(173 days)
The Baxano, Inc. Microblade Shaver and Accessories are designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.
The Microblade Shaver and Accessories are used to access the neural foramen and decompress targeted areas. The Microblade Shaver is pulled into the foramen with the Distal Handle and tissue is removed by pulling up on the distal handle to cut the targeted soft tissue and bone. The Accessories include a Probe, Guide, Needle Wire and Distal Handle. The Microblade Shaver is made of stainless steel and is flexible, with a low profile, to allow access to compromised neural areas when exposure is otherwise difficult to obtain.
The provided text describes a 510(k) premarket notification for the Microblade Shaver and Accessories. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving device performance through specific acceptance criteria and detailed clinical studies with reported metrics like sensitivity, specificity, and accuracy for diagnostic devices.
Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found in submissions for AI/ML-driven diagnostic devices, is not present in this document.
The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance data and cadaver studies used to demonstrate equivalency to predicate devices, not to meet specific quantitative performance metrics as would be the case for AI-enabled diagnostic tools.
Here's an analysis of what is available in the document, framed as closely as possible to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated) | Reported Device Performance (from Cadaver Studies) |
|---|---|
| Device meets design specifications. | Not explicitly quantified, but implied by successful use in cadaver studies. |
| Device meets intended performance characteristics for removing bone in compromised neural areas. | Provided comparable tissue removal with commercially available rongeurs. |
| No visible damage to neural structures during use. | No visible damage to neural structures. |
| Ease of use comparable to the standard of care. | Ease of use comparable to the standard of care (when compared to commercially available rongeurs). |
Explanation: The "acceptance criteria" here are qualitative and focused on demonstrating functional equivalence and safety in a simulated surgical environment, rather than quantitative performance thresholds.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: "multiple cadaver studies" - The exact number of cadavers or procedures is not specified.
- Data Provenance: Cadaver studies. The country of origin is not specified, but the submission is to the U.S. FDA. The studies were prospective in the sense that the device was used in a controlled simulation environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified, but described as "physicians skilled in procedures for decompressing neural foramen and lateral recess."
- Qualifications: "skilled in procedures for decompressing neural foramen and lateral recess." Specific years of experience or board certifications are not provided.
4. Adjudication Method for the Test Set
- No explicit adjudication method (like 2+1 or 3+1 consensus) is described. The results are from direct observation and assessment by the participating physicians.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study (MRMC for comparing human readers with/without AI assistance) is not relevant to a mechanical surgical instrument. The comparison was between the Microblade Shaver and "commercially available rongeurs" by skilled physicians in cadaver studies. No AI component is involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a manual surgical instrument; there is no 'algorithm only' component.
7. The Type of Ground Truth Used
- Expert Observation and Assessment: The "ground truth" was established by the participating physicians based on their direct observation of tissue removal, neural structure integrity, and ease of use in the cadaveric setting, compared to existing predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
Summary of Device and Study Focus:
This 510(k) submission is for a mechanical surgical instrument. The "study" referenced is a series of non-clinical mechanical performance tests and cadaver studies. The purpose of these studies was to demonstrate functional equivalence and safety compared to existing predicate devices already on the market, not to establish performance metrics (like sensitivity/specificity) against a "ground truth" derived from patient data, as would be the case for a diagnostic AI device. The criteria are largely qualitative and revolve around successful operation and comparable outcomes in a simulated environment.
§ 882.4840 Manual rongeur.
(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).