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510(k) Data Aggregation
(11 days)
BAXANO ULTRA LOW PROFILE RONGEUR
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 accessory devices are used to access the neural foramen and decompress targeted areas. The Rongeur attaches to a needle wire and is pulled into the foramen with the distal handle also attached to the needle wire. Tissue is removed by pulling up on the distal handle to decompress the impinged nerve root. The accessories include a probe, guide and needle wire, which are used to explore the foramen, and position the needle wire through soft tissue and the skin.
The provided text describes a 510(k) submission for a medical device (Baxano Ultra Low Profile Rongeur) and does not contain the typical structure of a study report with defined acceptance criteria and detailed quantitative performance results. The focus is on demonstrating "substantial equivalence" to a predicate device.
Therefore, many of the requested fields cannot be directly extracted or are not applicable in the context of this document. I will fill in what can be inferred and explicitly state what information is missing.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Device meets original design specifications and intended performance characteristics for removing bone in compromised neural areas. | Mechanical performance tests were conducted to verify that the modified device meets original design specifications and intended performance characteristics, based on the application for removing bone in compromised neural areas. (No specific quantitative metrics or thresholds are provided for "meets original design specifications" or "intended performance characteristics"). |
| Device provides comparable decompression to the predicate device. | The ULP Rongeur was used in multiple cadaver studies by physicians skilled in procedures for decompressing neural foramen and lateral recess. Results demonstrated that the ULP Rongeur in combination with the integrated Probe and Guide, provided comparable decompression to the predicate device. (No specific quantitative measure of "comparable decompression" is provided, nor the predicate device's performance for comparison). |
| Device is at least as safe and effective as the predicate device. | Baxano has determined, based on the performance testing and cadaver studies, that the ULP Rongeur and accessories conform to the design specifications and are at least as safe and effective as the predicate device for accessing and decompressing bone in the spinal column. (This is a conclusion based on the other tests, not a separate measurable performance outcome). |
| Modified Probe and Guide maintain intended functionality and ease of manipulation. | The Probe and Guide have been integrated into one tool, which contains a stiffer Guide for easier manipulation. (Implied, but no direct performance measure of "easier manipulation" compared to the predicate). |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not explicitly stated. The text mentions "multiple cadaver studies," but the number of cadavers or specific cases is not provided.
- Data Provenance: Cadaver studies. The country of origin is not specified but is presumably the US given the context of a US-based company submitting to the FDA. The studies were likely "prospective" in the sense that they were designed to test the modified device, but performed on "retrospective" biological material (cadavers).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not explicitly stated. The text mentions "physicians skilled in procedures for decompressing neural foramen and lateral recess."
- Qualifications of Experts: "Physicians skilled in procedures for decompressing neural foramen and lateral recess." No specific number of years of experience or board certifications are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not mentioned. It's unclear how "comparable decompression" was assessed or whether multiple physicians independently assessed and then adjudicated findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, this was not an MRMC study and does not involve AI assistance. The study described is a mechanical performance and cadaver study on a surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" was likely assessed by expert physicians through observation and potentially measurements during cadaver studies, focusing on the ability to achieve "comparable decompression." This falls under expert assessment/observation in a cadaveric setting.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This refers to performance testing and cadaver studies involving a physical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for a physical surgical rongeur.
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