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The Intra-Lock Bone Fixation System is indication and fixation of bone graft, bone filling materials, and/or barrier membranes used to regenerate bone in the oral cavity.

The Intra-Lock Bone Fixation System consists of titanium alloy self-tapping screws, which are tapered and have a minimum diameter of 1.5mm with lengths of 3mm, 6mm, 7mm, 8mm, 9mm, 10mm and 11mm and a maximum diameter of 2.0mm with lengths of 4mm, 5mm, 9mm, 11mm, 13mm, and 15mm. Tenting screws are also available in the 1.5 mm diameter. The spacer part of the tenting screws is available in 2mm, 6mm, 8mm and 10mm lengths. The screws are manufactured using Ti-6Al-4V alloy (ASTM F-136) and adhere to standards tested under ASTM F-543. This system also includes accessories used to fixate the screws, membranes or bone graft to the host bone including a tapered driver, and a cassette. The screws are designed for removal from the patient after such time when sufficient bone regeneration is demonstrated. The devices are sold non-sterile. Single-use only.

The provided text is a 510(k) summary for the Intra-Lock Bone Fixation System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting standalone performance studies or clinical trials with acceptance criteria for the new device itself.

Therefore, many of the requested elements about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, or MRMC studies are not applicable and not found within this document. This is typical for 510(k) submissions where reliance on predicate device performance and non-clinical testing for equivalence is key.

However, I can extract information regarding non-clinical performance data and the reason for the absence of clinical data.

Section 1: Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission primarily focused on demonstrating substantial equivalence to a predicate, the document does not present "acceptance criteria" in the traditional sense of a performance study for the new device with specific statistical targets (e.g., sensitivity, specificity). Instead, the performance is evaluated against established standards to show that the new device is as safe and effective as the predicate.

The non-clinical performance tests conducted are:

Section 2: Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated for each mechanical test. The document mentions "All tested Unifix screws" for torsion testing, implying a sufficient number for the test.
• Data Provenance: This refers to non-clinical performance data generated by the manufacturer, Intra-Lock International, Inc. It is not patient or human-derived data, so terms like "country of origin" or "retrospective/prospective" are not applicable in this context.

Section 3: Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Not applicable. For mechanical and sterilization tests, ground truth is established by engineering standards (e.g., ASTM F-543, ISO 17665-1) and internal quality control, not by human experts adjudicating clinical outcomes.

Section 4: Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving reader disagreement. For non-clinical, objective tests, the results of the test itself determine the outcome.

Section 5: If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. An MRMC study was not done. This device is a bone fixation system, not an imaging or diagnostic AI device that would typically undergo MRMC studies.

Section 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 (screws), not an algorithm or AI software. Therefore, standalone performance in the context of AI is not relevant.

Section 7: The type of ground truth used

• For mechanical tests: Engineering specifications and standards (e.g., ASTM F543).
• For sterilization: Industry standards (ISO 17665-1).
• For biocompatibility: Benchmarking against previously cleared devices and accepted biocompatibility of materials (ISO 10993-1).

Section 8: The Sample Size for the Training Set

• Not applicable. This product is a physical bone fixation system, not a machine learning or AI algorithm that requires a "training set."

Section 9: How the Ground Truth for the Training Set Was Established

• Not applicable. As stated above, there is no training set for this type of device.

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The Salvin Tenting Screw System is used to stabilize, fixate, and/or support bone filling materials and /or barrier membranes used for regeneration of bone in the oral cavity.

The Salvin Tenting Screw System is a set of bone screws and instrumentation. The system consists of a set of screws (one diameter and three lengths) and the driver used to implant these screws. The devices are delivered non-sterile. The screws are made from titanium alloy (Ti-6Al-4V ELI), as described by ASTM F136. The screws come in one diameter – 1.5mm (5.0mm head diameter), and three lengths – 7mm, 8mm, and 9mm. The screws incorporate a 4mm thread length adjacent to a polished neck.

The provided document is a 510(k) summary for the Salvin Tenting Screw System, a medical device. This type of document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a standalone study with acceptance criteria and device performance in the way one might for diagnostic accuracy or clinical outcomes.

Therefore, the information requested regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or typically found in this type of FDA submission for a Class II fixation device.

However, I can extract the relevant information regarding performance testing and how substantial equivalence was demonstrated:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a pass/fail table format. Instead, it states that "demonstrated substantial equivalence" to the predicate. The performance data is focused on demonstrating mechanical similarity to the predicate device.

• Drive Torque: Comparable to Osteogenics Pro-Fix™ device
• Axial Pullout: Comparable to Osteogenics Pro-Fix™ device
• Self-Tapping Force: Comparable to Osteogenics Pro-Fix™ device | "demonstrated substantial equivalence" to the predicate device (Osteogenics Pro-Fix™) leading to the conclusion that "mechanical performance" is equivalent. |
  | Sterilization Validation | Met acceptance criteria (typically defined by AAMI standards for sterility assurance level) | "met the acceptance criteria." |
  | Geometric Comparisons | Comparable geometry to Osteogenics Pro-Fix™ device | "demonstrated substantial equivalence" to the predicate device. |

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the document. For mechanical testing per ASTM standards, a statistically significant number of samples would typically be tested, but the exact number isn't provided here.
• Data Provenance: The tests are bench tests performed on the physical devices. The country of origin of the data is not specified, but the applicant is Salvin Dental Specialties, Inc. based in Charlotte, NC, USA. The study design is not a clinical study, but rather a materials and mechanical performance comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as this is a mechanical and material performance comparison, not a diagnostic accuracy study requiring expert ground truth for interpretation.

4. Adjudication method for the test set

• Not applicable for mechanical performance testing.

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 is not an AI/software device or a diagnostic device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device (dental screw), not an algorithm or software.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For mechanical properties, the "ground truth" is defined by the relevant ASTM standards (e.g., ASTM F543-13), and the comparison is made against the performance of a legally marketed predicate device.
• For sterilization, the "ground truth" is meeting the specified Sterility Assurance Level (SAL) criteria.

8. The sample size for the training set

• Not applicable. This is not a machine learning device, so there is no "training set."

9. How the ground truth for the training set was established

• Not applicable for the reasons mentioned above.

Study Summarized:

The study described is a series of bench tests and geometric comparisons performed on the "Salvin Tenting Screw System" to demonstrate its substantial equivalence to a predicate device, the "Pro-Fix™ Tenting Screw" produced by Osteogenics Biomedical (K093719), and a reference predicate "Salvin Dental Fixation Screw System" (K073342).

The tests performed included:

• ASTM F543-13 for mechanical properties (Torsional Properties, Drive Torque, Axial Pullout, Self-Tapping Force).
• Sterilization Validation.
• Geometric comparisons.

The conclusion was that the Salvin Tenting Screw "is substantially equivalent to the Osteogenics Pro-Fix™ predicate device" based on these performance tests and geometric comparisons, as well as shared indications for use, prescription status, material (Ti-6Al-4V ELI), and non-sterile provision for single-use.

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