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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 magnification during vitreoretinal surgery.

The Endoview™ Sapphire Contact Lens Set consists of one sterilization container, one lens ring (either infusion or non-infusion), and one each of the following lenses: Plano Concave, Symmetric Concave-Concave, Asymmetric Concave, Prism 15° - Concave, Prism 30° Concave, and a Prism Concave-Concave Lens. The lenses, rings and sterilization container may be sold separately or as a set. During vitreoretinal surgery, the surgeon requires the aid of a contact lens in order to visualize the posterior segment of the eye. First, the ring is sewn onto the sclera to hold the lens in place on the cornea. The customer has the option of choosing a ring with an infusion port, which eliminates the need for the surgeon to constantly place irrigant on the corneal. Once the ring is in place, the surgeon places one of the lenses in the ring in order to visualize the posterior segment of the eye. The surgeon changes the lenses during the case depending on where visualization is required.

The provided text is a Premarket Notification [510(k)] Summary for the "Endoview™ Sapphire Lens Set" by American Medical Devices, Inc. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study with acceptance criteria for device performance in the way a clinical trial or AI/software validation would.

Therefore, the document does not contain the specific information requested in your prompt regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/software device.

The study presented here is a comparison to predicate devices to demonstrate that the Endoview™ Sapphire Lens Set is as safe and effective as existing products.

Here's a breakdown of why many of your categories cannot be filled from this document:

• Acceptance Criteria and Reported Device Performance: Not applicable in the context of this 510(k) submission. The "performance" being assessed is substantial equivalence to predicate devices, not meeting specific quantitative clinical performance metrics.
• Sample size for the test set and data provenance: No test set in the sense of clinical data is described. The comparison is feature-based against existing devices.
• 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" in this context would refer to the characteristics and performance of the predicate devices, which are established by their prior marketing clearance.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical contact lens, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for substantial equivalence is the established safety and effectiveness of the identified predicate devices.
• The sample size for the training set: Not applicable. There is no "training set" for a physical medical device in this context.
• How the ground truth for the training set was established: Not applicable.

However, I can extract the substantial equivalence comparison, which serves as the "study" for this type of submission:

1. Table of Acceptance Criteria and the Reported Device Performance

In a 510(k) submission, "acceptance criteria" relate to demonstrating that the new device shares characteristics with legally marketed predicate devices, thereby establishing "substantial equivalence." The "performance" is the new device's features matching or being comparable to the predicate devices.

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not applicable. This is a comparison of design features and materials, not a clinical data set. The "sample" can be considered the set of predicate devices identified by the manufacturer (DORC, Grieshaber, Ocular Instruments).
• Data Provenance: The "data" pertains to the specifications and characteristics of the Endoview™ Sapphire Lens Set and those of the predicate devices. This information is derived from the manufacturer's design specifications and existing market information for predicate devices.

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

• Not applicable. The ground truth is established by the known characteristics and approved status of the predicate devices as legally marketed medical devices. The FDA regulatory staff (like the Director of the Division of Ophthalmic Devices) assess the submission.

4. Adjudication method for the test set:

• Not applicable. The assessment is a regulatory review for substantial equivalence, not a clinical 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 is a physical surgical device, not an AI/software diagnostic tool.

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

• Not applicable. This is a physical surgical device.

7. The type of ground truth used:

• Substantial Equivalence: The "ground truth" is the established safety, effectiveness, and intended use of the legally marketed predicate devices (DORC, Grieshaber, Ocular Instruments). The new device is compared feature-by-feature to these predicates to demonstrate that it raises no new questions of safety or effectiveness. Additionally, the use of Sapphire as a material had prior FDA clearance in other ophthalmic devices (K853129, K860852, K861744).

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of a physical device's 510(k) submission.

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

• Not applicable.

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For illumination and irrigation/aspiration during surgery.

The American Medical Devices, Inc 19 and 20 ga. Endolight™ End Irrigating Endo-Illuminators are for illumination and irrigation during surgery. It consists of a stainless steel needle, delrin handpiece, PMMA fiberoptic fiber with plastic cladding, aluminum connector, and silastic tubing with luer lock connector. It connects to any conventional light source via an aluminum accessory adapter, which is packaged separately. This device also connects to any standard syringe with a male luer lock. The surgeon can then use the device to irrigate and aspirate while illuminating.

The provided text describes a premarket notification (510(k)) for the American Medical Devices, Inc., 19 and 20 Ga. Endolight™ End Irrigating Endo-Illuminator. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria.

This submission is focused on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing performance against specific acceptance criteria through a clinical or performance study. The core of this 510(k) is a comparison of design features, materials, and intended use with predicate devices.

Therefore, I cannot provide the requested information from the given text as it is not present. The document focuses on regulatory approval based on equivalence, not on a detailed performance study with acceptance criteria.

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For irrigation/aspiration during eye surgery.

The American Medical Devices, Inc 19 and 20 ga. Endosoft™ Soft Tip Needles are for irrigation/aspiration during eye surgery. The device consists of a stainless steel needle with a plastic luer lock on one end and a protruding piece of soft silastic tubing at the tip. This device connects to any conventional extrusion handpiece with a male luer lock adapter.

This document is a 510(k) Premarket Notification summary for the American Medical Devices, Inc., 19 and 20 Ga. Endosoft™ Soft Tip Needles. It describes the device and claims substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on device characteristics, indications for use, materials, and sterilization methods, rather than performance metrics.

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For illumination during ophthalmic surgery

The American Medical Devices, Inc., 19 and 20 ga. Endolight™ Fiberoptic Endo- Illuminators are for illumination during ophthalmic surgery. The device consists of a stainless steel needle with a delrin handpiece, PMMA fiberoptic fiber with plastic cladding and an aluminum connector. This device connects to any conventional light source via an aluminum accessory adapter, which is packaged separately.

This 510(k) summary (K970875) describes a fiberoptic endo-illuminator. However, the document does not contain information regarding acceptance criteria or a study proving the device meets specific acceptance criteria.

The provided text focuses on:

• Device Description: The physical characteristics and materials of the Endolight™ Fiberoptic Endo-Illuminator.
• Indications for Use: For illumination during ophthalmic surgery.
• Substantial Equivalence Comparison: A table comparing the device's features (packaging, indication, materials, sterilization) to predicate devices (Storz, Grieshaber & Co) to demonstrate substantial equivalence.
• Sterility Information: Details on ETO sterilization, packaging, SAL, and residue levels, as well as pyrogenicity testing (LAL method).
• FDA Clearance Letter: Official communication from the FDA confirming the device's substantial equivalence and clearance to market.

Therefore, I cannot provide the requested table and study details as they are not present in the provided document.

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For illumination during surgery. Regular Monofilament - Inserts into any standard Fiberoptic Pic Set. Fine Monofilament - Inserts into any standard Fiberoptic Forceps.

The American Medical Devices Endolight™ Regular and Fine Monofilaments are for illumination during surgery. The Regular Monofilament inserts into any standard pic set. The Fine Monofilament inserts into any standard fiberoptic forceps. These fibers allow the surgeon to use bi-manual technique during surgical procedures. The devices are identical except for the fact that the Regular Monofilament is a 19 ga. fiber and the Fine Monofilament is a 20 ga. fiber.

This is a 510(k) premarket notification for a medical device (fiberoptic monofilaments for surgical illumination), not an AI/ML device. Therefore, the provided text does not contain information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement typically associated with evaluating AI/ML device performance.

The document focuses on demonstrating substantial equivalence to predicate devices, sterilization methods, and material descriptions. It does not involve any algorithm performance, human-in-the-loop studies, or standalone algorithm evaluations.

As such, I cannot extract the requested information regarding AI/ML device performance and evaluation from this document.

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