification for a soft contact lens and does not describe an AI medical device. Therefore, it does not contain the specific information required to answer the questions about AI device acceptance criteria, study design, expert involvement, or ground truth establishment.
The document focuses on demonstrating substantial equivalence to a predicate device for a new contact lens product, the Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens.
Here's a breakdown of why the requested information for an AI/device study cannot be extracted from this document:
- No AI Component: The device is a physical contact lens, not an algorithm or software that processes medical images or data.
- Acceptance Criteria: The document assesses the contact lens's physical properties, safety, and efficacy through non-clinical and clinical studies, but these are not "acceptance criteria" for an AI model's performance metrics (e.g., sensitivity, specificity, AUC).
- Study Design: The clinical study described is a 3-month trial comparing the new lens to a control lens in subjects, focusing on biomicroscopy, adverse events, visual acuity, wearing times, and comfort. This is a standard clinical trial design for a medical device, not an AI performance study.
- Ground Truth/Experts/Adjudication: These concepts are central to validating AI models where human expert labels or definitive diagnoses are used as "ground truth." For a contact lens, the "ground truth" relates to clinical outcomes in patients, not expert review of images.
- MRMC Study/Standalone Performance: These are specific types of studies for AI algorithms (Multi-Reader Multi-Case for human-AI interaction, standalone for algorithm-only performance). They are irrelevant for a physical contact lens.
- Training Set/Ground Truth Establishment for Training: These concepts apply to the development and validation of machine learning models. A contact lens does not have a "training set" in this sense.
In summary, this document is appropriate for a medical device submission (contact lens) but does not provide the information requested for an AI medical device.
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(48 days)
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is the mixture of two sterile solutions, Progent A (active ingredient, sodium hypochlorite) and Progent B (active ingredient, potassium bromide). Progent A and B are mixed in a Progent Vial. Menicon Rinse solution is used once the lens soaking cycle is complete. The Progent treatment is recommended every two weeks. The frequency may vary according to the condition of your lens. Follow your eye care professional's directions (to a maximum of every 5 days).
The provided text describes a 510(k) premarket notification for the "Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses." However, it explicitly states that no new clinical or non-clinical studies were performed for this particular submission (K173136).
The device's clearance is based on its prior approvals and the fact that there are no product formulation changes. Therefore, the device's acceptance criteria and the study that proves it meets those criteria are established through substantial equivalence to predicate devices (Boston Cleaner and Boston Advance Cleaner) based on historical data, not new studies presented within this document.
As such, I cannot provide a table of acceptance criteria and reported device performance from a new study conducted for this 510(k) submission, nor can I detail sample sizes, expert qualifications, or adjudication methods for studies not conducted as part of this submission. The document explicitly states:
- "Non-clinical studies were unnecessary for this application. Menicon Progent Protein Remover has been cleared in prior applications. There are no product formulation changes made in this application therefor no non-clinical studies were required." (Page 4)
- "Clinical studies were unnecessary for this application. Menicon Progent Protein Remover has been cleared in prior applications. There are no product formulation changes made in this application therefor no clinical studies were required." (Page 4)
The "Conclusion" section on page 4 further reinforces this by stating: "Based upon the product history and data presented, the Menicon Progent Protein Remover can be used as safely and as effectively as the Boston Cleaner and the Boston Advance Cleaner."
Therefore, the requested information points regarding new studies (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to the immediate content of this 510(k) summary as no such new studies were performed. The acceptance criteria essentially stem from the historical performance and regulatory compliance of the predicate devices and the Menicon Progent Protein Remover's prior clearances.
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(236 days)
The Qualis is intended for preparing motile human sperm for use in the treatment of infertile couples by intracytoplasmic sperm insertion (ICSI) fertilization.
The Qualis is a sterile, disposable, plastic laboratory dish that contains four chambers connected through micro-channels and is designed to be used in conjunction with commercially available culture medium to selectively separate motile spermatozoa (sperm) for non-motile spermatozoa and cellular debris.
The provided text describes the "Qualis" device, a sterile, disposable, plastic laboratory dish designed to separate motile spermatozoa from non-motile spermatozoa and cellular debris for use in intracytoplasmic sperm insertion (ICSI) fertilization. The document evaluates the device's substantial equivalence to a predicate device, the "Research Instruments Migration Sedimentation Chamber."
The acceptance criteria are not explicitly listed in a table format within the provided text. However, the functional and safety testing paragraph and the substantial equivalence discussion highlight key performance and safety aspects that were evaluated.
Here's an attempt to parse the acceptance criteria and performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Performance: Effectiveness in separating motile sperm (presumably for ICSI fertilization) | "The final design validation study demonstrated that the subject device is effective." (This suggests the device successfully achieved its intended function, likely assessed by the quality and quantity of separated motile sperm.) |
| Safety: Biocompatibility with human sperm | "The result of HSSA testing demonstrated that the subject device is safe." (Indicates the device does not adversely affect sperm viability or function.) |
| Human Sperm Survival Assay (HSSA) Requirement | Passed HSSA testing. |
| Human Sperm Motility/Morphology Assessment | Testing included human sperm motility/morphology. (While a specific pass/fail isn't stated, the overall conclusion of "functional performance and safety requirements" implies satisfactory results.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states: "To verify that device design met its functional performance and safety requirements, representative sample of the device underwent testing including human sperm survival assay (HSSA) and human sperm motility/morphology."
- Sample Size: The exact sample size used for the test set (i.e., the number of Qualis devices tested, or the number of sperm samples used for testing each device) is not specified in the provided text. It mentions "representative sample of the device."
- Data Provenance: The provenance of the data (country of origin, retrospective or prospective) is not specified.
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)
The document does not mention the use of experts to establish ground truth for the test set in the context of the device's functional or safety testing. The evaluation primarily relies on laboratory assays (HSSA, motility/morphology) which typically have objective measures. The ground truth for these assays would generally be the predetermined laboratory standards or comparison to controls, rather than expert consensus on interpretation of complex data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not mention any adjudication method, as the tests described (HSSA, motility/morphology) are typically objective laboratory measurements rather than subjective assessments requiring multiple reviewers.
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 as the Qualis device is for sperm preparation in assisted reproduction, not an AI-assisted diagnostic imaging device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable as the Qualis device is a physical laboratory instrument for sperm processing, not an algorithm or software. It is a standalone device in the sense that its functional performance and safety were evaluated independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the functional and safety testing appears to be based on objective laboratory measurements and established biological assays.
- For "functional performance" in sperm separation, the ground truth would likely be the quantitative analysis of enriched motile sperm populations (e.g., count, motility percentage, morphology) compared to established benchmarks or predicate device performance.
- For "safety" (HSSA), the ground truth is the survival and viability of human sperm after exposure to the device, measured against controls and established safety limits for cell viability.
8. The sample size for the training set
This section is not applicable. The Qualis device is a physical product, not a machine learning model, so there is no concept of a "training set" in the context of its development and validation.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as above (no training set for a physical device).
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