(56 days)
The Parcus SLIK Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Biceps Tenair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
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 Anchors are designed for use in the attachment of soft tissue to bone. The devices are made from either Polyetheretherketone (PEEK) or Carbon Fiber Reinforced Polyetheretherketone (PEEK CF). The Parcus SLiK Anchors are provided sterile.
The provided text is a 510(k) summary for the Parcus SLiK Anchors, a medical device intended for the attachment of soft tissue to bone. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study proving performance against specific acceptance criteria for a novel AI/ML or diagnostic device.
Therefore, many of the requested categories (e.g., sample size for test/training sets, expert consensus, MRMC study, ground truth establishment) are not applicable to this type of device submission and the information provided. The "study" here refers to mechanical performance testing, not clinical performance or AI algorithm validation.
Here's an attempt to extract the relevant information and explicitly state what is not applicable based on the provided document:
Acceptance Criteria and Device Performance
The document does not explicitly list quantitative acceptance criteria in a table format. Instead, it describes performance evaluations done to demonstrate substantial equivalence to predicate devices. The implied acceptance criterion for the Parcus SLiK Anchors is that their mechanical performance (strength, elongation, insertion torque, failure torque) is comparable to or better than the cleared predicate devices, thereby not raising new safety or efficacy concerns.
Table of Acceptance Criteria (Implied) and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Comparable strength under cyclic loading to predicate devices. | "Devices were evaluated for strength and elongation under cycle loading... Results were compared with test data for the predicate devices and demonstrated substantial equivalency." |
| Mechanical Performance: | |
| Comparable elongation under cyclic loading to predicate devices. | "Devices were evaluated for strength and elongation under cycle loading... Results were compared with test data for the predicate devices and demonstrated substantial equivalency." |
| Mechanical Performance: | |
| Acceptable ultimate failure conditions comparable to predicate devices. | "Devices were evaluated for strength and elongation under... ultimate failure conditions. Results were compared with test data for the predicate devices and demonstrated substantial equivalency." |
| Insertion Safety: | |
| Sufficient safety factor during insertion based on insertion torque and failure torque values compared to predicate devices. | "In addition, insertion torque and failure torque values were determined in order to ensure the necessary safety factor exists during insertion of the device. Results were compared with test data for the predicate devices and demonstrated substantial equivalency." |
| Biocompatibility/Pyrogenicity: | |
| No additional concerns regarding pyrogenicity. | "LAL testing was conducted on a comparable device and it was concluded that the SLiK Anchors do not raise any addition concerns regarding pyrogenicity." |
Study Details (as per the provided document)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document states "testing was conducted on the worst case configurations." It does not specify the exact number of devices tested for each configuration.
- Data Provenance: The testing was conducted by or for Parcus Medical, LLC (Sarasota, Florida, USA). It is a prospective engineering/mechanical test, not a retrospective analysis of clinical data.
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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 mechanical device, not an AI/ML or diagnostic imaging device requiring expert interpretation for ground truth. "Ground truth" in this context is the physical, measured performance of the anchors in a standardized test setup.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None Applicable. This is a mechanical device; there's no "adjudication" in the sense of reconciling human interpretations. The results are physical measurements.
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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 implantable device, not a diagnostic or AI-assisted system. No human reader involvement or MRMC study was performed.
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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 implantable device. There is no algorithm to test in a standalone manner.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this engineering study is the direct physical measurement of mechanical properties (strength, elongation, torque values) under defined test conditions, and comparison to the known performance of predicate devices. There is no clinical or biological "ground truth" beyond meeting design specifications and demonstrating comparable performance to the predicate.
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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. 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.