(315 days)
The Ultrazonix Spine Minimal-Invasive Disc System is intended for use by professional medical personnel for coagulation and decompression of intervertebral disc material to treat symptomatic patients with annular disruption of contained herniated lumbar discs. The safety and efficacy of this device has not been established in the thoracic and cervical intervertebral regions of the spine and should not be used in those regions.
The Ultrazonix Spine Minimal-Invasive Disc System is intended for use by professional medical personnel for coagulation and decompression of intervertebral disc material to treat symptomatic patients with annular disruption of contained herniated lumbar discs. The safety and efficacy of this device has not been established in the thoraci and cervical intervertebral regions of the spine and should not be used in those negions. The Ultrazonix Spine Minimal-Invasive Disc System is comprised of a non-disposable Control Unit, and a sterile, single-use Probe Kit. These two major component parts are described as follows: a) Non disposable Control Unit This contains a power supply, a high frequency-generator, an amplifier, an independent safety system and a user interface with an alphanumerical display and a key pad and a foot-operated switch. The probe and a foot-operated switch are connected to the Control Unit. High frequency induced ultrasound is emitted from the probe and controlled by means of the foot-operated switch. b) Sterile, single-use Probe Kit, consisting of A blunt 500 mm long stainless steel Guide Pin with a diameter of 2 mm. The Guide Pin is used as a pathfinder to navigate towards the spinal disk under fluoroscopic guidance. A 5.3 mm Dilator which is used to prepare a canal for the Introducer. It has a conical front which ensures as little harm as possible is done to adjacent tissue and blood vessels A 6 mm Introducer which is a thin walled, approximately 180 mm long tube with a handle to be used as a guide for the Probe. It is placed over the Dilator and when the desired position against the disk is reached the Guide Pin and the Dilator are removed and The ultrasonic Probe is inserted into the Introducer. It consists of a thin shaft with a piezo ceramic transducer placed at the front /tip.
The provided text describes a 510(k) premarket notification for the Ultrazonix Spine Minimal-Invasive Disc System.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics for the device’s efficacy (e.g., a certain percentage of disc decompression or coagulation effectiveness). Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices. The performance data section refers to "in vitro and animal study evaluations" and "current clinical experiences" showing the device "functions as intended" and is "safe and efficient in coagulation and decompression of disc tissue."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: The device must be demonstrated to be equally safe and effective as legally marketed predicate devices, specifically the Oratec SpineCATH / ORA-50S Auto Temp Electro Thermal Spine System. This implies similar indications for use and technological characteristics. | - In vitro and animal study evaluations: Showed the Ultrazonix Spine Minimal-Invasive Disc System "functions as intended." |
- Sufficiency of pre-clinical data: Data gathered was deemed "sufficient" to qualify the system as "safe and efficient in coagulation and decompression of disc tissue."
- Current clinical experiences: Also showed the product is "safe in coagulation and decompression of lumbar discs."
- Technological Characteristics: The device is considered "the same" as the predicate for coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated lumbar discs. Any differences "do not raise new questions of safety and effectiveness." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size for human test subjects or the provenance (country, retrospective/prospective nature) of the "current clinical experiences" mentioned. It only refers to "in vitro and animal study evaluations" and "current clinical experiences."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The type of study described (pre-clinical and clinical experience for safety and efficacy) does not typically involve independent experts establishing ground truth in the same way an AI diagnostic device study would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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 was not an AI diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers' improvement with AI assistance would not be applicable, and no such study is mentioned. The device described is a surgical tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This was not an AI diagnostic device, so a standalone algorithm performance study is not applicable. The device itself is a standalone medical tool for performing a procedure, and its performance was assessed through in vitro, animal, and clinical experiences.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document implicitly uses physiological outcomes (demonstrated coagulation and decompression of disc tissue) and patient safety and efficacy from "current clinical experiences" as the ground truth indicators. The "in vitro and animal study evaluations" would also assess direct physical effects of the device on tissue.
8. The sample size for the training set
This is not an AI/ML device, so there is no "training set." The device's design and operational parameters would be developed through engineering and experimental testing, not machine learning training.
9. How the ground truth for the training set was established
As it is not an AI/ML device, there is no training set or ground truth established for one.
§ 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.