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510(k) Data Aggregation
(262 days)
MectaScope System is used to examine human joints such as knee and shoulder from the inside during arthroscopic diagnostic procedures, providing surgeons with magnified images on a monitor.
The MectaScope System is comprised of rigid scopes use to examine joints, a sheath used to access the surgical site, and obturators to facilitate the initial access of the sheath into the joint cavity in preparation for arthroscopic procedures.
The rigid scopes, manufactured primarily from stainless steel, provide a circular field of view and are available in two (2) different directions of view, 30° and 70°. The sheath, manufactured from stainless steel and EPDM, is introduced into the joint using the obturators and maintains a stable portal during the arthroscopic procedure. The obturators, manufactured with stainless steel and EPDM, are provided with or without a handle; the obturator with a handle is compatible with a Ø 1.5 mm k-wire. The MectaScope System components are provided non-sterile and are reusable.
The MectaScope scopes are designed to be used with legally marketed camera and control units and are connected to legally marketed available light-guide cables via the light connector (designed in accordance with ISO 18339). Manufacturer specific light guide adapters are provided with the MectaScope System including adapters for Olympus/Storz, Richard Wolf, and ACMI light guide cables.
The provided document is a 510(k) Premarket Notification from the FDA for the "MectaScope System," an arthroscope. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance criteria through a clinical trial or extensive standalone performance study as would be seen for novel AI/software devices.
Therefore, many of the typical questions for AI/software device acceptance criteria and studies (like sample sizes for test/training sets, expert adjudication, MRMC studies, effect sizes, etc.) are not directly applicable or detailed in this type of submission because the MectaScope System is a physical medical device (an arthroscope) and not a software-driven diagnostic or AI prediction tool. The performance data presented focuses on mechanical integrity and functional comparison to the predicate device, not diagnostic accuracy in the way an AI would be evaluated.
Here's an attempt to answer your questions based only on the provided text, highlighting what is (and isn't) present:
Acceptance Criteria and Study for the MectaScope System
Based on the provided FDA 510(k) summary, the "acceptance criteria" and "study" are interpreted in the context of demonstrating substantial equivalence for a physical medical device (arthroscope) rather than an AI/software device. The focus is on comparing the MectaScope System's functional performance and characteristics to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table with specific numerical acceptance criteria alongside reported performance for each criterion. Instead, it describes general categories of testing and asserts that "Design verification testing was undertaken and demonstrates that the subject device performs to specification and as intended." And that "Testing was conducted according to written protocols with acceptance criteria that were based on standards."
However, we can infer some "performance" points from the "Comparison of Technological Characteristics" and "Performance Data" sections.
| Acceptance Criterion (Inferred from testing) | Reported Device Performance (as stated in document) |
|---|---|
| Maintain visual field and viewing direction as per ISO 8600 | "visual field and viewing direction testing per ISO 8600" (Passed implicitly, as substantial equivalence was claimed) |
| Meet concentricity requirements as per ISO 18339 | "concentricity test per ISO 18339" (Passed implicitly) |
| Compatible with predicate's fluid passage mechanism for sheath (comparison study) | Performed a comparative study of "fluid passage (volume unit per time) with the MectaScope Rotating Sheath and the KARLSTORZ Arthroscope Sheath" (Implied non-inferiority or equivalence) |
| Functionality in a simulated use environment (cadaver testing) | "cadaver testing" (Implied successful performance in a relevant clinical setting) |
| Efficacy of cleaning and sterilization procedures | "cleaning and sterilization validation" (Implied successful validation ensuring reusability safety) |
| Mechanical integrity and performance on "worst-case device configurations" | "mechanical studies were performed on worst-case device configurations" (Implied meeting desired mechanical performance) |
| System components provide a circular field of view | Stated as a characteristic of the rigid scopes. |
| Available in 30° and 70° directions of view | Stated as a characteristic of the rigid scopes. |
| Reusable | Stated as a characteristic of the rigid scopes. |
| Compatibility with legally marketed camera, control units, and light-guide cables | Stated as a design feature and demonstrated by provision of adapters. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices or cases. For a physical device, testing would involve a certain number of manufactured units or components. The document mentions "worst-case device configurations" were tested, implying specific representative samples.
- Data Provenance: Not specified. Standard practice for device testing would be internal laboratory testing by the manufacturer. The document does not indicate country of origin for the data or whether the studies were retrospective or prospective in a clinical sense, as they are engineering/bench tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not stated. The "ground truth" for this device's performance is based on engineering specifications, international standards (ISO 8600, ISO 18339), and functional comparisons, not on expert interpretations of medical images or diagnoses.
- Qualifications of Experts: Not applicable/not stated. The performance is assessed by engineers and technicians against predefined technical standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no subjective interpretation or consensus-based ground truth required that would necessitate an adjudication method like 2+1 or 3+1. Testing is objective and quantitative (e.g., measuring dimensions, fluid flow, visual field).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. This type of study is specifically designed for evaluating diagnostic accuracy of medical imaging interpretations, often involving human readers with and without AI assistance. The MectaScope System is a tool for providing magnified images for diagnostic procedures, not a diagnostic interpretation software itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable in the context of an AI algorithm. The "performance" refers to the physical functionality of the arthroscope itself (e.g., image quality, structural integrity, compatibility), which is inherently "standalone" in that it functions according to its design, independent of human interpretation aspects.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device's performance is based on:
- Engineering Specifications: Designed performance parameters.
- International Standards: e.g., ISO 8600 for visual field, ISO 18339 for concentricity.
- Predicate Device Performance: Functional equivalence or non-inferiority compared to the legally marketed predicate device (Karl Storz Arthroscopic Telescopes).
- Functional Demonstrations: Successful performance in relevant simulated environments (cadaver testing) and under "worst-case" conditions.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is a physical device, not an AI algorithm that undergoes "training" on a dataset. The design and manufacturing processes are iterative but do not involve a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training: Not applicable, as there is no "training set" for this type of device. The design and manufacturing are based on established engineering principles, material science, and adherence to medical device standards.
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