Search Results

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
• 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 BIOCOMPOSITE 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). The proposed HEALIX ADVANCE SP BIOCOMPOSITE Anchor is offered in two sizes, 4.9 mm and 5.5 mm and is molded from Absorbable Biocryl Biocomposite ((Polylactic Acid (PLA) and Tricalcium Phosphate (TCP)) material. The dilator is comprised of Non-absorbable PEEK (Polyetheretherketone). The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is provided sterile via Ethylene Oxide (EO) sterilization and is for single use only.

The provided text describes a medical device, the HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor, and its substantial equivalence to predicate devices, but it does not contain acceptance criteria for device performance or a study demonstrating that the device explicitly meets such criteria with numerical performance data.

The "Non-clinical Testing" section outlines the types of tests performed and generally 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." However, it does not provide:

• Specific numerical acceptance criteria (e.g., minimum fixation strength, maximum cyclic migration).
• Reported numerical performance results of the HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor from these tests.
• Details of any statistical study that would compare these numerical results against predefined acceptance criteria.

Therefore, I cannot populate the table or answer most of your detailed questions regarding acceptance criteria and study particulars because the necessary information is not present in the provided text.

Based on the available information, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: The tests are described as "in-vitro" and "non-clinical," which implies laboratory testing of the device itself rather than human or animal studies. The country of origin of the data is not specified, but the applicant (Medos International SARL) is based in Switzerland, and the testing was likely conducted in a similar regulated environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable as the "test set" described relates to in-vitro mechanical and material properties of the device, not a diagnostic or clinical outcome requiring expert consensus. The "ground truth" here would be the physical measurements and material properties of the device itself.

4. Adjudication method for the test set:

• Not applicable for in-vitro mechanical testing.

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:

• This question is not applicable. The device is a surgical anchor, not an AI-powered diagnostic or assistive tool.

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

• This question is not applicable. The device is a physical surgical implant, not an algorithm.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" would be the objective physical and material properties of the device measured through standardized laboratory tests (e.g., force, torque, displacement).

8. The sample size for the training set:

• This question is not applicable. The device is a physical surgical implant, which does not involve a "training set" in the context of machine learning or AI.

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

• This question is not applicable for the same reason as above.

Additional Information from the text:

• Sterilization Validation: Ethylene Oxide Sterilization was validated according to ANSI/AAMI/ISO 11135: 2014 to a SAL (Sterility Assurance Level) of 1 x 10^-6.
• EO Residuals: Tested per AAMI/ANSI/ISO 10993-7:2008.
• Non-pyrogenic: Determined to be non-pyrogenic per ANSI/AAMI ST-72:2011, USP, and EP using the bacterial endotoxin testing (BET) method.

Ask a specific question about this device

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

Details Regarding the Study/Testing:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. The sample size for the training set:

   • Not Applicable. This device does not use machine learning or AI, so there is no "training set."

8. 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.

Ask a specific question about this device