(115 days)
The SECURE-LOCK is indicated for fixation of bone or soft tissue to bone, and is intended as a fixation device, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair such as Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.
The SECURE-LOCK fixation device consists of a sterile and non-absorbable polyester and ultrahigh molecular weight polyethylene blended braid that forms a loop on a titanium alloy button. The button sits on the cortex over the exit to a bone tunnel, suspending the loop inside the tunnel to provide secure, strong fixation for ligament repair and reconstruction. The SECURE-LOCK fixation device is supplied with polyester sutures that are used to assemble and deliver the device.
The provided text describes the 510(k) summary for the SECURE-LOCK device, a suspensory fixation device for ACL/PCL repair and reconstruction. It outlines the device's characteristics, intended use, and performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "reported device performance" values for clinical efficacy. Instead, it lists various performance tests conducted to demonstrate the device's mechanical properties, safety, and substantial equivalence to a predicate device. The conclusion states that the device provides "appropriate mechanical properties and is relatively safe for its use."
However, based on the tests conducted, we can infer performance areas:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Properties | |
| Implant Tensile Strength (Sufficient for fixation) | Tested (result reported as demonstrating "appropriate mechanical properties") |
| Implant Fatigue (Durability over time) | Tested (result reported as demonstrating "appropriate mechanical properties") |
| Pulling Suture Tensile Strength (Sufficient for delivery) | Tested (result reported as demonstrating "appropriate mechanical properties") |
| Suture Diameter (Meeting manufacturing specifications) | Measured (result reported as demonstrating "appropriate mechanical properties") |
| Biocompatibility & Safety | |
| Biocompatibility (No adverse biological reactions) | Tested in accordance with ISO 10993-1 (Implied to meet standards for safety) |
| Pyrogenicity (Absence of fever-inducing substances) | Bacterial endotoxin testing performed on representative devices (XTREME-LOOP and SECURE-LOOP) using Limulus Amoebocyte Lysate (LAL) method. Results met FDA requirements of and meets specification limits. Final product batch release testing for endotoxins will be carried out on the subject device in accordance with ANSI/AAMI ST72:2019. |
| MRI Compatibility (Safe for use in MR environment) | Tested (Implied to meet standards for safety in an MR environment) |
| Functional Equivalence | |
| Performance in Simulated Use Conditions (Effective function) | Formal assessment of the SECURE-LOCK design in simulated use conditions (Implied satisfactory performance) |
| Characterization of UHMWPE (Material integrity) | Tested (Implied to meet standards for material integrity) |
| Substantial Equivalence to Predicate (Overall safety/efficacy) | Concluded to be substantially equivalent to the Arthrex ACL Tightrope (K112990), with differences being minor and not raising safety/effectiveness concerns. |
Study Details
The document describes performance testing rather than a clinical study with a test set of human subjects. The assessment is based on bench testing of the device itself and its materials.
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Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set. The "test set" here refers to physical devices and materials undergoing various laboratory tests (tensile strength, fatigue, etc.). There is no mention of the specific number of devices tested for each performance test, but it is implied that representative samples were used. Data provenance is internal laboratory testing.
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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. Ground truth for mechanical and material properties is established by recognized engineering and material science standards and measurement techniques, not expert consensus in the diagnostic sense.
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Adjudication method for the test set: Not applicable for device performance testing against established standards. Results are compared directly to pre-defined specification limits or industry standards (e.g., ISO, USP, ANSI/AAMI).
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a device 510(k) submission focused on demonstrating substantial equivalence through bench testing and material characterization, not a comparative clinical effectiveness study involving human readers or patient outcomes, especially not in the context of AI.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a medical device (fixation implant), not a software algorithm or AI device.
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The type of ground truth used:
- Mechanical Performance: Engineering specifications, industry standards (e.g., for tensile strength, fatigue, suture properties).
- Biocompatibility: ISO 10993-1 standards.
- Pyrogenicity: FDA requirements ( specification limits.
- MRI Compatibility: Recognized standards for safety in MR environments.
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The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable.
§ 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.