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NeedleCam HD™ Visualization System Indications for Use: The NeedleCam HD™ Visualization System is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.

NeedleCam HDTM Visualization System is comprised of an Image Capture Box, a Camera Handpiece (including an LED light source) that captures still images and full resolution video, and External Power Supply. The camera has a quick-release optical connector that adapts to a wide variety of Bio Vision Technologies' surgical endoscopes. The device is used with an endoscope to visualize and illuminate an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures.

The BioVision NeedleCam HD™ Visualization System submitted a Special 510(k) and did not conduct a study to prove the device meets acceptance criteria, but rather demonstrated substantial equivalence to a predicate device (BioVision SurgView™ Integrated Visualization System K082293) based on similarities in intended use, design, physical characteristics, and geometry, as well as modifications that are considered incremental changes and do not affect safety and effectiveness.

Here’s a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or a direct comparison of such metrics against predefined thresholds. Instead, it relies on a comparison of technological characteristics to a predicate device, arguing that the new device is "substantially equivalent."

The table below summarizes the key comparisons made between the applicant device (NeedleCam HD™ Visualization System) and the predicate device (SurgView™ Visualization System K082293), highlighting similarities and differences. The implied "acceptance criteria" here are that the new device's characteristics are either identical or demonstrably equivalent/improved without compromising safety and effectiveness.

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

The document explicitly states: "Clinical testing was not used to prove substantial equivalence." Therefore, there was no test set of clinical data, no sample size, and no data provenance relevant to clinical performance. The evaluation was primarily based on engineering and design comparisons.

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)

Since no clinical testing was performed, no ground truth was established by experts for a test set.

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

Not applicable, as no clinical test set 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 a visualization system (hardware), not an AI-assisted diagnostic tool, and 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 device; there is no standalone algorithm performance to evaluate in this context.

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

Not applicable, as no clinical test set requiring ground truth was used. Substantial equivalence was based on technological similarity to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. No algorithm or machine learning component is described that would require 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 system is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.

The NeedleView CH is a rigid Fiberoptic scope with a working channel designed for single use. The product consists of a 17,000 pixel coherent silica fiber bundle, 30um diameter light fibers and a stainless steel channel encased in a stainless steel shaft. The effective field of view is 80° in air and 62° in water. The direction of view is 0°. The scope has retaining groves to incorporate a drape that will cover the camera and cord that connects to the Surg View System. The NeedleView CH Scope Kit consists of a fiber-optic based micro-endoscope (3.4mm Outer Diameter, 1.85mm Working Channel, 160mm Working Length), 12F Cannula (4mm Inner Diameter), 12F Dilator(4mm Diameter), 14Gx127mm Tuohy Needle, 18Gx152mm Tuohy Needle, #11 Scalpel, Guidewire (70cm Length), Hemostasis Valve Adapter (HVA), and a sterile drape. All of these items are disposable and for single-use only. The micro-endoscope is made to couple with a non-disposable system hand piece that contains a light source and camera, which is available separately.

This document is a 510(k) summary for the NeedleView CH™ Scope Kits, a medical device for arthroscopic and endoscopic procedures. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, thereby eliminating the need for extensive clinical trials.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on non-clinical performance and biocompatibility testing to demonstrate substantial equivalence. It does not provide specific numerical "acceptance criteria" or "reported device performance" in the format of a clinical trial outcome with metrics like sensitivity, specificity, or accuracy. Instead, it lists the types of performance tests conducted for various components of the NeedleView CH™ Scope Kit and states that these tests were "completed" or "utilized" specific standards. This implies that the device met the requirements of these standards for each test.

Since no specific numerical performance criteria or results are detailed in the provided text, a table like the one requested cannot be fully constructed with explicit numerical values. However, we can infer the categories of acceptance based on the tests conducted.

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

The document does not specify the sample sizes used for any of the performance tests. The data provenance is also not explicitly stated beyond the fact that these tests were performed by BioVision Technologies, LLC, for their device. This is typical for 510(k) submissions focusing on substantial equivalence through non-clinical bench testing, where detailed sample sizes for each specific test component are often included in the full test reports, not generally in the summary document.

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

Not applicable. This submission relies on performance testing against established engineering and biocompatibility standards, not on expert-adjudicated "ground truth" for diagnostic or clinical outcomes. There were no human experts evaluating the performance in a clinical context for the purpose of establishing ground truth for a test set in the way one would for an AI diagnostic device.

4. Adjudication Method for the Test Set:

Not applicable. As the tests described are physical, mechanical, and biological evaluations against standards, there is no "adjudication method" involving human reviewers in the context of clinical interpretation or diagnosis. The results of the tests would be pass/fail based on the specified standard's criteria.

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. A MRMC comparative effectiveness study was not performed. This device is a physical medical instrument (an arthroscope/endoscope), not an AI-assisted diagnostic or interpretative system. The submission explicitly states: "Clinical testing was not used to prove substantial equivalence."

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

No. This device is a physical instrument for visualization, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used:

For the performance and biocompatibility testing, the "ground truth" used is implicitly the established scientific and engineering standards (e.g., ISO 10993-1, ASTM F2096, ISO 11607-2, etc.). The device's components had to meet the performance specifications outlined in these standards. There is no pathology, outcomes data, or expert consensus serving as "ground truth" in the clinical sense for this type of submission.

8. The Sample Size for the Training Set:

Not applicable. Since this is not an AI/machine learning device, there is no "training set."

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

Not applicable. No training set was used.

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The SurgView™ Integrated Visualization System is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.

The SurgView™ Integrated Imaging System is a video endoscope/arthroscope imaging system consisting of the following components:

1. A Light Source/Display/Image Capture device that includes a monitor, image processor, Xenon light source, camera unit, and a camera hand piece with integrated fiberoptic cable.
2. A semi-rigid Fiberoptic Scope designed for one time use, in a variety of diameters, lengths, and viewing angles.
3. Supplemental Instruments that can be used interchangeably throughout the procedure. They include a cannula, trocar, obturator, and cannula plug.
4. Procedural Kit that contains a variety of sterile items used to aid in the procedure.

Here's a summary of the acceptance criteria and study information for the "SurgView™ Integrated Visualization System" based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary, does not detail specific performance acceptance criteria or report a direct comparison of the device's performance against such criteria using quantitative metrics (e.g., sensitivity, specificity, accuracy).

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on:

• Similarities in intended use, design, and materials, physical characteristics and geometry.
• Compliance with recognized electrical safety and electromagnetic compatibility (EMC) standards.

Therefore, instead of a direct performance table, the "acceptance criteria" are implied to be adherence to the design and safety characteristics of the predicate devices.

Missing Information: It's important to note that this 510(k) summary does not provide specific quantitative performance metrics (e.g., resolution, light intensity, image fidelity) for the device, nor does it explicitly state acceptance thresholds for such metrics. The acceptance is based on demonstrating equivalence, primarily through non-clinical testing and adherence to standards.

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

• Sample Size for Test Set: Not applicable. The document states, "Clinical testing was not used to establish substantial equivalence to predicate devices." The evaluation was based on non-clinical testing and comparison to predicate devices, which typically does not involve a "test set" in the sense of clinical data.
• Data Provenance: Not applicable, as clinical testing was not performed for this submission.

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

• Not applicable. No clinical test set was used, and thus no ground truth established by experts in this context.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set was used.

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

• Not applicable. The device is a visualization system (arthroscope/endoscope) and there is no mention of artificial intelligence (AI) or an MRMC study in the provided text.

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

• Not applicable. The device is not an AI algorithm; it's a visualization system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not applicable for performance evaluation against a specific clinical ground truth. The "ground truth" for the submission is the established safety and performance of the listed predicate devices, and the device's compliance with relevant electrical and EMC standards.

8. The Sample Size for the Training Set

• Not applicable. The device is not an AI algorithm that undergoes training.

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

• Not applicable. The device is not an AI algorithm, and therefore there is no training set or associated ground truth establishment.

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