(89 days)
The Multitak Suture System is intended for soft tissue to bone suture fixation for the following indications: Knee Shoulder Extra-capsular repairs: Bankart lesion repairs Medial collateral ligament S.L.A.P. lesion repairs Lateral collateral ligament Acromio-clavicular repairs Posterior oblique ligament Capsular shift/capsulolabral reconstruction Iliotibial band tenodesis Deltoid repair Rotator cuff tear repairs Biceps tenodesis Foot and Ankle Medial/lateral repairs, reconstructions Achilles tendon repairs (Gamekeeper's Thumb) Midfoot and forefoot repairs Hallux valgus reconstruction Elbow Ulnar or radial collateral ligament reconstructions Tennis elbow repair Biceps tendon reattachment Patellar tendon repair VMO advancement Joint capsule closure Hand/Wrist Collateral ligament repair Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction
The anchor is tubular in shape and is preassembled threaded with USP size 2-0 through 2 braided polyester suture. An Introduction Device holds the anchor and delivers it into the bone through a predrilled hole. The sutures can then be used to secure the soft tissue to the bone.
The provided text describes the "Multitak Suture System" and its intended use, but it does not contain acceptance criteria or a detailed study that proves the device meets specific performance criteria. The "Performance Data" section is very brief and general.
Here's an analysis of the information that is available, and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated: The document does not define specific quantitative acceptance criteria (e.g., minimum pullout strength in Newtons, insertion force limits). | "found to demonstrate pullout strengths superior to those of a suture only reattachment technique." |
| Not Explicitly Stated: The document does not define specific quantitative acceptance criteria for insertion and locking. | "Insertion testing was performed to verify insertion and locking at all indicated sites." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study appears to be a laboratory-based biomechanical test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The "ground truth" here relates to biomechanical performance (pullout strength, insertion), not expert interpretation of medical images or clinical outcomes. The study was a laboratory-based mechanical test.
4. Adjudication Method for the Test Set
- Not applicable. This was a laboratory mechanical test, not a study requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a MRMC comparative effectiveness study was not done. The study described is a laboratory-based mechanical test comparing the device to a "suture only reattachment technique."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a medical device (suture anchor), not an algorithm or AI system.
7. The Type of Ground Truth Used
- Biomechanical Measurements: The ground truth was established through direct physical measurements of pullout strength and verification of insertion and locking mechanisms in a laboratory setting. This is a form of engineered or physical ground truth, not pathology, expert consensus, or outcomes data.
8. The Sample Size for the Training Set
- Not applicable. This is a medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
Summary of What's Missing and Why:
The provided document is a 510(k) summary for a medical device (a suture anchor system). These summaries typically focus on demonstrating substantial equivalence to predicate devices, rather than providing the detailed technical and statistical results of comprehensive clinical or AI performance studies.
Specifically, for the "Performance Data" section:
- It states that the device was "compared in pullout testing to the predicate device" and "found to demonstrate pullout strengths superior to those of a suture only reattachment technique." However, it does not provide:
- Specific quantitative pullout strength values for the device or the comparator.
- Statistical significance testing details (e.g., p-values, confidence intervals).
- The type of material used for testing (e.g., cadaver bone, synthetic bone).
- The number of samples tested (sample size).
- It states "Insertion testing was performed to verify insertion and locking at all indicated sites." Again, no specific data, methodology, or acceptance criteria are given.
Therefore, while the document confirms performance testing was done, it lacks the detailed information required to fully answer many of your questions, particularly regarding specific numerical acceptance criteria, sample sizes, and detailed performance metrics.
§ 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.