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510(k) Data Aggregation
(254 days)
CORE ESSENCE ORTHOPAEDICS, LLC
ferroFibre 14 Stainless Steel Sutures are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair.
The ferroFibre™ Stainless Steel Suture is available in United States Pharmacopocia (USP) sizes 5-0 to #5 in various lengths. The ferroFibre multifilament stainless stecl sutures are supplied storile, armed with cutting needles. The sutures are fabricated from 316 stainless steel that meets ASTM F138-03.
The provided text describes a 510(k) submission for the ferroFibre™ Stainless Steel Suture. This document focuses on the regulatory clearance for a medical device and does not contain information about an AI/ML powered device, nor does it detail a clinical study with acceptance criteria and reported device performance in the way requested.
The document outlines performance testing conducted to characterize biocompatibility, diameter, and tensile strength according to ISO 10993 standards and USP Monographs. However, it does not provide specific acceptance criteria or reported performance values for these tests. It also does not include details on sample sizes for testing, ground truth establishment, expert involvement, or any multi-reader multi-case (MRMC) studies, as these types of studies are not relevant for the regulatory approval of a non-AI/ML surgical suture device.
Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device performance and clinical study design for this submission. The content is about a traditional medical device (surgical sutures) and its regulatory clearance based on substantial equivalence to existing products.
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(78 days)
CORE ESSENCE ORTHOPAEDICS, LLC
reVERTO™ Shape Memory Staples are intended for use in:
Fixation of Osteotomies of the Hand, Foot and Tibia
Arthrodesis of the Joints of the Hand and Foot
Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament
reVERTO™ Shape Memory Staples are also indicated for adjunctive fixation of Small Bone Fragments of:
The Upper Extremity, such as the Radius, Ulna, Humerus, Clavicle and Scapula
The Lower Extremity, such as the Tibia, Fibula and the Femur
The Upper Torso, such as the Sternum and the Ribs
reVERTO™ Shape Memory Staples are dynamic compression implants that use shape memory metal nickel-titanium alloy called NiTinol (see below for more information on NiTinol). The NiTinol construction causes the legs of the implant to deflect, thereby creating a compressive force across the site of fixation. reVERTO Shape Memory Staples are advantageous to screws and plates in that they require less disruption of the surrounding bone for implantation and provide a 'low-profile' fixation. The most important factor related to the use of NiTinol is its ability to maintain a compressive force across the site of fixation during the healing process.
This document is a 510(k) summary for the reVERTO™ Shape Memory Staples and does not include performance data from a specific study to demonstrate the device meets acceptance criteria. The submission focuses on establishing substantial equivalence to previously cleared predicate devices based on intended use, materials, and operational principles, rather than presenting a detailed clinical or performance study with acceptance criteria and results.
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets those criteria from the provided text. The document does not describe such a study or present a table of acceptance criteria and reported device performance.
Here's a breakdown of why the requested information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The 510(k) summary is for regulatory clearance based on substantial equivalence, not a detailed performance study report.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no such test set or study data is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no test set requiring ground truth establishment is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. The device is a physical bone fixation staple, not an AI-assisted diagnostic or therapeutic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical bone fixation staple, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The provided document is a regulatory submission demonstrating substantial equivalence, which is a different type of submission than one detailing a clinical or performance study with specific acceptance criteria and results for a novel device.
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(67 days)
CORE ESSENCE ORTHOPAEDICS, LLC
reNOVO Suture Anchors are intended to secure soft tissue to bone of:
The Shoulder:
Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Roatator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair
The Elbow:
Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair
The Hand and Wrist:
Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons
The Ankle and Foot: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction
The reNOVO™ Suture Anchors range in size from 2.0mm to 5.5mm in diameter. The anchor portion consists of a threaded titanium (ASTM F136/ ISO 5832-3) segment that provides a self drilling and self tapping thread. The anchor eyelet provides a means to attach the range of suture sizes utilized on the anchors. The size of sutures used in the reNOVO line range from size 3-0 thru size 2 (USP) nonabsorbable UHMW polyethylene UltraFibre™ sutures. A single use driver and handpiece hold the excess suture and deliver the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to the bone.
The reNOVO™ Suture Anchor will be provided sterile for single use applications.
The sizes and materials are designed to address the indications cited.
This 510(k) submission for the reNOVO™ Suture Anchor System does not describe specific acceptance criteria and a study demonstrating the device meets those criteria in the way a performance study for, for example, an AI/ML device would. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria or reported device performance metrics (e.g., tensile strength thresholds, pull-out force requirements) is provided in the document. The claim is one of substantial equivalence, meaning the device is considered to perform similarly to already legally marketed devices.
2. Sample size used for the test set and the data provenance
No test set or associated sample size is mentioned in the document. The submission is based on a comparison to existing devices, not a new performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no test set in the conventional sense, and thus no ground truth to be established by experts.
4. Adjudication method for the test set
Not applicable. There is no test set or adjudication process described.
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
Not applicable. This is a medical device (suture anchor), not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device submission, the "ground truth" for demonstrating safety and effectiveness is established by showing that its intended use, materials, operational principles, and indications are equivalent to those of predicate devices that have already been cleared by the FDA.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
Summary of the Study (Basis for Substantial Equivalence):
The "study" that proves the device meets the "acceptance criteria" (which, in this context, is substantial equivalence) is a comparison to predicate devices.
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Acceptance Criteria (Implicit for Substantial Equivalence): The reNOVO™ Suture Anchor System must be shown to be substantially equivalent in intended use, materials, operational principles, and indications for use to legally marketed predicate devices. This implicitly means that its performance characteristics (e.g., mechanical properties, biocompatibility) are expected to be similar or equal to those of the predicate devices.
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Reported Device Performance (Implicit): The submission claims that "Core Essence Orthopaedics reNOVO suture anchors are substantially equivalent to the currently marked devices and present no substantial differences in design, material, intended use and function to the products on the table above." This statement serves as the "reported device performance" in the context of a 510(k) for a device like this.
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Predicate Devices Used for Comparison:
In essence, for this 510(k), the "study" is the analytical comparison of the reNOVO™ Suture Anchor System's characteristics (design, materials, indications, operational principles) against those of multiple already-cleared predicate suture anchors, rather than a separate clinical or bench performance study with specific metrics. The FDA's clearance (K071520) indicates they found this comparison sufficient to establish substantial equivalence.
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