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Stryker Arthroscopes are endoscopic devices into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle elbow, and feet (plantar fascia release).

Stryker Arthroscopes are tubular optical instruments used to provide a view of internal patient anatomy for examination, diagnosis, and therapy during arthroscopic procedures. The devices are available in a variety of outer diameters and working lengths.

The arthroscopes are reusable devices initially supplied as non-sterile to the user and requiring the user to process the device for initial use, as well as to reprocess the device after each use. The devices are available in an evepiece and a C-Mount design. The evepiece arthroscopes connect to the camera system through a separate coupler; the C-Mount arthroscopes connect directly to the camera system through an integrated coupler.

Stryker's arthroscopes achieve their intended use by guiding light to illuminate and image an arthroscopic joint, then relaying the image out of the surgical site for processing and display by a separate camera system. The arthroscopes' optical system consists of a series of lenses, which includes an objective lens to image the intended object, a relay rod lens system to transmit the image along the working length, and an ocular lens to form the final image size.

The provided document is a 510(k) Summary for the Stryker Arthroscopes. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies on AI algorithms or advanced performance metrics. As such, the document does not contain the information required to answer many of the questions asked, particularly those related to acceptance criteria, AI performance, ground truth, and sample sizes for AI studies.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document provides a table of tests performed and their results, but it does not explicitly state the acceptance criteria for each test. It only indicates "PASS" for all tests.

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

This information is not provided in the document. The document describes tests primarily related to the physical and functional aspects of the arthroscope (electrical safety, packaging, biocompatibility, cleaning, sterilization, mechanical performance), not data-driven performance studies typically associated with AI/software devices.

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)

This information is not provided. The device is an arthroscope, a physical optical instrument. The tests mentioned are for its physical and functional characteristics, not for diagnostic accuracy that would require expert-established ground truth.

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

This information is not provided. As explained above, the tests are primarily for physical and functional performance, not diagnostic accuracy requiring adjudication.

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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance in this document. The device is a traditional arthroscope, not an AI-powered diagnostic tool.

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

There is no mention of an algorithm or standalone performance in this document.

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

This information is not applicable/provided. The performance tests are for physical device characteristics, where "ground truth" would be defined by engineering specifications and standards, not clinical diagnostic outcomes.

8. The sample size for the training set

There is no mention of a training set as this is not an AI/machine learning device.

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

There is no mention of a training set or its ground truth, as this is not an AI/machine learning device.

Summary based on available information:

The provided document is a 510(k) summary for a traditional medical device (Stryker Arthroscopes) and demonstrates substantial equivalence to a predicate device based on design, intended use, operating principles, technological characteristics, and safety features. The performance testing focuses on standard engineering, safety, and reprocessing validations rather than AI-specific performance criteria or clinical diagnostic accuracy studies. Therefore, most of the questions related to acceptance criteria for AI performance, ground truth, and sample sizes for AI studies cannot be answered from this document.

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The Smith+Nephew Arthroscopes is indicated to provide illumination and visualization in:

· Diagnostic and Operative arthroscopic procedures for the hip, knee, shoulder, wrist, ankle, elbow, and feet.

In addition, Smith+Nephew 4 mm diameter rigid athroscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

The proposed Smith+Nephew 4KO Direct View/Video Arthroscopes are a line extension to the previously cleared K971253 and are surgical instruments used for illumination and visualization of surgical sites within articular cavities, body cavities, hollow organs and canals.

The Arthroscopes are designed with various angle specifications for directions of view and working lengths for access to various locations. The Arthroscopes are shipped non-sterile and must be cleaned, inspected and sterilized prior to each use. Both designs consist of a long tube containing a series of rod lenses that work to transfer the image of the patient's anatomy, through an associated visualization camera system, to a central monitor for clinical use in treatment.

The direct view scopes require attachment to an endocoupler and the VideoEndoscopes are attached to a Smith+Nephew C-Mount camera head.

Illumination is provided through a bundle of optical fibers internal to the Endoscope that transmits light from an external source to illuminate the image.

This inquiry pertains to a 510(k) premarket notification for the "Smith+Nephew Arthroscopes" (K201349). The provided documentation describes a medical device, specifically an arthroscope, which is a type of endoscope used for visualization during diagnostic and operative arthroscopic procedures.

The information provided does not describe an AI/ML powered device, nor does it detail a study that proves the device meets specific acceptance criteria in the manner one would typically expect for an AI/ML product. The document instead focuses on demonstrating substantial equivalence to a predicate device through performance testing of the physical arthroscope.

Therefore, many of the requested fields cannot be filled as they are explicitly related to AI/ML device testing and evaluation.

Here's a breakdown of the available information and why other fields cannot be completed:

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

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

This information is not provided in the document. The document refers to "Performance Testing" in general terms for the physical device but does not specify sample sizes for these tests, nor the origin or nature of the data (e.g., patient data, in-vitro testing).

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)

This information is not applicable as the device is a physical arthroscope, not an AI/ML diagnostic or image analysis tool requiring expert ground truth for a test set.

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

This information is not applicable for the reasons stated above.

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

This information is not applicable as this is not an AI/ML device, and no MRMC study is detailed for its comparison or human-in-the-loop performance.

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

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable for the reasons stated above. The "ground truth" for a physical arthroscope's performance would relate to physical specifications and functional tests, not clinical diagnostic ground truth.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device and therefore does not have a "training set."

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

This information is not applicable as this is not an AI/ML device and therefore does not have a "training set" or associated ground truth establishment process.

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Integrated Endoscopy's Nuvis® Battery Arthroscope is an endoscopic device introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy . Integrated Endoscopy's Nuvis® Battery Arthroscopes are indicated for use in arthroscopic procedures performed in the knee, shoulder, hip, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).

Integrated Endoscopy's Battery Arthroscope is an optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, and hip joint. Integrated Endoscopy's Battery Arthroscope has a 141mm working length, an outside diameter of 4mm, a field of view of 105 °, and a direction of 30 °. The Arthroscope is Battery Powered and three selectable light settings. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 141mm. The Arthroscope is supplied sterile and is for SINGLE USE ONLY. DO NOT REUSE OR RE-STERILIZE.

The provided document describes the FDA 510(k) premarket notification for the "Nuvis Battery Arthroscope" by Integrated Endoscopy, Inc. This submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets novel acceptance criteria through a full-scale clinical study with extensive data analysis as typically seen for AI/ML-based medical devices.

The information primarily concerns the performance data summary for a medical device, specifically an arthroscope, and its comparison to a predicate device for FDA 510(k) clearance. It is not a study that proves an AI/ML device meets specific acceptance criteria in the sense of a multi-reader, multi-case study with AI assistance. Therefore, many of the requested points related to AI/ML device validation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this document.

The document discusses "acceptance criteria" in terms of meeting design and performance requirements through bench testing, rather than clinical performance metrics in AI/ML validation.

Here's the information extracted from the provided text as it pertains to the device's validation:

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

The document does not present a formal table of acceptance criteria with specific quantitative thresholds met, but rather summarizes that the device "met all specified design and performance requirements" and "passed electromagnetic compatibility (EMC), electrical safety and biocompatibility testing requirements." Performance was demonstrated through direct comparison to the predicate device and established standards.

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The provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called "Precision Ideal Eyes Arthroscopes". This letter primarily deals with the administrative aspects of the FDA's substantial equivalence determination and regulatory compliance requirements.

It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.

Therefore, I cannot fulfill your request for this specific information based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a 510(k) submission summary, or a clinical study report for the device.

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The Prosurg's Neo-Arthroscope ™ -Digital Video Arthroscopic System (which includes Digital Video Arthroscope, Single use Outer Sheath is intended to provide an internal view or image of the interior of a joint through surgical opening during examination, diagnostic / operating, arthroscopic / endoscopic treatment procedures including examination, diagnostic & surgical procedures for treatment of knee, shoulder, ankle, elbow, Hip, wrist (Carpel Tunnel Syndrome), hand, TMJ (Temporal Mandibular Joint), Spine, Disc and feet (Planter fascia Release) using surgical devices and accessories.

The Single Use Digital Video Arthroscope design incorporates a CMOS imaging sensor and built-in LEDs (Light Emitting Diodes) or fiber optic mounted at the distal end or in the sidewall, connecting wires along the length of the hollow tubular structure and a USB / HD Connector at the distal end of the Arthroscope containing CMOS sensor and LEDs / Fiber optic is protected by sealed, clear optical window. The Single Use Neo- Arthroscope is designed to be completely isolated from irrigation and suction fluid pathways. The design of sealed distal end and proximal end of the outer sheath / cannula also prevents any fluid or tissue contact with Neo-Arthroscope.

The Neo-Arthroscope ™ - Digital Video Arthroscopic System consists of four main components:

• (a) Digital Video Arthroscope with CMOS Sensor & Built-in LEDs / Fiber optic. (Patient Contact Item)
• (b) Single Use, Outer Sheath / Cannula with Suction / Irrigation, a separate, dedicated channel for insertion of video Arthroscope and /or Trocar for insertion. (Patient Contact Item)
• (c ) Laptop /Tablet computer with windows Operating System, TV monitor module and Video processing Software. (Commercially Available, Non patient Contact Item)
• (d) USB 2.0 / HD Connecting Cables. (Commercially Available, Non Patient Contact Item)

The provided document focuses on the 510(k) premarket notification for the "Neo-Arthroscope™ - Single Use Digital Video Arthroscopic System." The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a statistical performance against acceptance criteria in the context of a diagnostic AI algorithm.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in this document. This document describes a medical device (an arthroscope) and its physical and functional characteristics, not software or AI performance.

The document describes "Performance Testing (Bench Testing)" but these tests are for the physical device's safety and effectiveness, not for a diagnostic algorithm's accuracy.

Here's what can be extracted regarding the device's validation from the provided text:

Performance Testing (Bench Testing) Categories:

The manufacturer, Prosurg, conducted performance testing (Bench Test Evaluation) as per FDA Guidance Document to demonstrate the safety and effectiveness of the Neo-Arthroscope™ device for its intended use. The following tests were completed:

• Dimensional Measurements (Outer Diameter, Working Length)
• Field of View (in air)
• Image Resolution (Number of Pixels)
• Direction of View
• LED Brightness, Voltage & Current measurement.
• USB / HD Connection compatibility with Laptop / Tablet / Monitor
• Electrical Safety Test (IEC 601-1)
• Electromagnetic Compatibility (IEC 601-1-2)
• Thermal (Heat) Temperature at the Distal Tip (LED)
• Product Labeling & IFU Requirements & Accuracy
• Packaging Integrity & Sterility Assurance Test
• Accelerated Aging Test (one Year)
• Sterilization Assurance Level (ISO 11135-1:2007)
• ETO Residual Levels (ISO 10993-7:2008)
• Biocompatibility (ISO 10993-1:2009)

Conclusion from the document:
"The results of the performance testing demonstrate that proposed Neo- Arthroscope Single Use Digital Video Arthroscopy system performs as well as predicate device and is considered safe and effective for its intended use."

Regarding your specific questions:

1. A table of acceptance criteria and the reported device performance: Not provided in the context of diagnostic accuracy. The performance tests listed are general safety and engineering specifications, not statistical performance metrics for decision-making.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device clearance, not an AI algorithm. The "test set" here refers to physical performance tests of the arthroscope itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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Integrated Endoscopy`s nuvis™ Arthroscope is an endoscopic device introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Integrated Endoscopy's nuvis™ Arthroscopes are indicated for use in arthroscopic procedures performed in the knee, shoulder, hip, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).

Integrated Endoscopy's nuvis™ Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, and hip joint. Integrated Endoscopy's nuvis™ Arthroscope has a 140mm working length, an outside diameter of 4mm, a field of view of 105°, and a direction of view of 30°. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 140mm. The Arthroscope is supplied sterile and is for Single Use Only. It is not intended to be re-used or re-sterilized.

The nuvis™ Arthroscope is a long tube containing a series of lenses. At the distal end, a lens captures the image of the object and transfers it via a series of lenses along the long tube to the eye piece or Camera Monitor System at the proximal end of the arthroscope. The nuvis™ Arthroscope is made of materials that are commonly used in medical devices such as stainless steel, copper, glass, sapphire and plastics. The operating site is magnified by approx. two to five times its actual size depending on the distance between the tip of the endoscope and the object being visualized.

This document describes the nuvis™ Arthroscope, a rigid endoscopic optical instrument for visualizing internal joint anatomy. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study with human readers and ground truth.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Reported Device Performance

Study Details:

The provided text does not describe a clinical study with human readers, specific patient data, or ground truth as typically understood for AI/CADe device evaluations. Instead, it describes engineering and non-clinical performance testing.

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Not applicable for a clinical study. The "performance testing also included comparison of images taken by the nuvis™ Arthroscope and its predicate, the Stryker Arthroscope." However, the number of images, cases, or specific test scenarios for this comparison is not provided.
   • Data provenance: Not applicable. The "comparison of images" would have been generated in a controlled, non-clinical environment rather than from patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human expert "ground truth" was established for a clinical evaluation in this submission. The "ground truth" for the performance tests was defined by engineering specifications and predicate device performance.

3. Adjudication method for the test set: Not applicable. There was no clinical test set requiring adjudication.

4. 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 study was done, as this is not an AI/CADe device. It is a manually operated arthroscope.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.

6. The type of ground truth used: For the image comparison, the implicitly defined "ground truth" was the expected image quality and performance of the predicate device (Stryker Arthroscope) and the design specifications for the nuvis™ Arthroscope. For other tests (EMC, electrical safety, biocompatibility), the ground truth was conformance to specific regulatory and industry standards.

7. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design and manufacturing process would involve internal testing and validation, but this is not typically referred to as a "training set" in this context.

8. How the ground truth for the training set was established: Not applicable.

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Mitek Sports Medicine Arthroscopes are indicated for use in arthroscopic procedures (such as the knee, shoulder, hip, ankle, elbow) to provide visualization during surgery.

The Mitek Arthroscope is a multi-angle, rigid 4.3 mm arthroscope that has the capability of varying direction of view from 10° to 90° which enables surgeons to maximize and optimize their field of view inside the joint from any given port. This reduces the need for multiple fixed-angle arthroscopes. The direction of view is altered by the direction of view dial; the direction of view is indicated by markings on the scope body. The Mitek Arthroscope provides a 55° field of view and a depth of field from 5mm to 40mm. The device shaft can also rotate by rotating the device (typically by the light post). A standard eyepiece located on the proximal end of the device is compatible with a standard camera coupler. The light post on the subject device is compatible with an ACMI light source. There are two light post stainless steel adaptors that accompany the Mitek Arthroscope. Two adapters are provided to facilitate connection with medical light source cables with a diameter of 5.0mm and smaller. The Mitek Arthroscope is a reusable device and must be cleaned and sterilized according to the user manual prior to every use.

This document describes the premarket notification (510(k)) for the Mitek Arthroscope, a medical device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful adherence to recognized standards and the passing of all specific tests.

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

The document does not explicitly state the sample size for the individual performance tests (Field of View, Fixed Focus, etc.). It mentions that "Verification tests of the Mitek Arthroscope included performance, cleaning validation and biocompatibility." The data provenance is not specified, but these are likely internal laboratory tests performed by the manufacturer. It is a prospective study in the sense that the tests were performed on the newly developed device to demonstrate its performance.

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

This device is an arthroscope, a medical instrument, not an AI or diagnostic device. Therefore, the concept of "ground truth established by experts" in the context of interpretation of medical images or data is not applicable here. The "ground truth" for the performance tests would be the established engineering specifications and measurement standards.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the context of multiple observers or interpretations, as this is a device performance test, not a diagnostic study. The "adjudication" is implied by the "Passed" results against established criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI systems to assess their impact on human reader performance. The Mitek Arthroscope is a surgical visualization device.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Summary of Testing" table (Table 3) directly presents the results of various performance tests of the Mitek Arthroscope itself (e.g., Field of View, Fixed Focus, Scope Resolution). The entire "Non-Clinical Testing" section describes these standalone performance assessments.

7. Type of Ground Truth Used

The ground truth used for the performance tests was based on engineering specifications and recognized national and international standards. For example, DIN ISO 8600-3:2004 (Optics and optical instruments -- Medical endoscopes and endoscopic accessories -- Part 3: Determination of field of view and direction of view of endoscopes with optics) explicitly defines how certain optical parameters should be measured and what constitutes acceptable performance. Similarly, other standards like EN 60601-18 and ISO 10993-1 provide the "ground truth" for electrical safety and biocompatibility, respectively.

8. Sample Size for the Training Set

This document describes the clearance of a physical medical device (an arthroscope), not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of machine learning. The device is manufactured based on design specifications.

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

As there is no training set for an AI algorithm in this context, this question is not applicable.

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The Video Trays listed above are used for loading surgical instruments in or to conveniently organize, sterilize, transport and store the instruments between uses. The Video Trays listed above are not intended to maintain sterility: they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.

The Video Trays listed above are intended to be used to enclose ConMed medical devices including hand instruments, trocars, camera heads, adapters, endoscopes, light guides, and bridge systems to steam sterilize the enclosed medical devices by a health care provider.

The instrument trays were validated as per below sterilization parameters: Steam (wrapped) sterilization Pre-vacuum cycle at 270 F ( 132 °C) for 4 minutes Cool down to 48°C for 118 minutes

VP1003 Video Extended Length Tray (RADEL) dry cycle is 35 minutes. ConMed Corporation instruments which can be sterilized in this tray are scopes with an outer diameter not less than 5.5mm or greater than 10mm with lengths no greater than 530mm. and light guides with a length no greater than 10ft.

VP1005 Video Tray Single Level (RADEL) dry cycle is 40 minutes. ConMed Corporation instruments which can be sterilized in this tray are Scopes. Sheaths, Cannulas and Bridge System with internal diameters not less than 2.3mm. outer diameter not less than 2.9mm or greater than 10mm, and with lengths no greater than 404mm. Non-Cannulated. Non-Porous instruments with outer diameters not less than 2.9mm or greater than 3.2mm and with lengths no greater than 404mm may also be sterilized in this tray.

VP1006 Video Arthroscope Tray (RADEL) dry cycle is 20 minutes. ConMed Corporation instruments which can be sterilized in this tray are scopes with diameters not less than 2.9mm or greater than 4mm. with lengths no greater than 233mm.

VP1007 Video Laparoscope Tray (RADEL) dry cycle is 25 minutes. ConMed Corporation instruments which can be sterilized in this tray are scopes with diameters not less than 5.5mm or greater than 10mm. with lengths no greater than 404mm.

VP1003 Video Extended Length Tray (RADEL), VP1005 Video Tray Single Level (RADEL), VP1006 Video Arthroscope Tray (RADEL) and VP1007 Video Laparoscope Tray (RADEL) - are constructed of RADEL with perforations to facilitate steam sterilant penetration, evacuation and drying. These trays are designed to fit any standard autoclave and are manufactured from durable, biocompatible materials that are corrosion resistant and compatible with the environment of repeated steam sterilization. Since the trays are perforated, an FDA cleared sterilization wrap K082177 must be used to maintain sterility of the contents. Interior structures of the trays have the ability to separately hold individual instruments during the entire duration they are in contact with the tray. Although these trays are reusable they will not be serviced or repaired.

We are looking at sterilamp.

1. Acceptance Criteria and Device Performance:

The acceptance criteria for each test and the corresponding device performance are detailed in the "Summary of Non Clinical Tests" section of the 510(k) summary, specifically on pages 9 and 10 of the provided document.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of trays tested for sterilization, cleaning, etc.). It refers to "three half cycles" for sterilization qualification, which likely indicates a specific number of sterilization runs. The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective, beyond indicating that the studies were conducted by ConMed Corporation (the submitter).

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

This device (sterilization containers) is not a diagnostic or prognostic device that relies on expert interpretation of images or other subjective data to establish ground truth. The ground truth for this type of medical device is established through objective performance metrics and standardized test methods (e.g., sterilization efficacy, material compatibility, mechanical strength). Therefore, information regarding "number of experts" or their "qualifications" for establishing ground truth in the context of diagnostic interpretation is not applicable and not provided in the document.

4. Adjudication Method for the Test Set:

Adjudication methods like "2+1" or "3+1" are typically used in studies where there is subjective interpretation of data (e.g., reviewing medical images). For a device like a sterilization container, the tests involve objective measurements and established scientific protocols (e.g., sterility testing, material strength testing). Therefore, an explicit "adjudication method" in the sense of expert consensus on subjective findings is not applicable and not mentioned in the document. The studies were concluded based on whether the results met the predefined acceptance criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a sterilization container, not a diagnostic or AI-assisted interpretation tool. The concept of "human readers improving with AI vs without AI assistance" is not relevant to this type of medical device.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study (algorithm only without human-in-the-loop performance) was not done. This device is a physical medical device (sterilization container), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not applicable.

7. Type of Ground Truth Used:

The ground truth used for these tests is based on objective performance metrics and established scientific and regulatory standards. This includes:

• Sterility Assurance Level (SAL) of 10^-6: This is a widely accepted standard for demonstrating effective sterilization.
• Material compatibility: Assessed against standards like ISO 10993 for biocompatibility.
• Mechanical integrity: Measured against standards like ANSI/AAMI ST77 for handle load requirements.
• Cleaning efficacy: Evaluated through validation studies to ensure effective removal of contaminants.
• Physical property maintenance: Ensuring the product and packaging withstand transportation conditions.

These are not based on expert consensus on subjective findings, pathology, or outcomes data in the way a diagnostic device would be.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable to this device. This is a physical medical device, not a machine learning model or algorithm that requires training data. The studies conducted are verification and validation tests of the device's physical and functional properties.

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

Since there is no "training set" for this physical device, the question of how its ground truth was established is not applicable. The device's performance is evaluated against predetermined, objective criteria as detailed in section 7.

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OSI Q System Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wrist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint.
Hip Diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondomatosis Unresolved hip pain Labral tears
OSI Q System Arthroscopes of appropriate size and length also are indicated for visualization and performance of arthroscopic surgical procedures on various structures of the spine, including nerve roots. foramina, intervertebral discs and the surrounding spinal structures.

OSI Q System Arthroscopes are rigid, fixed arthroscopes with a wide-angle view and a rod lens imaging system with a fiber optic illumination system to provide visualization of various anatomic structures during diagnostic and operative arthroscopic procedures. OSI Q System Arthroscopes have surgical stainless steel shafts and lens housing for durability and are available with various angles of view. The optical components are sealed to provide a durable focusing mechanism. The arthroscopes may be attached to a video camera and are available in various sizes, diameters and lengths, to provide for differences in arthroscopic surgical site and surgeon preference. OSI Q System Arthroscopes have a working length of 175.5 mm to 212.5 mm. diameters ranging from 3.1 mm to 5 mm. an angle of view (direction of view) of either 30° or 70°, and a field of view of either 90° or 100°. Visualization sheaths are provided in three designs, with diameters of either 5 mm or 6.1 mm, an angle of view of 0°, 30°, or 70°, and working lengths ranging from 151 mm to 185.5 mm.
The arthroscope main body tube, insertion tube, and optic tube are all made from 304 stainless steel. The other patient contacting parts of the arthroscope are the objective window (sapphire), eutectic solder, and USP Class VI epoxy, and are the same materials used in the predicate OSI Arthroscopes (K091398). The visualization sheaths are made from 316 stainless steel.
Arthroscopes are provided non-sterile and are reusable. Visualization sheaths are provided sterile for single use only.

Acceptance Criteria and Study for OSI Q System Arthroscopes (K133018)

Based on the provided 510(k) summary, the OSI Q System Arthroscopes were determined to be substantially equivalent to previously marketed predicate devices (K091398 and K992782) and therefore did not require new clinical or non-clinical studies to establish acceptance criteria or prove performance. The submission relies on the established performance of the predicate device K091398 to demonstrate the performance of the subject device.

1. Table of Acceptance Criteria and Reported Device Performance

Since no new studies were conducted, the "acceptance criteria" for the subject device are implicitly met by its technological characteristics being "the same as" or "similar to" the predicate devices. The performance reported for the subject device is directly tied to the predicate.

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

• Sample Size: Not applicable. No new test set was used. The submission relies on existing data and regulatory clearances of predicate devices.
• Data Provenance: Not applicable for a new test set. The data provenance for the predicate device K091398 (Orthopedic Sciences, Inc., Arthroscope) and K992782 (NuVasive, Inc., Spinal Arthroscope) would be tied to their original clearances, which are not detailed in this summary.

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

• Not applicable. No new test set requiring expert ground truth establishment was used for this submission.

4. Adjudication method for the test set

• Not applicable. No new test set required adjudication for this submission.

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 arthroscope, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

• Not applicable. This device is an arthroscope, not a standalone algorithm.

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

• Not applicable. The substantial equivalence determination is based on the comparison of the device's technological characteristics to legally marketed predicate devices, not on direct clinical ground truth generation for the subject device itself.

8. The sample size for the training set

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

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

• Not applicable. As this is not an AI/machine learning device, no training set or its associated ground truth establishment methods are relevant.

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