(241 days)
Intended for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).
The Inflatable Bone Tamp (IBT) was designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter.
The provided document is a 510(k) summary for the CareFusion AVAmax Vertebral Balloon. It describes the device, its intended use, comparison to a predicate device, and performance data from non-clinical tests.
Here's an analysis of the document to address your request:
1. A table of acceptance criteria and the reported device performance
The document provides "Performance Test Summary - New Device" which lists the characteristic and results summary. It doesn't explicitly state "acceptance criteria" with numerical targets, but rather describes the performance in relation to requirements. I will interpret "acceptance criteria" as the implied requirements based on the "Results Summary."
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Inflation pressure | Exceed minimum burst pressure in a constrained environment | "The balloon catheters exceeded the requirements for the minimum burst pressure in a constrained environment" |
| Inflation volume | Exceed minimum burst volume in an unconstrained environment | "The balloon catheters exceeded the requirements for the minimum burst volume in an unconstrained environment" |
| Balloon double wall thickness | Substantially equivalent to predicate devices | "The double wall thickness of the balloons was substantially equivalent to that of the predicate devices" |
| Simulated Use | Substantially equivalent performance | "Cadaveric simulated use testing demonstrated substantial equivalence in performance." |
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 primarily describes non-clinical performance and does not detail specific sample sizes for tests beyond implying multiple "balloon catheters" were tested for inflation pressure and volume. For the "Simulated Use" test, it mentions "Cadaveric simulated use testing," but does not specify the number of cadavers.
- Test Set Sample Size: Not explicitly stated, beyond implying multiple "balloon catheters" and "cadaveric" in the simulated use.
- Data Provenance: Not specified, but given it's a 510(k) by CareFusion (a US-based company), it's likely conducted in the US. The testing is prospective in nature as it's part of premarket notification for a new/modified device.
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 tests described are primarily engineering/performance tests (inflation pressure, volume, thickness) and a simulated use on cadavers. These types of tests do not typically involve human "experts" establishing a diagnostic ground truth in the way a clinical study would (e.g., radiologists reviewing images). The assessment of performance would be based on objective measurements and observations by the test engineers/personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document describes non-clinical performance testing, not a study involving human readers or subjective assessments that would require an adjudication method.
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
No, a multi-reader, multi-case comparative effectiveness study was not done. The document explicitly states "N/A - No clinical tests were conducted for this submission." This device is a medical device (vertebral balloon), not an AI diagnostic tool, so such a study is irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (vertebral balloon), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- Inflation Pressure & Volume: The "ground truth" is based on objective physical measurements against predefined engineering requirements or industry standards.
- Balloon double wall thickness: Objective physical measurement.
- Simulated Use (Cadaver): "Ground truth" would be the observed mechanical performance and ability to perform the intended function (create a cavity, reduce fracture, prevent cement leakage simulation) in the cadaveric model, assessed against the performance of the predicate device. This is a functional assessment rather than a diagnostic one.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm-based device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.