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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:

1. 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.
2. Sample size used for the test set and the data provenance: No test set is described.
3. 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.
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, as this is a physical medical device, not an AI or imaging diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. 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.

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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.

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.

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