(126 days)
The HEALIX ADVANCE SP PEEK Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:
• Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair
• Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral collateral ligament reconstruction, iliotibial (IT) band tenodesis
• Foot/Ankle: Achilles tendon repair
The HEALIX ADVANCE SP PEEK Anchor is a two-piece “self-punching” design consisting of a cannulated, threaded anchor and dilator which are permanently implanted into the body. The anchor-dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). During implantation the stay suture may be discarded or incorporated into the repair at the surgeon's discretion. The proposed HEALIX ADVANCE SP PEEK Anchor is offered in two sizes, 4.9 mm and 5.5 mm and is molded from Polyetheretherketone (PEEK) material. The HEALIX ADVANCE SP PEEK Anchor is provided sterile via Ethylene Oxide (EO) sterilization and is for single use only.
Here's an analysis of the provided text regarding the HEALIX ADVANCE™ SP PEEK Anchor, focusing on acceptance criteria and supporting studies.
Based on the provided FDA 510(k) summary for the HEALIX ADVANCE™ SP PEEK Anchor, the device is a medical implant, and the approval process primarily focuses on engineering and biocompatibility performance testing rather than AI/machine learning performance. Therefore, many of the requested categories related to AI/ML studies (such as MRMC, standalone algorithm performance, number of experts for ground truth, sample size for training set, etc.) are not applicable to this specific device and submission.
The acceptance criteria here concern the mechanical integrity, sterility, and biocompatibility of the anchor.
Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Fixation Strength | Verification activities were performed on the proposed device and/or its predicates. Performance testing included evaluation of fixation strength. Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. (Specific values or thresholds for "fixation strength" are not provided in this summary but would have been part of the full submission). |
| Insertion Torque | Verification activities were performed on the proposed device and/or its predicates. Performance testing included evaluation of insertion torque. Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. (Specific values or thresholds for "insertion torque" are not provided). |
| Torque to Failure | Verification activities were performed on the proposed device and/or its predicates. Performance testing included evaluation of torque to failure. Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. (Specific values or thresholds for "torque to failure" are not provided). |
| Cyclic Migration at Time Zero | Verification activities were performed on the proposed device and/or its predicates. Performance testing included evaluation of cyclic migration at time zero. Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. (Specific values or thresholds for "cyclic migration" are not provided). |
| Sterilization (EO) | Validated according to ANSI/AAMI/ISO 11135: 2014 to a Sterility Assurance Level (SAL) of 1 x 10^-6. |
| EO Residuals | Tested per AAMI/ANSI/ISO 10993-7:2008. (Specific results confirming compliance are not provided but implied by stating successful testing). |
| Non-pyrogenic | Determined to be non-pyrogenic per the requirements set forth in ANSI/AAMI ST-72:2011, United States Pharmacopeia (USP), and European Pharmacopeia (EP) using the bacterial endotoxin testing (BET) method. (Specific results confirming compliance are not provided but implied by stating successful testing). |
| Biocompatibility (Material) | The PEEK material is identical to that present in the reference device- HEALIX ADVANCE™ KNOTLESS PEEK Anchor (K171114). The Suture Anchor design, anchor materials, principle of operation and indications for use are similar when compared to the predicate Arthrex PushLock Suture Anchors (K101679, K082810, K071177, K061863, K051219). Implied acceptable biocompatibility based on substantial equivalence to previously cleared devices with similar materials. |
Details Regarding the Study/Testing:
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Sample size used for the test set and the data provenance:
- The 510(k) summary does not specify the exact number of samples (e.g., how many anchors were tested for fixation strength, how many were subjected to cyclic migration). This information would typically be detailed in the full test reports submitted to the FDA, but is summarized here.
- Data Provenance: The device is manufactured by Medos International SARL in Switzerland (CH 2400, Switzerland), though the submitter is DePuy Synthes Mitek in Massachusetts, USA. The testing would have been conducted by the manufacturer or a contracted lab. The studies are non-clinical (benchtop and lab-based), not human subject data. Therefore, concepts like country of origin for data (in a clinical sense) or retrospective/prospective are not directly applicable.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For this type of medical device (suture anchor), "ground truth" is established by engineering standards, material specifications, and validated test methods, not by expert interpretation of clinical data in the way one would for an AI diagnostic algorithm. The "experts" involved would be engineers, materials scientists, and quality assurance specialists.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where subjective interpretation is involved. For engineering performance testing, the results are quantitative and objective, based on validated test protocols and measuring equipment.
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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:
- Not Applicable. This device is a mechanical implant, not an AI diagnostic tool. MRMC studies are used to evaluate diagnostic imaging devices or AI algorithms that assist human interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a mechanical implant with no AI component, so there is no algorithm to test in a standalone manner.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For mechanical performance tests (fixation strength, torque, migration): The "ground truth" is determined by engineering specifications and validated biomechanical test methods that simulate physiological loads. The objective is to demonstrate that the device meets predefined mechanical thresholds and performance characteristics.
- For sterilization and biocompatibility: The "ground truth" is established by international standards (ISO, AAMI) and regulatory guidelines (USP, EP), which define acceptable levels for sterility, endotoxin, and material safety.
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The sample size for the training set:
- Not Applicable. This device does not use machine learning or AI, so there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.
In summary, the HEALIX ADVANCE™ SP PEEK Anchor is a conventional medical device whose substantial equivalence and safety/effectiveness are demonstrated through non-clinical engineering, material, and sterilization testing, not through AI/ML performance studies or clinical reader studies.
§ 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.