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The Smith & Nephew TRUCLEAR Operative Hysteroscope 5C and Sheath 5C are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

The subject TRUCLEAR Operative Hysteroscope 5C and TRUCLEAR Sheath 5C are modifications to the TRUCLEAR Operative Hysteroscope 5.0 and TRUCLEAR Sheath 5.6 previously cleared in K112134. The TRUCLEAR Operative Hysteroscope 5C is a rigid hysteroscope with a slanted distal tip that is intended for use in office based, hospital and ambulatory surgical centers. The operative hysteroscope incorporates an optical fiber bundle design in order to reduce the overall diameter of the needle portion of the hysteroscope and still provide adequate space in the working channel for instrumentation. The Smith & Nephew TRUCLEAR Operative Hysteroscope internal design consists of a "D" shaped working channel into the needle portion of the hysteroscope. The working channel also acts as an inflowchannel.

This document is a 510(k) premarket notification for a medical device called the TRUCLEAR Operative Hysteroscope 5C and Sheath 5C. This type of submission does not typically include an acceptance criteria table or a detailed study proving the device meets specific performance metrics in the way a clinical trial for a new drug or novel AI algorithm would. Instead, it focuses on demonstrating "substantial equivalence" to a legally marketed predicate device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, AI-related studies) are not applicable to this type of regulatory submission for this particular device.

Here's an analysis based on the provided text, addressing the applicable points:

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

This document does not provide a formal table of acceptance criteria with specific numerical thresholds for performance. The "acceptance criteria" are implied by the demonstration of "substantial equivalence" to the predicate device and success in the non-clinical bench testing. The reported "performance" is qualitative, showing that the device meets drawing dimensions, achieves clear vision within a certain time, and has reduced insertion force.

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

• Test Set Sample Size: The document does not specify the exact sample size for the individual non-clinical tests (e.g., how many hysteroscopes and sheaths were tested for dimensional inspection, flow and visualization, or insertion force). It refers to "all devices" in some instances but doesn't provide a number.
• Data Provenance: The testing was "non-clinical bench testing," meaning it was conducted in a lab setting, not on human subjects. The country of origin of the data is not specified, but the applicant (Smith & Nephew, Inc.) is based in Andover, MA, USA, and the submission is to the US FDA, so it's likely conducted or overseen in the USA. The data is prospective for the purpose of this submission (i.e., new testing was performed for this modified device).

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

Not applicable. This is a bench study on a physical medical device, not an AI algorithm requiring expert consensus for ground truth on clinical images or data. The "ground truth" for these tests comes from objective measurements against engineering specifications and comparisons to the predicate device.

4. Adjudication method for the test set

Not applicable. There was no expert adjudication needed for these non-clinical bench tests. The tests involve objective measurements and observations.

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 submission is for a physical medical device (hysteroscope and sheath), not an AI-powered diagnostic tool. MRMC studies are typically relevant for evaluating the impact of AI algorithms on human reader performance.

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

Not applicable. This is for a physical medical device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was based on:

• Engineering specifications and drawing dimensions (for dimensional inspection).
• Objective measurements (e.g., time to clear vision, insertion force measurements).
• Comparison to the performance of the legally marketed predicate device (for substantial equivalence).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no training set for this physical medical device.

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The Smith & Nephew TRUCLEAR Operative Hysteroscope is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

Smith & Nephew's TRUCLEAR Operative Hyteroscope is a rigid hysteroscope that is intended for use in office based, hospital and ambulatory surgical centers. The operative hysteroscope incorporates an optical fiber bundle design in order to reduce the overall diameter of the needle portion of the hysteroscope and still provide adequate space in the working channel for instrumentation. The Smith & Nephew TRUCLEAR Operative Hysteroscope internal design consists of a "D" shaped working channel into the needle portion of the hysteroscope. The working channel also acts as an inflow-channel.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew TRUCLEAR Operative Hysteroscope:

This document is a 510(k) Summary of Safety and Effectiveness for a medical device seeking substantial equivalence to a predicate device, not a report on a clinical study for a novel AI or diagnostic device. Therefore, many of the requested fields (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone algorithm performance) are not applicable as the submission focuses on engineering and performance testing to demonstrate equivalence, rather than a clinical efficacy study with human interpretation of data.

1. Table of Acceptance Criteria and Reported Device Performance

The "study" that proves the device meets the acceptance criteria is the sum of these various performance, optical, electrical, and materials testing. The objective was to demonstrate substantial equivalence to the predicate device (Smith & Nephew Operative Hysteroscope cleared in K013870) based on these technical characteristics.

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 applicable in the context of a 510(k) for a physical medical device. The "test set" would refer to the specific physical units of the TRUCLEAR Operative Hysteroscope that underwent the various performance, optical, mechanical, and safety tests. The document does not specify the number of units tested. This kind of submission typically involves engineering and bench testing rather than patient data.
• Data Provenance: Not applicable in the context of patient data. The testing was likely conducted in laboratories or facilities belonging to Smith & Nephew or a contracted testing organization, presumably in the USA given the company address. This is engineering/bench data, not clinical data from patients.

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. Establishing ground truth by experts is relevant for diagnostic devices that process clinical data (e.g., images, signals) and require human interpretation as a gold standard. For this physical hysteroscope, the "ground truth" for its performance is determined by objective measurements against established engineering, optical, and safety standards and comparison to the predicate device's known performance.

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

• Not applicable. Adjudication methods are typically used in clinical studies where human readers or interpreters might disagree on an outcome. This document describes engineering and performance testing.

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. An MRMC comparative effectiveness study is not mentioned and is not relevant for a 510(k) submission of a physical hysteroscope which is not an AI diagnostic device.

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

• No. This is not an algorithm or AI device. It is a physical instrument.

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

• The "ground truth" used for this submission is based on engineering specifications, recognized national and international standards (e.g., IEC 60601, ISO 10993, AAMI TIR), and the established performance characteristics of the predicate device. The objective was to show that the new device met these objective criteria and performed comparably to the legally marketed predicate.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. This is not an AI/machine learning device.

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