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The Kinamed SuperCable Iso-Elastic Cerclage System is intended to be used in the following: repair of long bone fractures due to trauma or reconstruction; reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy; sternotomy closure; and sublaminar and intrafacet wiring of the spinal column.

The Kinamed SuperCable® Iso-Elastic™ Cerclage System consists of an implantable cable and locking clasp (the locking clasp consists of a clip and a wedge). The cable is comprised of a monofilament core of nylon with a jacket of ultra-high molecular-weight-polyethylene (UHMWPE) fibers braided around the nylon core. Manual instrumentation is used for applying the cable. The subject of the present Special 510(k) submission is a line addition of a cable implant whose locking clasp is manufactured using a metal injection molding (MIM) process.

The provided document is a 510(k) summary for the Kinamed SuperCable® Iso-Elastic™ Cerclage System. It describes a line extension to an existing device, specifically a change in the manufacturing process for the locking clasp. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical efficacy studies typically found for novel devices.

Therefore, the document does not contain the detailed information requested for acceptance criteria, device performance studies, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies that would be present for an AI/ML-based medical device or a device requiring new clinical efficacy data.

Based on the information provided in the document:

1. A table of acceptance criteria and the reported device performance

The document mentions "Performance testing of the SuperCable Iso-Elastic Cerclage System includes ISO 10993 testing, Bacterial endotoxin levels (LAL), Static construct tensile testing, and Fatigue construct tensile testing." However, the specific acceptance criteria and the reported results for each of these tests are not provided in this 510(k) summary. The document only states that the device "meets the specifications of ASTM F2885 (Type 1, Densified)" for the locking clasp material. This implies the acceptance criteria for the material are the ASTM F2885 specifications.

2. Sample size used for the test set and the data provenance

Not applicable. This submission is for a modification to an existing device (change in manufacturing process for a component), not an AI/ML device that uses test sets or clinical data in the typical sense for performance evaluation. The performance testing mentioned (tensile, fatigue, etc.) would be conducted on a sample of manufactured devices, but the sample sizes are not reported.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth establishment by experts is not relevant for this type of device modification.

4. Adjudication method for the test set

Not applicable.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI-based algorithm.

7. The type of ground truth used

Not applicable in the context of clinical "ground truth." The "ground truth" for this device would be defined by engineering specifications and material standards (e.g., ASTM F2885 for the material, and internal specifications for tensile strength and fatigue life).

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable.

Summary of what is presented in the document regarding acceptance criteria and study:

The submission focuses on demonstrating that a manufacturing change (Metal Injection Molding for the locking clasp) does not alter the safety or effectiveness of the device compared to the predicate. The basis of substantial equivalence is outlined by comparing properties such as:

• Same polymer cable
• Same intended use
• Same indications for use
• Same raw material alloy (Ti-6Al-4V) for locking clasp (though the manufacturing process changed)
• Same design
• Similar size and dimensions
• Same type of mating components
• Same shelf life
• Same biocompatibility
• Same sterilization and packaging methods

The performance testing mentioned (ISO 10993, LAL, Static construct tensile testing, Fatigue construct tensile testing) would serve as the "studies" to prove the device meets acceptance criteria, which would be the established specifications derived from the predicate device's performance and relevant standards. However, the specific data from these tests and the exact acceptance criteria are not included in this summary. The key statement regarding acceptance criteria is that the material "meets the specifications of ASTM F2885 (Type 1, Densified)."

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The Arthrex FiberTape Cerclage suture is intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair. When used as a bone fixation cerclage the suture is intended for:

• · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
• · Sternotomy indications including the "rewiring" of osteotomized sternums.
• · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
• · Repair of long bone fractures due to trauma or reconstruction.

The Arthrex FiberTape Cerclage suture is available as a flat braided suture or assembled in a loop configuration. The Arthrex FiberTape Cerclage suture is braided from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester materials identical to those used in other cleared Arthrex sutures (K032245, K041553 and K122374). For the loop assembly, the looped end of the suture is tied as a hitch over a sheath that secures a double looped suture.

The provided document is a 510(k) premarket notification for the Arthrex FiberTape Cerclage suture, seeking clearance for its use as a bone fixation cerclage. This document focuses on demonstrating substantial equivalence to predicate devices based on design features, intended use, and performance data from various studies.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format with corresponding reported performance values for each criterion. Instead, it describes various tests performed to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion for each test is that the Arthrex FiberTape Cerclage performs equivalently or acceptably compared to the cleared predicate devices.

However, based on the Substantial Equivalence Summary, we can infer the types of performance aspects evaluated:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (e.g., number of units, number of tests) used for each of the performance tests (fatigue strength, tensile force, creep, knot strength, wear testing, bacterial endotoxins).

• Data Provenance: The studies appear to be pre-clinical, benchtop (in-vitro) studies conducted by the manufacturer (Arthrex Inc.) for the purpose of demonstrating substantial equivalence. There is no indication of country of origin for the data provided, nor whether it is retrospective or prospective, as these terms usually apply to clinical studies involving human or animal subjects. These are laboratory-based tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information (number of experts, qualifications) is not applicable to the studies described. The tests performed are mechanical and chemical characterizations of the device, not diagnostic or clinical assessment studies that would require expert interpretation to establish a ground truth. The "ground truth" here is objective measurement against defined physical or chemical properties and standards (e.g., tensile strength, presence of endotoxins).

4. Adjudication Method for the Test Set

This is not applicable as there are no "readers" or subjective interpretations requiring adjudication for the benchtop tests described. The results are quantitative measurements.

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 is not applicable. The device is the "Arthrex FiberTape Cerclage suture," which is a physical surgical suture, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related effectiveness metrics are irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. As stated in point 5, this is not an AI algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the tests performed is based on objective, quantifiable physical and chemical properties and established standards.

• For mechanical tests (fatigue, tensile, creep, knot strength, wear), the "ground truth" is the measured performance data compared against the performance of predicate devices and engineering specifications.
• For the Bacterial Endotoxins Test, the "ground truth" is compliance with the pyrogen limit specifications outlined in USP .

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is a physical product.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set.

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The DPR Cable is intended for:

• Spinal applications include sublaminar and intraspinous process wiring for trauma applications.
• Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
• Sternotomy indications including the "rewiring" of osteomized sternums.
• Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
  The device is intended for single patient use only.

The DPR Cable is a flexible, multi-strand ultra-high molecular weight polyethylene (UHMWPE) cerclage cable. The device is intended to provide stabilization of bony segments.
The DPR Cable is made of woven ultra-high molecular weight polyethylene fibers which incorporate bismuth trioxide (Bi₂O₃). The addition of bismuth trioxide allows for radiographic visualization both during and after surgical procedures. The device is supplied sterile in double-layer packages. The DPR Cable is intended for single patient use only. DPR Cable is MR safe.

The provided text is a 510(k) Premarket Notification for a medical device called the "DPR Cable." This document primarily focuses on establishing substantial equivalence to a predicate device for regulatory approval, rather than detailing a clinical study with acceptance criteria for an AI/algorithm-based device.

Therefore, many of the requested details regarding acceptance criteria, study design for proving device performance (especially for an AI/algorithm), ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies do not apply to this type of regulatory submission for this medical device.

The document discusses biomechanical testing to show equivalence in performance characteristics to predicate devices, but this is not an AI/algorithm study.

Here's an attempt to extract relevant information, highlighting where the requested details are not applicable based on the provided text's context as a 510(k) for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating equivalence to predicate devices through biomechanical testing, rather than explicit criteria for an AI's accuracy or clinical performance. The table in the document (Page 5) compares the technological characteristics and certain performance metrics with the predicate device.

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