(87 days)
Kyphon Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction for fractures and/or creation of a void in cancellous bone.
The Kyphon Inflatable Bone Tamp is a bone tamp with an inflatable component at the distal end. It is designed to compress cancellous bone and/or move cortical bone as it inflates. The Inflatable Bone Tamp has a nominal length of 40 cm and consists of a double lumen catheter shaft constructed from two coaxially aligned tubings. The inflatable component is mounted near the distal tip of the catheter tubing. Two radiopaque marker bands are attached to the inner tubing and located at the proximal and distal ends of the inflatable component. A side arm adapter attached to the proximal end of the Inflatable Bone Tamp provides access to the catheter lumens. Inflation and deflation are accomplished by connecting the side arm port with an inflation syringe. The straight arm port is continuous with the inner lumen of the catheter to allow placement of a removable stiffening stylet, which attaches to the Luer fitting of the straight arm.
The Kyphon Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a quantitative, pass/fail format. Instead, it describes a series of mechanical and preclinical tests performed to verify the device meets specifications and intended performance characteristics. The reported performance is generally stated as having met these specifications.
| Test (Acceptance Criteria Implicitly Met) | Reported Device Performance |
|---|---|
| Maximum Inflation Volume | Performed according to design specifications. |
| Inflated Length | Performed according to design specifications. |
| Inflated Diameter | Performed according to design specifications. |
| Fatigue Performance | Performed according to design specifications. |
| Maximum Recommended Inflation Pressure | Performed according to design specifications. |
| Overall Length | Performed according to design specifications. |
| Working Length | Performed according to design specifications. |
| Shaft Diameter | Performed according to design specifications. |
| Inflation Time | Performed according to design specifications. |
| Deflation Time | Performed according to design specifications. |
| Tamp Insertion Force | Performed according to design specifications. |
| Tamp Withdrawal Force | Performed according to design specifications. |
| Bond Strength - Outer Tubing to Side Arm | Performed according to design specifications. |
| Bond Strength - Inner Tubing to Luer | Performed according to design specifications. |
| Bond Strength - Luer to Y-Adapter | Performed according to design specifications. |
| Biocompatibility Testing | Demonstrates the device is biocompatible. |
| Performance in reducing fractures and creating voids in cancellous bone | Can reduce fractures and create voids in cancellous bone, in the same manner and with the same results as predicate conventional bone tamps. |
| Product performance in bone | Conformed to design specifications. |
| Risks of tamping | Same as those of conventional bone tamps. |
| Risks of product failure | Same as those of inflatable dissectors and other inflatable medical products. |
| Sterilization | Meets the requirements of ANSI/AAMI/ISO11135:1994 for EtO sterilized devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document indicates that preclinical testing was conducted in "isolated, fractured, cadaveric vertebral bodies" and "fractured tibial plateaus in cadaver knees and in unfractured vertebral bodies in cadaver spines." No specific numerical sample size is provided for the number of cadaveric specimens used.
- Data Provenance: The data is retrospective in the sense that cadaveric specimens are used, representing post-mortem human bone. The country of origin for the cadaveric specimens is not specified in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the preclinical cadaveric testing. The evaluation appears to be based on physical measurements and observations of the device's performance in reducing fractures and creating voids, directly compared to predicate conventional bone tamps.
4. Adjudication Method for the Test Set
No adjudication method is described, as the evaluation seems to be based on direct physical and mechanical observations rather than subjective assessments requiring expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed. The study focuses on the standalone performance of the device and its equivalence to predicate devices, not on human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance assessment was conducted. The mechanical and preclinical tests were performed on the device itself (and in cadaveric bone) to evaluate its physical properties and functional performance independent of human-in-the-loop interaction in a clinical setting. The conclusion states "the Kyphon Inflatable Bone Tamp meets design specifications and performs like conventional bone tamps, elevators and curettes," which refers to its standalone performance.
7. Type of Ground Truth Used
The ground truth for the preclinical testing was based on direct observation and measurement of the device's ability to:
- Reduce fractures
- Create voids in cancellous bone
- Conform to design specifications in bone
- Demonstrate mechanical properties (e.g., inflation parameters, bond strengths, fatigue)
- Exhibit biocompatibility
This can be categorized as direct physical and functional performance, objectively measured against defined engineering specifications and comparisons to predicate device performance.
8. Sample Size for the Training Set
No mention of a "training set" is made in the document. This project appears to be a 510(k) submission for a physical medical device, not an AI/machine learning algorithm, so the concept of a training set is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned or implied by the nature of the device and study, this question is 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.