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The xact™ foldable lens inserter is a device intended to fold the AVS 3-piece foldable lens, 6mm or 7mm optic, and assisting in placing it into the capsular bag of the eye to replace the natural crystalline lens during normal smallincision cataract surgery. It provides a small tubular pathway in which the foldable lens can be placed into the eye with a continuous forward motion.

The xact lens inserter (Model 6mm / 7mm) is a light weight plastic, single use, disposable device. It has a multi piece design, with an injector/handpiece unit and a separate cartridge.

The lens is delivered manually by action of the plunger. The final delivery is done by a screwthread action. The final injection needs 2- 3 turns with screw thread until the final position of the plunger. The plunger allows for forward and backward action during delivery. The front end of the plunger is visible during delivery.

The lens inserter (Model 6mm / 7mm) is for both handed use: one hand for gripping and directing, while activating the plunger with the other. The plunger doesn't rotate inside the handpiece.

The lens is rolled rather than folded. The cartridge or rolling/folding mechanism locks in place on the handpiece.

The provided text contains information about a 510(k) summary for the xact™ Injector, an intraocular lens inserter. However, it does not include the specific details required to answer your questions about acceptance criteria, a study proving device meeting criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document only states that:

"The xact™ lens inserter (Model 6mm / 7mm) has been tested in vitro for proper functioning under various conditions of use. The results of these performance tests demonstrate that the xact™ lens inserter (Model 6mm / 7mm) reliably delivers the Advanced Vision Science® 3-piece foldable lens without impacting the optical performance, the dimensions or the cosmetic appearance of the lens."

This statement confirms that performance tests were conducted and the device met certain functional requirements related to lens delivery and preservation of lens quality. However, it does not provide the specific "acceptance criteria" or the detailed "study" information requested.

Therefore, I cannot fill in the table or provide the specific details for the requested points based solely on the provided text. The document is a 510(k) summary, which often summarizes testing results without detailing the methodology or specific acceptance criteria in the public-facing document.

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The CM3910 is a device intended to take images of the anterior segment of the eye which includes the cornea, iris, pupil, anterior chamber and lens, to evaluate and analyse

• · Corneal shape
• · Lens shape
• · Pachymetry (thickness of the cornea)
• · Pupil size
• · Lens thickness
• · Condition of the lens
  • o Location of cataracts (nuclear, subcapsular and or cortical), using Scheimpflug slit imaging with densitometry
  • State of the lens (opaque crystalline lens) o
• · Condition and position of implants (e.g. iOLs, phakik IOLs, intracorneal rings)
• · Anterior chamber (size, volume and angle)
• · Scheimpflug Image
• · Position of the cornea relative to iris and lens

The CM 3910 Double-Scheimpflug Camera is a non-invasive, diagnostic system designed for the analysis of the anterior eye segment by means of Scheimpflug and Placido images. The Scheimpflug images are based on the Scheimpflug Principle for Slit Image photography. The system is table mounted and AC powered. The device consists of a measurement unit and a control unit with a CPU. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for taking images. The measuring unit takes pictures by a rotating scan of the anterior eye segment. It also includes a top view for eye tracking means and Placido imaging in the near infrared. From the acquired pictures, the control unit calculates a 3D-model and the topography of the eye.

The provided text is a 510(k) summary for the CM 3910 Rotating Double Scheimpflug Camera. This type of document is submitted to the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. While it describes the intended use, device description, and comparison to predicate devices, it does not provide specific acceptance criteria or an analytical study proving the device meets those criteria in the way you've requested for performance metrics like sensitivity, specificity, etc.

The summary states: "The CM 3910 is proven effective for its intended uses through internal performance tests." However, it does not elaborate on these internal performance tests, their methodologies, acceptance criteria, or the results.

Therefore, many of your requested points cannot be answered from the provided text. I will address the points that can be inferred or explicitly stated.

Acceptance Criteria and Study for CM 3910 Rotating Double Scheimpflug Camera:

Based on the provided 510(k) summary, the primary "acceptance criterion" for this device, as presented to the FDA, is its substantial equivalence to existing legally marketed predicate devices (Pentacam Scheimpflug Camera and Orbscan II™ Keratometer). The study that "proves the device meets the acceptance criteria" is essentially the product comparison demonstrating this substantial equivalence on various characteristics.

The summary highlights the following as rationale for substantial equivalence, implying these are the key "acceptance criteria" for demonstrating equivalence:

• Same intended use: Taking photos of the anterior segment of the eye for evaluation and analysis.
• Same measuring principles: Slit Scan and Placido Disc.
• Same photographic medium: CCD Camera.
• Comparable light sources: Wavelength and intensity.
• Same features: Head stabilizing device, fixation target, joystick.
• Classification: Non-invasive as defined in 21 CFR §812.3(k).

Here's a breakdown of your requested information, with disclaimers for what is not present in the document:

1. Table of acceptance criteria and the reported device performance:

   • Note: The document does not provide quantitative acceptance criteria (e.g., target accuracy, precision, sensitivity, specificity) for specific clinical measurements (e.g., corneal shape, pachymetry) of the CM 3910, nor does it provide detailed quantitative performance results from a clinical study for these parameters. The "performance" assessment here is implied through comparison to predicate devices.

   Acceptance Criterion (Implied for Substantial Equivalence to Predicate)

   Reported Device "Performance" (Comparison to Predicate)

   Intended Use

   CM 3910: Taking photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye, to evaluate and analyze various parameters (Corneal shape, Lens shape, Pachymetry, Pupil size, Lens thickness, Condition of the lens (cataracts, opaque lens), Condition and position of implants, Anterior chamber (size, volume, angle), Scheimpflug Image, Position of the cornea relative to iris and lens).

Predicate (Pentacam): Same.
Predicate (Orbscan II™): Scan, map and display the geometry of the anterior segment of the eye (broader, but overlaps). Conclusion: Same intended use. |
| Measuring Principle | CM 3910: Rotational scan of Double-Scheimpflug slit images merged with Placido Disc images.
Predicate (Pentacam): Rotational scan of Scheimpflug slit images.
Predicate (Orbscan II™): Parallel scanned slit images and Placido Disc images. Conclusion: Uses same core principles (Slit Scan and Placido Disc). |
| Photographic Medium | CM 3910: CCD Camera.
Predicate (Pentacam): CCD Camera.
Predicate (Orbscan II™): CCD Camera. Conclusion: Same photographic medium. |
| Light Sources | CM 3910: Blue LED Light (UV-free) 470 nm, max. 15 mWsec.
Predicate (Pentacam): Blue LED Light (UV-free) 475nm, max. 2.5 Wsec.
Predicate (Orbscan II™): Not specified for flash. Infrared LED 810nm for observation (CM 3910) vs 800nm (Pentacam). Conclusion: Comparable wavelength and intensity (CM 3910 and Pentacam). |
| Core Features | CM 3910: Head stabilizing device, fixation target, joystick for measurement head adjustment.
Predicates: Implied to have similar features or the absence of new/different features in CM 3910 does not raise safety/effectiveness concerns. Conclusion: Uses the same features. |
| Classification | CM 3910: Class II, MXK.
This classification is not directly stated for the predicates in this document, but implied to be equivalent. Conclusion: Non-invasive diagnostic system. |

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

   • Not provided. The document states "The CM 3910 is proven effective for its intended uses through internal performance tests," but it does not describe any specific clinical test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The primary "test" presented for FDA submission is the comparison to predicate devices, which relies on the established performance of those devices rather than new clinical data for the CM 3910.

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

   • Not applicable / Not provided. Since no specific clinical test set and ground truth establishment methodology are described for the CM 3910's "internal performance tests" in this summary, information about experts and their qualifications is not available.

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

   • Not applicable / Not provided. No adjudication method is mentioned as a specific clinical test set is not 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 an imaging system, not an AI-assisted diagnostic tool for human readers in the traditional MRMC sense. It provides images and calculated parameters. The document does not describe any studies comparing human reader performance with or without the device, or with differing versions of the device.

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

   • Yes, to an extent. The "internal performance tests" mentioned are likely standalone tests evaluating the device's ability to acquire and process images and calculate parameters. The device itself is an "algorithm only" type in that it performs calculations based on acquired images to provide data like corneal shape, pachymetry, etc. The document does not provide details of these tests or their results. The "Product Comparison" table implicitly serves as a standalone comparison against predicate device specifications.

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

   • Not provided. For the device's "internal performance tests," the type of ground truth used is not specified. For the substantial equivalence argument, the "ground truth" is essentially the established safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set:

   • Not applicable / Not provided. As this is not an AI/ML device relying on a "training set" in the common sense, no such information is provided. Its calculations are based on established optical and geometric principles.

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

   • Not applicable / Not provided. See point 8.

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The Amadeus II Epikeratome is intended for use in performing lamellar corneal resections. This is the same intended use as previously cleared for the Amadelis microkeratome, K993190.

The Amadeus II Epikeratome is intended for use in the separation of epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.

The Amadeus II Epikeratome is a modification of the ACCM/Amadeus Microkeratome, which is firmly established in the market for several years. In the course of a product update, the designs of blade and blade holder have been modified to provide surgeons with the option to perform Epi-LASIK.

The surgical principles of the Amadeus II Epikeratome and its predicate device are essentially identical. To perform a lamellar corneal resection, the cornea is held in position by means of a suction ring, and vacuum is applied to increase intraccular pressure to a level allowing the epikeratorne blade to move across the cornes in a mode similar to that of a carpenter's plane. The corneal flap is made by the same open ating principle as in the predicate device, i.e., a blade is advancing and simultane opelva oscillating horizontally and perpendicular to the advancement direction. A Control Unit provides power and a controlled vacuum for fixing the eye.

The comeal flap created by the epikeratorne consists of the entire epithelium, while in the predicate device it consists of the entire epithelium plus parts of the stroma. This difference in flap structure is obtained by modifications of the blade and thre hlade holder.

Like its predicate device, the Amadeus II Epikeratome comprises three major groups of components:

• a) A Handpiece, incorporating the Suction Unit, the Blade Holder, the Epikeratome Epi-A handpiece, IntoSperating theit. The Handpiece offers several safety features designed to prevent product malfunction or incorrect use, and allows the surgeon to handle the Epikeratome with only one hand.
• b) A Control Unit with touch-screen interface, managing the epikeratome's cutting A Gontrol Only With toutic documentation of the chosen cutting parameters and user interface dialogs.
• c) Two footswitches that serve to actuate and discontinue the epikeratome cutting r wo rocedure. The standard actuation footswitch serves to initiate suction and the epikeratome cutting action.

Disposable components of the Amadeus II Epikeratome system are 1) a sterile plastic epikeratome blade and 2) a sterile vacuum tubing kit. Additionally, an autoclavable instrument tray is provided for sterilization.

This device is an Amadeus II Epikeratome, a surgical tool used to separate the epithelium from the cornea. The device is a modification of a predicate device, the Amadeus Microkeratome (K993190), and is used for lamellar corneal resections.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Unfortunately, the provided document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., flap thickness, precision, consistency, failure rates) for the Amadeus II Epikeratome.

Instead, the submission focuses on demonstrating substantial equivalence to its predicate device. The rationale for substantial equivalence is based on:

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

The document mentions "Design controls (e.g., risk assessment, design verification and design validation), as well [as a] non-clinical study, were used to demonstrate that the changes made to the device are safe and effective."

However, no specific sample size for a test set is provided within this 510(k) summary. The details of this "non-clinical study" (e.g., lab testing, animal models, cadaver eyes) and data provenance are not elaborated upon. The context strongly suggests this was not a clinical study involving human patients.

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

Given that the document refers to a "non-clinical study" and focuses on substantial equivalence based on engineering and design similarities, there is no mention of experts being used to establish ground truth for a test set in the way one would for diagnostic AI.

For a surgical device like an epikeratome, "ground truth" would likely relate to objective measurements of flap quality, thickness, smoothness, consistency, and epithelial integrity, possibly performed by engineers or specialized technicians during laboratory testing, rather than human experts evaluating subjective outcomes.

4. Adjudication Method for the Test Set

As no specific test set involving human interpretation of data is described, there is no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted or reported for this device. This is a surgical instrument, not an AI diagnostic system where human readers would interpret results.

6. Standalone Performance Study (Algorithm Only)

No, a standalone performance study in the context of an algorithm's performance (without human-in-the-loop) was not conducted or reported. This device is a mechanical surgical tool.

7. Type of Ground Truth Used

Based on the documentation, the "ground truth" likely refers to:

• Engineering specifications and design requirements: Ensuring the modified blade and blade holder achieve the desired epithelial flap while maintaining the core operating principle.
• Performance metrics in non-clinical testing: This would involve objective measurements (e.g., using imaging, microscopy, or physical gauges on excised tissue or models) to confirm flap characteristics, cutting precision, and consistency.
• Compliance with safety standards: Verification that the device's safety features function as intended.

The document does not mention pathology, outcomes data from human patients, or expert consensus in relation to a specific test set.

8. Sample Size for the Training Set

Since this is a mechanical surgical device and not an AI/machine learning system, the concept of a "training set" for an algorithm does not apply.

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

As there is no training set mentioned, this question is not applicable.

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