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The Sovereign™ Cataract Extraction System is a phacofragmentation system for use with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Sovereign™ Cataract Extraction System is designed to provide the surgical capabilities desired by the Anterior Segment/Cataract Surgeon for use in the cataract extraction.

The Sovereign™ Cataract Extraction System is a phaccemulsification system which is used by ophthalmic surgeons during cataract surgery. Accessories, which are connected to the consoles, aid the surgeon in breaking up and removing the cataract from the patient's eye. The Sovereign™ Cataract Extraction System is a modification of a previous device and is substantially equivalent to the predicate devices listed above.

The provided Premarket Notification 510(k) Summary for the Sovereign™ Cataract Extraction System describes non-clinical performance testing rather than a clinical study with acceptance criteria in the format typically associated with AI/ML device evaluations. This submission precedes the widespread use of such technologies in medical devices.

Therefore, the information you requested about acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for AI/ML devices is not applicable or extractable from this document.

However, I can extract the information relevant to the performance testing that was conducted as described in the document.

Acceptance Criteria and Device Performance (Based on "Brief summary of nonclinical tests and results"):

Additional Information (Not Applicable/Not Provided in the Document for AI/ML specific criteria):

1. Sample size used for the test set and the data provenance: Not applicable. The document mentions "in vivo model system" but does not specify sample sizes or data provenance in the context of clinical test sets. This was likely bench and animal testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML models (e.g., expert consensus on images or pathology) is not relevant to this type of device and testing.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 a surgical system, not an AI diagnostic or assistance tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical system that requires a human operator (ophthalmic surgeon).
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is the performance of the predicate devices against which the Sovereign™ system's performance was compared in non-clinical settings (e.g., "in vivo model system"). The document implies that the established functionality and performance characteristics of the predicate devices served as the standard for comparison.
7. The sample size for the training set: Not applicable. This device does not use an AI/ML algorithm that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The study referenced in the 510(k) summary is a "performance testing" of the Sovereign™ Cataract Extraction System. This testing was non-clinical and involved comparisons to predicate devices (other AMO® cataract extraction devices). The primary purpose was to demonstrate "substantial equivalence" to previously cleared devices rather than to meet specific statistical performance metrics against a clinical ground truth as would be required for an AI/ML diagnostic system. The testing covered functional aspects like phacoemulsification, irrigation, diathermy, vitrectomy, and fluidics in an "in vivo model system," as well as durability studies for reusable components.

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The Eye Irrigator, Ocular Irrigating System, is indicated for use as an eyeirrigating device. It is designed especially for post-traumatic injury, chemical exposure and burns, permitting irrigation of the eye and under the upper eyelid, with sterile saline.

The Eye-Deal Eye Inigator, an ocular irrigator, consists of a plastic irrigation tube that works like a shower-head to irrigate continuously from under the upper eye-lid. The device is held in place with the lower speculum wire resting within the lower lid. The frame of the irrigator can be applied using adhesive tape provided, to the cheek of the patient, to stabilize the irrigator during the procedure. The device is designed to provide approximately 20 minutes of irigation using a standard saline bag.

The provided text describes a 510(k) submission for the "Eye-Deal Eye Irrigator" and a preliminary study conducted to support its substantial equivalence. However, it does not explicitly define acceptance criteria in a quantitative manner or present a rigorous study designed to prove the device meets such criteria. Instead, the study aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not define explicit, quantitative acceptance criteria in the way you might expect for a typical performance study (e.g., "device must achieve 90% sensitivity"). Instead, the 'acceptance' is based on demonstrating substantial equivalence to the predicate device, the Morgan Lens. The reported performance is qualitative for the most part.

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

• Sample Size: "Six patients and 12 total eyes" were compared.
• Data Provenance: Not explicitly stated, but clinical studies are generally conducted in the country of origin of the submitter unless otherwise specified. Given the company is based in Wisconsin, USA, and the correspondent in Minnesota, USA, it is highly probable the data is from the USA. The study was prospective as it involved actual comparison in patients.

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

The study does not describe establishing a "ground truth" using experts in the clinical sense (e.g., diagnosis verification). Instead, it compares the physical performace of two devices in terms of fluorescein clearance, patient tolerance, and ease of use. The "technicians" or "emergency care providers" who inserted the device would be the evaluators of "ease of insertion," and the patients provided feedback on "tolerance."

4. Adjudication Method for the Test Set

Not applicable in the typical sense. The study was a direct comparison of device performance parameters (fluorescein clearance, tolerance, ease of use) between the Eye Irrigator and the Morgan Lens, rather than a diagnostic performance study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a medical device (physical irrigator), not an AI 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.

7. The Type of Ground Truth Used

For the clinical comparison, the "ground truth" was the direct observation of fluorescein clearance by an observer (likely a clinician), patient self-reported tolerance, and clinician assessment of ease of use. This is essentially an observational outcome comparison.

For the material and sterilization aspects:

• Materials: Laboratory testing against ISO 10993-1 standards (biocompatibility assays).
• Sterilization: Process validation based on physical/biological indicators to achieve a Sterility Assurance Level (SAL) of 10-6.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm requiring a training set.

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

Not applicable, as no training set was used.

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For infusion of fluid and air during vitrectomy.

During a vitrectorny, it is necessary to irrigate balanced salt solution (BSS) into the eye to replace the natural vitreous. If a retinal hole is present, the surgeon must then replace the balanced salt solution (BSS) with air to prevent the fluid from remaining under the retina. One of the problems associated with fluid/air exchange is development of cataracts. The Moistair™ Tubing Set humidifies the dry air prior to introduction into the eye. In order to humidify the air, 1 cc of balanced salt solution (BSS) is injected into the injection port on the humidifying filter prior to use.

Here's an analysis of the provided text regarding acceptance criteria and study information for the American Medical Devices, Inc. Moistair™ Fluid/Air Tubing Set:

It's important to note that this 510(k) summary (K974561) is for a Class II medical device and focuses primarily on establishing substantial equivalence to a predicate device. Substantial equivalence typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness profile as a legally marketed predicate device. This often means testing to ensure it meets performance requirements similar to or demonstrably equivalent to its predicate, rather than establishing entirely new performance criteria through extensive clinical trials.

The provided document does not contain detailed acceptance criteria tables with specific quantitative metrics or a full study report in the way one might expect for a complex, novel device or a clinical outcome study. Instead, it describes compliance with established standards and performance characteristics in comparison to a predicate.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, a formal table of quantitative acceptance criteria is not present. However, we can infer performance characteristics the device meets. The device relies on existing standards for sterilization and pyrogenicity.

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

The document does not describe "test sets" in the context of clinical or performance data for specific device outcomes beyond sterility and pyrogenicity.

• Sterility and Pyrogenicity Validation: These are typically performed on a statistically significant sample size from manufacturing lots according to AAMI and LAL method guidelines, respectively. The specific sample sizes for these validations are not mentioned in this summary.
• Data Provenance: The document does not describe patient data or clinical trial data collection. The information presented is related to manufacturing validation and device characteristics, not clinical performance. Thus, concepts like "country of origin of the data" or "retrospective/prospective" studies are not applicable to the information provided.

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

This information is not applicable or not provided in the context of this 510(k) submission. "Ground truth" in this document refers to established standards and methods for sterilization and pyrogenicity, which are determined by regulatory bodies and scientific consensus, not individual experts for a specific test set.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Adjudication methods are typically used in clinical studies or expert reviews of ambiguous cases. Here, compliance is determined by validated laboratory methods (AAMI Overkill, LAL Method) against established regulatory limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or described. This type of study is relevant for diagnostic imaging devices where human readers interpret results, and would evaluate the impact of an AI algorithm on reader performance. The Moistair™ Fluid/Air Tubing Set is a therapeutic/surgical device, not a diagnostic imaging device.

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

No, a standalone AI algorithm performance study was not done or described. This device is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and performance claims is primarily based on:

• Established scientific and regulatory standards: Such as AAMI guidelines for ETO sterilization and the LAL Method for pyrogenicity.
• Engineering and design specifications: Demonstrating that the device's materials and construction are substantially equivalent to a legally marketed predicate device.
• Predicate device's known safety and effectiveness: The Moistair™ Tubing Set establishes substantial equivalence to the Grieshaber & Co. device, implying that the predicate's extensive history and regulatory clearance serve as a "ground truth" for acceptable performance for this device type.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

Not applicable. As there is no training set for an AI algorithm.

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For intermittent or continous irrigation, flushing, and cleansing of eyes

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "ML Disposable ALK Tubing". It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot provide the requested information based on the given text. The text does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the number/qualifications of experts.
• Information on adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
• The type of ground truth used.
• Information about training sets or how their ground truth was established.

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