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The OneUse - Plus Microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the comea.

List of components

• Power unit
• Motor
• Suction rings
• Applanator lenses
• Footswitches
• Keratome head
• Keratome blade

a) Power unit
The power unit used for the OneUse - Plus Microkeratome is the same as the power unit used for the predicate devices One Up Disposable keratome Head (K981742) & CARRIAZO BARRAQUER II Microkeratome (K002191) 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.
Only one of the above power options can be selected at the time by means of a 2 position switches in the front panel.
The front panel has several displays and features:

• Vacuum pressure gauge,
• Gas pressure gauge,
• Battery level indicator,
• Battery charge indicator,
• Connectors:
  DC motors outlets, Gas turbine outlet Gas outlet, Vacuum outlet
  The back panel has several displays and features:
• Connectors:
  Gas inlet, Foot pedals,
• Battery charger.
  All connectors are of different types for preventing connection mistakes.

b) Keratome motor
The drive system has two built-in electrical motors (one motor for the blade oscillation and one motor for the advance of the microkeratome).

c) Keratome head
In the keratome head, a blade activated by an oscillation motor is inserted.
Different heads are available in order to adjust the thickness of the cut.

d) Suction rings
The suction rings are used to fixate and pressurize the eye and to provide a base for the microkeratome heads.

e) Applanator lenses
The applanator lenses are made of clear methylmethacrylate with a stainless steel handle.
They are used with the rings to check disk diameter before the cut.
The upper part is convex for magnification.
The base part (contact part) is plane, with an engraved and calibrated reticule diameter.

f) Keratome blade
The blade is made of two parts: the metal part in low carbon steel, and the plastic blade holder, which is not in contact with the patient's eye.
Different blades are available in order to adjust the thickness of the cut.

The provided text describes the MORIA S.A. OneUse - Plus Microkeratome and its intended use, but it does not specify explicit acceptance criteria in a quantitative format. Instead, it mentions general performance characteristics demonstrated through studies.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit quantitative acceptance criteria are not stated, the table below consolidates the qualitative performance mentioned in the "Discussion of tests and results" section.

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

• Sample Size for Test Set:
  • In-vitro studies: Performed on "porcine eyes." The exact number of porcine eyes is not specified.
  • In-vivo studies: 54 human eyes.
• Data Provenance:
  • The document does not explicitly state the country of origin for the data for either the in-vitro or in-vivo studies.
  • The studies were conducted as part of a premarket notification, implying they were prospective safety and performance assessments. However, the exact nature (e.g., fully prospective clinical trial, observational study) is not detailed beyond "in-vivo studies."

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

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for the test set. It mentions "in-vivo studies on 54 human eyes showed..." and "In-vitro studies on porcine eyes demonstrated...", suggesting clinical or laboratory assessments, but details on expert involvement in defining the "truth" for these assessments are absent.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any mention of an effect size regarding human reader improvement with or without AI assistance. The device is a microkeratome, a surgical instrument, not an AI diagnostic tool.

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

This concept is not applicable as the device is a mechanical surgical microkeratome, not an algorithm or AI system. Its performance is inherently tied to its use by a human surgeon.

7. Type of Ground Truth Used

The "ground truth" for the performance claims would be:

• In-vitro studies (porcine eyes): Direct measurements of flap thickness, assessment of corneal resection safety, and quality (bed smoothness) using laboratory techniques.
• In-vivo studies (human eyes): Clinical assessment of the quality of the corneal flap, its thickness, safety, and smoothness in a real-world surgical context. This would likely involve post-operative examinations and clinical measurements. The term "equivallently to the predicate device" suggests a comparative clinical outcome as a "ground truth" for equivalence.

8. Sample Size for the Training Set

No information is provided regarding a separate "training set" or its sample size. This is consistent with a mechanical device where performance is typically evaluated through direct testing rather than training a machine learning model.

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

As no training set is mentioned or applicable in the context of this mechanical device, this information is not provided.

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The BD K-4000™ Microkeratome System is a battery powered device intended to produce a corneal resection for refractive laser applications and procedures in Ophthalmic surgery, such as Laser In-situ Keratomileuses (LASIK) surgery.

The BD K-4000™ Microkeratome System is a battery operated, fully automated Keratome. The Microkeratome is a precise cutting device uniquely designed for added comfort, speed and accuracy. The Microkeratome's unique shape is designed to offer more comfort and efficiency while delivering precision and accuracy.

The BD K-4000™ Microkeratome major components are:

• Console containing the motor drive and control circuitry, Vacuum system and battery power source
• Front Panel controls for operating the system;
• Surgical Handpiece connected to the console by multi-conductor cable
• Vacuum tubing set:
• Two pedal Footswitch for actuation of the handpiece and vacuum system;
• External Battery Charger.

The provided 510(k) summary for the BD K-4000™ Microkeratome System does not contain detailed acceptance criteria or a specific study proving the device meets those criteria in the way a clinical trial or performance study for a diagnostic AI device would. Instead, this document is a summary for a medical device, specifically a surgical instrument, seeking substantial equivalence to predicate devices already on the market.

Therefore, the information requested, such as specific performance metrics (like sensitivity, specificity, F1 score), sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable in the context of this 510(k) submission for the BD K-4000™ Microkeratome System.

The document states:

• "Performance studies were done to assess the performance and equivalence of the principal devices to the predicate devices currently marketed in the United States."
• "All results from the studies show equivalence between the principal devices and the predicate devices. Therefore, the K-4000 is substantially equivalent to the predicate devices."

This indicates that the "study" was focused on demonstrating substantial equivalence to existing, legally marketed devices (BD K-3000™ Microkeratome, K984537 and K022637), rather than meeting specific quantifiable performance metrics against a defined ground truth for a diagnostic task. The criteria for acceptance were likely related to functional performance (e.g., cutting precision, safety features), material compatibility, and intended use, all benchmarked against the predicate devices.

Here's how to address the questions given the available information:

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

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 for Test Set: Not specified. (The studies were likely bench testing, engineering verification, and perhaps limited in-vivo or ex-vivo testing comparing the device's functional outputs to predicate devices, rather than a clinical trial with a "test set" in the diagnostic sense.)
• Data Provenance: Not specified.

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)

• Number of Experts & Qualifications: Not applicable for this type of device and submission. Ground truth in this context would likely be engineering specifications, material standards, and functional output measurements.

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

• Adjudication Method: Not applicable.

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

• MRMC Study: No, not applicable. This is a surgical instrument, not a diagnostic AI system.

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

• Standalone Performance: Not applicable. This device is a battery-operated, fully automated microkeratome; its "performance" is inherently standalone in its function as a cutting device, but it doesn't involve "algorithms" in the AI sense or human-in-the-loop diagnostic interpretation. The user operates the device.

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

• Type of Ground Truth: Not explicitly stated but would likely be based on engineering specifications, physical measurements (e.g., blade precision, suction force), material properties, and comparison of outcomes (e.g., flap thickness, consistency) with the predicate devices through laboratory or ex-vivo testing.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not use machine learning or AI that requires a "training set."

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned or implied.

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The BD K-3000™ Microkeratome System is a battery powered device intended to produce a corneal resection for refractive laser applications and procedures in Ophthalmic surgery, such as in Laser In-situ Keratomileuses (LASIK) surgery. The corneal resection is consistently of a predetermined diameter, thickness and uniform surface quality for precise lamellar cuts and consistent flap generation.

The BD K-3000™ Microkeratome System is a battery operated, fully automated Keratome device to produce a corneal resection prior to laser ablation l laser applications and procedures such as, in Laser In-situ Keratomileusus K) surgery. The Microkeratome is a precise cutting device uniquely designed for comfort, speed and accuracy. The BD K-3000™ Microkeratome System enables ons to cut precision flaps quickly and easily. The Microkeratome's unique shape is ned to offer more comfort and efficiency while delivering precision and accuracy. e Microkeratome system features:

• One-piece fully assembled handpiece allows complete assembly prior to positioning on the eve
• he handpiece is ergonomically designed and of titanium construction to increase rgeon comfort
• components are fully interchangeable for flexibility
• keratome system consistently produces a corneal resection of a predetermined er, thickness and uniform surface quality.
• ratome head assures depth consistency. The head houses a precision blade elivers constant drive alignment through a double dovetail suction ri
• keratome handpiece contains dual motors. One controls oscillation of the e and a second translates the head across the eve.
• teratome handpiece automatically returns to home position without oscillating.

The information provided is about the Becton Dickinson K-3000™ Microkeratome System, a device for producing corneal resections in ophthalmic surgery. The document is a 510(k) PreMarket Notification from 2002.

Acceptance Criteria and Device Performance Study

The document indicates that the device's performance was evaluated through in-vitro studies using porcine eyes. The criteria tested were related to the quality and consistency of the corneal resection.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated regarding the number of porcine eyes used. The text only mentions "in-vitro studies on porcine eyes."
• Data Provenance: In-vitro studies on porcine eyes. This means the data is from animal tissue, not human patients. It is prospective testing in an ex-vivo setting. The country of origin of the data is not specified.

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

• Number of Experts: Four (4)
• Qualifications of Experts: Described as "experienced surgeons." No further details on their specific specialties (e.g., ophthalmologists) or years of experience are provided.

4. Adjudication Method for the Test Set:

The document states that the four experienced surgeons "rated the quality of the stromal bed after corneal resection of porcine eyes and qualitatively evaluated the Microkeratome blade sharpness and corneal resection quality." This indicates a qualitative assessment by multiple experts, but no specific adjudication method (like 2+1 or 3+1 consensus) is detailed. It appears to be an independent qualitative evaluation by each surgeon.

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

No MRMC comparative effectiveness study was done. The study focuses solely on the performance characteristics of the device itself and compares it to a predicate device for substantial equivalence, not on the improvement of human readers with AI assistance.

6. Standalone Performance (Algorithm Only):

This device is a physical surgical instrument, not an AI algorithm. Therefore, a "standalone (i.e., algorithm only without human-in-the-loop performance)" study is not applicable and was not performed. The performance evaluated is of the device as a total system in operation.

7. Type of Ground Truth Used:

The ground truth for the performance evaluation was based on a qualitative assessment by "experienced surgeons" of the "quality of the stromal bed" and "corneal resection quality" on porcine eyes. This can be categorized as expert qualitative assessment / expert consensus on animal tissue.

8. Sample Size for the Training Set:

This device is a mechanical surgical instrument, not a learning algorithm. Therefore, there is no "training set" in the context of machine learning.

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

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

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The M2 SINGLE USE microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

List of components
a) Power unit
b) Motor
c) Suction rings
d) Applanator lenses
e) Footswitches
f) Keratome head with pre-inserted Keratome blade

The M2 SINGLE USE microkeratome is intended for use in creating a corneal flap for LASIK surgery or other treatments requiring initial lamellar resection of the cornea.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria for the M2 SINGLE USE microkeratome. Instead, it relies on demonstrating equivalence to predicate devices and qualitative performance. The reported performance is based on in-vivo and in-vitro studies:

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • In-vitro: Not specified, but stated as "in-vitro studies on porcine eyes."
  • In-vivo: 72 human eyes.
• Data Provenance: The document does not explicitly state the country of origin. Given the submitter's location (MORIA S.A. in France), it is plausible the studies were conducted in Europe, but this is not confirmed. The studies are implicitly prospective for the M2 SINGLE USE microkeratome as they are conducted to demonstrate its performance.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts or their qualifications used to establish ground truth for either the in-vitro or in-vivo studies. The "Discussion of tests and results" section simply states what was "demonstrated" by the studies.

4. Adjudication Method

The document does not mention any adjudication method for the test set.

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

No MRMC comparative effectiveness study is mentioned. The study compares the M2 SINGLE USE microkeratome to predicate devices, but there is no indication of human readers improving with or without AI assistance, as AI is not a component of this device.

6. Standalone Performance

Yes, the studies described are for the standalone performance of the M2 SINGLE USE microkeratome, as it is a physical device and not an AI algorithm requiring human-in-the-loop interaction. The performance metrics listed describe the device's inherent ability to create corneal flaps.

7. Type of Ground Truth Used

• In-vitro studies (porcine eyes): The ground truth for flap thickness consistency, safety, and quality of corneal resections would likely be based on direct measurements, microscopic examination, and qualitative assessment by trained surgical or pathology personnel.
• In-vivo studies (human eyes): The ground truth for safety, ability to create circular lamellar resection, predetermined diameter and thickness, and bed smoothness would be assessed directly by the operating surgeon and through post-operative clinical evaluations, possibly including imaging techniques for flap dimensions and quality. This primarily relies on expert assessment/clinical observation.

8. Sample Size for the Training Set

This information is not applicable as the M2 SINGLE USE microkeratome is a mechanical device, not an AI/machine learning algorithm that requires a "training set."

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

This information is not applicable for the reason stated above (it's not an AI/machine learning device).

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Millenium Microkeratome is indicated for use in refractive surgery, or other treatment requiring initial lamellar resection of the cornea, circular and predetermined diameter and thickness.

Millenium Microkeratome is electrically powered manual mechanical cutting instrument for severing a thin layer of corneal tissue (flap) from the surface of the eve. Microkeratome includes Fixation Ring, cutting Head and operates by Control Unit. The Fixation Ring is placed against the eye. Cutting blade oscillate inside special Insert placed in to the Head. Electric Motor is used to drive the blade. Forward manual movement of the Head against Fixation Ring creates resection of cornea tissue. Different Fixation Rings and Inserts determinate diameter and thickness of resection. Control Unit - power independent with built-in rechargeable battery provide vacuum to hold Fixation Rind on the eye and electric power to control Electric Motor.

The Millenium Microkeratome is an electrically powered mechanical cutting instrument for severing a thin layer of corneal tissue (flap) from the surface of the eye. Its intended use is in refractive surgery or other treatments requiring initial lamellar resection of the cornea, circular and of predetermined diameter and thickness.

Acceptance Criteria and Device Performance:

Study Details:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients." The study was conducted on "porcine eyes." The number of porcine eyes is not specified.
   • Data Provenance: The study was non-clinical and conducted on porcine eyes. There is no mention of country of origin, as it's an animal model study. It is a prospective study in the sense that the device was used on these eyes for testing.

2. Number of Experts and Qualifications:

   • No information provided regarding the number or qualifications of experts used to establish ground truth.

3. Adjudication Method:

   • No information provided on an adjudication method. The assessment appears to be a direct comparison of the corneal lamellar resection to that achieved by predicate devices.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was done. This study is for a medical device (a microkeratome) that performs a surgical procedure, not an imaging or diagnostic device that requires human interpretation.

5. Standalone Performance Study:

   • Yes, a standalone study was performed. The device was tested directly on porcine eyes to evaluate its ability to perform corneal lamellar resection. The results were then compared to the performance of predicate devices.

6. Type of Ground Truth Used:

   • The ground truth was established by comparing the corneal lamellar resection produced by the Millenium Microkeratome to that produced by "predicated devices." The equivalence was determined based on the physical characteristics of the resected tissue. This implicitly refers to device performance characteristics rather than a clinical ground truth like pathology or patient outcomes.

7. Training Set Sample Size:

   • Not applicable/not provided. This is a non-clinical device performance study, not a machine learning model.

8. How Ground Truth for Training Set was Established:

   • Not applicable/not provided. This is a non-clinical device performance study, not a machine learning model.

Summary of the Study:

The study was a non-clinical test on porcine eyes to demonstrate that the Millenium Microkeratome could achieve corneal lamellar resection equivalent to that produced by predicate devices (Plancon microlamellar keratome and Evolution power unit). The fundamental conclusion was that the technological differences (primarily electric motor vs. gas turbine) did "not raise any new issues of safety, effectiveness, or performance of the product." The focus was on establishing functional equivalence for the intended use rather than clinical efficacy or human-in-the-loop performance.

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The Insight Technologies Instruments, Model K3000 Keratome System is designed to produce a corneal flap.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device (Keratome System, Model K3000). It acknowledges that the device is substantially equivalent to a predicate device and can be marketed.

However, the provided text DOES NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input. The letter is purely an FDA clearance notice, not a study summary.

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The CARRIAZO BARRAQUER microkeratome is intended for use in patient undergoing surgery or other treatment requiring initial lamellar resection of the cornea, circular and of predetermined diameter and thickness.

The CARRIAZO BARRAQUER microkeratome system composition includes: a) Power unit, b) Keratome head, c) Keratome blade, d) Motor, e) Footswitches, f) Applanator lenses, g) Suction rings. The power unit includes pumps for producing vacuum and can operate the keratome by means of a 12 V DC motor or by means of a nitrogen motor. The keratome head adapts to the turbine or to the motor and includes the blade. Different heads are available to adjust the thickness of the cut. The suction rings are used to fixate and pressurize the eye and provide a base for the microkeratome. The applanator lenses are made of clear methylmethacrylate with a stainless steel handle and are used with the rings to control disk diameter before the cut.

Here's an analysis of the provided text regarding the MORIA CARRIAZO BARRAQUER microkeratome, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria and a detailed study explicitly proving the device meets them are not directly stated. The document primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study against predefined numerical targets.

However, we can infer the implicit "acceptance criteria" through the comparative statements made for substantial equivalence and the intended use. The performance is then deemed "met" by stating equivalence.

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

The provided text does not describe a specific test set with a sample size. The demonstration of safety and effectiveness is based on the claim of substantial equivalence to legally marketed predicate devices, not on a new, independent clinical or performance study with a defined test set.

• Sample Size: Not applicable/not provided for a specific test set.
• Data Provenance: Not applicable, as no new clinical or performance data is presented. The claim relies on the established safety and effectiveness of the existing predicate devices.

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

Since no new test set or clinical study is described, there's no mention of experts establishing ground truth for such a set within this document. The "ground truth" for the device's acceptability is the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

As there is no described test set that required human adjudication, no adjudication method is mentioned or applicable in this submission.

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

No, an MRMC comparative effectiveness study is not mentioned in this document. The submission relies on substantial equivalence.

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

This device is a surgical instrument (microkeratome), not an algorithm or a diagnostic tool with a standalone performance. Therefore, the concept of "standalone performance" for an algorithm is not applicable here. Its performance is always inherent in its use by a surgeon.

7. The Type of Ground Truth Used

The "ground truth" relied upon for this submission is the historical regulatory approval and established safe and effective use of the predicate devices (PLANCON microlamellar keratome, HANSA Automatic corneal shaper, and HANSA Hansatome) that have been used for similar intended purposes for years. The assumption is that if this new device performs "equivalently," its safety and effectiveness are also established.

8. The Sample Size for the Training Set

There is no mention of a training set in this document. This submission is for a physical medical device, not a machine learning or AI-based system that would typically employ training sets.

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

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

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The Insight Technologies Instruments, Model K-1000 Keratome System is designed to produce a corneal flap.

The model K-1000 keratome features a high speed, low torque nitrogen driven motor, which drives a reciprocating surgical blade will be a single-use, disposable device that will be filed under a separate 510k. The keratome head is preset to produce a corneal resection approximately 160 microns in depth with the corresponding blade insertion and flap diameter of approximately 10.0mm. The model K-1000 keratome system is battery operated and may also operate from its charger. The power unit provides on/off footswitch controls for the keratome head and drive assembly, and suction to the suction ring. Analog gauges located on the front panel of the unit indicate nitrogen pressure and suction level supplying the appropriate connectors.

The K-1000 Keratome System does not contain information to completely answer the request; however, I can provide the following:

The provided document describes the Insight Technologies Instruments, LLC, Model K-1000 Keratome System, which is a medical device. The document is a 510(k) summary for premarket notification to the FDA. It compares the K-1000 Keratome System to previously marketed predicate devices (Plancon Instruments Lamellar Keratoplasty System Model L.K.S. and S.C.M.D. Keratomes of Arizona TurboKeratome System by SCMD Model MLK) to demonstrate substantial equivalence.

This document focuses on regulatory compliance, design characteristics, safety certifications (electrical safety, sterilization), and comparison with predicate devices, rather than a clinical study demonstrating performance against specific acceptance criteria. The device being described is a surgical instrument (keratome) used to create a corneal flap, not an AI or diagnostic device that would typically have the performance metrics requested in the prompt.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC study, standalone performance) are not applicable or available in this document.

However, I can extract information related to what constitutes "acceptance criteria" in the context of this device's regulatory submission, which primarily revolves around safety, design, and equivalence to predicate devices, rather than a clinical accuracy study.

Acceptance Criteria and Device Performance (Based on provided document)

Since this is a mechanical surgical instrument and not an AI or diagnostic device, the "acceptance criteria" are related to design specifications, safety standards, and demonstrated substantial equivalence to predicate devices. There isn't a "reported device performance" in terms of clinical accuracy or diagnostic metrics as typically seen for AI. Instead, the performance is implicitly accepted by meeting design specifications and safety standards.

Information Not Applicable or Not Available from the Document:

Due to the nature of the device (mechanical surgical instrument) and the type of document (510(k) summary for substantial equivalence), the following information is not applicable or not provided:

1. Sample size used for the test set and the data provenance: Not applicable. Performance data in a clinical trial sense is not presented for this type of device in a 510(k) summary, which relies on demonstrating equivalence to known safe and effective devices.
2. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. No clinical test set or ground truth establishment process is described.
3. Adjudication method for the test set: Not applicable. No clinical test set is described.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for diagnostic or AI-assisted devices, not a mechanical keratome.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
6. The type of ground truth used: Not applicable. No "ground truth" as typically defined for AI/diagnostic devices is mentioned. The "ground truth" for a mechanical device is its adherence to design specifications and safety standards, and its functional performance as intended.
7. The sample size for the training set: Not applicable. No AI model or training set is involved.
8. How the ground truth for the training set was established: Not applicable. No AI model or training set is involved.

The "study" that proves the device meets the acceptance criteria is primarily the design and testing adhering to specified electrical safety standards (ANSI/AAMI ES1-1993, IEC 601-1) and comparison to predicate devices to establish substantial equivalence. The FDA's review and concurrence of the 510(k) submission served as the ultimate "proof" in the regulatory context, allowing the device to be marketed.

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