(196 days)
The Balex Bone Expander System is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.
The Balex Bone Expander System is designed to reduce compression fracture and create a void in cancellous bone in the spine. By creating a space in the operating point, the major benefits of the Balex Bone Expander System are the reduction in pain and the increase of patient`s functional abilities, which allow for the patient's return to the previous level of activity.
The Balex Bone Expander System consists of the Balloon Expander and Balloon Catheter. They are used with Cement Dispenser System, Cement Mixer System and Syringe which are Class I, 510k exempt devices.
The Balloon Catheter consists of an inner-outer tube, inflatable balloon located at the balloon tip. The radiopaque markers located at the balloon tip end allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Expander consists of a pressure gauge, compression cylinder, a connect Line and a 3 way valve. The Balloon Expander is used for inflating the balloon by rotating the plunger clockwise. The lock mechanism maintains pressure. All the components are supplied sterile and are disposable.
The provided document is a 510(k) summary for the Balex Bone Expander System. It describes the device, its intended use, and a comparison to predicate devices, but it does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the format requested.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and performance tests for safety and biocompatibility. It lists several non-clinical performance tests conducted, but it does not provide specific acceptance criteria values for these tests or detailed results demonstrating compliance.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: While a list of performance tests is provided, specific quantitative acceptance criteria and corresponding reported device performance values are not included.
- Sample size used for the test set and the data provenance: The document mentions "non-clinical tests" but does not specify sample sizes or data provenance for these tests.
- Number of experts used to establish the ground truth... and their qualifications: This is not applicable as the document describes a non-clinical evaluation, not a study involving human or image-based ground truth established by experts.
- Adjudication method for the test set: Not applicable for non-clinical performance and safety tests.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or implied. The evaluation is for a physical medical device (bone expander), not an AI algorithm.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
- Type of ground truth used: Not applicable in the traditional sense. The "ground truth" for the non-clinical tests would be defined by the standards and specifications against which the device is tested (e.g., burst pressure limits, material strength requirements).
- Sample size for the training set: Not applicable as this is a physical medical device, not an AI model.
- How the ground truth for the training set was established: Not applicable.
Summary of available information (related to your questions, but not directly answering them due to content limitations):
The document lists the following performance tests and standards, implying that these are the areas where the device's performance was evaluated to ensure safety and effectiveness:
- Sterilization Validation Tests in accordance with ISO 10993-7
- Shelf Life Tests in accordance with ASTM F1980, ASTM F88, ISO11737-2
- Biocompatibility Tests in accordance with ISO 10993 (Cytotoxicity, Maximization sensitization, Material-mediated pyrogenicity, Acute Systemic toxicity, Intracutaneous reactivity)
- Extraction Test (Non-volatile Residue, Residue on Ignition, Heavy Metals, Buffering Capacity)
- EO Gas Sterilization Residual
- Appearance for Balloon
- Balloon Dimensions
- Burst Pressure (constrained and unconstrained)
- Balloon leakage
- Pressure gauge precision
- Inflation and deflation time
- Insertion force and withdrawal force
- Tensile and tensile bond strength
- Balloon fatigue test
The document concludes that "The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences." This indicates that the device met the internal specifications and regulatory requirements based on these tests, but the specific numerical acceptance criteria and performance data are not disclosed in this summary.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.