(276 days)
STOMA bone block screws are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process in the oral cavity and maxillomandibular surgical field.
STOMA bone block screws are not intended to remain in the body permanently. After they have fulfilled their supportive function such as is the case after healing of a transplant, or healing of a fracture, for example, they need to be removed completely.
The screw head has either an inner square, or a cross slot. The screw thread is self-tapping and has two different thread leads. Dimensions: Length: 4 mm, 6 mm, 8 mm, 10 mm, 12 mm, 14 mm, 16 mm; Diameter: ø1.0 mm, ø1.2 mm, ø1.6 mm. The screws can be delivered in a cassette along with suitable accessories such as a screwdriver and pilot drill as basic equipment or re-ordered separately in different packaging units.
The provided 510(k) summary does not describe a study involving a device that uses AI or machine learning, nor does it provide acceptance criteria and performance data in the format typically associated with such studies (e.g., sensitivity, specificity, accuracy, F1-score).
This document pertains to the STOMA Bone Block Screws, Steel, which are described as non-active bone surgery implants used for the fixation of transplanted bone blocks during augmentation processes. The submission focuses on demonstrating substantial equivalence to a predicate device (STOMA Bone Screws, K51871) based on material composition, intended use, and functional properties.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: No specific quantitative performance metrics or acceptance criteria for statistical evaluation are present. The "performance" is implicitly demonstrated through substantial equivalence to an already marketed device.
- Sample size used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no test set for clinical performance evaluation described.
- Adjudication method 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, as this is a physical medical device, not an AI or imaging diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Acceptance and "Study" Information (as applicable to this document):
The acceptance of the STOMA Bone Block Screw, Steel is based on demonstrating substantial equivalence to a predicate device, the STOMA Bone Screws (K51871). This is a common pathway for medical device clearance by the FDA for Class II devices.
The "study" or justification provided relies on comparing the new device to the predicate device in terms of:
- Intended Use: Both are for the treatment of bone fractures, specifically for the fixation of transplanted bone blocks during augmentation in the oral cavity and maxillomandibular surgical field.
- Technological Characteristics: The new device (and implicitly the predicate) are bone screws with similar designs (screw head types, self-tapping threads) and dimensions (length and diameter ranges).
- Materials: Both use biocompatible materials (though specific material is not detailed beyond "Steel," and the biocompatibility requirement is stated as met through raw material composition).
- Sterilization: Both are delivered non-sterile and require user sterilization via a validated steam-sterilization process.
Conclusion stated in the 510(k) summary: "Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that STOMA Bone Screws are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act."
In essence, for this type of device and submission, the "acceptance criteria" revolve around successfully arguing and demonstrating that the new device is as safe and effective as a legally marketed predicate device, thereby meeting the requirements for substantial equivalence. There is no performance study in the traditional sense involving human patients or complex data analysis as would be expected for AI/ML devices.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.