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510(k) Data Aggregation
(109 days)
SALVIN DENTAL SPECIALTIES, INC.
The Salvin Bone Tack System is designed to stabilize a barrier membrane onto a region of cortical plate. This may be used in craniofacial, maxillofacial, or mandibular bone. Considerations such as quality of bone, bone type, functional loads exerted, general patient health and others should be carefully evaluated prior to use.
The Salvin Bone Tack System consists of 3mm and 5mm Titanium (Ti-6Al-4V) bone tacks and associated instrumentation. The devices are provided non-sterile.
This document describes a 510(k) premarket notification for the Salvin Dental Specialties Bone Tack System. A 510(k) submission seeks to demonstrate that a new device is "substantially equivalent" to one or more legally marketed predicate devices, rather than proving its safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on this substantial equivalence rather than explicit acceptance criteria and a study proving device performance against those criteria in the way one might see for a novel device.
Given the nature of a 510(k) for this type of device, the acceptance criteria are not explicitly numerical performance metrics but rather a demonstration of equivalence in design, materials, and intended use to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k)) | Reported Device Performance (as per submission) |
|---|---|
| Substantial Equivalence to Predicate Device | Determined to be substantially equivalent to other devices cleared by the agency for commercial distribution. |
| Design Equivalence | Engineering drawings demonstrated substantial equivalence, if not identical, to predicate devices in terms of design. |
| Material Equivalence | Detailed inspectional analysis demonstrated substantial equivalence, if not identical, to predicate devices in terms of materials of composition (Titanium (Ti-6Al-4V)). |
| Indications for Use Equivalence | Demonstrated substantial equivalence, if not identical, to predicate devices in terms of indications for use (stabilize a barrier membrane onto a region of cortical plate in craniofacial, maxillofacial, or mandibular bone). |
| Associated Characteristics Equivalence | Demonstrated substantial equivalence, if not identical, to predicate devices in terms of other characteristics as may be associated with the manufacture of any medical device. |
| Non-Sterile Presentation | Devices are provided non-sterile. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. No "test set" in the traditional sense of a clinical or performance study was used. The submission relies on engineering equivalency and comparison to a predicate device.
- Data Provenance: Not applicable. The data primarily consists of engineering drawings and inspectional analysis of the device itself, compared to the known characteristics of the predicate device (IMTEC Bone Tac, K973180). This is internal manufacturer data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of clinical expert review is not relevant for this 510(k) submission, which relies on engineering and regulatory assessment of equivalence.
4. Adjudication method for the test set
Not applicable. There was no test set requiring expert adjudication.
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 bone tack system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
For a 510(k) submission for a device like this, the "ground truth" is established through:
- Reference to the predicate device's known characteristics and regulatory clearance.
- Engineering specifications and material science data for the proposed device, demonstrating it meets the same functional and safety profiles as the predicate.
- Intended Use statements that align with those of legally marketed predicate devices.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device submission.
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(119 days)
SALVIN DENTAL SPECIALTIES, INC.
The device is intended for use in internal fixation of small bones including the craniofacial and maxillofacial skeleton affected by trauma, or for reconstruction. Single patient use only
The Salvin Dental Specialties Titanium Fixation Screw System consists of 1.5mm and 2.0mm Titanium (Ti-6Al-4V) bone screws in lengths of 4, 6, 8, 10, 13 and 15mm. The 2.0mm diameter screws are “emergency” screws. The devices are provided non-sterile.
This document describes a 510(k) premarket notification for the "Salvin Dental Specialties, Inc. Titanium Fixation Screw System". The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through clinical studies. Therefore, many of the requested categories related to acceptance criteria, ground truth, and clinical study details are not directly applicable or available in this type of submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not define specific performance acceptance criteria in terms of clinical metrics (e.g., sensitivity, specificity, accuracy) or statistical thresholds. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical testing.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Design: Substantially equivalent to predicate devices. | Engineering drawings reviewed, deemed substantially equivalent. |
| Materials of Composition: Substantially equivalent to predicate devices. | Titanium (Ti-6Al-4V) bone screws, deemed substantially equivalent. |
| Indications for Use: Same as predicate devices. | "internal fixation of small bones including the craniofacial and maxillofacial skeleton affected by trauma, or for reconstruction." - deemed substantially equivalent. |
| Mechanical Testing: Meets standards like ASTM F 543-02 for metallic bone screws. | Mechanical testing performed (referenced as "mechanical testing have demonstrated"), but specific results/metrics are not detailed in this summary. |
| Labeling: Consistent with predicate devices. | Labeling reviewed, deemed substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Directly applicable "test set" sample size for evaluating performance against clinical acceptance criteria is not mentioned because no clinical study with human subjects (patients) was conducted or referenced for this 510(k) submission.
- Data Provenance: Not applicable, as this submission relies on engineering design, material specifications, and non-clinical mechanical testing, rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts & Qualifications: Not applicable. No "ground truth" for a clinical test set was established in this context. The determination of substantial equivalence relies on regulatory review of technical documentation by FDA reviewers.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as there was no clinical test set requiring expert adjudication.
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
- MRMC Study: No MRMC comparative effectiveness study was conducted or referenced. This device is a mechanical fixation screw, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" in this context is the regulatory standard of "substantial equivalence" to legally marketed predicate devices, established through engineering specifications, material properties, intended use, and non-clinical mechanical testing (e.g., compliance with ASTM F 543-02). It is not based on expert consensus, pathology, or outcomes data from a clinical trial for this specific device.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is a physical device, and the evaluation relies on established engineering principles and comparison to existing devices, not machine learning or AI models that require training data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model for this device.
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