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The Surgistar 2400-LSK Microkeratome is indicated for use as a replacement blade in the Moria LSK-ONE Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.

The Surgistar 2410-CB Microkeratome blade is indicated for use as a replacement blade in the Moria Carriazo Barraquer Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.

The Surgistar 2420-M2 Microkeratome blade is indicated for use as a replacement blade in the Moria Carriazo Barraquer II Keratome also known as the M2. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.

The Surgistar 2400-LSK is a replacement microkeratome blade for the Moria LSK-ONE Keratome. The blade consists of a 420 low carbon stainless steel blade and a plastic holder attached to the blade. The 2400-LSK blades are single-use, disposable blades.

The Surgistar 2410-CB is a replacement microkeratome blade for the Moria Carriazo Barraquer Keratome. The blade consists of a 420 low carbon stainless steel blade and a plastic holder attached to the blade. The 2410-CB blades are single-use, disposable blades.

The Surgistar 2420-M2 is a replacement microkeratome blade for the Moria Carriazo Barraquer II Keratome. The blade consists of a 420 low carbon stainless steel blade and a plastic holder attached to the blade. The 2420-M2 blades are single-use, disposable blades.

The provided text describes three medical devices: Surgistar Microkeratome Blade Models 2400-LSK, 2410-CB, and 2420-M2. All three are replacement blades for specific Moria microkeratomes, intended for use in corneal lamellar resection surgery. The studies presented aim to demonstrate substantial equivalence to their respective predicate devices.

Here's an analysis of the acceptance criteria and the studies that prove the devices meet them, for each model:

Surgistar Microkeratome Blade, Model No. 2400-LSK

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the exact sample size for each performance test (dimensional, sharpness, fit).
• For the non-clinical porcine eye studies, the sample size is also not specified.
• The data provenance is stated as "non-clinical porcine eye studies," indicating animal studies. The country of origin is not explicitly mentioned but implied to be within the manufacturer's operation given the context of a 510(k) submission.

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

• Not applicable as these are primarily engineering and observational performance tests. The "ground truth" for these tests would be objective measurements and direct observation of functionality, not expert consensus on qualitative data.

4. Adjudication Method for the Test Set:

• Not applicable. The tests described are objective measurements (dimensional, sharpness, fit) and direct observation of results (corneal lamellar sections in porcine eyes).

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

• No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems involving human interpretation.

6. Standalone (Algorithm Only) Performance Study:

• No, a standalone algorithm-only performance study was not done. The device is a physical blade, not an AI algorithm.

7. Type of Ground Truth Used:

• Dimensional Equivalency: Manufacturer's specifications for the predicate device.
• Sharpness: Standardized sharpness testing criteria.
• Keratome Fit: Engineering specifications for the predicate keratome head.
• Corneal Lamellar Sections: Visual and/or histological assessment of the sections produced in porcine eyes, compared to those produced by the predicate, without specific details on the exact metrics or how "equivalence" was defined.

8. Sample Size for the Training Set:

• Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

• Not applicable.

Surgistar Microkeratome Blade, Model No. 2410-CB

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the exact sample size for each performance test.
• For the non-clinical porcine eye studies, the sample size is also not specified.
• The data provenance is stated as "non-clinical porcine eye studies," indicating animal studies.

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

• Not applicable.

4. Adjudication Method for the Test Set:

• Not applicable.

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

• No.

6. Standalone (Algorithm Only) Performance Study:

• No.

7. Type of Ground Truth Used:

• Dimensional Equivalency: Manufacturer's specifications for the predicate device.
• Sharpness: Standardized sharpness testing criteria.
• Keratome Fit: Engineering specifications for the predicate keratome head.
• Corneal Lamellar Sections: Visual and/or histological assessment of the sections produced in porcine eyes, compared to those produced by the predicate, without specific details.

8. Sample Size for the Training Set:

• Not applicable.

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

• Not applicable.

Surgistar Microkeratome Blade, Model No. 2420-M2

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the exact sample size for each performance test.
• For the non-clinical porcine eye studies, the sample size is also not specified.
• The data provenance is stated as "non-clinical porcine eye studies," indicating animal studies.

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

• Not applicable.

4. Adjudication Method for the Test Set:

• Not applicable.

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

• No.

6. Standalone (Algorithm Only) Performance Study:

• No.

7. Type of Ground Truth Used:

• Dimensional Equivalency: Manufacturer's specifications for the predicate device.
• Sharpness: Standardized sharpness testing criteria.
• Keratome Fit: Engineering specifications for the predicate keratome head.
• Corneal Lamellar Sections: Visual and/or histological assessment of the sections produced in porcine eyes, compared to those produced by the predicate, without specific details.

8. Sample Size for the Training Set:

• Not applicable.

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

• Not applicable.

Summary of Device Substantial Equivalence Claims:

For all three blades, Surgistar conducted a series of performance tests to demonstrate substantial equivalence to their respective predicate devices. These tests focused on:

• Dimensional Equivalency: Comparing the new blade's dimensions to the specifications of the predicate.
• Sharpness: Ensuring the new blade performs equivalently in sharpness tests.
• Keratome Fit: Confirming the new blade properly fits the specified microkeratome head.
• Non-clinical Porcine Eye Studies: Verifying that the new blade produces equivalent corneal lamellar sections in an animal model, indicating comparable functional performance during the intended surgical procedure.

The conclusions for all three devices stated "substantially equivalent" based on these performance tests. The studies are not designed for AI/ML algorithms or human reader performance, but rather for physical device characteristics and functionality in a laboratory/animal setting.

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The Surgistar Microkeratome is indicated for use as a replacement blade in the Chiron Vision Automatic Corneal Shaper Surgical Instrument (ACS). The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.

Replacement Stainless Steel Blade for Chiron Automatic Corneal Shaper Blade

The Surgistar Inc. Microkeratome Blade (K992978) does not describe a study to prove the device meets acceptance criteria in the provided text. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting results from a comprehensive performance study with acceptance criteria.

However, the document does list dimensional and sharpness equivalency criteria which can be interpreted as acceptance criteria for manufacturing and functional attributes. The "reported device performance" would then be the measured characteristics of the Surgistar blade, demonstrating its equivalence to the predicate device.

Here's an analysis based on the information provided, framed around "acceptance criteria" where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "Reported Device Performance" for the Surgistar blade is implicitly stated as meeting these specifications since the document is asserting equivalence based on these criteria. The table shows the predicate device's measurements for comparison against the Surgistar specifications.

Details of the study that proves the device meets the acceptance criteria (based only on the provided text):

The provided text does not describe a formal study to prove the device meets acceptance criteria in the sense of a clinical trial or performance study. Instead, it presents a comparison of technological characteristics and dimensional/sharpness equivalency between the Surgistar Microkeratome Blade and a legally marketed predicate device (Chiron Vision Corp Automatic Corneal Shaper Surgical Instrument blade).

The "proof" stems from the assertion that the Surgistar blade's specifications fall within or are equivalent to the measured characteristics of the predicate device, implying that if the predicate device is safe and effective, then the Surgistar device, with similar characteristics, should also be.

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 the test set: Not explicitly stated. The data presented "CHIRON ACS BLADE AS MEASURED" likely refers to measurements taken on a sample of the predicate device. The size of this sample is not specified.
• Data provenance: Not explicitly stated. Given the context, it is presumed to be retrospective measurements of the predicate device. Country of origin is not mentioned.

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

• Not applicable. The "ground truth" here is the measurement of physical attributes of the predicate device, not an expert assessment of medical images or outcomes. These measurements would typically be performed by trained technicians or engineers using calibrated equipment.

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

• Not applicable. Adjudication methods are relevant for qualitative assessments or interpretations, not for direct physical measurements.

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 MRMC comparative effectiveness study was done. This device is a surgical blade, not an AI-assisted diagnostic tool.

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

• No standalone algorithm performance study was done. This device is a physical surgical blade.

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

• The "ground truth" for the comparison is based on physical measurements of the predicate device's dimensions and sharpness.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm-based device requiring a training set. The Surgistar blade's "design" or "specifications" (which could be analogously considered as its "training") are based on engineering design and the characteristics of the predicate device.

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

• Not applicable. As above, there is no training set in the context of this device. The specifications for the Surgistar blade were established to be equivalent to the predicate device, with manufacturing tolerances.

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