(30 days)
The HEALIX ADVANCE SP PEEK Anchor is 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 ligament reconstruction, iliotibial (IT) band tenodesis
Foot/Ankle: Achilles tendon repair
The HEALIX ADVANCE SP Biocomposite Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair
- Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral ligament Knee: reconstruction, iliotibial (IT) band tenodesis
- Foot/Ankle: Achilles tendon repair (4.9mm & 5.5mm only)
The proposed HEALIX ADVANCE SP PEEK and BIOCOMPOSITE Anchors is a line extension to the currently marketed HEALIX ADVANCE SP Anchor family. Both versions of the device consist of a two-piece "self-punching" design consisting of a cannulated, threaded anchor (PEEK or BIOCOMPOSITE) and PEEK (Polyetheretherketone) 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). Following anchor-dilator implantation, the stay suture is discarded.
The proposed HEALIX ADVANCE SP PEEK and BIOCOMPOSITE Anchors will be available in a new size option, 6.5 mm, molded from either Polyetheretherketone (PEEK) material or Absorbable Biocryl Biocomposite ((Polylactic Acid (PLA) and Tricalcium Phosphate (TCP)) material.
Both the HEALIX ADVANCE SP PEEK Anchor and HEALIX ADVANCE SP BIOCOMPOSITE Anchor are provided sterile via Ethylene Oxide (EO) sterilization and are for single use only.
This FDA 510(k) summary describes a medical device, the HEALIX ADVANCE™ SP PEEK Anchor and HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor. It is a submission for substantial equivalence to previously cleared devices, making it a "line extension." Therefore, the document focuses on demonstrating that the new devices are as safe and effective as the predicate devices, rather than establishing de novo acceptance criteria for an entirely new technology using a clinical study.
Here's an analysis based on the provided text, addressing your questions where applicable:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission for a line extension of an existing product, the "acceptance criteria" are implicitly met by demonstrating that the new device performs equivalently to the predicate devices in specific non-clinical tests. The document doesn't provide explicit numerical acceptance criteria values that the device had to meet (e.g., "pull-out strength must be > X N"). Instead, it states that "Performance testing included evaluation of in-vitro fixation strength at zero, six and twelve weeks, insertion torque, torque to failure and cyclic migration at time zero." and concludes that "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use."
The comparison is made against the predicate devices (K182941 for PEEK and K191242 for BIOCOMPOSITE). The core assertion is that the new 6.5mm size options perform comparably to the already cleared sizes and materials.
Implicit Acceptance Criteria and Reported Performance (derived from text):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent in-vitro fixation strength at 0, 6, 12 weeks to predicate | Demonstrated to be suitable for intended use, comparable to predicate devices. |
| Equivalent insertion torque to predicate | Demonstrated to be suitable for intended use, comparable to predicate devices. |
| Equivalent torque to failure to predicate | Demonstrated to be suitable for intended use, comparable to predicate devices. |
| Equivalent cyclic migration at time zero to predicate | Demonstrated to be suitable for intended use, comparable to predicate devices. |
| Sterilization validated to ANSI/AAMI/ISO 11135: 2014 (SAL of 1 x 10-6) | Validation confirmed. |
| EO residuals tested per AAMI/ANSI/ISO 10993-7:2008 | Testing confirmed. |
| Non-pyrogenic per ANSI/AAMI ST-72:2011, USP, EP | Confirmed (using bacterial endotoxin testing (BET) method). |
| Comparable indications for use and technological characteristics to predicate devices | Similar indications and identical design/principle of operation for PEEK anchor; similar design/principle and subset of indications for BIOCOMPOSITE anchor. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical testing, not human clinical trials. Therefore, the "test set" refers to the samples of the devices used in the mechanical and biocompatibility tests. The specific number of devices (sample size) used for each test (e.g., how many anchors were tested for pull-out strength) is not specified in this summary.
Data Provenance: The data is from "verification activities" and "performance testing" conducted by the manufacturer, DePuy Synthes Mitek, a Johnson & Johnson company. It's retrospective in the sense that it's data collected to support the submission, but it's not retrospective patient data. It's lab-generated, in-vitro test data. The country of origin of the data is implied to be where the testing was performed, likely the United States (where DePuy Synthes Mitek is located) or Switzerland (Medos International SARL).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This question is not applicable. For a device like a suture anchor, "ground truth" in the context of clinical outcomes would typically be established in a clinical trial by expert clinicians (e.g., orthopedic surgeons) evaluating patient outcomes, or by pathology reports. However, for a 510(k) submission based on non-clinical testing for substantial equivalence, such expert-established ground truth for a "test set" (meaning patient data) is not relevant or described. The "ground truth" for the non-clinical tests is the measured physical properties of the device.
4. Adjudication Method for the Test Set:
This question is not applicable for non-clinical, in-vitro testing. Adjudication methods (like 2+1, 3+1) are used in clinical studies or evaluations of imaging/diagnostic devices where multiple expert interpretations need to be reconciled to establish a consensus ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where the performance of human readers with and without AI assistance is evaluated across multiple cases. The device in question is a physical surgical implant, not a diagnostic tool requiring human interpretation of medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, this question is not applicable. This device is a physical implant, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.
7. The Type of Ground Truth Used:
For this device, the "ground truth" is based on objective physical measurements from in-vitro mechanical tests (fixation strength, torque, cyclic migration) and validated sterilization/biocompatibility testing against established standards (e.g., ANSI/AAMI/ISO, USP, EP). There is no pathology, outcomes data, or expert consensus (in the sense of clinical decision-making) used for "ground truth" in this 510(k) summary as it is focused on demonstrating substantial equivalence through non-clinical means.
8. The Sample Size for the Training Set:
This question is not applicable. There is no "training set" in the context of this device. Training sets are used for machine learning or AI algorithms, which this device is not.
9. How the Ground Truth for the Training Set was Established:
This question is not applicable as there is no training set for this device.
§ 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.