(284 days)
The iO-Tome Device is used for cutting bone for the purpose of removing a facet joint (facetectomy) of the spinal column.
The iO-Tome Device is a design modification of the iO-Flex MicroBlade Shaver. It is comprised of a proximal handle, rigid shaft, and flexible cutting platform used for cutting bone for the purpose of removing a facet joint (facetectomy) in the lumbar spinal column. The flexible cutting platform is comprised of two parallel cutting elements that run along a flat flexible metallic substrate. The metallic substrate has two plastic protectors that temporarily cover the parallel cutting elements during introduction of the device into the foramen and protect the underside of the cutting platform during bimanual reciprocations. After the device is introduced and positioned within the foramen with the use of the iO-Flex System accessories and connected to the iO-Wire and Distal Handle, the user pulls up on the handles thereby exposing the parallel cutting elements. The user can then proceed with bimanual reciprocations cutting through the targeted facet joint.
Here's an analysis of the provided text regarding the iO-Tome Device, structured to address your specific points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | All pre-determined acceptance criteria were met, and results passed for Cytotoxicity, Sensitization, Intracutaneous Study, and Systemic Toxicity. |
| Sterility Assurance Level (SAL) | Achieved an SAL of 10^-6 through validated accelerated e-beam radiation process. Performance qualification studies (Bioburden Recovery Validation, Bioburden Characterization, Dose Map Verification) successfully demonstrated "Equivalent Product" status with predicate, allowing same validated e-beam process. |
| Stability (Shelf Life & Integrity) | Stability testing performed to determine minimum shelf life for product sterility and device integrity. Specific results are not detailed, but the summary states the device conforms to all design and performance specifications. |
| Functional & Structural Integrity | Thoroughly tested on the bench to evaluate and verify that it meets its design and performance specifications. Cadaveric and in vivo porcine testing confirmed that the subject device meets all design and performance specifications for its intended use. No new/different safety or effectiveness issues observed. |
| Substantial Equivalence | Device found to be substantially equivalent to the predicate MicroBlade Shaver based on same indications for use, technological characteristics, design verification, and performance testing results. No new or different questions of safety or effectiveness raised. |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
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Sample Size for Test Set:
- Biocompatibility: Not explicitly stated, but typically involves a number of samples for each test type (e.g., 3-5 replicates per test for ISO 10993 studies).
- Sterility: Sample size for bioburden, characterization, and dose map verification studies is not specified in the provided text. These studies usually involve a representative number of units from manufacturing lots.
- Stability: Not explicitly stated, but stability studies require a set number of units tested at various time points.
- Functional/Structural (Bench Testing): Not explicitly stated, but generally involves multiple units to demonstrate robustness.
- Cadaveric & In Vivo Porcine Testing: The exact number of cadavers or animals used is not specified.
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Data Provenance: Not explicitly stated. The studies are described as "bench tests," "cadaveric," and "in vivo porcine testing." The location where these tests were conducted or the origin of the cadavers/animals is not provided. It is likely prospective testing specifically for this device's clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies mentioned (biocompatibility, sterility, stability, functional/structural, cadaveric, in vivo porcine) are primarily engineering and biological performance tests, not clinical evaluations requiring expert interpretation of medical images or patient outcomes for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/provided as the studies described are laboratory and animal model tests, not human clinical studies involving expert adjudication of diagnostic outcomes.
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
An MRMC comparative effectiveness study was not conducted. The iO-Tome device is a surgical instrument (manual rongeur), not an AI-powered diagnostic or imaging tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The iO-Tome is a physical surgical device, not an algorithm. Its performance is inherent in its mechanical function, material properties, and biological interaction, not in a standalone algorithmic capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the iO-Tome device is established through:
- Biocompatibility Standards: Compliance with ISO 10993-1 and FDA 21 CFR Part 58, which define established biological responses (e.g., no cytotoxicity, no sensitization).
- Sterility Standards: Adherence to ANSI/AAMI/ISO standards (e.g., 11737-1, 11137-2) for demonstrating a specified Sterility Assurance Level (SAL).
- Stability Standards: Compliance with ASTM standards (e.g., F1980-07, D4332-01, D4169-08, F2096-04, F88-09) that define accepted methods for evaluating shelf life and package integrity.
- Functional/Structural Integrity: Bench test results showing the device meets its design and performance specifications. This implies engineering specifications (e.g., cutting force, flexibility, durability) are the ground truth.
- Cadaveric and In Vivo Porcine Testing: Confirmation that the device meets all design and performance specifications for its intended use (cutting bone for facetectomy) in a relevant biological model. This would involve surgical success (e.g., ability to cut the bone as intended, absence of damage to surrounding structures, proper device function without breakage).
8. The sample size for the training set
This is not applicable. The iO-Tome device is a mechanical surgical instrument, not a machine learning or AI model. Therefore, there is no "training set" in the context of data-driven algorithm development. Its design and manufacturing are based on engineering principles and material science, not data training.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device. The design and validation are based on established engineering principles, material properties, and regulatory standards for medical devices.
§ 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).