(174 days)
RENOVA SPINE BALLOON CATHETER is intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacrylate (PMMA) bone cements).
The RENOVA SPINE BALLOON CATHETER is a single use disposable sterile device available in 3 different models depending on the dimensions of the balloon: 10 mm, 15 mm and 20 mm.
RENOVA SPINE BALLOON CATHETER is a single use catheter (double lumen tube) with a balloon at the distal end.
The balloon catheter is normally inserted through a needle / working cannula and inflated through an inflation device.
The catheter has two separate lumens connected to a Y connector at the proximal end of the catheter. The outer lumen of the catheter is used to inflate the balloon while the central lumen contains a removable stylet used to aid in the introduction of the balloon catheter.
The provided text does NOT describe a study involving an AI/ML powered medical device. Instead, it is a 510(k) premarket notification for a medical device called the "RENOVA SPINE BALLOON CATHETER." This device is used in balloon kyphoplasty and is a physical, non-software device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing of its physical properties.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, as the document does not contain any details related to AI/ML device performance, ground truth establishment, expert adjudication, or clinical studies involving AI assistance.
The content discusses:
- Device Name: Renova Spine Balloon Catheter
- Intended Use: Reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty.
- Predicate Device: InterV Kyphoplasty Catheter and InterV Kyphoplasty Catheter (Mini) (K150322)
- Performance Data: This section refers to mechanical tests conducted on the physical device, such as Balloon Deflation Time, Burst Pressure, Fatigue Strength, etc. These are standard engineering tests for physical medical devices, not AI/ML model performance metrics.
- Clinical Data: Stated as "N/A," indicating no human clinical trials were required for this submission, which is common for 510(k)s demonstrating substantial equivalence based on physical and functional similarity to an existing device.
Without information about an AI/ML component, it is impossible to answer the specific questions related to AI/ML device acceptance criteria and study methodology.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”