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The InnerVue™ Diagnostic Scope System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. Examples of generic surgical use include the visualization of joints within the body. These joints can include, joints located in the torso/trunk, upper/lower extremities, and the temporomandibular joint.

The InnerVue™ Diagnostic Scope System consists of five (5) main parts: hardware, software, instrumentation and procedural kit(s).

Hardware: The hardware consists of the following components: Monitor, keyboard, image processor, Xenon light source, camera unit, power supply, printer, handpiece (which incorporates the camera head and light cable), a slide-out working surface and a storage drawer.

Software: The software enhances the image from the scope to remove fiber optic pixilation without adding distortion. The software allows the operator to record and print still images as well as record and archive audio and video information recorded during the procedure.

Scope: A rigid fiber optic scope designed for one-time use.

Supplementary Instruments: Supplementary instruments consist of four (4) pieces that can be used interchangeably throughout the procedure. The four components are a cannula, a trocar, and a cannula plug. Both disposable supplementary instruments are available with the system.

Procedural Kits: Supplementary items to assist in the surgical procedure.

The provided text states, "Clinical Testing: None provided as a basis for substantial equivalence." This means that no clinical study was conducted to prove the device meets acceptance criteria specific to its diagnostic or operational performance related to medical outcomes.

Instead, the device's substantial equivalence and performance are based on compliance with electrical safety and general medical equipment standards.

Here's the breakdown of the information requested, based on the provided text:

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)

Not applicable. No clinical testing with a test set was conducted for substantial equivalence. The performance assessment was based on compliance with electrical and safety standards, not clinical data or patient samples.

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

Not applicable. No clinical testing was performed, so no experts were used to establish ground truth for a test set.

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

Not applicable. No clinical testing was 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. No MRMC study was mentioned or conducted, as the device is not an AI-assisted diagnostic tool and no clinical testing was performed for substantial equivalence.

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

Not applicable. No standalone algorithm performance was assessed as this is a medical device for visualization and illumination, not an AI or algorithm-based diagnostic tool. The performance was assessed against safety and electrical standards.

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

Not applicable. Ground truth in a clinical sense was not established as no clinical testing was performed. The "ground truth" for compliance was the requirements outlined in the specified electrical and medical device safety standards.

8. The sample size for the training set

Not applicable. No training set was used as this device does not involve machine learning or AI that requires a training set.

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

Not applicable. No training set was used.

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This device is to be used by a trained physician for viewing the interior cavity of the human body through either a surgical or natural opening.

The InnerVue™ Diagnostic Scope System consists of 5 main parts; the hardware, the software, the scope, the instrumentation and the procedural kit.

Hardware: The hardware consists of the following components: Monitor, keyboard, image processor, Xenon light source, camera unit, power supply, printer, handpiece (which incorporates the camera head and light cable), a slide-out working surface, and a storage drawer.

Software: The software enhances the image from the scope to remove fiber optic pixelation. The software allows the operator to record and print still images as well as record and archive audio and video information recorded during the procedure.

Scope: A rigid fiberoptic scope designed for one time use.

Supplemental Instruments: Supplemental instruments consist of 4 pieces that can be used interchangeably throughout the procedure. The four components of the instrumentation are the cannula, the trocar, the obturator, and the cannula plug.

Procedural Kit: The procedural kit contains many sterile items to aid in the procedure.

This 510(k) summary describes a medical device, the InnerVue™ Diagnostic Scope System. However, it explicitly states that clinical testing was not used to establish substantial equivalence to predicate devices. Instead, equivalence was based on similarities in intended use, non-clinical testing, physical characteristics, and geometry.

Therefore, many of the requested criteria regarding acceptance criteria and study details cannot be provided from this document, as a formal study proving the device meets specific acceptance criteria based on clinical performance was not conducted or submitted with this 510(k).

Here's what can be extracted based on the provided text, and what cannot:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics or thresholds. The 510(k) process for this device relied on demonstrating substantial equivalence to a predicate device (Davlite Microendoscope, K020310) based on non-clinical aspects.
• Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported since no clinical study was conducted. The device's "performance" is implicitly deemed equivalent to the predicate through its design and intended use similarities.

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

• Not applicable. No test set was used for a clinical study to establish performance, as clinical testing was not conducted.

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. No test set requiring expert ground truth was used for performance evaluation.

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

• Not applicable. No test set requiring adjudication was used.

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 an endoscope system, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

• Not applicable. This is a hardware/software system for viewing, not an algorithm-only diagnostic system. No standalone algorithm performance was assessed for regulatory purposes.

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

• Not applicable. No clinical ground truth was established or used for performance validation of this device.

8. The sample size for the training set

• Not applicable. This device does not use machine learning in a way that would require a "training set" for performance evaluation in the context of diagnostic accuracy. The software mentioned "enhances the image... to remove fiber optic pixelation," which implies image processing rather than a learnable AI model requiring a training set for diagnostic classification.

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

• Not applicable. No training set for a diagnostic AI was used.

Summary based on the document:

The InnerVue™ Diagnostic Scope System's acceptance was based on substantial equivalence to an existing legally marketed device (Davlite Microendoscope, K020310). This equivalence was established by demonstrating similarities in:

• Intended Use: Viewing the interior cavity of the human body through surgical or natural openings.
• Non-clinical testing: Not detailed in this summary, but implies bench testing or other engineering evaluations.
• Physical characteristics and geometry: Design and form factor comparisons.

Crucially, this device did not undergo clinical testing to establish its performance or meet specific diagnostic acceptance criteria.

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