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The asap arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrlst (carpal tunnel syndrome), temporal-mandibular joint, ankle and elbow.

The asap arthroscope is reusable and has to be sterilized prior to each procedure by the user.

The intended use for the asap arthroscope is according to relevant medical indication by trained physicians only.

The asap arthroscope is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system.

The basic design of the asap arthroscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light quide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.

The provided document is a 510(k) summary for a medical device (asap arthroscope). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this type of regulatory submission for a simple arthroscope does not typically contain detailed studies with acceptance criteria, reported performance metrics, or information related to AI/algorithm performance, multi-reader multi-case studies, or specific ground truth establishment methods as you've requested.

The document's purpose is to demonstrate that the new arthroscope is "substantially equivalent" to already legally marketed devices, primarily by showing similar design, materials, indications for use, and compliance with relevant standards. It focuses on safety and effectiveness through equivalence, rather than new performance claims that would necessitate rigorous quantitative studies of diagnostic accuracy.

Therefore, most of the information you've requested cannot be extracted from this document based on the nature of the device (a reusable arthroscope, not an AI-powered diagnostic tool).

Here's an attempt to answer what can be inferred or directly stated, and where the information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document implies that the acceptance criteria are met if the asap arthroscope is "substantially equivalent" to the predicate device (AMO Arthroscope K962330) in terms of specifications, intended use, materials, and compliance with voluntary standards.
• Reported Device Performance: The document states that the "specifications and intended use of the asap arthroscope are the same to those of the claimed predicate devices. There are no significant differences between the asap arthroscope and the claimed predicates in design or conditions of intended use." It also mentions successful validation of the ability to repeatedly sterilize the device.

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

• Information Not Provided: This type of information (sample size, data provenance for specific tests) is not typically detailed in a 510(k) for a basic arthroscope. The review is based on bench testing, material equivalence, and standard compliance, not clinical diagnostic performance studies on patient 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)

• Information Not Provided: Ground truth as described (e.g., for diagnostic accuracy) is not relevant or applicable to this device and its 510(k) submission.

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

• Information Not Provided: Adjudication methods are not relevant for the type of evaluation performed for this device.

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

• Information Not Provided & Not Applicable: This is a rigid arthroscope, not an AI-powered diagnostic device. MRMC studies or AI assistance are not relevant.

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

• Information Not Provided & Not Applicable: This is a rigid arthroscope, not an algorithm.

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

• Information Not Provided & Not Applicable (in the requested context): The "ground truth" for this device relates to engineering specifications, material properties, and functionality, verified through bench testing and compliance with standards, rather than clinical diagnostic outcomes or expert consensus on medical images/data.

8. The sample size for the training set

• Information Not Provided & 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

• Information Not Provided & Not Applicable: As above, no training set. The "ground truth" for the device's properties is established by engineering principles, material science, and regulatory standards.

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Like other legally marketed arthroscopes, the AMO Arthroscope is indicated for use in minimally invasive procedures of the knee, shoulder and ankle joints, for joint examination, biopsy, arthroscopy, diagnosis of ioint disease.

The device provides a clear view of the joint structures such as femoral condyles, medial meniscus, cruciate ligament, and other anatomical structures.

The AMO Arthroscope is a device that will be provided non-sterile for arthroscopic procedures. The device has a basic design similar to those already sold legally in the U.S.A. Its construction consists of an eyepiece, body, light guide and a shaft. The shaft contains an outer tube, an inner tube, with light-carrying fibers sandwiched between these tubes. The inner tube contains the optical system.

This 501(k) submission for the AMO Arthroscope (K962330) primarily focuses on establishing substantial equivalence to a predicate device (Storz 7200BW Arthroscope) based on design principles, materials, function, and indications for use. It's important to note that this submission predates many of the rigorous clinical study requirements often seen for AI/ML-based devices or devices requiring extensive performance data today.

Therefore, the provided text does not contain information related to acceptance criteria and a study proving the device meets those criteria in the way you've outlined for AI/ML devices. The submission emphasizes material biocompatibility and functional similarity rather than quantitative performance metrics from a specific study.

However, I can extract information related to the closest equivalents to your requested categories, acknowledging that they are not structured as you would find for an AI/ML device study.

Here's a breakdown based on the provided text, indicating where information is not present (N/A) for your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of quantitative performance metrics for AI/ML devices.

The "acceptance criteria" here are implicitly tied to the general understanding of a safe and effective arthroscope at the time, and its substantial equivalence to the predicate. The performance is described qualitatively in terms of

• Biocompatibility: "The biological safety of the AMO arthroscope has been defined through the selection of materials that demonstrated appropriate levels of biocompatibility. The proposed AMO Arthroscope was designed with similar base materials."
• Function: "The device provides a clear view of the joint structures such as femoral condyles, medial meniscus, cruciate ligament, and other anatomical structures." and "function and device design have been developed to ensure the device is safe, effective, and substantially equivalent in materials, function and intended use to commercially available arthroscopes."

There are no numerical performance metrics (e.g., sensitivity, specificity, accuracy) provided in this document.

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

N/A. No formal "test set" or clinical study with a defined sample size is described for the AMO Arthroscope. The evaluation relies on comparison to the predicate device's established safety and effectiveness.

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

N/A. No ground truth establishment by experts is described in the context of a performance study for the AMO Arthroscope. The ground truth for device safety and effectiveness is implicitly derived from the predicate device and general medical understanding of arthroscopes.

4. Adjudication Method for the Test Set

N/A. No test set or adjudication method is described.

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

N/A. This type of study is not mentioned. The submission is focused on demonstrating equivalence to an existing device, not on improving human reader performance with AI.

6. Standalone (Algorithm Only) Performance

N/A. The AMO Arthroscope is a physical medical device, not an algorithm. Standalone performance as applied to AI/ML devices is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the AMO Arthroscope's safety and effectiveness is primarily established through:

• Predicate Device Equivalence: The Storz (Karl Storz) 7200BW Arthroscope is the basis for comparison, implying its known safety and effectiveness serves as a benchmark.
• Material Biocompatibility Data: Reference to "materials that demonstrated appropriate levels of biocompatibility" suggests reliance on established standards and testing for materials science, rather than patient outcomes or pathology from this specific device.

8. Sample Size for the Training Set

N/A. No "training set" in the context of AI/ML or a clinical study is mentioned.

9. How Ground Truth for the Training Set Was Established

N/A. No "training set" or explicit ground truth establishment process is described beyond the general understanding of arthroscope function and material properties.

Summary of Device Evaluation in the K962330 Submission:

The provided document describes a substantial equivalence determination rather than a performance study with specific acceptance criteria and detailed quantitative results. The key arguments for acceptance are:

• Similar Design Principles and Technological Features: The AMO Arthroscope uses the "same basic design principles and technological features as the proposed AMO Arthroscope."
• Similar Base Materials: "The proposed AMO Arthroscope was designed with similar base materials. These materials are similar to those used in other legally marketed brands of arthroscopes, including the predicate device."
• Similar Indications for Use: "Like other legally marketed arthroscopes, the AMO Arthroscope is indicated for use in minimally invasive procedures of the knee, shoulder and ankle joints, for joint examination, biopsy, arthroscopy, diagnosis of ioint disease."
• Qualitative Performance: "The device provides a clear view of the joint structures..."

The acceptance criteria are implicitly that the device is as safe and effective as the predicate device when considering these aspects. The "study" proving this largely consists of comparing the specifications and intended use to the predicate.

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