(61 days)
The MITEK TIGHT-N™ Tendon Docking Anchor is indicated for use for reattachment of soft tissue to bone for the following procedures:
• Shoulder: Biceps tenodesis
• Knee: Medial patellofemoral ligament repair/reconstruction (MPFL), posterior oblique ligament repair (POL), medial collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, anterolateral ligament (ALL) reconstruction, Iliotibial (IT) Band Tenodesis
The MITEK TIGHT-NTM Tendon Docking Anchor is designed to reattach soft tissue to bone when used in conjunction with suture (provided separately). The anchor is preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable "stay suture". The proposed anchor will be offered in three sizes: 5.5 mm, 7.0 mm, and 8.5 mm and is molded from PEEK (Polyetheretherketone) material. The proposed anchor is provided sterile via Ethylene Oxide (EO) sterilization and is for single use only.
The provided text describes a medical device's 510(k) submission to the FDA, focusing on establishing substantial equivalence to a predicate device. It details the device's description, technological characteristics, indications for use, and a summary of non-clinical testing. However, it does not contain information about the acceptance criteria and the results of a study as typically outlined for AI/ML device performance.
Specifically, the document focuses on:
- Device Name: MITEK TIGHT-N™ Tendon Docking Anchor
- Regulatory Classification: Class II, Product Code MBI, regulated under 21 CFR 888.3040 (Fastener, Fixation, Nondegradable, Soft Tissue).
- Predicate Device: K201749 Arthrex Biocomposite 3.9mm SwiveLock Anchor.
- Technological Characteristics: The proposed anchor is a suspensory push-in anchor made of PEEK material, while the predicate is an interference thread-in anchor made of PEEK and PLLA/βTCP. Both secure soft tissue to bone.
- Non-clinical Testing:
- Biocompatibility
- Shelf-life
- Pyrogenicity
- Endotoxin testing
- Performance testing (fixation strength and fatigue strength)
- Ethylene Oxide Sterilization validation per ANSI/AAMI/ISO 11135:2014 to a SAL of 1 x 10^-6.
- EO residuals testing per AAMI/ANSI/ISO 10993-7:2008.
- Non-pyrogenic determination per ANSI/AAMI ST-72:2011, USP, and EP using Bacterial Endotoxin Testing (BET).
- Conclusion: "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." And "Based on similarities in the intended use, technological characteristics, and performance in comparison to the predicate devices, the proposed MITEK TIGHT-NTM Tendon Docking Anchor has shown to be substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act."
Missing Information (relevant to AI/ML device studies):
The document does not provide the following information that would be expected for a detailed description of acceptance criteria and the study proving a digital or AI/ML device's performance:
- A table of acceptance criteria and reported device performance: This would typically list metrics like sensitivity, specificity, accuracy, AUC, F1 score, etc., with pre-defined thresholds for acceptance and the observed performance.
- Sample size used for the test set and data provenance: No test set sample size or details about data origin (e.g., country, retrospective/prospective) are mentioned.
- Number of experts used to establish ground truth and their qualifications: Not applicable, as this is a physical medical device.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for this type of device.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: For this physical device, "performance testing" includes mechanical tests like fixation strength and fatigue strength, and biological tests like biocompatibility and sterilization efficacy. These are not "ground truth" in the AI/ML sense.
- Sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text describes the regulatory clearance for a physical medical device (tendon docking anchor) based on substantial equivalence and non-clinical performance testing. It does not contain the characteristics of an AI/ML device study, and therefore, the specific requested details regarding acceptance criteria and performance studies for such devices are not present.
§ 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.