(91 days)
The KFx Tissue Fixation System and optional accessories are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow.
Specifically:
Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs.
Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis, patellar tendon repair.
Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.
The KFx Tissue Fixation System consists of
- KFx Nail Bone Anchor with two suture leads, mounted to a single use handle .
- . KFx Suture Lock Bone Anchor mounted to a single use handle
- . Optional KFx Targeting Grasper
- Optional Suture Management Device(s) .
- . Optional Screw Removal device
- Optional Starter Awl .
The provided 510(k) summary for the KFx Tissue Fixation System and Accessories does not contain information about the acceptance criteria and a study proving the device meets those criteria, as typically described in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures. Instead, it focuses on demonstrating substantial equivalence to predicate devices through physical bench testing and biocompatibility assessment.
Here's an analysis of the provided information based on your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Physical Bench Testing: | |
| Device meets specifications | "demonstrate that the KFx Tissue Fixation System meets its specifications" |
| No new issues of safety or effectiveness | "does not raise new issues of safety or effectiveness" |
| Biocompatibility: | |
| Biocompatible materials | "The materials used in the KFx Tissue Fixation System are biocompatible." |
| Materials commonly used and in predicates | "The same materials are used in the identified predicates and are also commonly used in similar medical devices." |
| Substantial Equivalence: | |
| Equivalent intended use | "The intended use... is substantially equivalent to the intended use of the suturing devices listed above." |
| Equivalent design and technology | "substantially equivalent devices with the same... design and technology characteristics" |
Note: The document implies acceptance criteria by stating the device "meets its specifications" and "does not raise new issues of safety or effectiveness," rather than specifying quantitative, pre-defined thresholds for performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the physical bench testing. It only states "Results of physical bench testing." The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the type of testing described (physical bench testing and biocompatibility). Ground truth is typically established for diagnostic or screening devices, often involving expert clinical review, pathology, or imaging interpretations.
4. Adjudication Method for the Test Set
This information is not applicable, as there is no mention of expert review or clinical adjudication methods being used for the physical bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or mentioned. The device is a physical fixation system, not a diagnostic or imaging device that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study for an algorithm was performed or mentioned. The device is a physical medical device, not an AI/algorithm-based system.
7. Type of Ground Truth Used
For the physical bench testing, the "ground truth" implicitly would be the engineering specifications and performance expectations for mechanical strength, durability, and functional integrity of the fixation system. For biocompatibility, the ground truth is established by standard material biocompatibility testing protocols (e.g., ISO 10993 series) against known compatible materials.
8. Sample Size for the Training Set
This is not applicable as the device is a physical medical device, not an AI/machine learning system that requires a training set.
9. How Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this type of device.
Summary of Study Type:
The study described is primarily a bench testing and biocompatibility assessment intended to demonstrate that the KFx Tissue Fixation System meets its engineering specifications and does not introduce new safety or effectiveness concerns compared to legally marketed predicate devices. This type of study supports a claim of substantial equivalence for a Class II medical device. It is not a clinical study involving patient outcomes, expert image interpretation, or AI performance evaluation.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.