(114 days)
The Arcadia ™ Steerable and Straight Balloon Catheters are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. These balloon catheters are to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement for use during percutaneous vertebral augmentation, such as kyphoplasty.
The Arcadia Balloon Catheters consist of a Y-Adapter with a dual-lumen catheter shaft and a balloon. The inner shaft lumen contains a stylet (either straight or articulating). The outer lumen is an inflation conduit for the balloon. A valved luer port on the Y-adapter allows for connecting an inflation device to inflate and deflate the balloon. Two marker bands are printed on the shaft and serve as indicators of when the distal tip of the balloon catheter has reached the distal end of the working cannula of the StabiliT® Introducer. Radiopaque markers are located on the proximal and distal end of the balloon to aid in balloon placement prior to inflation. The exterior surface of balloon is covered by a lubricant which ease access through the introducer cannula. The Arcadia Steerable Balloon Catheter features a mechanism that enables steering of the device. The Arcadia Straight Balloon Catheter has a removable stylet.
The Arcadia™ Balloon Catheter underwent non-clinical performance testing to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Device Performance (Implied from "met the requirements") |
|---|---|---|
| Biocompatibility Testing | Device meets applicable ISO 10993-1:2018 requirements (including Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, and Pyrogenicity). | All biocompatibility testing met the requirements of the respective test methods, thus supporting the biocompatibility of the subject device. |
| Insertion and Withdrawal Force | Insertion and withdrawal of the device through the introducer do not create forces that would damage the balloon catheter. | Design validation testing confirmed that the subject device conforms to user needs and intended uses. Performance testing demonstrates equivalence between the subject device and the predicate device. (This implies the force criteria were met, though specific values are not provided). |
| Inflated Balloon Dimensions (Unconstrained) | Inflated balloon dimensions are similar to similarly labeled predicate devices. | Performance testing demonstrates equivalence between the subject device and the predicate device. (This implies the balloon dimensions were similar to predicates). |
| Articulated Angle and Radius (for Steerable device) | Articulation profile of steerable devices matches that of tools used to create channels in the bone for balloon placement. | Performance testing demonstrates equivalence between the subject device and the predicate device. (This implies the articulation profile met the criteria). |
| Deflation Time with Contrast Solution | Deflation time is similar to predicate devices of the same size and volume profile. | Performance testing demonstrates equivalence between the subject device and the predicate device. (This implies the deflation time was similar to predicates). |
| Constrained Max Pressure Testing | Device is capable of sustaining its maximum rated pressure when the balloon is constrained. | Performance testing demonstrates equivalence between the subject device and the predicate device. (This implies the device sustained its maximum rated pressure). |
| Unconstrained Burst Volume | Device exceeds its maximum volume rating before burst failure. | Performance testing demonstrates equivalence between the subject device and the predicate device. (This implies the device exceeded its maximum volume rating before burst). |
| Tensile Force Testing | Device material and bond strengths exceed forces that may be applied during normal clinical use. | Performance testing demonstrates equivalence between the subject device and the predicate device. (This implies the material and bond strengths exceeded anticipated clinical forces). |
| Shelf-life | N/A (implied from the statement). | The Arcadia Balloon Catheter is qualified and labeled as a sterile, single-use device with the 6-month shelf-life at this time. |
2. Sample size(s) used for the test set and the data provenance:
The document does not specify the exact sample sizes for each non-clinical test.
No clinical studies were conducted, so there is no patient data or data provenance (e.g., country of origin, retrospective/prospective). The tests performed are all in-vitro or benchtop tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device underwent non-clinical (benchtop) testing, not studies involving human interpretation or expert ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This device underwent non-clinical (benchtop) testing.
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:
Not applicable. This is a medical device (balloon catheter), not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (balloon catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical tests was established by defined engineering specifications, industry standards (e.g., ISO, ASTM, USP), and comparison to predicate device characteristics. For example, for "Inflated Balloon Dimensions," the ground truth was that the dimensions should be "similar to similarly labeled predicate devices."
8. The sample size for the training set:
Not applicable. This is a medical device that underwent non-clinical testing, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.