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510(k) Data Aggregation
(254 days)
Phantom XL Insulated Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site, to assist in locating those nerves at risk during the surgical procedure.
Phantom XL Insulated Dilators are used as instruments to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The Phantom XL Insulated Dilators are available in monopolar configuration and four diameter sizes (8, 13, 18, 22 and 22mm Grooved). They are supplied sterile, are non-pyrogenic, and are intended for single use only. The 8 mm dilators are made of stainless steel and are visible under fluoroscopy, while the remaining sizes are made of aluminum alloy and are radiolucent.
The provided document appears to be a 510(k) premarket notification for a medical device called "Phantom XL Insulated Dilators." It details various performance tests conducted to demonstrate the device's safety and effectiveness and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Electrical Safety | Impedance of current carrying connections | To have sufficiently low impedance so that they will not interfere with any stimulator signal passed through them. | Met applicable requirements (per IEC 60601-1) |
| Dielectric Strength Test | To be sufficiently separated from the conductive portions to prevent any stimulator signal from reaching any part of the Phantom XL Insulated Dilators except the intended delivery point. | Met applicable requirements (per IEC 60601-1) | |
| Temperature Test | Not to introduce any additional heating to the patient as part of the stimulation process. | Met applicable requirements (per IEC 60601-1) | |
| Waveform capture | Not to significantly alter the waveform of the stimulator output. | Met applicable requirements (per IEC 60601-1) | |
| Electromagnetic Compatibility | Emissions tests | Not to impact the emission profile of electrical stimulus and medical monitoring equipment. | Met applicable requirements (per IEC 60601-1-2) |
| Immunity tests | Not to increase the sensitivity to adverse conditions of electrical stimulus and medical monitoring equipment. | Met applicable requirements (per IEC 60601-1-2) | |
| Biocompatibility | Cytotoxicity (ISO Elution Method) | Biological reactivity must be less than or equal to a grade 2. | No evidence of causing lysis or toxicity. Reactivity is less than grade 2. (Non-Cytotoxic) |
| ISO Intracutaneous Study (Irritation) | The difference between the test extract overall mean score and corresponding control overall mean score is 1.0 or less. | Difference between test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.2. (Non-irritant) | |
| ISO Guinea Pig Maximization Sensitization Test | No evidence of causing delayed dermal contact sensitization. | Showed no evidence of causing delayed dermal contact sensitization. (Non-Sensitizer) | |
| ISO Systemic Toxicity (acute) | No mortality or evidence of systemic toxicity from the extracts. | No mortality or evidence of systemic toxicity from the extracts. (Non-Toxic) | |
| Sterilization & Residuals | Sterilization Validation | A minimum Sterility Assurance Level (SAL) of 1 x 10-6. | Completed to assure a minimum SAL of 1 x 10-6. |
| Bacterial Endotoxin | FDA criteria for medical device: maximum of 20 EU/device. (Also criteria for device contacting cerebrospinal fluid: maximum of 2.15 EU/device, though noted as N/A for this device). | 0.720 EU/Device, 0.880 EU/Device, < 0.200 EU/Device. (Passes FDA criteria) | |
| Ethylene Oxide residual | 4 mg/device. | Range: <0.12 - 0.15 mg/device. (Passes) | |
| Ethylene Chlorohydrin residual | (Implicitly, to be within acceptable limits for a residual). | Range: <0.10 - <0.15 mg/device. |
2. Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for most performance tests (e.g., how many dilators were tested for electrical safety, EMC, or sterilization residuals).
- For biocompatibility, the tests were conducted consistent with ISO 10993 standards, which generally outline sample size requirements, but the specific numbers for each test are not explicitly stated in this summary.
- Data provenance: Prospective, as these tests were performed specifically for the 510(k) submission to demonstrate the device's characteristics. The country of origin of the data is not specified, but the testing adhered to international standards (IEC, ISO) and U.S. GLP regulations (21 CFR 58), implying a globally recognized testing methodology.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable (N/A) to the types of studies described. The studies are engineering and biological bench tests/laboratory tests, not diagnostic studies that would require expert human review for ground truth establishment. For example, for cytotoxicity, the "ground truth" is determined by observing cell lysis or toxicity in a lab setting, not by expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic studies where human experts are making judgments that need to be reconciled for ground truth. The studies described here are objective, quantifiable physical and biological tests.
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:
- This information is N/A. The "Phantom XL Insulated Dilators" are a surgical instrument for nerve localization during spine surgery using electrical stimulation. They are not an AI-powered diagnostic device, nor are they a device that involves human "readers" or interpretations in the way an AI diagnostic tool would. Therefore, an MRMC study or an assessment of AI-assisted human performance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is N/A. As explained above, this is a physical medical device (surgical dilators) and not an algorithmic or AI-based system that would have "standalone" performance in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the electrical safety, EMC, and sterilization studies, the "ground truth" is established by objective measurements against predefined technical standards (e.g., specific voltage limits, impedance values, temperature increases, bacterial endotoxin concentration, residual levels).
- For biocompatibility, the "ground truth" is established through laboratory observations and measurements of biological responses (e.g., cell lysis, erythema, edema, signs of sensitization or systemic toxicity in animal models) compared against documented acceptable biological response criteria from international standards.
8. The sample size for the training set:
- This information is N/A. The device is not an AI/ML-based system that requires a "training set." It's a physical medical device.
9. How the ground truth for the training set was established:
- This information is N/A for the same reason as point 8.
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