(108 days)
STOMA Bone 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 and / or in combination with bone plates and bone meshes in the oral cavity and maxillomandibular surgical field.
STOMA Bone Screws are developed and manufactured to be used as non-active bone surgery implants. The bolt head of the STOMA Bone Screw is either self tapped by a square, hexagon or cross slot. The screws will be delivered in a cassette / container including accordingly screw driver and pilot drill. The bone screws are available in 1.3mm in length 4 mm to 1.6mm and 2.0mm diameter and lengths ranging from 4mm to 16mm.
This document describes the STOMA Bone Screws, a medical device used for the fixation of bone fractures and transplanted bone blocks in oral and maxillomandibular surgery. The provided text is a 510(k) premarket notification and subsequent FDA letter, which primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a detailed study proving performance against specific acceptance criteria.
Therefore, much of the requested information regarding acceptance criteria and a dedicated study to prove device performance is not explicitly available in the provided text. The submission relies on demonstrating that the STOMA Bone Screws are substantially equivalent to predicate devices, implying that if the predicates are safe and effective, then the new device, being substantially equivalent, also meets safety and effectiveness requirements.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report specific performance metrics for the STOMA Bone Screws. The primary "performance" reported is its substantial equivalence to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The core acceptance criterion for 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device. This implies that the device will perform similarly to the predicate in terms of safety and effectiveness. | STOMA Bone Screws are "substantially equivalent to other legally marketed bone screws from different manufacturers." |
| Biological compatibility (no adverse reactions) | "All requirements of biocompatibility are met through the composition of the used material. The used titanium alloy is also used in many other medical devices, especially implants." |
| Material properties | Made from "substantially equivalent or identical material" (titanium alloy) compared to competitors. |
| Sterilization efficacy | Can be sterilized by the user using a validated steam-sterilization process according to DIN EN 554 / ISO 11134 (137°C / 280°F, 3 bar, for min. 15 minutes). |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. The 510(k) submission does not describe a performance study with a test set of data. The submission focuses on a comparison of device characteristics (design, materials, indications for use) to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. Since no performance study with a test set generating a ground truth is described, information on experts is not available.
4. Adjudication method for the test set
Not applicable/Not provided. There is no described test set or adjudication method.
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 device is a physical bone screw and not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical bone screw, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. No specific clinical performance study requiring a "ground truth" for a test set is described. The "ground truth" in a 510(k) substantial equivalence submission, in a broader sense, is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable/Not provided. As this is a physical medical device and not an AI/ML algorithm requiring a training set, this information is not relevant or provided.
9. How the ground truth for the training set was established
Not applicable/Not provided. See answer to #8.
Summary of the "Study" (510(k) Submission):
The "study" presented here is a Substantial Equivalence Comparison (as stated in Section 4 of the document). This is a regulatory pathway where the applicant demonstrates that their new device is as safe and effective as a legally marketed predicate device, without needing to conduct extensive new clinical trials.
The basis for proving substantial equivalence for the STOMA Bone Screws includes:
- Comparison of Indications for Use: The STOMA Bone Screws are indicated for "treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process and / or in combination with bone plates and bone meshes in the oral cavity and maxillomandibular surgical field." This would have been compared to the indications of the predicate devices.
- Comparison of Device Properties/Technology: The physical characteristics, materials, and method of sterilization are compared. STOMA Bone Screws are made of titanium alloy, similar to the predicate devices.
- Biocompatibility: The material (titanium alloy) used is noted to be "also used in many other medical devices, especially implants," and meets biocompatibility requirements. This implies reliance on established knowledge and data for this material.
- Predicates Referenced: The document explicitly lists examples of predicate devices: OSTEOMED CORP. (K961418), KLS-Martin MMF Screw (K980760), and/or Synthes (USA) 1.3 Craniofacial Screws (K021850). The FDA's decision letter confirms that the device was found substantially equivalent to the indications referenced against legally marketed predicate devices.
In essence, the "study" is a regulatory comparison, not a direct performance study of the STOMA Bone Screws themselves.
§ 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.