(86 days)
The PIPELINE Access System is intended to provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the port, down to the lamina, with its attachment to a rigid arm to provide a self-locking method of access to the spinal site which can be visualized using a microscope or loupes, and through which surgical instruments can be manipulated.
The PIPELINE II Access System consists of a series of dilators and tubular retractors with integrated light source of various lengths and diameters to provide access to the spine for minimally invasive procedures. The PIPELINE II Access System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The provided text describes the PIPELINE II Access System, a self-retaining retractor for neurosurgery. However, it does not contain the kind of performance data, acceptance criteria, or study details typically associated with AI/ML devices or diagnostic tools that would have such reported metrics.
The document is a 510(k) summary for a physical surgical device, and its "Performance Data" section simply states: "Performance data were submitted to characterize the PIPELINE II Access System components." This indicates that the performance data refers to the physical properties and functionality of the surgical components themselves (e.g., material strength, dimensions, sterilizability), not to accuracy, sensitivity, or specificity metrics like those found in AI/ML or diagnostic device studies.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance for an AI/ML or diagnostic device.
- Sample sizes used for test sets.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
§ 882.4800 Self-retaining retractor for neurosurgery.
(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).