(47 days)
The KMI K2 Bone Screw System™ will be used on indications that are common with presently marketed devices. The indications for use of the K2 Bone Screw System™ are fixation/stabilization of small bone hand or small bone forefoot fractures.
The KMI K2 Bone Screw System™ will be offered in Ti-6Al-4V ELI. It will be available in common styles and assorted lengths for bone fracture fixation and stabilization. Initially, a range of eleven screw lengths will be made available in 2.8 mm diameter (10-30 mm), and eight screw lengths will be made available in the 2.4 mm (6-20 mm) diameter screw. Both screw types are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated at center.
This document is a Summary of Safety and Effectiveness Information for the K2 Bone Screw System™ by Kinetikos Medical Inc. (KMI). The document is a 510(k) premarket notification to the FDA for a Class II medical device.
Based on the provided text, there is no acceptance criteria or a study described that proves the device meets specific performance criteria through empirical data analysis. The document focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than presenting a performance study with acceptance criteria.
Here's an analysis based on your requested information, acknowledging the limitations of the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, no specific performance acceptance criteria are mentioned, nor is there a report of device performance against such criteria. The document states:
- "No performance standards applicable to the Bone Screw have been established by the FDA."
- The titanium alloy (6AL-4V ELI) used "meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F136-84)."
- The system "meet the ASTM standards (ASTM B348-83, F136-84, F67-88) for material and design for medical application."
Therefore, a table of acceptance criteria and reported device performance, as you've requested for a typical AI/software device, cannot be constructed from this document. The "performance" discussed primarily relates to material standards and design equivalence to existing 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. There is no "test set" or clinical study described in this document for the K2 Bone Screw System™. The focus is on demonstrating substantial equivalence to predicate devices.
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. This document does not describe a study involving expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or adjudication method 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 screw system), not an AI/software product that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a medical device (bone screw system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no "ground truth" used in the context of a performance study described in this document. The "ground truth" for the device's acceptable performance is implicitly established by its adherence to material standards (ASTM) and its substantial equivalence to other legally marketed bone screws that have a known clinical history.
8. The sample size for the training set
Not applicable. This document does not describe the development or testing of an AI model, and therefore, no "training set" is mentioned.
9. How the ground truth for the training set was established
Not applicable. As above, no training set or AI model development is described.
Summary of the document's approach to "Acceptance Criteria" and "Proof":
The document demonstrates the safety and effectiveness of the K2 Bone Screw System™ primarily through:
- Substantial Equivalence: Listing several predicate devices that are "substantially equivalent in design, composition and function." This is the core argument for its market approval.
- Material Standards Compliance: The materials used (Ti-6Al-4V ELI alloy and stainless steel) meet established ASTM standards (F136-84, B348-83, F67-88, F899-84). These standards serve as inherent "acceptance criteria" for the material properties.
- Known Clinical Performance: Stating that "Bone Screw systems in general have been used for many years, and the clinical performance is well known and documented," implying that the K2 system, being substantially equivalent, would share this established safety and effectiveness profile.
In essence, this FDA submission relies on regulatory precedents and established material science standards, not on a new clinical performance study with specific acceptance criteria that would typically be seen for a novel device or AI/software.
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FDA Notification of:
Summary of Safety and Effectiveness Information Product: K2 Bone Screw System™
Summary of Safety and Effectiveness Information
For Release Upon Request Only
Regulatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807.92
Company Name / Contact:
| Company: | KMI (Kinetikos Medical Inc.)3950 Sorrento Valley BlvdSan Diego, Ca 92110 |
|---|---|
| Contact: | Regulatory Affairs DepartmentKMI3950 Sorrento Valley BlvdSan Diego, Ca 92110(619) 558-2233 |
| Establishment Registration Number: | 2028840 |
| Classification Name: | Smooth or Threaded Bone FixatioFastener |
| Common Used Name: | Bone Screw |
| Trade Proprietary Name: | K2 Bone Screw System™ |
The FDA has classified similar products as a Class II device by the Orthopedic Device Section of the Surgical and Rehabilitation Devices Panel at Section 888-304. The product code generally refereed to is HWC ( Product Code: HWC ) , and KMI submits this application under this designation.
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FDA Notification of:
Summary of Safety and Effectiveness Information Product: K2 Bone Screw System™
Performance Standards:
No performance standards applicable to the Bone Screw have been established by the FDA. However, the titanium alloy 6AL-4V ELI alloy used to manufacture the KMI screws meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F136-84).
Package and Labeling:
Package labeling has been developed to industry standards. Packaging is also standard commercially available type quality and is stored in a fashion which prevents damage to the container or package the device is in.
System Description:
The KMI K2 Bone Screw System™ will be offered in Ti-6Al-4V ELI. It will be available in common styles and assorted lengths for bone fracture fixation and stabilization. Initially, a range of eleven screw lengths will be made available in 2.8 mm diameter (10-30 mm), and eight screw lengths will be made available in the 2.4 mm (6-20 mm) diameter screw. Both screw types are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated at center.
Indications for Use:
The KMI K2 Bone Screw System™ will be used on indications that are common with presently marketed devices. The indications for use of the K2 Bone Screw System™ are fixation/stabilization of small bone hand or small bone forefoot fractures.
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Image /page/2/Picture/0 description: The image shows the logo for Kinetikos Medical Incorporated. The logo is in black and white and features the letters KMI in large, bold font. Above the letters, the word "KINETIKOS MEDICAL" is written in a smaller font. Below the letters, the word "INCORPORATED" is written in a smaller font.
FDA Notification of:
Summary of Safety and Effectiveness Information Product: K2 Bone Screw System™
Confidential
Substantial Equivalent Devices:
This product is substantially equivalent in design, composition and function to other orthopedic screws manufactured and approved for market.
| Ace Medical Company: | K903810 | |
|---|---|---|
| Alphatec Medical: | K921622 | |
| Howmedica: | K931524 | |
| Aesculap: | K940207 | |
| Osteomed: | K924018 | |
| Zimmer: | K792022 | |
| A.O. Synthes:K792291 | ||
| Johnson & Johnson | K? | |
| ISI Manufacturing | K? |
The KMI K2 Bone Screw System™ meet the ASTM standards (ASTM B348-83, F136-84, F67-88) for material and design for medical application. The bone screws are of the same thread configuration and length as offered by Ace Medical, A.O. Synthes, Zimmer, Johnson & Johnson, Alphatec and many other orthopaedic companies. The minor and major diameters as well as the head size are comparable.
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Summary of Safety and Effectiveness Information Product: K2 Bone Screw System™
Confidential
Instrumentation:
KMI K2 Bone Screw System™ instrumentation used for the preparation and insertion of the K2 Bone Screws is considered to be general orthopaedic instrumentation. The system includes standard manual orthopaedic surgical instruments of the appropriate size and type. All K2 System instruments are manufactured from stainless steel meeting ASTM F899-84 standards.
Product Sterilization:
KMI will supply all instruments and implants Non-Sterile. Non-Sterile implants are packaged in "clean only" condition. The labeling of the implants and instruments clearly indicates their sterility status. The package insert contains a sterilization/re-sterilization guideline.
Summary:
Substantial Equivalence for the KMI K2 Bone Screw System™ may be found in comparison with devices from a number of manufactures. Bone Screw systems in general have been used for many years, and the clinical performance is well known and documented.
Another measure of the Safety and Effectiveness of a medical device is how it performs in long term use. The basic design concept of bone screws for use in the fixation and stabilization of fractures has had over 75 years of clinical evaluation. Uses, Indications, limitations and surgical techniques are well understood. Standardized manufacturing methods, design practices, material selections and testing techniques are known and represented within the guidelines of this submittal.
§ 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.