(86 days)
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.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.