Search Results

The Mport™ Foldable Lens Placement System is a Class I device indicated for compressing and inserting a Soflex™ (formerly Chiroflex II) series multi-piece intraocular lens into the eye during small incision cataract surgery.

The Mport™ Foldable Lens Placement System is a device designed to compress and insert a Soflex™ multipiece foldable intraocular lens into the eye during normal small incision cataract surgery. The Mport™ is a single use only disposable device. The Mport™ materials the same as those materials used in the lens/patient contacting cartridge of the predicate device (polypropylene).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Mport™ Foldable Lens Placement System:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Implied" Criteria: The document does not explicitly list "acceptance criteria" with numerical thresholds. Instead, it states that various tests "showed no negative impact" or "supported the fact that technological changes do not raise any new issues," which serves as the de-facto acceptance standard for substantial equivalence.

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

The document does not specify a distinct "test set" sample size for the studies mentioned. The testing summarized appears to be a series of non-clinical, bench-top tests rather than human subject trials with a defined test set.

• Data Provenance: Not explicitly stated. Given the nature of the device (a lens insertion system) and the tests performed (optical specifications, biocompatibility, sterilization), the data is most likely from laboratory and bench testing, rather than human clinical data. The country of origin is not mentioned, but the submitting company is Chiron Vision Corporation in Claremont, California, USA, suggesting the testing was likely conducted in the US or under US regulatory guidance. The studies are retrospective in the sense that they were conducted before the 510(k) submission to demonstrate the device's characteristics.

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

Not applicable. The ground truth for the non-clinical tests described would be derived from objective measurements and scientific principles (e.g., optical measurement standards, biocompatibility guidelines, sterilization efficacy standards), not human expert consensus on a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human-adjudicated test set in this non-clinical evaluation.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The Mport™ is a surgical tool for inserting an intraocular lens.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable in the context of an AI algorithm. The device itself is a mechanical-surgical tool. The "standalone" performance here refers to the device's ability to compress and insert the lens without causing damage or issues, which was evaluated through the non-clinical tests.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on:

• Objective Measurements/Standards: For optical specifications (diopter, resolution, cosmetic appearance), it would be against predefined optical engineering standards and specifications for the lens.
• Biocompatibility Standards: Adherence to established ISO or ASTM standards for materials in contact with the body.
• Sterilization Efficacy Standards: Adherence to established standards for ethylene oxide (EO) sterilization.
• Functional Adequacy: The ability to successfully deliver the lens without damage, as per the device's intended function.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical tool, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Hansatome™ microkeratome is a precision-manufactured instrument indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.

The Hansatome™ microkeratome is a precision-manufactured instrument designed for cutting a precise corneal disc of preselected thickness and diameter. The device is intended for use in performing lamellar corneal resections. The Hansatome™ Microkeratome materials are similar to those used in the predicate device.

This submission for the Hansatome™ Microkeratome is a 510(k) premarket notification, claiming substantial equivalence to a predicate device (Automatic Corneal Shaper, K913697). As such, it focuses on demonstrating that the new device is as safe and effective as the predicate, rather than providing extensive de novo clinical study data to meet specific acceptance criteria for performance. The summary explicitly states that the technological changes "do not raise any new issues of safety, effectiveness or performance of the product," relying on the predicate's established performance.

Therefore, the "acceptance criteria" here are primarily about demonstrating equivalence in performance to the predicate device in non-clinical tests.

Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study described is a non-clinical comparative test.

1. Sample size used for the test set and the data provenance: Not specified. The document states "will be tested" and "was found to perform equivalently," implying non-clinical testing was conducted, but details on sample size or data provenance (e.g., in-vitro tests on cadaver eyes, animal models) are not provided. It is considered retrospective as per the K913697.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was a non-clinical comparison focusing on mechanical performance (creation of corneal resections) and material equivalence, not expert-adjudicated clinical outcomes.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human adjudication of clinical data is described.

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 is a mechanical surgical device, not an AI-assisted diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical surgical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" implicitly refers to the established performance characteristics and specifications of the predicate device. The performance of the new device was compared against these. For the "creation of corneal resections," the ground truth would likely be quantitative measurements of the consistency, thickness, and diameter of resections performed by the device on an appropriate test medium (e.g., cadaveric eyes, synthetic cornea models).

7. The sample size for the training set: Not applicable. As a non-AI mechanical device, there is no "training set."

8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Synergist™ Power Pack is intended for use in cataract surgery or other ophthalmic surgical procedures where precision surgical tissue removal is required.

The Synergist™ Power Pack is an accessory device that operates in conjunction with currently marketed Phaco Emulsifier Aspirator Systems used in ophthalmic surgery. The Synergist™ replaces the ultrasonic handpiece of the host console. As such, it is intended for use in cataract surgery or other ophthalmic surgical procedures where precision surgical tissue removal is required. The Synergist™ delivers two distinct surgical capabilities: 1) load compensating ultrasonic handpiece power, and 2) Tmesis™ multifunction handpiece capability.

The Synergist™ Power Pack consists of:

Power Pack Console
Connector Cables
Tmesis™ multi-function handpiece,
Adjunct Footswitch
Ultra Tip™ Pack in various configurations

The Synergist™ Power Pack utilizes the programmable features of the Phaco Emulsifier host console but contains no software or firmware. It is controlled by the amplified signal of the host console by measuring the handpiece output of the host console and establishing that exact power level to the connected handpiece. Displayed power levels and energy summations on the host console are precisely maintained by the Synergist™. The Power Pack neither provides or utilizes power from the host console.

This document describes a medical device, the Synergist™ Power Pack, and claims substantial equivalence to a predicate device, the Phacotron™ Gold Multifunction Ultrasonic (Tmesis™) Handpiece. The provided text is a K960414 510(k) summary. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting de novo clinical studies with detailed acceptance criteria and performance data for the novel device itself.

Therefore, many of the requested elements for describing standalone device performance and a comparative effectiveness study involving AI with human readers are not applicable or extractable from this specific type of regulatory submission. The information below reflects what can be inferred or directly extracted from the provided text, indicating where information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

No explicit "acceptance criteria" for the Synergist™ Power Pack as a standalone device's performance are provided in terms of specific metrics like accuracy, sensitivity, or specificity, nor are there reported performance statistics for these. The document focuses on demonstrating substantial equivalence to the predicate device's operational characteristics and intended use.

The comparison table provided in the 510(k) focuses on technological characteristics for substantial equivalence:

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

• Not Applicable. The 510(k) submission does not describe a "test set" of data or patients to evaluate the Synergist™ Power Pack's performance in a clinical study with specific metrics. The substantial equivalence claim is based on comparing the device's technical specifications and intended use to an existing predicate device.
• The document implies that the device operates "in conjunction with currently marketed Phaco Emulsifier Aspirator Systems" and "replaces the ultrasonic handpiece of the host console," suggesting its performance is tied to the established safety and efficacy of the host systems and the predicate handpiece.

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

• Not Applicable. As no specific clinical "test set" or evaluation requiring ground truth establishment for the Synergist™ Power Pack's performance is described, this information is not provided.

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

• Not Applicable. No clinical test set or adjudication method is 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 device is a surgical accessory (a phacofragmentation system component), not an AI-assisted diagnostic or decision-support tool for human "readers." The concept of "human readers improve with AI vs without AI assistance" does not apply to this device.

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

• Not Applicable. This device is a physical surgical accessory. It does not perform "algorithm only" functions in the sense of an AI or software-based medical device. Its operation is inherently "human-in-the-loop" as it is controlled by a surgeon via a footswitch and integrates with an existing Phaco Emulsifier host console.

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

• Not Applicable. As no specific clinical test set requiring ground truth is detailed for the Synergist™ Power Pack, this information is not provided. The "ground truth" for this type of submission is the demonstrated safety and effectiveness of the predicate device and the assertion that the new device is substantially equivalent in terms of technology, intended use, and performance characteristics.

8. The sample size for the training set

• Not Applicable. This device is a physical surgical instrument accessory. It does not utilize machine learning or AI models, and therefore does not have a "training set" in that context.

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

• Not Applicable. As stated above, there is no "training set" for this type of device.

Ask a specific question about this device