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510(k) Data Aggregation
(240 days)
BIOMET ACCESS SYSTEM
The Biomet probes/guidewires and dilators are intended for tissue dilation and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery.
The Biomet insulated probes/guidewires and dilators are intended to dilate tissue and be used as intraoperative neuromonitoring (IONM) stimulation accessories by connectially available IONM equipment for locating and identifying peripheral nerves including spinal nerve roots during spinal surgery. The Biomet insulated probes/guidewires have a length of 305mm, an exposed stimulation area of .167 cm², and an outer diameter of 2.6mm. The Biomet insulated dilators have a length ranging from 229mm to 254mm, an exposed stimulation are of .167 cm², an inner diameter ranging from 3.2mm to 9.8mm, and an outer diameter ranging from 5.8mm to 13.8mm.
This Biomet submission (K132373) is for nerve stimulation accessories (probes/guidewires and dilators), not for a device that relies on AI/ML. Therefore, the requested information elements related to AI/ML device performance (such as sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) are not applicable and are not present in this 510(k) summary.
The acceptance criteria and supporting studies for this device are focused on electrical and mechanical performance, as well as biocompatibility, to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Non-cytotoxic (ISO 10993-5) | No evidence of cytotoxicity |
| Sensitization | Non-sensitizing (ISO 10993-10) | No evidence of sensitization | |
| Irritation | Non-irritant (ISO 10993-10) | No evidence of irritation | |
| Systemic Toxicity | No systemically toxic (ISO 10993-11) | No signs of toxicity | |
| Pyrogen Test | Non-pyrogenic | No signs of pyrogens | |
| Electrical Performance | Total Resistance | Equivalent to predicate devices | Results demonstrate equivalence |
| System Impedance | Equivalent to predicate devices | Results demonstrate equivalence | |
| Current Density | Equivalent to predicate devices | Results demonstrate equivalence | |
| Mechanical Performance | Mechanical Testing | Equivalent to predicate devices | Results demonstrate equivalence |
| Material Conformance | Wrought Stainless Steels | ASTM F899:2012 compliance | Device conforms to ASTM F899:2012 |
| Sterilization | Radiation Sterilization | AAMI/ANSVISO 11137-2:2006 compliance | Device conforms to AAMI/ANSVISO 11137-2:2006 |
| Ethylene Oxide Sterilization | ANSI/AAMI/ISO 11135-1:2007 compliance | Device conforms to ANSI/AAMI/ISO 11135-1:2007 | |
| Packaging | Performance Testing | ASTM D4169:2009 compliance | Device conforms to ASTM D4169:2009 |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each bench test conducted (Total Resistance, System Impedance, Current Density, Mechanical/Electrical Testing) or for the biocompatibility tests. It states that "Biocompatibility testing was conducted" and "Bench testing was conducted," implying a sufficient number of samples were tested to gain confidence in the results, but the specific N is not provided. The data provenance is internal testing by Biomet Spine.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this type of device (electrical stimulus and dilator) is based on objective measurements from bench testing and adherence to recognized standards, not subjective expert assessment of data like images or clinical outcomes.
4. Adjudication method for the test set
Not applicable. There was no expert adjudication process involved for the objective bench and biocompatibility testing. The outcomes are concrete measurements against defined standards or comparisons to predicate device performance.
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
Not applicable. This device is not an AI/ML-driven diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument (probes/guidewires and dilators) used with commercially available neuromonitoring equipment during surgery. It does not have an "algorithm-only" or "standalone" performance in the AI/ML sense.
7. The type of ground truth used
The "ground truth" for this device's performance is established through:
- Objective Bench Test Measurements: Electrical properties (resistance, impedance, current density) and mechanical integrity were measured and compared to predicate devices' known performances and acceptable ranges.
- Biocompatibility Standards: Adherence to international standards like ISO 10993 (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity) where "ground truth" is defined by the absence of adverse biological reactions as per the standard's methodologies.
- Material and Sterilization Standards: Compliance with recognized ASTM and AAMI/ISO standards for materials and sterilization processes.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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