(177 days)
The Baxano, Inc. Ultra Low Profile Rongeur is designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.
The ULP Rongeur and Access Tools are used to access the neural foramen and decompress targeted areas. The Rongeur is pulled into the foramen with the distal handle and tissue is removed by pulling up on the distal handle to decompress the impinged nerve root. The Access accessories include a probe, guide and needle wire.
Since this is a 510(k) premarket notification for a medical device (a surgical rongeur), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally framed around demonstrating substantial equivalence to a predicate device, rather than explicit numerical performance targets like those for AI/Software as a Medical Device (SaMD).
Here's an analysis based on the provided text, structured to answer your questions where applicable, and noting where information typical for AI/SaMD studies is not present for this type of device:
Acceptance Criteria and Device Performance Study for the Baxano Ultra Low Profile Rongeur (K062711)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Substantial Equivalence) | Reported Device Performance and Evidence |
|---|---|
| Indications for Use: Same as predicate devices (accessing, cutting, and biting soft tissue and bone involving the spinal column). | The ULP Rongeur has the same indications for use as the predicates; to access, cut, and bite soft tissue and bone involving the spinal column. The Access Tools also have the same intended uses as commercially available probes and guides for discectomy procedures. |
| Technological Characteristics: Same materials and similar design as predicate devices (stainless steel, curved, low profile for access to compromised neural areas). | The ULP Rongeur is made of stainless steel and is curved, with a low profile, to allow access to compromised neural areas. These are the same materials and technological characteristics as the predicate devices. Access Tools (probe and guide) are substantially equivalent to existing commercial products. |
| Safety and Effectiveness: Demonstrate comparable safety and effectiveness to predicate devices; no new questions of safety or effectiveness. | Mechanical Performance Tests: Conducted to verify the device meets design specifications and intended performance characteristics for removing bone. |
| Cadaver Studies: Used by skilled physicians. Results demonstrated "comparable decompression with no visible damage to neural structures" and "an ease of use comparable to the standard of care," when compared to commercially available rongeurs. No specific quantitative data provided in this summary. |
2. Sample Size for Test Set and Data Provenance
- Test Set Description: The "test set" in this context refers to the cadaver studies and mechanical performance tests.
- Sample Size:
- Mechanical Performance Tests: Not specified.
- Cadaver Studies: "multiple cadaver studies." The exact number of cadavers or individual tests is not quantified in the provided text.
- Data Provenance: Not explicitly stated, but cadaver studies are typically conducted in a laboratory or research environment. It is not "retrospective or prospective" in the medical record sense, but rather an experimental study. The country of origin is not mentioned.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not explicitly stated, but referred to as "physicians skilled in procedures for decompressing neural foramen and lateral recess."
- Qualifications: "skilled in procedures for decompressing neural foramen and lateral recess." Specific specialties (e.g., neurosurgeon, orthopedic spine surgeon) or years of experience are not provided.
- Ground Truth Establishment: The physicians' feedback and observations during the cadaver studies, regarding "comparable decompression with no visible damage to neural structures" and "ease of use," served as the qualitative assessment against the "standard of care" (commercially available rongeurs).
4. Adjudication Method for the Test Set
- No formal adjudication method (like 2+1, 3+1 consensus) is described. The results appear to be based on the observations and feedback of the participating "skilled physicians" during the cadaver studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a "Multi-Reader Multi-Case (MRMC) comparative effectiveness study" as understood in imaging or AI contexts was not performed. This device is a manual surgical instrument, not an AI or imaging diagnostic tool. The performance assessment was based on human expert evaluation of its use in a cadaveric setting compared to standard tools.
- Therefore, an "effect size of how much human readers improve with AI vs. without AI assistance" is not applicable.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only without human-in-the-loop performance) study was not done. This device is a manual surgical rongeur and does not involve any algorithms or AI components.
7. Type of Ground Truth Used
- The ground truth in this context was expert assessment/consensus (from skilled physicians during cadaver studies) regarding the device's ability to achieve "comparable decompression with no visible damage to neural structures" and "ease of use comparable to the standard of care," alongside mechanical performance data against design specifications. It is not pathology or outcomes data from live patients.
8. Sample Size for the Training Set
- This concept is not applicable as the device is a manual surgical instrument and does not involve machine learning or AI models with training sets.
9. How the Ground Truth for the Training Set Was Established
- This concept is not applicable given the nature of the device.
Summary of Device-Specific Context:
It's crucial to understand that this document describes a traditional medical device (a surgical tool), not a software or AI-driven diagnostic device. Therefore, the "acceptance criteria" and "study" focus on demonstrating substantial equivalence to existing, legally marketed predicate devices through:
- Comparison of Indications for Use.
- Comparison of Technological Characteristics (materials, design).
- Non-Clinical Performance Data (mechanical tests and cadaver studies) to confirm that the device performs as intended and introduces no new safety or effectiveness concerns compared to established methods/devices.
The type of rigorous, quantitative performance metrics and study designs common for AI/SaMD are not typically found in these types of 510(k) submissions for manual surgical instruments.
§ 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).