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The RxSight Contact Lens is indication and treatment in the anterior segment of the eye.

The RxSight Contact Lens is a reusable diagnostic contact lens intended for intraocular visualization and therapy. The RxSight Contact Lens is used to maintain optical quality of the corneal surface and will provide lid stabilization to prevent blinking during therapeutic procedures that require magnification of the eye.

The RxSight Contact Lens is designed around the classic diagnostic contact lens with similar design including an optical element with a specific magnification to provide excellent visualization.

The optical component of the RxSight Contact Lens is made from polymethylmethacrylate (PMMA). The anodized aluminum cone houses the PMMA contact lens.

The provided document is a 510(k) summary for the RxSight Contact Lens, which seeks to establish substantial equivalence to a predicate device. It is not a study that proves the device meets specific acceptance criteria based on performance metrics that would typically be described with sensitivity, specificity, or similar statistical measures. Instead, the "acceptance criteria" here refer to conformance with regulatory requirements and equivalence to a predicate device, demonstrated through a comparison of physical characteristics and specific types of testing.

Therefore, many of the requested fields are not applicable because this is not a performance study in the traditional sense of evaluating an algorithm or diagnostic tool against a ground truth.

Here's the information that can be extracted and synthesized based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of a clinical performance study with a "test set" for accuracy metrics like sensitivity/specificity. The testing performed was for biocompatibility, sterilization, and general finished product performance, not a diagnostic accuracy study. The document does not specify the number of individual devices or materials tested for these purposes.
• Data Provenance: Not applicable. The testing described is laboratory-based (biocompatibility, sterilization, physical performance) rather than clinical data from human subjects from a specific country or collected retrospectively/prospectively.

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

• Not applicable. "Ground truth" in the sense of expert-established diagnostic labels is not relevant for this type of device (a diagnostic contact lens) and the types of testing described (biocompatibility, sterilization, physical characteristics).

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring expert adjudication of diagnoses.

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 device is a diagnostic contact lens, not an AI-powered diagnostic system. No MRMC study was conducted.

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

• Not applicable. This device is a physical diagnostic contact lens, not an algorithm.

7. The Type of Ground Truth Used

• Ground Truth: For biocompatibility and sterilization, the "ground truth" would be established by the relevant ISO standards (ISO 10993-1, ISO10993-5, ISO10993-10, ISO 10993-7) and their specified testing methodologies and acceptance limits. For physical characteristics and intended use, the "ground truth" is typically defined by engineering specifications and direct comparison to the predicate device's established characteristics. It is not an expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device, so there is no training set in that context.

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

• Not applicable. There is no training set.

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The ENDOCULAR VIEWING LENSES AND SILICONE RING family allows visualizations of the retina, the vireous humor, the lens, the iris, the anterior chamber, as well as other ocular structures during surgical procedures or consultation.

The endocular viewing lens is a passive device that is used to view the fundus of the eye by placing it on the cornea.

The "ENDOCULAR VIEWING LENSES AND SILICONE RING" family includes devices comprised of an endocular viewing lens and/or of a cornea support that allows for stabilization of this lens on the eye. This range allows one to view the retina, the vitreous humor, the lens, the iris, the angle of the anterior chamber, as well as other ocular structures during surgical procedures or consultation.

This document is a 510(k) Premarket Notification summary for the "ENDOCULAR VIEWING LENSES AND SILICONE RING" device. Based on the provided text, the device is not an AI/ML medical device and therefore the concepts of acceptance criteria for an AI model, training/test sets, ground truth establishment by experts, adjudication, or MRMC studies, do not apply.

The device is a passive ophthalmic viewing lens classified as a Class II medical device. The 510(k) submission establishes substantial equivalence to legally marketed predicate devices, primarily based on the following:

• Intended Use: The device is used to view ocular structures during surgical procedures or consultation, which is similar to the predicate devices.
• Design: The device includes various types of viewing lenses and a silicone ring, comparable to the predicate devices.
• Materials: The materials used (PMMA, OKP4 Polyester Optical Plastic, silicone) are similar to those used in predicate devices.
• Mechanical Safety and Performance: No specific details are provided on performance metrics, but the claim of substantial equivalence implies comparable safety and performance.

Non-clinical tests performed:

• ISO 10993-5 In vitro cytotoxicity
• ISO 10993-10 Irritation
• ISO 10993-10 Sensitization

Clinical tests:

• No clinical studies were performed. The submission states: "No clinical studies were performed."

Therefore, the request for acceptance criteria and study details related to AI/ML performance is not applicable to this 510(k) submission.

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The Volk Single-Use Contact Laser and Diagnostic Lenses (Direct Contact) are indicated for use as diagnostic lenses for eye fundus examinations and use in the therapy of intraocular abnormalities.

The Volk Disposable Contact Laser and Diagnostic Lenses are a family of diagnostic and therapeutic contact lenses used for eye fundus examinations and therapy of intraocular abnormalities. The family consists of two (2) lenses, including the following: Iridotomy Lens and Capsulotomy Lens.

The family of Volk Disposable Contact Laser and Diagnostic Lenses are designed around the classic Volk Contact Laser and Diagnostic Lenses. Each model lens is similar in design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use.

The lenses are provided sterile for single use.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This document is for the Volk Disposable Contact Laser and Diagnostic Lens, a Class II medical device. It's a 510(k) premarket notification, which means the manufacturer is claiming substantial equivalence to legally marketed predicate devices, rather than submitting a full-blown PMA (Premarket Approval) which would typically require extensive clinical trials.

The provided text focuses on demonstrating substantial equivalence, not on establishing specific performance criteria against a predefined standard for a novel device. As such, there is no detailed "acceptance criteria" table in the traditional sense of performance metrics because the device is a contact lens and its primary function is direct visualization, similar to existing devices.

However, based on the "Performance Data" section, we can infer the critical acceptance criteria and studies that were performed to support the device's safety and effectiveness for its intended use, leveraging its similarity to predicates.

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

Regarding the study that proves the device meets the acceptance criteria, and further details as requested:

This submission is a 510(k) for a device claiming substantial equivalence, not a de novo or PMA where extensive clinical studies proving novel performance are typically required. Therefore, the "studies" mentioned are primarily validation testing to confirm specific aspects of the device's manufacturing and stability, rather than clinical trials assessing diagnostic accuracy or treatment efficacy compared to a gold standard.

2. Sample sizes 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 sample sizes for the sterilization validation testing or the shelf-life testing. These would typically be determined by established standards for such validation (e.g., ISO standards for sterilization, statistical sampling for shelf-life).
• The data provenance is not explicitly stated as country of origin, but it is implied to be from the manufacturer's internal testing (Volk Optical Inc. in Mentor, Ohio, USA). These would be prospective validation studies designed to test the sterility and shelf life of the newly manufactured disposable lenses.

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

• Not applicable / Not mentioned. For sterilization and shelf-life testing, "ground truth" is established by laboratory measurements against defined specifications (e.g., microbial load reduction, chemical stability) rather than expert consensus on a diagnostic outcome.
• For the optical performance, the "ground truth" and expertise would logically stem from the design and manufacturing capabilities of Volk, which has a long history in ophthalmic optics, and the clinical experience with their predicate devices. The statement "Each model lens is similar in design, but provide different optical elements to provide excellent visualization" suggests reliance on established optical design principles and potentially in-house optical testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable / Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of medical images or patient outcomes requires reconciliation among multiple experts. The studies cited are laboratory-based validation tests (sterilization, shelf life) which rely on analytical measurements and adherence to protocols, not human adjudication.

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 device is a passive optical lens, not an AI-powered diagnostic system. No MRMC study was performed or is relevant for this type of device.

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

• Not applicable. This device is a physical optical lens, not an algorithm or AI system. Its function inherently requires a human operator (the clinician) to use it for diagnosis or therapy.

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

• For sterilization validation: The ground truth is the absence of viable microorganisms to a specified sterility assurance level (SAL), measured by biological indicators and microbiological testing methods.
• For shelf-life testing: The ground truth is the stability of the device's material properties, packaging integrity, and sterility over time, measured by physical, chemical, and microbiological tests at various time points.
• For optical performance: The ground truth is (implicitly) the ability to provide "excellent visualization," which is assessed by design specifications and comparison to the known performance of predicate lenses.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

• Not applicable. As above, no training set for an AI model.

Summary of the 510(k) Approach:

The core of this 510(k) submission relies on substantial equivalence to predicate devices that have been legally marketed. The performance data provided mainly addresses the differences between the proposed device and its predicates – specifically, the fact that the new lenses are disposable and sterile. Therefore, the critical acceptance criteria and studies focus on proving the safety and efficacy of these new features (sterility and stability over a shelf life) for a device that otherwise shares fundamental design and intended use with its predicates. No complex clinical trials or AI performance evaluations are presented because they are not required for this type of device and submission pathway.

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The Sensor Medical Family of Vitrectomy Lenses and Products allows visualization of the ocular fundus, vitreous and retinal structures during vitrectomy surgery.

The Sensor Medical Family of Vitrectomy Lenses and Products includes single-use, disposable, sterile devices for use during vitrectomy surgery. The following devices are included in the family: Plano Lens, Magnifier Lens, Bi-Concave Lens, 20 degree Prism Lens, 30 degree Prism Lens, Osher 78 D Lens, Suture Ring, Silicone Ring, and Lens Forceps.

The Sensor Medical Family of Vitrectomy Lenses and Products is designed around the classic Goldmann contact lens. Each style of lens is of similar design, with slight variations in the posterior surface shape to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with an operating microscope, the ophthalmic lenses provide a binocular and stereoscopic view of the specific optical region of the eye.

The lenses typically consist of a PMMA (acrylic) optical element that is applied for a short period of time directly on the globe or cornea of the eye.

Here's a breakdown of the acceptance criteria and the "study" (or lack thereof) based on the provided text, structured according to your request:

Acceptance Criteria and Device Performance

This submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, there are no explicit acceptance criteria for device performance in the traditional sense (e.g., sensitivity, specificity, accuracy metrics).

The "acceptance criteria" here are implied by the demonstration of substantial equivalence to the predicate device. The performance is deemed acceptable if the new device is as safe and effective as the predicate.

Study Information (or lack thereof)

This submission relies on a demonstration of substantial equivalence to a predicate device (Ocular Instruments Disposable Vitrectomy Lens Kit, K012096), rather than a new clinical or performance study of the Sensor Medical devices themselves. The document explicitly states: "No performance data is provided since no new questions of safety and effectiveness are raised."

Given this, many of your requested points are not applicable.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No test set was used for a performance study. Comparison was based on design specifications and intended use against a cleared predicate device.
2. 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. No ground truth establishment for a test set was performed.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was used.
4. 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 device is an optical lens for direct visualization during surgery, not an AI-assisted diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device, to which the new device is being compared.
7. The sample size for the training set: Not applicable. No training set was used.
8. How the ground truth for the training set was established: Not applicable. No training set was used.

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The Diagnostic Lenses are intended to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures. Diagnostic lenses are indicated for use during vitreoretinal surgical procedures.
Allow visualization of the ocular fundus, vitreous, and retinal structures during vitreoretinal surgery.

The Super View Disposable BIOM Lens Set(s) consists of multiple sterile, disposable, thermoplastic lenses for both contact and non-contact use in conjunction with an operating microscope equipped with a BIOM wide-angle viewing system.

This 510(k) premarket notification for the "Super View Disposable BIOM Lens Set" from Insight Instruments, Inc. does not contain a study to prove acceptance criteria in the traditional sense of a clinical trial or performance study with defined metrics.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device. This is a common pathway for Class II medical devices, where the focus is on showing that the new device is as safe and effective as a legally marketed device, rather than proving novel efficacy.

Therefore, many of the requested elements for a study proving acceptance criteria are not explicitly present in this document. I will fill in the table and address the other points based on the information provided, highlighting where data is absent due to the nature of the 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The concept of "acceptance criteria" in this context is implicitly about demonstrating substantial equivalence across these characteristics. There are no quantitative performance metrics (e.g., optical resolution, magnification, field of view metrics) or statistical thresholds explicitly stated as acceptance criteria for the performance of the device itself. The "performance" being reported is the similarity to the predicate device.

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

• Sample Size: Not applicable. This document does not describe a performance study with a test set of data. The "test" is the comparison of characteristics against the predicate device.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable. No ground truth was established by experts for a test set in this submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set was analyzed by multiple reviewers requiring adjudication.

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

• MRMC Study: No. This device is a diagnostic lens, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

• Standalone Performance: No. This device is a physical diagnostic lens. It does not involve an algorithm or AI component to have a "standalone" performance in that sense.

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

• Type of Ground Truth: Not applicable in the context of a performance study. The "ground truth" for this 510(k) submission is the characteristics and established safety/effectiveness of the predicate device. The new device's characteristics are compared against the predicate as the benchmark.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document does not describe the development or training of an algorithm or AI model.

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

• Ground Truth for Training Set: Not applicable.

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The Haag-Streit Contact Glasses are a family of diagnostic and therapeutic contact lenses used in the examination of the eye fundus, retina and irido-corneal angle, and for the laser therapy of intraocular abnormalities.

The HS Contact Glasses is a family of diagnostic and therapeutic contact lenses used for eye examination and therapy of intraocular abnormalities. The HS Contact Glass family is designed around the classic Goldmann contact lenses. All HS Contact Glass models are of similar design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with the HS 900 slit-lamp, the HS Contact Glasses provide a binocular and stereoscopic view of the specific optical region of the eye. The HS Contact Glass typically consists of an aluminum housing, one or more mirror elements and a carved of time directly on the globe or cornea of the eye. The HS contact glass family has two principal modes of use. Those used with laser radiation for therapy of ocular abnormalities. HS Contact Glasses used in diagnostic procedures are made of acrylic plastic (PMMA). These are doolgnou with slit-lamps, such as fundus, the vitreous and the may of HS diagnostic Contact Glasses have the Flaag Otreit Bookine by Goldmann: 59/ 66/ 73 degrees.

The provided text describes a 510(k) summary for Haag-Streit Contact Glasses, a family of diagnostic and therapeutic contact lenses. This submission focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with detailed acceptance criteria and reported device performance metrics in the way one would for a novel AI device or a device requiring clinical trial data.

Therefore, many of the requested sections (e.g., acceptance criteria table with reported performance, sample sizes for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) are not applicable to this type of regulatory submission.

Here's an analysis based on the provided text, indicating which points are not applicable (NA) in this context:

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

Explanation: The 510(k) submission for the Haag-Streit Contact Glasses aims to demonstrate that the device is substantially equivalent to existing, legally marketed predicate devices. This regulatory pathway typically does not involve setting specific quantitative performance acceptance criteria or conducting a clinical study to generate new performance data against those criteria. Instead, it relies on demonstrating that the new device has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness compared to 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)

• Not Applicable. No test set or clinical data is mentioned as part of this 510(k) submission. The submission focuses on product descriptions and comparison to predicate devices, not on proving performance through a clinical study.

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. Ground truth establishment is not relevant for this 510(k) submission, as it does not involve a clinical study requiring such a process.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are not relevant for this 510(k) submission, as it does not involve a clinical study requiring such a process.

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. No MRMC study was performed or is mentioned. The device is a diagnostic/therapeutic contact lens, not an AI-powered diagnostic tool.

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

• Not Applicable. The device is a physical contact lens, not an algorithm. Standalone performance as described is not relevant.

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

• Not Applicable. Ground truth is not relevant for this 510(k) submission, as it does not involve a clinical study requiring such a process.

8. The sample size for the training set

• Not Applicable. Training sets are not relevant for this 510(k) submission, as it does not involve machine learning or AI development.

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

• Not Applicable. Ground truth establishment for a training set is not relevant for this 510(k) submission.

Summary of the Study/Submission:

The document is a 510(k) Premarket Notification Summary of Safety and Effectiveness for the Haag-Streit Contact Glasses. The "study" in this context is the process of demonstrating substantial equivalence to legally marketed predicate devices.

• Device: Haag-Streit Contact Glasses (a family of diagnostic and therapeutic contact lenses).
• Intended Use: Diagnostic and therapeutic examination of eye fundus, retina, and irido-corneal angle, and for laser therapy of intraocular abnormalities.
• Mechanism of Equivalence: The submission asserts that the Haag-Streit Contact Glasses are substantially equivalent to other diagnostic and therapeutic contact lenses already cleared by the FDA. Key predicate devices mentioned are:
  • Volk Optical Inc. (Quadraspheric Fundus Lens- K943125 and K023221)
  • Ocular Instruments Inc. (Saurenghi Scan Laser Lens- K014170)
• Basis of Equivalence: The submission highlights that the diagnostic and laser therapy HS Contact Glasses are constructed of PMMA (Polymethylmethacrylate), similar to previously cleared lenses. They are designed around the classic Goldmann contact lenses and provide similar optical elements for visualization and laser therapy when used with a slit-lamp.
• Conclusion: The FDA determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls.

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The devices are indicated for use as diagnostic contact lenses for eye fundus examinations and use in the therapy of intraocular abnormalities. The devices are sterile, single use, disposable lens systems.

The subject device is a diagnostic and therapeutic contact lens system used for eye fundus examination and therapy of intraocular abnormalities. The lens is one element made from PMMA (polymethylmethracryalate). The lens is a sterile, disposable, single use device.

This document is a 510(k) summary for a medical device called "Volk Disposable Vitrectomy Lenses." A 510(k) submission is typically for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics in the way AI/ML devices often require.

Therefore, many of the requested elements for an AI/ML device study – like acceptance criteria in terms of performance metrics (sensitivity, specificity), expert involvement for ground truth, sample sizes for test/training sets, or MRMC studies – are not applicable to this type of traditional medical device submission.

The "study" here is a comparison with predicate devices to demonstrate substantial equivalence, not a clinical performance study as one would expect for AI/ML.

Here's a breakdown of what can be extracted based on the provided document:

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

• Acceptance Criteria: The primary "acceptance criterion" for a 510(k) is demonstrating "substantial equivalence" in design, intended use, materials, and sterile presentation (if applicable) to one or more legally marketed predicate devices. There are no explicit performance metrics (e.g., accuracy, sensitivity, specificity) stated as acceptance criteria in this document because it's a contact lens, not a diagnostic algorithm.
• Reported Device Performance: The document asserts that the Volk Disposable Vitrectomy Lenses are "substantially equivalent in design, material, classification, and intended use" to the predicate devices. The "performance" being demonstrated is the functional equivalence of the lens for its intended diagnostic and therapeutic use.

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

• Not Applicable. This is not an AI/ML device or a clinical performance study involving a "test set" in the context of data. The "test" here is a comparison of device specifications to predicate devices.

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

• Not Applicable. See point 2. Ground truth establishment for a diagnostic algorithm is not relevant for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. See point 2.

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 a software device involving human readers or AI assistance.

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

• Not Applicable. This is a physical contact lens, not an algorithm.

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

• Not Applicable. There is no "ground truth" in the AI/ML sense. The "ground" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. See point 2.

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

• Not Applicable. See point 2.

In summary: The provided document describes a 510(k) submission for a traditional medical device (a contact lens). The "study" referenced is a comparison to predicate devices for substantial equivalence, not a performance study of an AI/ML diagnostic or therapeutic algorithm. Therefore, the questions designed for AI/ML device evaluation are largely not applicable.

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The Vitrectomy Lenses are intended to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures. Vitrectomy lenses are indicated for use during vitreoretinal surgical procedures.

D.O.R.C. Vitrectomy Lens includes a variety of designs both sterile, single use, disposable vitrectomy lenses, as well as vitrectomy lenses intended to be reused which are sold non-sterile.

This document is a 510(k) summary for the D.O.R.C. Vitrectomy Lens, indicating that it has been found substantially equivalent to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The provided text is a regulatory filing, not a scientific study report.

Therefore, I cannot provide the requested information from the text. The document focuses on regulatory approval based on substantial equivalence, not on performance metrics against predefined acceptance criteria.

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The disposable Vitrectorny Set is used in the context of vitrectorny procedures. The self-blocking infusion cannula with infusion tubing provides the saline solution or balanced saline solution throughout the procedure, ensuring that the eye retains its tonicity. No sutures are required. The knife is used for making a calibrated and non-leaking incision into which the self-blocking infusion cannula is inserted. The lens, used with microscope, facilitates visualization of the retina by canceling the corneal diopter. An edge, which has a frosted ring on its upper side to avoid edge glare effects, allows users to position and move the lens on the cornea with forceps.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to FCI Ophthalmics, Inc., regarding several ophthalmic devices: Disposable Vitrectomy Lenses, Disposable Infusion Cannula, and Surgical Knife.

This document confirms substantial equivalence of these devices to previously marketed predicate devices. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter is an administrative notification of regulatory clearance, not a performance study report.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on:

1. Regulatory Clearance: Granting permission to market the devices based on substantial equivalence.
2. Device Classification: Class II, Class I, and Class I for the respective devices.
3. Indications for Use: Describing the intended purpose of each component within the vitrectomy set.
4. General Regulatory Requirements: Reminding the manufacturer of ongoing obligations like registration, labeling, and good manufacturing practices.

Crucially, there is no mention of specific acceptance criteria (metrics, thresholds), study designs, sample sizes, expert ground truth establishment, or any performance data that would answer the questions posed.

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The device is indicated for use as a diagnostic contact lens for eye fundus examinations and use in the therapy of intraocular abnormalities.

Not Found

This document is a 510(k) premarket notification from the FDA regarding the "Contact Laser & Diagnostic Lenses" by Volk Optical, Inc. It determines that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. The document is a regulatory approval notice, not a study report.

Therefore, I cannot provide the requested information from the given input.

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