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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/capsulelabral 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: Exira-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 an 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: an implantable bone 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® Iid, and the finished product is sterilized by irradiation. Both the anchor and inserter are designed for single use only.

The provided text describes the MultiFIX S Knotless Fixation System, which is a medical device. The document is a 510(k) premarket notification summary submitted to the FDA. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics for a novel AI device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in this document because it pertains to a different type of medical device evaluation (AI/software-as-a-medical-device), not a substantially equivalent hardware device.

The document states: "No clinical or animal data are included in this submission." and "Bench testing was performed on both the proposed and predicate devices. The test results demonstrate that the proposed MultiFIX S meets its design, performance, and safety specifications."

This means the evaluation was based on non-clinical (bench) testing and comparison of technological characteristics to a previously cleared device (K140604).

Here's an overview of the information that is available:

1. A table of acceptance criteria and the reported device performance:

The document does not provide a specific table of acceptance criteria with numerical targets and reported performance. Instead, it states broadly that "The test results demonstrate that the proposed MultiFIX S meets its design, performance, and safety specifications." and "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."

The "Comparison of Technological Characteristics" table (on page 5 of the document) highlights the similarities between the predicate and proposed device, implying that the proposed device met acceptance criteria by being "Same" as the predicate for most characteristics, or providing acceptable alternatives (e.g., additional qualified suture threads).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample size: Not specified. The document only mentions "Bench testing was performed."
• Data provenance: Not applicable in the context of clinical/patient data, as it's bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. Ground truth as typically defined in AI/diagnostic studies is not relevant for this type of bench testing for substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. There was no expert-based adjudication in the context of this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC study was done. This device is a surgical fixation system, not an AI diagnostic tool that human readers would interact with.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a hardware medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• For bench testing, the "ground truth" would be engineering specifications and validated test methods (e.g., tensile strength, fixation strength) according to established standards. This is not explicitly detailed but is implied by "meets its design, performance, and safety specifications."

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. This is not an AI/machine learning device.

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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

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.

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