(70 days)
The Parces SLIK Fix Screw is in soft tissue to bone reattachment procedures. Specific indications are the following:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bicepair, Biceps Tenodesis, Capsular Shift or Capsulolabral Repair, Fictorial Sepairion Repair, SLAP Lesion Repair,
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Olique Ligament Repair, Extra Capsular Reconstruction, Lateral Conaleral Ligament Repar, Posterior Oblique Ligare
Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
The Parcus SLiK Fix Screws are designed for use in the attachment of soft tissue to bone. The screws are made from either Polyetheretherketone (PEEK) or Carbon Fiber Reinforced Polyethersether only in Chiler Polyen Fiber PEEK) or Carbon Fiber Reinforced
Polyetheretherketone (PEEK CF) and utilize a PEEK washer for graft/suture positioning. The Parcus SLiK Fix Screws are provided sterile.
This is a premarket notification for a medical device (K170877) and as such, it primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed study proving the device meets specific acceptance criteria via a clinical trial or algorithm performance study.
Based on the provided document, here's a breakdown of the available information regarding acceptance criteria and supporting studies:
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Table of Acceptance Criteria and Reported Device Performance:
The document does not present a formal table of acceptance criteria with specific quantitative thresholds for the new device's performance, nor does it provide detailed numerical results of those tests. Instead, it refers to "worst-case configurations" testing and a comparison to predicate devices to demonstrate "substantial equivalency."
Acceptance Criteria (Implied) Reported Device Performance Mechanical strength and elongation under cyclic loading Evaluated. Results were compared with the predicate device and "demonstrated substantial equivalency." (Specific values not provided) Mechanical strength and elongation under ultimate failure conditions Evaluated. Results were compared with the predicate device and "demonstrated substantial equivalency." (Specific values not provided) Insertion torque Determined. Values were compared to the predicate device to ensure "the necessary safety factor existed during insertion of the device." (Specific values not provided) Failure torque Determined. Values were compared to the predicate device to ensure "the necessary safety factor existed during insertion of the device." (Specific values not provided) Pyrogenicity Testing was conducted on a comparable device, and it was concluded that the SLiK Fix Screws do not raise any additional concerns regarding pyrogenicity. (Specific test results not provided, but the conclusion of non-pyrogenic is reported.) Overall safety and efficacy (demonstration of substantial equivalence) The device is "very similar to the predicate Parcus Medical devices in that they are comprised of the same materials, are manufactured in comparable fashions, and are intended for the same indications." Even though the SLiK Fix Screws are shorter and larger in diameter, testing (as described above) has shown "the combination of these features does not raise any concerns regarding the safety or efficacy of the device." -
Sample size used for the test set and the data provenance:
The document doesn't specify the exact sample sizes (number of devices) used for the mechanical or pyrogenicity testing. It only mentions "Devices were assembled and testing was conducted on the worst case configurations."
The data provenance is internal testing performed by Parcus Medical, LLC. No information is given regarding country of origin of data or if it's retrospective/prospective, but given it's a premarket submission, it would be prospective testing specifically for this submission.
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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. This is a medical device (screw) submission, not an AI/imaging diagnostic device. Ground truth as typically understood for AI models (e.g., expert consensus on images, pathology results) is not relevant here. The "ground truth" for mechanical testing is derived from engineering principles and validated test methods.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 are used for expert review in diagnostic studies, not for mechanical testing of hardware.
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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 is a physical medical device (fixation screw), not an AI or imaging device involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the performance data, the "ground truth" is based on:
- Engineering Test Standards: Standardized mechanical testing protocols for strength, elongation, and torque.
- Predicate Device Performance: The performance of previously cleared devices (Parcus PEEK CF Interference Screws, Parcus 35/45 Knotless PEEK CF Push-In Suture Anchors, Parcus Twist PEEK Suture Anchors) serves as the benchmark for "substantial equivalence."
- Biological Safety Standards: Pyrogenicity testing follows established standards for biocompatibility.
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The sample size for the training set:
Not applicable. This is a physical medical device, not an AI model requiring a training set.
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How the ground truth for the training set was established:
Not applicable. This is a physical medical device, not an AI model.
§ 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.