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The VisuMax Femtosecond Laser is cleared for the following indications for use:

· In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea;

· In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea;

· In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty;

· In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting;

· In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.

The VisuMax Femtosecond Laser is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. The cutting action of the VisuMax laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.

The provided text describes the 510(k) premarket notification for the Carl Zeiss Meditec VisuMax Femtosecond Laser (K173371). The focus of this submission is on software modifications to enable an additional indication for use: "creation of tunnels for placement of corneal ring segments."

The submission concludes that the device is substantially equivalent to predicate devices, but it does not contain specific acceptance criteria, comprehensive study designs, or detailed results typically found in a clinical study report. Instead, it provides a summary of the performance testing.

Here's an attempt to extract the requested information based only on the provided text, with acknowledgments for missing data:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "Test acceptance criteria...were met" but does not explicitly define the quantitative metrics or thresholds for these criteria. The acceptance criteria above are inferred from the description of the tests.

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

• Sample Size for Test Set: The document mentions "a series of corneal models" and "all corneas tested in this manner," but does not specify the exact number (sample size) of ex vivo corneas or corneal models used for performance testing.
• Data Provenance: The testing involved "ex vivo corneas" and "corneal model material." The country of origin is not specified, and the data is retrospective in the sense that it's laboratory/bench testing and not a prospective clinical trial on human subjects for this specific claim.

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

• The document mentions "ex vivo corneas" and "corneal model material" for performance testing. The evaluation of cut quality mentions "judged to be of good cut quality," implying subjective assessment.
• However, the number of experts and their qualifications (e.g., radiologists with X years of experience) used to establish ground truth or evaluate these ex vivo tests are not specified in the provided text.

4. Adjudication Method for the Test Set

• The document implies subjective judgment for cut quality ("judged to be of good cut quality").
• However, a formal adjudication method (e.g., 2+1, 3+1) is not described for any aspect of the performance testing in the provided text. The non-contact optical techniques used for dimensional measurements suggest objective assessment rather than adjudication by human experts.

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

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study to assess improvement in human readers with/without AI assistance was not done/described in this submission. This device is a surgical laser, not an AI diagnostic tool that assists human readers.

6. Standalone Performance Study (Algorithm Only)

• A standalone performance study focused on the algorithm's performance without human-in-the-loop was not explicitly described in the conventional sense of AI diagnostic devices. The performance data presented focuses on the physical output of the laser system (tunnel cuts) after software modifications. The software itself was verified and validated against functional requirements.

7. Type of Ground Truth Used

• For the physical performance tests related to tunnel cuts, the "ground truth" was established based on physical measurements using non-contact optical techniques in ex vivo corneas and corneal model materials. Cut quality was assessed subjectively against "performance test acceptance criteria."
• For the software, the "ground truth" was its adherence to specified performance, accuracy, functionality, and safety requirements during verification and validation (V&V) testing.

8. Sample Size for the Training Set

• The document describes software modifications to an existing device and performance testing, not the development or training of a machine learning model.
• Therefore, a "training set" for an AI algorithm is not applicable/not mentioned in this submission.

9. How Ground Truth for the Training Set Was Established

• As a "training set" for an AI algorithm is not applicable, the method for establishing its ground truth is not mentioned. The software verification and validation process involved testing the modified software against predefined functional specifications and safety requirements.

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The Epi-K is intended for use in the separation of the cornea in preparation for subsequent surgical procedures on denuded cornea.

The Evolution 3E Console includes pumps for producing vacuum for use with a keratome in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea. The Evolution 3E Console power unit has been designed to operate the keratome by means of electric motor or turbine.

The provided document describes a 510(k) premarket notification for the "EPI K Console" (also referred to as "Evolution 3E Console" and "Moria Evolution 3E Console"). This submission is for modifications to an existing device, the "Epi-K", which was cleared under K043183. The key changes are a transition from a purely battery-powered device to a mains-powered device with battery backup, and minor software revisions.

The document does not contain the detailed information required to answer the specific questions about acceptance criteria and a study proving the device meets them in the context of diagnostic performance or clinical effectiveness. This is because the device, a keratome power unit, is a surgical instrument. The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing of performance specifications, electrical safety, EMC, and software verification/validation, rather than clinical efficacy as would be required for a diagnostic or therapeutic device with a clinical endpoint.

However, I can extract the available information and highlight what is missing:

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

Explanation: The document states that "The verification and validation activities, as identified by the risk analysis... were conducted to ensure that the modified device is as safe and effective as the predicate device, have been completed and demonstrate that the predetermined acceptance criteria have been met." However, it does not provide the specific quantitative or qualitative acceptance criteria for each test (e.g., minimum battery life, vacuum pressure range) nor the specific numerical results obtained for these tests. It only states that the acceptance criteria were met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. This document only refers to engineering verification and validation testing, not a clinical study on a patient sample.
• Data Provenance: Not applicable, as it's not a clinical data set. The testing was conducted internally by the manufacturer (MORIA S.A., France).
• Retrospective/Prospective: Not applicable.

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. The ground truth for this type of device (keratome power unit) would be based on engineering specifications and physical measurements, rather than clinical expert consensus on medical images or diagnoses.

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

Not applicable. This testing involves engineering verification and validation, not a diagnostic assessment requiring expert 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 surgical instrument (keratome power unit), not an AI-powered diagnostic tool used by human readers for interpretation. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for this device's performance would be established by:

• Engineering Specifications: Defined acceptable ranges for vacuum pressure, motor speed, battery performance, electrical parameters, etc.
• International Standards: Conformance to standards like IEC 60601-1 and IEC 60601-1-2 for electrical safety and EMC.
• Functional Testing: Verifying that the device components and software perform their intended functions as designed (e.g., pumping, vacuum generation, power conversion).

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable.

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The EpiVision™ SL System is indicated for the separation of the epithelium from the comea in preparation for subsequent surgical procedures on the denuded comea and for use in the making of a corneal flap in patients undergoing LASIK treatment.

The EpiVision™ SL System is a fully automated, AC powered ophthalmic keratome system. The EpiVision™ SL System is used to produce a lamellar corneal flap in an Epithelial Separation or LASIK procedure. With these methods, the refraction of the comea is changed using a laser treatment, a comeal flap is created. However, this flap is not completely separated (except when an epithelial free flap is desired), but remains connected by a small segment of the flap to the eyeball. This segment is called the hinge. The hinge size, the advancing speed during cutting, and the oscillation frequency of the cutter are fixed parameters. The user cannot change these parameters. The EpiVision™ SL System's function is to remove an eye's upper corneal layer (epithelium) using an Epithelial Separation method or to create a cut in the epithelium of the cornea for using a LASIK operation method, after which the contour of the cornea is treated with a vision-correcting laser is not manufactured by Gebauer Medizintechik GmbH. The oscillating Separator/Blade, with fixed parameters creates a separation between the epithelium and Bowman's layers, or a cut in the epithelium. The EpiVision™ SL System is a motor driven Microkeratome which is composed of a Console with power-cable, a Handpiece with a removable Handpiece-cable, a Footswitch, with different colored Foot-pedals, a Single-Use-Set/Single-Use LASIK Set for EpiVision™ SL and a Disposable Tubing System for Epi Vision™ SL System. The Single-Use Set/Single-Use LASIK Set for EpiVision™ SL consists of a Head, a Suction-Ring and a Separator. The components should be assembled per the assembly description in Section 7 of the Users Manual. The EpiVision™ SL System is operated exclusively by the Footswitch. On top of the Console are LEDs which provide optical signals for "on" and "off" of the console, activated vacuum, vacuum level and run cycle. In addition to LEDs there are acoustical signals which sound when 0.75 bar vacuum is achieved, when the vacuum is deactivated, when the vacuum level drops below 0.6 bar during a run cycle, and when the Handpiece has reached the forward stop and the reverse stop. The EpiVision™ SL Control Console is comprised of a Vacuum. The EpiVision™ SL System includes a choice of sterile Single-Use Sets/Single-Use LASIK Sets to allow the System User to select the appropriate ring size and head on an individual patient basis. The EpiVision™ SL system is designed for use with disposable tubing that is readily available/commercially approved within the United States for other approved microkeratome systems.

Here's a breakdown of the acceptance criteria and study information for the Gebauer EpiVision™ SL System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (a 510(k) Premarket Notification Summary) does not explicitly list quantitative acceptance criteria in a dedicated table format. Instead, the rationale for substantial equivalence focuses on functional similarity and safety compared to predicate devices.

However, the "Non-Clinical Performance Data" section mentions: "The effectiveness of the device was confirmed during bench testing which was designed to evaluate the functional ability of the Gebauer EpiVision™ SL System to create highly precise epithelial incisions with constant cut thickness."

While not quantitative, the implied acceptance criteria are:

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

• Sample Size for Test Set: Not mentioned. The document states "bench testing" was performed for effectiveness but does not specify sample size (e.g., number of cuts, number of eyes/models).
• Data Provenance: The testing appears to be "in-vitro non-clinical performance data" (bench testing), implying the data was generated in a lab setting rather than from human patients. No country of origin is explicitly stated, but the company is Gebauer Medizintechnik GmbH (German), and testing was conducted by "UL-Germany" and "independent testing house." This suggests European or international lab conditions. The study is retrospective in the sense that it's bench testing and not a clinical trial.

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

Not applicable. This device's performance was evaluated through bench testing against established engineering and functional parameters, not via expert interpretation of diagnostic output that would require a "ground truth" established by medical experts for a diagnostic task.

4. Adjudication Method for the Test Set

Not applicable, as this was functional bench testing against engineering specifications, not an assessment requiring adjudication by multiple readers/experts.

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

No. The document explicitly states: "No clinical performance data has been submitted." The safety and effectiveness were solely assessed through non-clinical bench testing and comparison to predicate devices, not through studies involving human readers or patient outcomes.

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

Yes, in a sense. The "effectiveness" mentioned refers to the device's inherent functional performance (creating precise incisions with constant thickness) in a standalone, automated manner. There is no "human-in-the-loop" aspect to its primary function of creating a corneal flap.

7. The Type of Ground Truth Used

The "ground truth" for the bench testing was based on engineering specifications and measurable physical parameters (e.g., precision of incision, constancy of cut thickness) derived from the device's design and intent to perform functions comparable to predicate devices. It was not based on expert consensus, pathology, or outcomes data in a medical diagnostic sense.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI that would require a "training set." Its function is mechanical and automated.

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

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

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The Carriazo-Pendular Microkeratome is indicated for shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea.

The Carriazo-Pendular is an AC powered microkeratome. Cutting head and blade are designed in a convex form similar to the cornea itself. Due to the unique pendulum motion of the Carriazo-Pendular, the cornea becomes more applanated in the center than in the periphery. This technology provides a homogeneous and predictable flap thickness and smooth cutting edges. The Carriazo-Pendular consists of: Carriazo-Pendular console, Cutting heads, Suction rings, Foot switches, Monitoring software.

The provided 510(k) summary for the Carriazo-Pendular Microkeratome (K082043) does not contain detailed acceptance criteria or a comprehensive study report with the level of detail requested. However, based on the available information, I can extract and infer some aspects of the performance and testing.

Here's a breakdown of the requested information, with clear indications of what is explicitly stated and what is not:

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 explicitly stated. The document mentions "Test on pig eyes and clinical performance data on human eyes." However, the exact number of pig eyes or human eyes is not provided.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the manufacturer is based in Germany. Clinical data could be from Germany or elsewhere.
  • Retrospective or Prospective: Not specified.

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

This information is not provided in the 510(k) summary. The document does not describe how ground truth was established for the "clinical performance data on human eyes" or for the pig eye tests. There is no mention of expert review or consensus for outcome assessment.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given that the summary does not detail the nature of the "clinical performance data" or how experts established ground truth, an adjudication method is not described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned. This device is a microkeratome (surgical instrument), not an AI-powered diagnostic imaging device that typically involves human readers. Therefore, the concept of human readers improving with or without AI assistance does not apply in this context.

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

This question is not directly applicable as the device is a surgical instrument, not an algorithm. The "Pendular Monitoring Software" is mentioned, but its performance is described as for "read out of relevant monitored data... for quality insurance, supporting the doctor in the process of improving the cutting execution and analysis of potential cut complications." This suggests it's an assistive tool for data analysis post-procedure, not a standalone diagnostic or automated system replacing a human operator.

7. The Type of Ground Truth Used

This information is not explicitly stated. For the "Test on pig eyes," the ground truth would likely involve precise measurements of flap thickness and quality (e.g., smoothness of edges, consistency), potentially assessed by histology or optical coherence tomography. For "clinical performance data on human eyes," outcomes could relate to actual flap thickness achieved in surgeries, visual acuity outcomes, or complication rates, but the method for establishing the true flap characteristics against which performance was measured is not described.

8. The Sample Size for the Training Set

This device does not appear to involve a "training set" in the context of machine learning or algorithms that learn from data. The "Pendular Monitoring Software" collects data, but its development is not described as involving a training set in the AI sense. Therefore, the sample size for a training set is not applicable/not provided.

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

As there is no mention of a "training set" in the context of an AI/ML algorithm learning, this question is not applicable.

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The Zyoptix XP Epi Separator System is indicated for the partial or complete delamination of the corneal epithelium in preparation for subsequent surgical procedures on the denuded cornea.

The Epi Separator System is designed exclusively for use with the Zyoptix XP Microkeratome. The Zyoptix XP Separator System, which consists of the Epi Head and single use Epi separator, are optional accessories for the Zyoptix XP microkeratome.

This document is a 510(k) Premarket Notification for the Zyoptix XP Epi Separator System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional study with acceptance criteria and performance metrics for a novel medical device. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes, and expert adjudication as one might see for an AI/algorithm-based device is not present.

However, based on the provided text, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for performance metrics in the typical sense (e.g., sensitivity, specificity, accuracy) is not explicitly defined because this submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel performance. The "performance" is implicitly tied to the device's ability to safely and effectively perform its intended use as compared to its predicate.

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

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/algorithm. The evaluation is based on design verification, risk analysis, and comparison to a predicate, not clinical trials with "test sets" in the AI sense.

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

Not applicable. There is no "ground truth" established by experts in the context of clinical data for this type of submission. The evaluation is engineering-focused on design and safety, and comparison to an existing device.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" and thus no adjudication method as understood in AI/clinical studies.

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 an AI-assisted device.

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

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the traditional sense of clinical outcome data or expert consensus on images. The "ground truth" here is compliance with engineering design specifications and safety standards, and functional equivalence to the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/algorithm device.

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

Not applicable. There is no training set.

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The Horizon Epikeratome™ is indicated when it is desired to use a single-use microkeratome system that is intended to be used solely to make anterior lamellar connections of preselected thickness and diameter and for the separation of the epithelium from the comea for subsequent surgical procedures and thatleter

The device consists of a control console and disposable HORIZON EPIKERATOME™ microkeratome hand pieces. The control console contains a suction pump, electronics, and a flexible cable to actuate the disposable microkeratome. The basic system sold consists of the control unit, disposable microkeratomes (sold sterile) for corneal resection, a special microkeratome for epithelial separation, practice microkeratomes (not sold sterile), and interconnection equipment, including hoses, cables, and footpedals.

The HORIZON EPIKERATOME™ microkeratome is a clear, automated, completely assembled, disposable microkeratome. It is made of biocompatible polycarbonate plastic and includes a separator also made of biocompatible polycarbonate plastic.. It is sold sterile and is for single use only. Each individual microkeratome is separately packaged in Tyvek, and is sterilized by gamma radiation. The hand ieces for corneal resection use a surgical -grade steel blade instead of a plastic separartor.

The microkeratome itself is powered by two electric motors located in the control unit; motion is transmitted to the keratomes by a flexible mechanical transmission cable. The motors are ULand CE approved. The central unit also supplies the suction. The single cable transmits both the motion to cause the blade (or separator) to oscillate and translate the device axially. As may be seen, there is no electricity transmitted to the keratome units. The microkeratome itself requires no assembly, but the central unit must be made before the operation. Separate units are available for different resection diameters and depths. The suction tubes are sold sterile one unit for a patient, and are sold with the microkeratomes.

The Horizon Epikeratome is a medical device designed for ophthalmological procedures, specifically for separating the epithelium from the cornea for subsequent surgical interventions. The information provided outlines the regulatory submission and claims of equivalence rather than a detailed performance study with specific acceptance criteria tables.

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, there is no explicit table of acceptance criteria or quantified performance metrics presented for the Horizon Epikeratome itself. The submission primarily relies on the device being "identical to the predicate device" in technology and principles, implying that the performance of the predicate device serves as the de facto benchmark.

However, the non-clinical tests conducted suggest implied acceptance criteria in certain areas:

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

• Test Set Sample Size: Not explicitly stated. The document mentions "tests with enucleated eyes" for animal studies, but the number of eyes or animals is not provided.
• Data Provenance:
  • Animal Studies: Performed on "enucleated eyes." The species or origin of these eyes is not specified.
  • Clinical Studies: No human clinical test set was used for the Horizon Epikeratome's performance evaluation as it was deemed not required due to equivalence with a predicate device.

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

Not applicable. As no human clinical test set was required for the Horizon Epikeratome due to its equivalence claim, there was no need for experts to establish ground truth in this context. The animal studies would likely have been evaluated by veterinarians or ophthalmic researchers, but specific details are not provided.

4. Adjudication Method for the Test Set:

Not applicable. Since no human clinical test set or formal multi-reader evaluation was conducted and reported, there's no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Since there is no change in technology or principles, a clinical test is not required" for the Horizon Epikeratome.

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

Not applicable. The Horizon Epikeratome is a mechanical microkeratome system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. The Type of Ground Truth Used:

• Animal Studies: For the animal studies on enucleated eyes, the ground truth would likely have been based on direct observation and measurement of the outcomes of the corneal and epithelial separation, potentially compared against the known effects of the predicate devices. This would involve surgical assessment, potentially histology, or other direct physical measurements on the excised eyes.
• Clinical Equivalence Claim: The ultimate "ground truth" for the device's market approval relied on its substantial equivalence to legally marketed predicate devices (Hawken Flapmaker, K981155, and the Norwood Abbey Centurion, K051486), asserting that their established safety and efficacy serve as the ground truth for an equivalent device.

8. The Sample Size for the Training Set:

Not applicable. The Horizon Epikeratome is a mechanical device and does not involve AI or machine learning, thus there is no "training set."

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

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

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The Norwood Abbey Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.

The Norwood Abbey Centurion SES Epikeratome is an AC-powered device that is used by incising the epithelium at a predetermined location and diameter using a high-speed oscillating separator made of PMMA. The device consists of the following main components and accessories: console, separator drive assembly, suction ring assembly (with 10.0 and 9.0mm suction franquece, separator anve assombly, oaction ing are may as embly (accessory), forceps and an epithelial separator. The Norwood Abbey Centurion SES Epikeratome contains a Head Unit Assembly (with The Norwood Abbey Container sizes) that allows the cornea to protrude through the ഴിയ വിവിധ വാടിനിന് caction is suspended from the end of the separator drive assembly housing that is moved by a drive mechanism along a forward path inside the suction ring nousing that is moved by a unve mechannel and vacuum for the suction ring are provided by user command via the console and foot pedal.

This submission, K051486, describes the Centurion SES™ Epikeratome, an AC-powered device for separating the corneal epithelium. The submission focuses on a new console for the device and its substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states "Bench testing" and "Functional test results." This implies a series of laboratory-based tests rather than studies involving human subjects or patient data.

• Sample Size: Not specified. Standard engineering and functional testing would likely involve testing multiple units of the device and observing performance over a range of operational parameters, but no specific count is given.
• Data Provenance: The testing appears to be prospective bench testing conducted by Norwood Abbey Limited in Australia. There is no mention of patient data, retrospective analysis, or specific country of origin for any human-derived data.

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

This type of information is not applicable to this submission. The device is for a surgical procedure (mechanical separation of epithelium), and its performance evaluation focused on its mechanical and functional equivalence to a predicate device, as demonstrated through bench testing. There is no mention of human-interpreted data (like medical images) that would require experts to establish ground truth.

4. Adjudication method for the test set

Not applicable. As the performance evaluation was based on functional and bench testing, there's no "ground truth" to adjudicate in the typical sense of expert review for diagnostic devices.

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

No. This is a mechanical surgical device, not a diagnostic imaging device with AI assistance. Therefore, an MRMC study is not relevant.

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

Yes, in spirit. The performance evaluation was entirely "standalone" in the sense that the device's functional characteristics were assessed directly through bench testing without human-in-the-loop performance testing in a clinical diagnostic context. The focus was on the machine's ability to perform its stated mechanical function.

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

The "ground truth" for this device's performance evaluation was defined by:

• Functional equivalence to the predicate device: The new console had to demonstrate it could perform the same functions as the predicate device.
• Consistency and reproducibility: The device had to consistently and reproducibly drive the separator assembly to remove epithelium.
• Lack of impact on safety or effectiveness: The modifications should not negatively affect the device's safety or its ability to perform its intended use.

These "ground truths" were assessed via a combination of engineering specifications, comparison to a predicate device's known performance, and functional testing to ensure consistent mechanical operation. It does not involve biological or clinical "ground truth" as you would find in diagnostic device submissions (e.g., pathology for a cancer detection device).

8. The sample size for the training set

Not applicable. This submission is for a mechanical surgical device without any machine learning or AI components that would require a "training set."

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

Not applicable. See point 8.

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The Epi-K 1 is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea.

List of components

• Power unit and footswitch .
• Handpiece / submitted device motor .
• Head and blade separator .
• Suction rings .

a) Power unit and footswitch
The power unit used for the submitted device Epi-K™ is the same as the power unit used for the predicate devices (OneUse - Plus Microkeratome K040297) already legally marketed in the USA by our company.
The power unit includes pumps for producing vacuum. The power unit has been designed to operate the Keratome by means of electric motor.
The front panel includes several displays and features:

• . Vacuum pressure gauge, Battery level indicator,
• . Battery charge indicator,
• Connector for the motorized handpiece of the submitted device .
• Vacuum outlet connector .
  The back panel includes connectors for footswitches and battery charger

b) Handpiece / submitted device motor
The submitted device handpiece has two built-in electrical motors (one motor driving the blade separator oscillation and one motor driving the advance of the handpiece across the cornea).

c) Head and blade separator
The submitted device head is disposable and is supplied with a pre-inserted blade separator The blade separator is made of two parts:

• The metal part in low carbon steel, and

• The plastic holder of the blade separator, which is not in contact with the patient's eye.

d) Suction rings
The suction rings are used to fixate and pressurize the eye and to provide a base for the head. Different rings are available in order to adjust the diameter of the epithelial flap. The rings are available in two versions:

• Reusable

• Disposable

The provided document is a 510(k) summary for the Moria Epi-K™ device, an epikeratome used for separating the epithelium from the cornea. It details the device, its intended use, and claims substantial equivalence to predicate devices, but does not specify numerical acceptance criteria or a dedicated study proving performance against acceptance criteria in the typical sense of a clinical trial with pre-defined endpoints and statistical analysis.

Instead, the submission relies on the concept of substantial equivalence to predicate devices that are already legally marketed. The "tests and results" section describes in-vitro and in-vivo studies to support the device's safety and efficacy, framing them in terms of their ability to perform the intended function similarly to established devices.

Here's an attempt to extract and frame the information requested, with necessary caveats due to the nature of the document:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

As explicit numerical acceptance criteria are not stated in this 510(k) summary, the "acceptance criteria" are inferred from the claims made about the predicate devices (which are legally marketed) and the stated purpose of the Epi-K™. The reported device performance is taken directly from the "Discussion of tests and results" section.

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

• Sample Size for In-vitro Test Set: Not explicitly stated, but "porcine eyes" are mentioned.
• Sample Size for In-vivo Test Set: 77 human eyes.
• Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The context suggests these were conducted by Moria S.A., a French company. The studies are described as "In-vitro" and "In-vivo," which implies prospective data collection for the purpose of this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies described are performance tests of the device itself rather than assessments requiring expert-established ground truth in the context of diagnostic accuracy. For the "quality of epithelium separation" or "safety" assessment, it's implied that trained professionals (e.g., ophthalmologists, pathologists) would have evaluated the outcomes, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the studies (device performance in creating a flap), a formal adjudication method for ground truth establishment (like 2+1 consensus) is less directly applicable than for diagnostic studies. Evaluations would likely involve direct observation and measurement by investigators.

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

No, an MRMC comparative effectiveness study was not mentioned. This type of study typically compares human readers' diagnostic performance with and without AI assistance. The Epi-K™ is a surgical device, not a diagnostic AI system, so this type of study would not be applicable.

6. Standalone (Algorithm Only) Performance Study

Not Applicable. The Epi-K™ is a mechanical surgical device with a motor, handpiece, and blade. It is not an algorithm or AI system, so a standalone algorithm-only performance study is irrelevant. The "performance" here refers to the device's ability to physically perform its intended function.

7. Type of Ground Truth Used

For the in-vitro porcine eye studies, the "ground truth" would be the direct observation and measurement of the "safety and efficacy" of flap creation and the "quality of epithelium separation" by qualified personnel.

For the in-vivo human eye studies, the "ground truth" for safety and ability to create a "hinged circular epithelial flap of predetermined dimensions" would be direct clinical observation and measurement during and after the procedure by the operating surgeon and clinical team. This could involve histological examination of the removed tissue, but specific details are not provided. Essentially, the "ground truth" is the observed physical outcome of the surgical procedure as performed by the device.

8. Sample Size for the Training Set

Not Applicable. The Epi-K™ is a mechanical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development.

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

Not Applicable. As there is no training set for an AI/ML model, this question is not relevant to the Epi-K™ device.

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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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The VISITOME 20-10 MICROKERATOME is intended for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

The Visitome 20-10 Microkeratome is an AC-powered device that is used for making a flap by incising the cornea at a predetermined thickness and diameter using a high-speed oscillating blade made of stainless steel. The device consists of the following main components and accessories: the control unit, a surgical unit (handpiece with drive assembly, positioning ring assembly, applanator assembly, and a stainless steel blade holder), a foot pedal, and tubing kit with filter and fluid collection container (accessory).

The provided 510(k) summary for the Visitome 20-10 Microkeratome offers limited details regarding formal acceptance criteria or a comprehensive study demonstrating adherence to such criteria in the way modern AI/software as a medical device (SaMD) submissions do. Instead, it focuses on substantial equivalence to predicate devices and performance testing related to basic functionality.

Here's an analysis based on the provided text, addressing the requested information to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "The new blade size has undergone performance evaluation testing in pig eyes."

• Sample Size for Test Set: Not specified, only that "pig eyes" were used. The number of eyes is not mentioned.
• Data Provenance: In vitro (or ex vivo) testing on pig eyes. The country of origin for the data is not mentioned, but the applicant is based in Switzerland, and the testing was likely conducted by or for them. This would be considered prospective data generation for the purpose of this submission, as the testing was performed specifically to evaluate the new blade size and device.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It's likely that veterinary ophthalmologists or ocular surgeons were involved in assessing the corneal flaps created on pig eyes, but this is not explicitly stated.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. The document does not describe any human review or adjudication process for the outcomes of the pig eye testing. Performance was likely assessed based on measurable physical characteristics of the created flaps (e.g., thickness, diameter, smoothness), rather than subjective expert consensus.

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

• Was an MRMC study done? No. This device is a surgical instrument, not an AI/SaMD diagnostic or assistive tool where human readers would typically be involved in evaluating performance data. Therefore, an MRMC study and the concept of "improving human readers with AI vs. without AI assistance" are not relevant to this type of device submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Yes, in a sense. The performance evaluation on pig eyes for the device (a mechanical instrument) without human intervention in the data collection/assessment process beyond operating the device and measuring outcomes. The device itself is standalone in its function of creating a corneal flap. However, this is not an AI algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the pig eye performance testing would have been objective measurements of the corneal flaps created, such as:

  • Flap thickness
  • Flap diameter
  • Quality/smoothness of the cut (e.g., microscopic evaluation of the stromal bed)
  • Absence of perforations or irregular cuts.

  This is not "expert consensus," "pathology," or "outcomes data" in the typical sense for a diagnostic device. It's based on physical and measurable characteristics of the device's output.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a mechanical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of an AI model. Device "training" would refer to its design, engineering, and iterative improvement processes, not data input for algorithm learning.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI algorithm. The design and validation of mechanical devices like this involve engineering specifications, material testing, prototyping, and bench testing, but not a data-driven training process with ground truth labels for an algorithm.

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