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Found 14 results
510(k) Data Aggregation
(119 days)
Austin Medical Ventures, Inc.
Synthecure Synthetic Calcium Sulfate is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Synthecure Synthetic Calcium Sulfate resorbs and is replaced with bone during the healing process.
Synthecure is provided sterile for single use only. Synthecure is biodegradable and biocompatible and may be used at an infected site.
Synthecure Synthetic Calcium Sulfate is indicated to be implanted into defects not intrinsic to the structural stability of the skeletal system. Synthecure is biocompatible and may be implanted at an infected site. Synthecure Synthetic Calcium Sulfate is presented as a powder and mixing solution which when mixed together forms a paste which may be injected, digitally implanted or applied to a mold provided to produce pellets.
The provided FDA 510(k) clearance letter pertains to a medical device called "Synthecure Synthetic Calcium Sulfate," a resorbable calcium salt bone void filler. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Based on the provided text, the device is a bone void filler and not a device that would typically have the acceptance criteria in the format requested. The document does not describe a study involving a "test set" with ground truth, expert adjudication, or human reader performance with or without AI assistance, as these are concepts more relevant to diagnostic or AI-powered devices.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the information contained in this FDA clearance letter. The letter focuses on demonstrating the physical, chemical, and biological safety and performance of the bone void filler device through a series of non-clinical tests.
However, I can extract the acceptance criteria as described for the non-clinical tests and the reported performance based on the information provided.
Acceptance Criteria and Study for Synthecure Synthetic Calcium Sulfate
The Synthecure Synthetic Calcium Sulfate is a resorbable calcium salt bone void filler. The provided 510(k) summary outlines non-clinical testing performed to demonstrate its safety and substantial equivalence to predicate devices, rather than a clinical study with a detailed test set and ground truth as might be expected for diagnostic or AI devices.
1. A table of acceptance criteria and the reported device performance
| Performance Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Sterilization must achieve a Sterility Assurance Level (SAL) of $1 \times 10^{-6}$ for the worst-case construct, in compliance with recognized standards. | Sterilization validation has been completed on the worst-case construct to an SAL of $1 \times 10^{-6}$. |
| Bacterial Endotoxin Testing | Testing must be performed according to ANSI/AAMI ST72:2011 and demonstrate acceptable endotoxin levels. | Testing is performed according to ANSI/AAMI ST72:2011, "Bacterial endotoxins – Test methods, routine monitoring and alternatives to batch testing." (Implies acceptable levels were met). |
| Packaging Validation | Packaging performance must be validated in accordance with ISO 11607-1:2019 and ISO 11607-2:2019 to ensure product integrity and sterility throughout its shelf life. | Packaging performance validation, in accordance with ISO 11607-1:2019 and ISO 11607-2:2019, was performed on the final packaging and sterilized device. (Implies successful validation). |
| Biocompatibility | Biological safety evaluation must be completed according to ISO 10993-1 requirements and FDA Guidance Document "Use of International Standard ISO 10993-1," demonstrating all materials are biocompatible for their intended use. | A biological safety evaluation has been completed for Synthecure according to ISO 10993-1 requirements and FDA Guidance Document "Use of International Standard ISO 10993-1." All materials contained in the proposed Synthecure have been evaluated in accordance with recognized standards and are characterized as being biocompatible. |
| Performance Testing - Bench | Chemical composition and physical properties (e.g., work and setting time) must be equivalent to predicate devices and maintain performance after aging, as per current industry standards and FDA guidance. | The chemical composition and physical properties of the subject and predicate devices were evaluated and demonstrated to be equivalent. Additionally, work and setting time tests were conducted on real-time aged samples to support that the device maintains its performance after aging. |
| Performance Testing - Animal | An in-vivo implantation study must demonstrate appropriate biological response, resorption, and replacement with bone at specified endpoints (e.g., 3, 6, and 12 weeks) in an animal model, showing performance comparable to expectations for bone void fillers. | An implantation study was conducted using New Zealand White Rabbits with study endpoints at 3, 6, and 12 weeks. (Implies successful outcomes demonstrating expected performance for bone void fillers, leading to substantial equivalence). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in terms typically used for diagnostic or AI studies. For the animal study, the sample size is not explicitly stated number of New Zealand White Rabbits, but it's an animal model.
- Data Provenance: The document implies that all testing (bench, animal, etc.) was conducted by or for Austin Medical Ventures, Inc. in support of their 510(k) submission. It's not applicable in terms of "country of origin for human data" as these are non-clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a bone void filler, and its evaluation relies on physical, chemical, and biological testing, not on expert interpretation of diagnostic images or clinical assessments to establish ground truth in the way a diagnostic device would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This device does not involve adjudication of expert opinions or interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a software algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device, "ground truth" is established through:
- Established standards and regulations: e.g., ISO 10993-1 for biocompatibility, ISO 11607 for packaging.
- Bench testing methodologies: Measuring physical and chemical properties.
- In-vivo animal models: Observing biological response, resorption rates, and bone ingrowth over time (e.g., 3, 6, and 12 weeks endpoints). The "truth" here is the biological reaction within the animal model.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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(131 days)
Metro Optics of Austin, Inc.
The Metro Soft, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity.
The Metro Soft, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The Metro Soft, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 0.75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Metro Soft, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Metro Soft, irregular cornea (efrofileon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lenses are fabricated from efrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates RB246 (1,4-Bis[4-(2-Methacryloxyethyl) phenylamino]-9, 10-Anthraquinone)as an integrated handling tint. The lenses are made by lathe-cut for individual patients. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 74% water by weight. The lenses will be manufactured in spherical, aspherical, toric, multifocal, multifocal toric and irregular cornea configurations.
The lens is supplied sterile in vials containing a buffered saline solution.
Here's an analysis of the acceptance criteria and supporting studies for the Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A), based on the provided text:
Important Note: The provided document is a 510(k) summary for a contact lens. For medical devices like this, the "acceptance criteria" generally refer to established standards and benchmarks for safety and performance (e.g., ISO standards, physical property ranges), and the "study that proves the device meets the acceptance criteria" refers to the non-clinical and, if applicable, clinical testing performed to demonstrate compliance and substantial equivalence to a predicate device. This is different from the type of "acceptance criteria" and "study" typically associated with AI/ML-based diagnostic devices, which would involve metrics like sensitivity, specificity, AUC, and performance against a ground truth dataset.
Since this is a contact lens and not an AI/ML device, many of the requested fields regarding AI/ML-specific study design (test set sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not applicable to this submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Metro Soft contact lens are primarily defined by:
- Compliance with established ISO standards for biocompatibility and material properties.
- Meeting specified physical and optical parameter ranges with defined tolerances.
- Demonstrating similar performance characteristics (material properties, shelf life, solution compatibility) to the predicate devices.
- Having an equivalent Indications for Use statement to the predicate devices.
| Acceptance Criteria (General Category/Standard) | Specific Acceptance Criteria (Example) | Reported Device Performance (Metro Soft) |
|---|---|---|
| Material Properties: | ||
| Refractive Index (wet) | Not explicitly stated as an "acceptance criterion" value, but compared to predicate. | 1.3770 |
| Visible Light Transmission (%). | Not explicitly stated as an "acceptance criterion" value, but compared to predicate. | 94.4% |
| Specific Gravity (wet) | Not explicitly stated as an "acceptance criterion" value, but compared to predicate. | 1.049 |
| Water Content | 74 ± 2% | 74 ± 2% (Meets criterion) |
| Oxygen Permeability (Dk) | Not explicitly stated as an "acceptance criterion" value, but compared to predicate. | 56 x 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) |
| Device Parameters (with Tolerances): | ||
| Base Curve | Range: 8.0mm to 9.5mm; Tolerance: ± 0.20mm | All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance. (Implies all these parameters meet their respective tolerances.) |
| Center Thickness | Range: 0.01mm to 0.50mm; Tolerance: ≤ 0.10 mm → ±0.010 mm + 10%; > 0.10 mm → ±0.015 mm + 5% | All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance. |
| Diameter | Range: 12.00mm to 16.00mm; Tolerance: ± 0.20mm | All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance. |
| Spherical Power | Range: -20.00 D to +20.00 D; Tolerance: 0.00 4.00 D → ±1.00 D | All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance. |
| Cylindrical Power (Multifocal Toric) | Range: -0.25 D to -4.00 D; Tolerance: 0.00 |
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(262 days)
Austin Miller Trauma LLC
The Austin Miller External Fixation System is intended to be used on adult or pediatic patients for stabilization of the long bones, feet, and pelvis. The most common indication of long bone or pelvic fractures, especially when the fractures are combined with soft tissue trauma. Additional indications include non-unions, periarticular fractures, infected fractures or non-unions, joint-bridging immobilization in severe soft-tissue and ligament injuries, arthrodeses, and osteotomies. It can be used in conjunction with internal fixation and can be used intraoperatively as a reduction tool.
The Austin Miller External Fixation System is an external fixation system that consists of various components used in the management of pelvic, feet and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application. All half pins and frame components are single use devices and are provided non-sterile.
The provided text does not contain information about acceptance criteria for a medical device's performance, nor does it detail a study proving such criteria are met in the context of AI/ML or diagnostic image analysis. Instead, the document is a 510(k) summary for the "Austin Miller External Fixation System," a surgical device used for stabilizing bones.
The document focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use: Bone stabilization for adult and pediatric patients with long bone, feet, and pelvic fractures, non-unions, periarticular fractures, infected fractures/non-unions, joint-bridging immobilization, arthrodeses, and osteotomies.
- Device Description: Consists of stainless steel bone pins, composite bars, and titanium clamps.
- Technological Characteristics: Similar materials, size, strength, stiffness, assembly, and adjustment methods compared to predicate devices.
- Performance Data (Mechanical and MRI Safety):
- Mechanical Testing: Pin pullout and strength testing (following ASTM F1541), grip testing of clamps, and construct testing to failure. These tests aimed to show equivalence or superiority to predicate devices in terms of load-bearing capacity.
- MRI Safety Testing: Force and torque testing in magnetic fields, image distortion testing, radiofrequency induced heating simulation, and radiofrequency induced heating testing. This was done to determine safe conditions for MRI scanning with the device implanted.
Therefore, I cannot fulfill the request as the provided text does not describe an AI/ML-based device or a study with acceptance criteria, ground truth, expert review, or sample sizes in the context of diagnostic performance.
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(238 days)
AUSTIN & ASSOCIATES, INC./TELOS MEDICAL EQUIPMENT
Memodyn Staple is intended for use in bone fixation on osteotomies, arthrodesis and fractures of the foot, ankle and hand.
Memodyn Staple is a nitinol alloy ASTM F2063-12 memory staple that comes in sizes ranging from 8mm to 20mm, and is used for bone fixation on osteotomies, arthrodesis and fractures of the small bones of the foot, ankle and hand.
The provided text describes the 510(k) premarket notification for the Memodyn Staple, a metallic bone fixation device. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against acceptance criteria in the context of an AI or diagnostic device.
Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this document. However, I can extract information related to the device's characteristics and the non-clinical testing performed.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantitative format for specific clinical performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device and showing the subject device performs similarly in non-clinical tests.
| Device Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Material | Must be ASTM F2063-12 Nitinol alloy, biocompatible and identical to predicate. | Made of Nitinol alloy ASTM F2063-12. All materials are biocompatible and identical to the predicate. |
| Overall Length | 8 – 20 mm | 8 – 20 mm |
| Staple Bridge/Top Width | 8 – 20 mm | 8 – 20 mm |
| OD of Staple | 1.7mm | 1.7mm |
| Static Four Point Bending | Performed as well as predicate. | Testing performed per ASTM F2063. Device fixation implant included staple static four point bending. |
| Dynamic Four Point Bending (Fatigue) | Performed as well as predicate. | Testing performed per ASTM F2063. Device fixation implant included dynamic four point bending (fatigue). |
| Elastic Compression Distribution of the Legs | Performed as well as predicate. | Testing performed per ASTM F2063. Device fixation implant included elastic compression distribution of the legs. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not stated. The "test set" here refers to the physical samples of the Memodyn Staple used for the non-clinical performance evaluation.
- Data provenance: Not explicitly stated. The tests were performed "per ASTM F2063," implying standard laboratory testing methods.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. For a medical device like a bone staple, "ground truth" is typically defined by engineering specifications, material properties, and in vitro performance tests, not expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set:
Not applicable. Adjudication methods are typically used for assessing disagreements among human readers or evaluators, which is not relevant for the non-clinical mechanical testing described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a physical medical device, not an AI or diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's evaluation is based on engineering standards and material specifications outlined in ASTM F2063 and comparison to the predicate device's established performance. This is a technical and performance specification ground truth.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.
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(274 days)
METRO OPTICS OF AUSTIN, INC.
The Metro Soft, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The Metro Soft, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The Metro Soft, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Metro Soft, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add nower of up to +4.00 diopters.
The Metro Soft, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The Metro Soft Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A. which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly bevond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The provided text describes a 510(k) summary submission for a medical device, the Metro Soft Silicone Hydrogel Daily Wear Soft Contact Lens. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing entirely new safety and effectiveness through extensive standalone clinical trials.
Therefore, the requested information about acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, or specific ground truth for an AI/algorithm-based device is not applicable to this document. This document details a regulatory submission for a contact lens, which is a physical device, and not an AI or algorithm.
Instead, the document outlines the following:
1. Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" in this context are the characteristics of the device that demonstrate its substantial equivalence to predicate devices. The performance is reported by direct comparison of its physical properties and intended use.
| Characteristic | Metro Soft (efrofilcon A) - New Device | Predicate (IntelliWave3, efrofilcon A) | Predicate (Metro Optics RevitalEyes, hioxifilcon B) | Predicate (Coopervision Biofinity, comfilcon A) | Predicate (Hydron Ltd. ActiFresh 400, lidofilcon A) |
|---|---|---|---|---|---|
| Intended Use | Daily wear for correction of ametropia, management of irregular corneal conditions. | Same as new device | Same as new device | Daily wear for correction of ametropia. | Daily wear for correction of ametropia. |
| Functionality | Same as predicate device | Focus light rays on retina | Focus light rays on retina | Focus light rays on retina | Focus light rays on retina |
| Indications | Daily wear, Silicone Hydrogel Soft | Daily wear, Silicone Hydrogel Soft | Daily wear, Soft | Daily wear, Silicone Hydrogel Soft | Daily wear, Soft |
| Production Method | Lathe-Cut, custom manufactured | Lathe-Cut, custom manufactured | Lathe-Cut, custom manufactured | Cast Molded, mass produced | Lathe-Cut, custom manufactured |
| USAN Name | efrofilcon A | efrofilcon A | hioxifilcon B | comfilcon A | lidofilcon A |
| Water Content | 74% | 74% | 48% | 48.0% | 74.0% |
| Oxygen Permeability | 60 x 10-11 cm2/sec | 60 x 10-11 cm2/sec | 15.89 x 10-11 cm2/sec | 128 x 10-11 cm2/sec | 28 x 10-11 cm2/sec |
| Specific Gravity | 1.139 | 1.139 | 1.142 | 1.142 | 1.060 |
2. Study Proving Device Meets Acceptance Criteria:
The study that "proves the device meets the acceptance criteria" in this context is the comparison demonstrating substantial equivalence to legally marketed predicate devices. The document explicitly states:
- Clinical Data: "The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k)." This indicates that clinical studies were performed for the material in a prior submission (likely K100221 for IntelliWave3).
- Non-clinical Testing: "A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the Metro Soft (efrofilcon A) Silicone Hydrogel Soft Contact Lenses... All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols."
- Key Finding for Substantial Equivalence: "The Metro Soft, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens is identical to the cleared Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K100221." And "The Metro Soft, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lenses have the identical manufacturing process (lathe-cut versus lathe-cut) as the marketed Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K100221."
No specific sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or training set details are provided because this is a 510(k) submission for a physical medical device, not an AI/ML algorithm requiring such specific performance validation methods. The "ground truth" for this submission relies on established safety and performance data of the predicate devices and general standards for biocompatibility and material properties of contact lenses.
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(149 days)
METRO OPTICS OF AUSTIN, INC.
The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint may be prescribed for the corrective ametropia (myopia, hyperopia, and astigmatism) in other wise non-diseased eyes that require a soft contact lens for the management of surgically altered corneas following LASIK, PRK or RK surgery.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint, which in the dry (unhydrated) state may be machined and polished to by cloud and prophilic nature of these materials allows the lens to become soft and pliable when immersed in an aqueous solution.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifileon B) soft hydrophilis contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appar somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are:
(Hioxifilcon B)
Refractive Index: 1.51 (dry) 1.42 (hydrated)
Light Transmission: greater than 94%
Surface Character: hydrophilic
Water Content: 49 %
Specific Gravity: 1.137 (hydrated)
Oxygen Permeability: 16.40 X 10 to the power of -11 (cm squared/sec) (ml O sub 2/ml x hPa @ 35 degrees C), (revised Fatt method)
This document is a 510(k) Premarket Notification for a medical device, specifically a soft contact lens. The purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This process does not involve extensive clinical trials with acceptance criteria, ground truth, or statistical analyses in the same way a PMA (Premarket Approval) would.
Therefore, the requested information regarding acceptance criteria, study details (sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this type of submission.
Instead, the submission focuses on demonstrating substantial equivalence based on material properties, intended use, and design similarity to existing predicate devices.
Here's what the document does provide, structured to address relevant aspects:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in the sense of predefined performance thresholds for a clinical study. Instead, it compares the new device's properties to existing, legally marketed predicate devices to establish substantial equivalence.
| Characteristic | Acceptance Criteria (Predicate Device Values) | RevitalEyes (New Device) Reported Performance |
|---|---|---|
| Intended Use | Corrective ametropia in non-diseased eyes; management of surgically altered corneas (FlexLens), or correction of visual acuity in aphakic/non-aphakic persons with non-diseased eyes with myopia or hyperopia (METRO-G). | Indicated for daily wear and may be prescribed in non-diseased eyes that require soft contact lens for management of surgically altered corneas following LASIK, PRK or RK surgery. |
| Functionality | Act as a refractive medium to focus light rays on the retina. | Same as predicate device. |
| Indications | Daily wear, soft (hydrophilic) contact lens. | Same as predicate device. |
| Production Method | Lathe-cut. | Same as predicate device (Lathe-cut). |
| FDA Group # | Group # 1 |
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(125 days)
AUSTIN MEDICAL, INC.
Surgical drapes made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. These are provided non-sterile to kit packers, who then may sterilize the drape as part of a kit.
Various types of surgical drapes
The provided text is a 510(k) Premarket Notification for "Surgical Drapes." This document is focused on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving device performance against such criteria.
The 510(k) pathway for medical devices largely relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device (one that was on the market before May 28, 1976, or has been reclassified). This process typically involves comparing the new device's technological characteristics and indications for use to those of the predicate device. Performance data, if included, is often used to support the claim of substantial equivalence rather than to meet specific, quantitatively defined "acceptance criteria" through a comprehensive clinical study.
Therefore, the requested information elements related to acceptance criteria, specific device performance metrics, sample sizes, ground truth, expert involvement, and comparative effectiveness studies are not applicable to this document. The document describes the device, its intended use, and compares it to a predicate device (Webster Enterprises – K864899) to demonstrate substantial equivalence, focusing on similarities in features and materials rather than statistical performance against predefined acceptance criteria.
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(133 days)
ZIMMER AUSTIN, INC.
The Wagner SL Revision Stem Lateral is intended for prosthetic replacement of the proximal femur in total hip arthroplasty. It is intended for press-fit application. Specific diagnostic indications include:
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis; and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Patients with failed previous surgery where pain, deformity, or dysfunction persists.
- Revision of previously failed hip arthroplasty.
Both the existing Wagner SL Revision Stem and the proposed Wagner SL Revision Stem Lateral are manufactured from forged titanium alloy and are available in three lengths (165mm, 185mm, and 205mm). The neck design of both stems is provided with the standard 12/14 taper for connection with any Zimmer modular femoral head utilizing a 12/14 taper.
The Wagner SL Revision Stem Lateral incorporates a circular stem cross-section and equally spaced conical anchorage ribs, which run nearly the full length of the stem, as do the ribs on the previously cleared Wagner SL Revision Stem. The surface of both stems is rough-blasted.
To achieve the lateralization of the modified device, the CCD (i.e., neck) angle was lengthened. To compensate for the increased bending moments and lateral stresses, which result from the increased offset, the rib structure was modified so that the greatest bending moment would not be at the base of the rib; and the ribs were widened, which led to an increase in the stem strength.
In addition, a threaded coupling was added to the proximal portion of the stem for use with the new impacter/extractor. The stem neck was shortened to increase the range of motion, and two small holes were added to the proximal portion of the stem for securing non-metallic suture material.
This document is a 510(k) summary for a medical device (hip implant) and does not contain detailed information about acceptance criteria or specific study results that would typically be associated with AI/ML device performance. The document focuses on demonstrating substantial equivalence to a predicate device.
Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details for an AI/ML device is not applicable to this document. The document describes a traditional medical device (hip implant) submission, not an AI/powered diagnostic or therapeutic device.
However, I can extract information related to the device description, intended use, and the concept of "substantial equivalence" as the primary "acceptance criterion" in this context.
1. A table of (implied) acceptance criteria and the reported device performance
In the context of a 510(k) submission for a non-AI/ML medical device, the "acceptance criteria" are generally that the new device is substantially equivalent to a legally marketed predicate device. This substantial equivalence is demonstrated through comparisons of:
| Implied Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance (Comparison of Wagner SL Revision Stem Lateral to Predicate: Wagner SL Revision Stem) |
|---|---|
| Material Composition | Both manufactured from forged titanium alloy. |
| Available Sizes | Both available in three lengths (155mm, 180mm, 205mm). |
| Neck Design | Both provided with the standard 12/14 taper for connection with Zimmer modular femoral heads. |
| Stem Cross-Section | Both incorporate a circular stem cross-section. |
| Anchorage Ribs | Both have equally spaced conical anchorage ribs running nearly the full length of the stem. |
| Surface Treatment | Both have a rough-blasted surface. |
| Intended Use | Both intended for prosthetic replacement of the proximal femur in total hip arthroplasty, for press-fit application, addressing similar diagnostic indications (NIDJD, IJD, failed previous surgery, revision arthroplasty). |
| Fundamental Design | "The device, as modified, is substantially equivalent in terms of fundamental design..." (Statement in "Basis of Substantial Equivalence") |
| Indications for Use | "...indications for use and intended use to the previously cleared, currently marketed Wagner SL Revision Stem." (Statement in "Basis of Substantial Equivalence") |
Note: The modifications in the "Wagner SL Revision Stem Lateral" (lengthened CCD angle, widened ribs for increased stem strength, threaded coupling, shortened stem neck, added holes for sutures) are presented as design changes that do not alter the fundamental safety and effectiveness to the point of requiring a PMA or new classification, thus maintaining substantial equivalence. These changes are improvements or variations within the established scope of the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document describes a traditional medical device (hip implant) and does not include information on a "test set" in the context of an AI/ML algorithm evaluation. The demonstration of substantial equivalence relies on design comparisons, material specifications, and performance characteristics (like strength considerations due to design changes). There are no data described that would fit the "test set" definition for an AI/ML device.
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)
Not applicable. As noted above, this 510(k) summary does not involve a "test set" or "ground truth" establishment by experts in the AI/ML sense. The approval is based on comparison to a predicate device and engineering design principles.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no described "test set" or adjudication process for clinical data in this 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a hip implant, not an AI/ML diagnostic device, so MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hip implant, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For a hip implant 510(k), "ground truth" typically relates to established clinical performance of the predicate device, material standards, and biomechanical principles, rather than a diagnostic 'truth' established for an AI algorithm.
8. The sample size for the training set
Not applicable. There is no AI/ML algorithm or associated "training set" described in this document.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML algorithm or associated "training set" described in this document.
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(27 days)
ZIMMER AUSTIN, INC.
The CLS™ Spotorno™ Femoral Stem is intended for cementless use in total hip replacement in treatment of the following:
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis and conditions of inflammatory degenerative joint disease (IJD), e.g. rheumatoid arthritis;
- those patients with failed previous surgery where pain, deformity, or dysfunction persists;
- revision of previously failed hip arthroplasty.
The CLS™ Spotorno™ Femoral Stem is intended for use as a prosthetic replacement of the proximal portion of the femur during total hip arthroplasty. This Special 510(k) incorporates the following changes as compared to the original device configuration: 1) addition of the CLS 125° stem, with an increased offset; and 2) incorporation of a slim neck and short taper. Below the resection line, the design of the modified stem remains the same as the legally marketed device.
The provided text describes a medical device submission, specifically a Special 510(k) for a modified femoral stem (CLS™ Spotorno™ Stem). The core of the provided information relates to the fatigue testing of this device to ensure it continues to meet safety and effectiveness standards after modifications.
Here's an analysis of the acceptance criteria and study as per your request:
Acceptance Criteria and Study Details for the CLS™ Spotorno™ Femoral Stem
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Survive physiological loading (fatigue testing) | All test samples met the acceptance criteria, thus indicating that the device, as modified, will survive physiological loading. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states "All test samples" but does not specify the exact number of samples used for fatigue testing.
- Data Provenance: The study was conducted by the manufacturer, Zimmer Austin, Inc. and Zimmer GmbH. The data is prospective, generated specifically for this 510(k) submission to demonstrate the safety and effectiveness of the modified device. The country of origin for the testing would be where Zimmer GmbH (Switzerland) or Zimmer Austin, Inc. (USA) conducted the tests, which is not explicitly stated but implied to be within the manufacturer's quality system.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This study involves mechanical fatigue testing, not a clinical study where expert ground truth on patient data would be established. The "ground truth" here is the physical performance of the device under simulated physiological loading conditions as defined by engineering standards for orthopedic implants.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is mechanical testing, not a clinical study requiring expert adjudication of observations. The "adjudication" is based on whether the test samples pass or fail the predetermined engineering acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a submission for a medical device (femoral stem) based on mechanical testing (fatigue testing), not an AI-enabled diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "standalone" performance here refers to the physical device itself (the femoral stem) undergoing mechanical testing without human interaction or an AI algorithm involved in its function or assessment during the test. The "algorithm" would be the engineering specifications and test protocols that determine acceptance.
7. The Type of Ground Truth Used
The ground truth used is derived from engineering standards and predetermined mechanical performance criteria for orthopedic implants, specifically for fatigue strength under physiological loading. These standards are typically established by regulatory bodies (e.g., ISO, ASTM) and industry best practices to ensure the long-term durability and safety of the implant.
8. The Sample Size for the Training Set
Not applicable. There is no AI algorithm being "trained" in this context. The study is a mechanical verification of a physical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no AI training set, there's no ground truth for it to be established.
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(78 days)
METRO OPTICS OF AUSTIN, INC.
The SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The SatureEyes II (acofilcon B) & (tetrafilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eves with myopia or hyperopia and may have astigmatism of 10.00 diopters or less where the astigmatism does not interfere with visual acuity.
The SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eves with myopia or hyperopia and are presbyopic.
The SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Toric Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes with myopia or hyperopia, have astigmatism of 10.00 diopters or less and are presbyopic.
Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
The SatureEyes II Soft Contact Lens for Daily Wear is fabricated from (acofileon A), (acofilcon B) or (tetrafilcon A), which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (acofilcon A), (acofilcon B) & (tetrafilcon A) soft hydrophilic contact lens a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out. it will become hard and appear somewhat warped however, it will return to its proper configuration when completely re-hydrated in the proper storage solution.
The non-ionic lens material, (acofilcon A), is a terpolymer based on high purity Glycerol Methacrylate2, 3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2 pyrrolidone (NVP), methyl methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and crossed-linked with Diallyl Maleate (DAM). It consists of 42% acofilcon A and 58% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4'.
The non-ionic lens material, (acofilcon B), is a terpolymer based on high purity Glycerol Methacrylate2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2 pyrrolidone (NVP), methy) methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and crossed-linked with Diallyl Maleate (DAM). It consists of 51% acofilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4'.
The non-ionic lens material, (tetrafilcon A), is a random terpolymer of 2-hydroxyethy) methacrylate, N-vinylpyrrolidone (NVP), methylmethacrylate (MMA), in a three dimensional network of terpolymer chains by divinylbenzene cross links. It consists of 58% (tetrafilcon A) and 42% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 163'.
This document describes the safety and effectiveness of the SatureEyes II contact lenses by demonstrating substantial equivalence to previously cleared predicate devices. The submission focuses on adding new materials (acofilcon A, acofilcon B, and tetrafilcon A) to an existing cleared device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to predicate devices across various characteristics. The "reported device performance" refers to the physical properties of the new materials, which are compared to the predicate devices.
| Characteristic | Acceptance Criteria (Predicate Device Examples) | Reported Device Performance (SatureEyes II - New Materials) |
|---|---|---|
| Intended Use | Daily wear, Soft Contact Lens | Daily wear, Soft Contact Lens |
| Indication | Correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia, and/or astigmatism (up to 10.00 diopters for some predicate models), and may be presbyopic. | Correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 diopters and may be presbyopic. (Specific versions for Spherical, Toric, Multifocal, Toric Multifocal listed.) |
| Production Method | Lathe-Cut | Lathe-Cut |
| Design | Spherical, Toric, Multifocal, Toric Multifocal | Spherical, Toric, Multifocal, Toric Multifocal |
| Hydrophilic Material | (hioxifilcon A), (hioxifilcon B) | (acofilcon A), (acofilcon B), (tetrafilcon A) |
| Water Content | (hioxifilcon A) - 58%, (hioxifilcon B) - 48% | (acofilcon A) - 58%, (acofilcon B) - 49%, (tetrafilcon A) - 43% |
| Specific Gravity | (hioxifilcon A) - 1.18 hydrated, (hioxifilcon B) - 1.142 hydrated | (acofilcon A) - 1.103 (hydrated), (acofilcon B) - 1.142 (hydrated), (tetrafilcon A) - 1.12 (hydrated) |
| Oxygen Permeability | (hioxifilcon A) - 25.50 X 10^-11, (hioxifilcon B) - 15.0 X 10^-11 (cm^2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method) | (acofilcon A) - 25.50 X 10^-11, (acofilcon B) - 15.8 X 10^-11, (tetrafilcon A) - 9.3 X 10^-11 (cm^2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method) |
| Light Transmittance | >95% (hioxifilcon A and B) | (acofilcon A) - >93%, (acofilcon B) - >94.8%, (tetrafilcon A) - >93% |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" and its sample size in the context of device performance data collected for the SatureEyes II lenses themselves within this submission. Instead, the approach taken is demonstrating substantial equivalence to predicate devices, which implies that the predicate devices have already undergone sufficient testing.
The provenance of the data presented for the new materials (e.g., refractive index, water content, oxygen permeability) is not specified as "country of origin" or "retrospective/prospective." This data appears to be inherent physical properties of the materials themselves, likely determined through laboratory testing during material development.
Pre-clinical performance data for cytotoxicity, systemic injection, and ocular eye irritation are referenced in other 510(k) submissions (K023349 & K024045 for Contamac Ltd. and K954139 for CooperVisions), implying that these tests were conducted on the specific materials or similar materials by those companies. The details of those studies (sample size, provenance) are not provided here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for the device's performance is based on its physical properties and comparison to existing, legally marketed predicate devices, not on expert labeling of a dataset.
4. Adjudication Method for the Test Set
This is not applicable as there is no specific test set undergoing human review or adjudication mentioned in this document.
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 is not applicable. The device is a contact lens, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a contact lens.
7. The Type of Ground Truth Used
The ground truth used for demonstrating substantial equivalence is:
- Physical and Chemical Properties: Laboratory measurements of material properties (water content, oxygen permeability, light transmission, refractive index, specific gravity) for the new materials.
- Established Performance of Predicate Devices: The known design, intended use, indications, and material properties of several already cleared contact lenses (MetroFocal Toric, Metro-G 55 (5X), Metro-G (3X)).
- Pre-clinical data: Referenced cytotoxicity, systemic injection, and ocular eye irritation tests from other 510(k) submissions. This suggests that the biological safety of the materials has been previously established or validated through these referenced tests.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of a machine learning algorithm for this medical device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
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