(65 days)
The MultiFIX S Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
The MultiFIX S Knotless Fixation System (MultiFIX S) is a laser marked PEEK implantable bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX S is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.
The MultiFIX S consists of two primary parts: a laser marked PEEK implantable bone anchor and an anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool. The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by irradiation. Both the anchor and inserter are designed for single use only.
This document is a 510(k) summary for the ArthroCare® Corporation MultiFIX® S Knotless Fixation System. It describes the device, its intended use, and demonstrates substantial equivalence to a predicate device, K132590.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Toxicological Testing (Gas and Liquid Chromatography Mass Spectrometry, FTIR) | Material is non-cytotoxic and equivalent to predicate. | "All toxicological... testing passed, demonstrating that the material is non-cytotoxic and equivalent to the predicate." |
| Biocompatibility Testing (Cytotoxicity) | Material is non-cytotoxic and equivalent to predicate. | "All... biocompatibility testing passed, demonstrating that the material is non-cytotoxic and equivalent to the predicate." |
| Bench Testing (Anchor Pound-in) | Anchor implant strength is not impacted by laser marking; implant screw body is successfully delivered sub-cortical. | "Bench testing in bone foam analog confirmed that the laser marking has no impact on implant strength as the implant screw body was able to be successfully delivered sub-cortical at the end of deployment. The test results demonstrate that the proposed MultiFIX S meets its design, performance, and safety specifications." |
| Mechanical Properties | Acceptable mechanical properties, substantially equivalent to predicate. | "Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate device when used in accordance with labeling." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the specific sample sizes for the toxicological, biocompatibility, and bench tests. It refers to "testing" in plural, implying multiple units were tested, but no numbers are provided.
- Data Provenance: The data is from non-clinical testing (toxicological, biocompatibility, and bench testing) performed by ArthroCare Corporation. There is no information about the country of origin of the data beyond the company's location in Austin, TX, USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate the performance of the new device with laser marking.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This device is a physical medical implant, not a diagnostic or AI-driven decision support system. Therefore, the concept of "ground truth" as established by human experts for a "test set" (like image data) does not directly apply in the same way.
- The "ground truth" for the non-clinical tests would be the objective measurements and pass/fail criteria for each test (e.g., cytotoxicity levels, force required for pound-in without impact on strength). The expertise involved would be in designing these tests and interpreting the results according to established scientific and regulatory standards for medical device evaluation. The document does not specify the number or qualifications of these testing personnel beyond the company's regulatory affairs contact.
4. Adjudication Method for the Test Set
- Again, as this is a physical implant evaluated through non-clinical laboratory tests, an "adjudication method" like 2+1 or 3+1 (common in expert review of medical images) is not applicable. The results of the non-clinical tests (e.g., chemical analysis, mechanical force measurements) are objective and are interpreted against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical or animal data are included in this submission." The evaluation relies entirely on non-clinical (bench) testing and comparison of technological characteristics to a predicate device to establish substantial equivalence.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This report is for a physical medical device (bone anchor), not a software algorithm or AI.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical tests was based on objective scientific and engineering measurements and established regulatory standards for material biocompatibility and mechanical performance of implantable devices. This includes:
- Chemical analysis results (Gas and Liquid Chromatography Mass Spectrometry, FTIR).
- Biocompatibility assay results (Cytotoxicity).
- Mechanical test results (anchor pound-in force, successful sub-cortical delivery).
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. Machine learning or AI models, which typically require training sets, are not involved.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth for it.
§ 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.