(21 days)
The Titan RC Tack is intended for soft tissue to bone fixation for the following indications:
SHOULDER
Repair of rotator cuff tears
Acromio-clavicular separation
Biceps tenodesis
Deltoid repair
KNEE
Extra-Capsular repairs
Reattachment of medial collateral ligament
Reattachment of lateral collateral ligament
Reattachment of posterior oblique ligament
Joint capsule closure
Patellar ligament and tendon avulsion repairs
Extra-capsular reconstruction
ITB tenodesis
ANKLE
Lateral and medial instability
Achilles tendon reconstruction and repair
The Titan RC Tack is a bioabsorbable implant intended for soft tissue reattachment to host bone in the shoulder, knee, and ankle. The implant consists of three individual components: a tip, sleeve and pin. Upon deployment, the pin is driven into the sleeve expanding the sleeve radially to gain bone fixation. The Titan RC Tack is a sterile, single use device offered in one size, 4.5mm.
Here's an analysis of the provided text regarding the Innovasive Titan RC Tack, focusing on acceptance criteria and the study proving it meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Ultimate holding strength at 3, 6, and 12 weeks in-vitro | "demonstrates substantially equivalent performance between the two devices" (Titan RC Tack and predicate RC Tack) |
Notes:
- The document explicitly states that the "Bone Model Testing" was conducted to evaluate the "ultimate holding strength at 3, 6, and 12 weeks in-vitro."
- The acceptance criteria themselves (e.g., a specific threshold in Newtons or a percentage of the predicate device's strength) are not provided in this document. The study's conclusion is that the new device's performance is "substantially equivalent" to the predicate, implying that the observed holding strengths met an unstated criterion for equivalence.
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify the sample size used for the bone model testing.
- Data Provenance: The study was "in-vitro" and involved "Bone Model Testing." This suggests a synthetic bone model rather than human or animal tissue. The country of origin of the data is not specified. It is a prospective study as it was conducted for the purpose of the 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
- This type of device (bone anchor) typically does not involve human expert interpretation for "ground truth" in performance studies of this nature (ultimate holding strength). The ground truth is objective, quantifiable mechanical measurements.
- Therefore, there were no experts establishing ground truth in the traditional sense, as this was a physical performance test, not an image interpretation or clinical diagnosis.
4. Adjudication Method for the Test Set
- No adjudication method like 2+1 or 3+1 was used. This is because the performance data is from objective mechanical testing, not subjective expert assessment or image review. The "adjudication" would be based on the objective measurement and comparison against predefined (but unstated in this document) statistical equivalence thresholds.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images. The Titan RC Tack is a surgical implant designed for mechanical fixation, which is evaluated through biomechanical testing, not image interpretation.
6. Standalone Performance Study
- Yes, a standalone performance study was done for the device. The "Bone Model Testing" evaluated the Titan RC Tack's "ultimate holding strength." While directly compared to the predicate device, it generated performance data for the Titan RC Tack itself, allowing for an assessment of its mechanical properties.
7. Type of Ground Truth Used
- The ground truth used was objective mechanical measurement (ultimate holding strength) from "in-vitro" bone model testing. This is a quantifiable physical property, not expert consensus, pathology, or outcomes data in the clinical sense.
8. Sample Size for the Training Set
- This device is not an AI/ML algorithm, so there is no concept of a "training set" in the context of machine learning. The term "training set" is not applicable here.
9. How Ground Truth for the Training Set was Established
- As this is not an AI/ML algorithm, there is no training set and thus no ground truth established for a training set. The "ground truth" for the performance study was the direct, objective measurement of the device's mechanical holding strength in the bone model.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.