(105 days)
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:
| Acceptance Criteria (e.g., minimum tensile strength) | Reported Device Performance (e.g., actual tensile strength result) |
|---|---|
| Not specified in the provided text. The text mentions performance tests conducted (fixation strength, insertion torque, torque to failure, cyclic migration), but does not state the specific acceptance criteria for these tests nor the numerical results obtained. | Not specified in the provided text. The text merely states, "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use," without providing quantitative outcomes. |
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.