(286 days)
The OsteoCool™ RF Ablation System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body in patients who have failed or are not candidates for standard pain therapy.
The OsteoCool™ RF Ablation System includes the following components:
- OsteoCool™ RF Ablation Kit consisting of:
a. OsteoCool™ Probe
b. OsteoCool™ Introducer
c. Tube Kit - Pain Management Pump Unit & Pump Connector Cable
- Baylis Pain Management Generator-TD
- DuoCool™ Connector Cable
The OsteoCool™ RF Ablation System is designed to deliver controlled radiofrequency (RF) energy in a bipolar manner with a cooling mechanism. The Baylis Pain Management Generator-TD operates together with the OsteoCool™ Probe to deliver the RF energy. The Pump Connector Cable connects the Pump Unit to the Baylis Pain Management Generator-TD, which powers and controls the pump speed for delivery of cooling fluid during the procedure. The DuoCool™ Connector Cable connects the OsteoCool™ Probe to the Baylis Pain Management Generator-TD to transmit RF current and thermocouple signals to and from the electrodes of the probe.
The OsteoCool™ Probe is a single-use device that is inserted through the OsteoCool™ Introducer to the target site. The introducer is used for skin penetration and facilitates the navigation and accurate placement of the probe at the target site. The Tube Kit is used with the Pump Unit to circulate water internally to cool the probe while it delivers RF energy. The OsteoCool™ Probe includes a thermocouple to monitor and control the tissue temperature throughout the procedure.
The provided document (K111523) is a 510(k) summary for the OsteoCool™ RF Ablation System, which details its intended use, device description, and substantial equivalence to predicate devices, primarily through performance testing. However, it does not include information on acceptance criteria for device performance, nor does it describe a study specifically designed to prove the device meets such criteria in terms of accuracy or clinical effectiveness with quantitative metrics.
Instead, the document details various engineering and preclinical tests conducted to demonstrate the device's safety and functionality in order to establish substantial equivalence to previously cleared devices.
Given the information provided, here's a breakdown of what can and cannot be answered regarding acceptance criteria and performance studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds, lesion size targets, or pain reduction percentages) that the device must meet to
be considered effective for its intended use (palliative treatment of metastatic lesions). Instead, it lists types of tests performed to ensure fundamental device functionality and safety.
Therefore, a table of acceptance criteria and reported device performance as typically understood for clinical efficacy cannot be generated from this document. The "performance" reported pertains to the device passing engineering and preclinical tests.
| Acceptance Criteria (Implied / Qualitative) | Reported Device Performance (as per document) |
|---|---|
| Biocompatibility: Meet ISO 10993 requirements | Passed: Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Systemic Toxicity (Acute) (Pg 3) |
| Mechanical Strength (OsteoCool™ Probe): Withstand specified forces | Passed: 40N or 15N steady pull test, 0.64J impulse test, Pressurization of 200psi, Cord Anchorage test over 100 or 200 cycles (Pg 3) |
| Mechanical Strength (OsteoCool™ Introducer): Withstand specified force | Passed: 200N of force without failure (Pg 3) |
| Mechanical Strength (DuoCool™ Connector Cable): Withstand specified forces | Passed: 40N or 15N steady pull test, 0.64J impulse test, Cord Anchorage test over 5000 cycles (Pg 3) |
| Electrical Safety: Meet high frequency leakage, dielectric strength | Passed: High frequency leakage current, High frequency dielectric strength (1.2 times rated voltage at 460 kHz), Mains frequency dielectric strength (1000V greater than rated voltage at 60 Hz) (Pg 3) |
| Thermocouple Accuracy: Establish accuracy of measurements | Tested: Accuracy of thermocouple measurements was established (no specific metrics provided, but implies satisfactory performance) (Pg 3) |
| Lesion Formation (Bench): Reproducible lesions of consistent size/shape | Examined: Ability to form reproducible lesions of consistent size and shape (no specific metrics provided, but implies satisfactory performance) (Pg 3) |
| Safety & Efficacy (Animal): Ablate bone tumors in vivo | Validated: Safety and efficacy in ablating bone tumors, including those in the vertebral body, validated in animal studies (no specific metrics provided, but implies satisfactory performance) (Pg 4) |
| Deliver RF Energy (Cadaver): Successfully deliver RF energy | Demonstrated: Ability to successfully deliver RF energy in osteoporotic human cadaver vertebrae (no specific metrics provided, but implies satisfactory performance) (Pg 4) |
| Additional Validation (Probe): Rough handling, visualization, connectivity | Performed: Rough Handling, Visualization, Connectivity (no specific metrics provided, but implies satisfactory performance) (Pg 4) |
2. Sample Size Used for the Test Set and Data Provenance
The document details engineering tests, bench tests, and preclinical studies, but not a "test set" in the context of a clinical study or a dataset for AI algorithm evaluation.
- Test Set Sample Size: Not applicable in the context of a clinical test set from human participants for performance evaluation against acceptance criteria. The "test sets" would refer to the samples used in the engineering and animal studies, which are not specified in terms of number. For instance, "animal studies" or "human cadaver testing" are mentioned, but the number of animals or cadavers is not provided.
- Data Provenance:
- Biocompatibility: Standardized tests typically using in-vitro or small animal models.
- Mechanical/Electrical/Thermocouple/Bench Testing: Likely laboratory-based, in-vitro testing.
- In-vivo Animal Testing: Animal studies (species and number not specified). This would be prospective.
- Human Cadaver Testing: Human cadaver studies (number not specified).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The document describes various validation tests, but not a process involving expert ground truth for a clinical test set.
4. Adjudication Method for the Test Set
This information is not provided in the document. No adjudication method is mentioned as there is no "test set" in the context of human data requiring expert review and consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned in this 510(k) summary. The device is not an AI diagnostic tool that assists human readers; it is a physical device for RF ablation.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done
Not applicable. The device is not an AI algorithm. It's an RF ablation system used by a physician. The term "standalone performance" typically refers to the performance of an AI algorithm independent of human input.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to performance evaluation of AI or diagnostic devices (e.g., pathology, clinical outcomes, expert consensus) is not explicitly mentioned in the context of determining the effectiveness of the RF ablation system's intended use (palliative treatment for metastatic lesions).
The "ground truth" in this context would be implied by the various performance tests:
- Biocompatibility: Conformance to ISO standards.
- Mechanical/Electrical: Engineering specifications and standards.
- Thermocouple: Known temperature standards.
- Bench Testing (Lesion Formation): Physical measurement of lesions.
- In-vivo Animal Testing: Observation of lesion formation and likely histological examination or imaging to confirm ablation efficacy in animal models.
- Human Cadaver Testing: Physical demonstration of RF energy delivery.
8. The Sample Size for the Training Set
Not applicable. The OsteoCool™ RF Ablation System is a hardware medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See point 8).
In summary, the 510(k) document primarily focuses on demonstrating substantial equivalence through a series of engineering, bench, and preclinical (animal, cadaver) tests to establish safety and fundamental functionality, rather than presenting a clinical study with quantitative acceptance criteria for efficacy in human patients or AI performance metrics.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.