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510(k) Data Aggregation
(116 days)
The KLS Martin SonicWeld RX (Resorb-X) is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, plates, screws and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation. The KLS Martin SonicWeld RX (Resorb-X) is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine. The SonicWeld Rx pins are designed only to be inserted with the SonicWeld Rx Sonotrode device.
The SonicWeld RX (Resorb-X) is identical to RESORB-X® SF (K051236) which consists of RESORB-X® Pins made of Poly (D, L) -Lactide-Acid (PDLLA) of various diameters and lengths that are implanted utilizing ultrasonic force generated by an ultrasonic unit that causes a phase transition in the pin, allowing the pin to adapt to the previously drilled pilot hole in the surgical site and utilize the micro undercuts of the bone for retention. The RESORB-X® SF pins are designed to be used in conjunction with RESORB-X® Resorbable Plating System plates (K011590).
The provided document is a 510(k) summary for the KLS Martin SonicWeld RX (Resorb-X) device. It is a premarket notification for a medical device seeking substantial equivalence to existing devices. This type of document focuses on establishing equivalence to predicate devices based on intended use and technological characteristics, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device or AI algorithm.
Therefore, many of the requested categories related to clinical study design, acceptance criteria, and AI performance evaluation are not applicable or cannot be answered from this document.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
Not applicable. This document does not establish new acceptance criteria for performance; instead, it asserts "substantial equivalence" to predicate devices based on chemical composition, implantation method, and general intended use. There are no specific performance metrics or acceptance criteria reported for the SonicWeld RX (Resorb-X) that would be presented in a table like this, as it is claiming to be identical or very similar to already cleared devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document does not describe a clinical study with a test set of patients/data. It is a regulatory submission for device clearance based on equivalence.
3. 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. There is no test set or ground truth establishment relevant to an AI algorithm or diagnostic performance in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) 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 document is for a medical device (bone plates, screws, pins), not an AI algorithm, and therefore, an MRMC study is not relevant to its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is established for device performance in the context of diagnostic accuracy, as this is not a diagnostic device nor does it involve the analysis of data. The "ground truth" for this submission is based on the previously established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI algorithm.
Summary of Relevant Information from the Document:
While the document doesn't fit the mold of an AI algorithm study, it does contain information about how the device's "acceptance" (i.e., regulatory clearance) was achieved based on equivalence, which is a form of "proof" in the regulatory context.
- Device: SonicWeld RX (Resorb-X) - Resorbable Plating System (pins, screws, plates, meshes)
- Intended Use: Fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. Non-load bearing applications for maintaining relative position of bony fragments, bone grafts, or bone graft substitutes in reconstruction of craniofacial or mandibular areas.
- Proof Method: Substantial Equivalence to predicate devices.
- Predicate Devices:
- Basis for Equivalence:
- Chemical Composition: Identical to RESORB-X Resorbable Plating System (K011590) and Resorb-X SF (K051236).
- Implantation Method: Identical to RESORB-X Resorbable Plating System (K011590) and Resorb-X SF (K051236).
- Expanded Indications: This submission expanded the indications for use to include non-load bearing applications in the mandible, which was deemed substantially equivalent to the predicates.
In this context, the "acceptance criteria" are implied to be the regulatory requirements for showing substantial equivalence, and the "study" is the comparison made to predicate devices within the 510(k) submission.
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(85 days)
KLS-Martin Rigid Fixation - Sterile is intended to provide, in sterile packaging, osteosynthesis products with the following indications for use.
K051236: The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins.
K032442: The KLS Martin Mandibular/Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
K971297: The KLS Martin Centre-Drive Drill-Free screws are intended for use in rigid i internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device reference.
K944565: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillocranio-facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.
K944561: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.
The KLS Martin Rigid Fixation - Sterile includes titanium plates of various shapes and thickness, titanium screws of various length and diameter, stainless steel twist drills of various length and diameter and stainless steel sonotrode tips that are provided in sterile packaging.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the KLS Martin Rigid Fixation - Sterile device:
This submission is for a medical device (bone plate, screws, drills, and sonotrode tips) provided in sterile packaging, not a software or AI/ML-based device. Therefore, many of the requested categories related to algorithm performance, training sets, and expert adjudication are not applicable.
The primary "study" in this context is the demonstration of substantial equivalence to predicate devices, focusing on the new aspect of sterile packaging and sterilization method.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Sterilization Method (Gamma Radiation) | Identical to cleared Resorb-X Resorbable Plating System (K011590). | This demonstrates the sterile packaging and sterilization method meets the standard set by a previously cleared device. |
| Manufacturing and Design | Identical to KLS-Martin Mandibular/Reconstruction System II (K032442), Centre-Drive Drill-Free Screw (K971297), Micro Osteosynthesis System (1.0) (K944561), and KLS-Martin Micro Osteosynthesis System (1.5mm) (K944565). | This indicates that the core mechanical components are unchanged from previously cleared devices, thus their performance characteristics are presumed to be the same. |
| Intended Use | Provides KLS Martin's osteosynthesis products in sterile packaging. Does not change the already cleared intended use of the component parts. | The sterilization process is not intended to alter the therapeutic or diagnostic function of the device but merely to deliver it in a sterile state. |
| Packaging (to identify sterile product) | Different stock numbers from originally cleared stock numbers to identify the product as sterile. | This is an administrative control to ensure proper identification of the sterile version. No performance criteria are associated with this beyond clear labeling. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a medical device (hardware) submission, not a software or AI/ML device requiring a test set of data. The "test" here refers to demonstrating manufacturing and sterilization equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. Ground truth as typically understood for AI/ML models is not relevant here. The "ground truth" for the device's functionality and safety is established through the previous clearance of the predicate devices and the validation of the sterilization process.
4. Adjudication Method for the Test Set
This is not applicable. There's no "test set" in the context of adjudication for AI/ML performance.
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. This is a hardware medical device; it does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a hardware medical device and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Previous FDA clearances: The KLS Martin Rigid Fixation - Sterile components (plates, screws, drills) have established safety and effectiveness through prior FDA clearances (K032442, K971297, K944561, K944565).
- Validated Sterilization Process: The sterilization method (gamma radiation) is considered "substantially equivalent" to one previously cleared (Resorb-X Resorbable Plating System K011590), implying its effectiveness in achieving sterility is already established.
8. The Sample Size for the Training Set
This is not applicable as this is not an AI/ML or software device.
9. How the Ground Truth for the Training Set was Established
This is not applicable as this is not an AI/ML or software device.
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