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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 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, and for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

The Norwood Abbey Centurion SES Epikeratome is an AC-powered device that is used for making a separation or flap 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: the drive control unit (DCU), handpiece, separator drive assembly, suction positioning ring assembly (now with 10.0 and 9.0mm sizes), a foot pedal, a tubing set with fluid collection assembly (accessory), and an epithelial separator.

The provided document describes the safety and effectiveness summary for the Norwood Abbey Centurion SES™ Epikeratome, specifically the 9.0mm suction ring. This submission is for a Class I device (regulated under 21 CFR 886.4370, Product Code 86 HNO, Keratome, AC - Powered) to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Bench testing" and "Functional test results" but does not specify the sample size for these tests. It also does not directly state the data provenance in terms of country of origin or whether the data was retrospective or prospective. Given that it's a 510(k) summary for a Class I device and the focus is on "bench testing" and "functional equivalence" to a predicate, the testing would typically be conducted in a controlled lab environment.

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

The document does not mention the use of experts to establish ground truth. The evaluation relied on demonstrable functional equivalence through bench testing.

4. Adjudication Method for the Test Set

Since no experts were used to establish ground truth (as per point 3), there was no adjudication method described or necessary.

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

No, an MRMC comparative effectiveness study was not mentioned or performed. The study focused on demonstrating functional equivalence through bench testing, not on human reader performance.

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

This device is a mechanical epikeratome, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable. The "performance data" refers to the mechanical function of the device itself.

7. The Type of Ground Truth Used

The "ground truth" for this submission appears to be derived from the demonstrated functional characteristics and performance of the predicate device. The new device's performance was compared against the known and accepted performance of the predicate in terms of its ability to separate epithelium consistently and reproducibly. It is based on engineering/bench test results showing direct functional equivalence, rather than a clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

This device is a hardware product, not an AI model. Therefore, the concept of a "training set" is not applicable.

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

As this is not an AI model, the concept of a "training set" and establishing its ground truth is not applicable.

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LAD-08 is indicated for ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.

The Norwood Abbey Model LAD-08 is a portable, handheld, battery powered bern hismater The Norwood Abbey Model LAD-60 is a portuois, handelength of 2.94 um and a beam diameter of I he radiant energy produced by thin itsel mas a m. spot-size of 6 mm at the treatment site. The radiation delivered by the device is sufficient to remove the stratum corneum of skin exposed to the treatment.

The provided document describes a medical device, the Norwood Abbey Model LAD-08 (Epiture™ Easytouch), a laser surgical instrument. However, the document explicitly states:

"No additional studies have been performed on the LAD-08."

This means the submission does not include any studies or data proving the device meets specific acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred:

1. A table of acceptance criteria and the reported device performance:
Not available. The document does not specify any acceptance criteria or report performance data for the LAD-08.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not available. No studies were performed, so there is no test set or related data.

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 available. No studies were performed, so no ground truth was established for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not available. No studies were performed.

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 laser surgical instrument, not an AI-assisted diagnostic tool for human readers. No MRMC studies were conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This refers to algorithm performance, and no algorithms were described or tested for this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not available. No studies were performed.

8. The sample size for the training set:
Not applicable. No training set for an algorithm was mentioned or used.

9. How the ground truth for the training set was established:
Not applicable. No training set for an algorithm was mentioned or used.

Summary based on the provided text:

The submission for the LAD-08 relies on a claim of substantial equivalence to predicate devices (LAD-01/06) rather than new clinical study data for its performance. The FDA cleared the device based on this substantial equivalence.

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The LAD device is indicated for the rapid production of local dermal anesthesia using topical OTC lidocaine 4%.
The LAD is indicated for the ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.

The Norwood Abbey Model LAD-01 is a portable, battery powered, single pulse Er: Y AG laser. The radiant energy produced by this laser has a wavelength of 2.94 um, duration of approximately 300 us, and a beam diameter or spot-size of 3 mm at the treatment site. The radiation delivered by the device is sufficient to remove the stratum corneum of skin exposed to the treatment.

Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and the study that proves it meets them:

Device: LAD, Model LAD-01 (Laser surgical instrument for general and plastic surgery and in dermatology)
Intended Use: Rapid production of local dermal anesthesia using topical OTC lidocaine 4%.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 320 subjects participated in the IRB, IDE approved study. Clinical observations were reported for 318 subjects.
• Data Provenance: The study was conducted over "two centers," suggesting a multi-site clinical trial. The document itself is from Norwood Abbey Limited, located in Australia, but the study is mentioned as being IRB, IDE approved, which implies a regulatory framework often associated with studies conducted in the US or under US regulatory guidance. The "retrospective or prospective" nature is not explicitly stated, but an "IRB, IDE approved study" involving subjects at two centers, with follow-up observations at 48 hours, strongly indicates a prospective clinical study.

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

This information is not provided in the document. The study protocols focused on subjective pain ratings by subjects and clinical observations by medical personnel, rather than expert interpretation of diagnostic images or data.

4. Adjudication Method for the Test Set

This information is not provided in the document. The study involved subjects rating their own pain and clinical observations by staff, not an adjudication process by multiple experts for a "ground truth" derived from interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?

No, an MRMC comparative effectiveness study was not conducted. This device is a laser surgical instrument, not an AI-powered diagnostic tool requiring human reader interpretation or improvement statistics. The study focused on the device's ability to achieve specific physiological and safety effects.

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

This question is not applicable. The LAD-01 is a physical device used in a medical procedure, not an algorithm. Its performance is inherent in its operation and interaction with the human body, not an "algorithm only" performance.

7. The Type of Ground Truth Used

• Pain Reduction: The "ground truth" for anesthetic efficacy was established by subjective pain ratings provided by the subjects themselves, after a standardized pain stimulus (full needle insertion).
• Safety: The "ground truth" for safety was established through clinical observations by medical personnel for adverse events, compared to a placebo.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The LAD-01 is a medical device, not a machine learning model, so there is no concept of a "training set" in the context of this submission. The study described is a clinical validation study, not a model training process.

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

This information is not applicable/not provided for the same reasons as point 8.

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