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The S-Mono is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. S-Mono is intended for single use only. It is intended for delayed loading.

The S-Mono is made of Titanium Alloy (ASTM F136) as the raw material. This device supports dental prosthesis such as an artificial tooth by surgically implanting it in the alveolar bone of the mandibular anterior region with a narrow tooth gap, and is intended to restore the patient's chewing function. It is one-body type which includes fixture and abutment. The surface of the fixture is treated using RBM (Resorbable Blast Media). It is roughened by blasting with hydroxyapatite powder and then pickling with nitric acid. The Temporary Cap is made of POM (Polyoxy Methylene) and intended to relieve the patient's foreign body sensation and protect the abutment part while the dental prosthesis is being manufactured. This cap is placed over the abutment part and is used temporarily before the dental prosthesis is placed. The material, dimension, and intended use of the subject devices are similar to devices currently marketed worldwide.

This document describes a 510(k) premarket notification for a dental implant system called S-Mono. The provided text, however, does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or performance study involving human subjects or AI algorithm performance metrics.

The document focuses on demonstrating substantial equivalence to predicate devices. This means that instead of proving the device meets certain performance metrics through standalone testing, the manufacturer compares the new device (S-Mono) to existing, legally marketed devices (predicates) and argues that it is as safe and effective because of similar intended use, materials, and technological characteristics.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details because this information is not present in the provided text.

The "Non-Clinical Testing" section describes several tests performed on the S-Mono, but these are primarily material, sterilization, shelf-life, and biocompatibility tests, not performance studies that would typically define "acceptance criteria" through clinical outcomes or diagnostic accuracy.

Non-Clinical Testing Information Provided:

• Sterilization validation testing: Performed according to ISO 11137 (gamma sterilization) and ISO 11737, ISO 17665-1, ISO 17665-2 (steam sterilization).
• Shelf-life testing: Performed according to ASTM F1980, ASTM F1929, and ISO 11737-2.
• Fixture surface characteristics evaluation: EDS (Energy-dispersive X-ray spectroscopy), SEM Analysis, and Surface Roughness Analysis were performed after RBM treatment.
• Biocompatibility tests: Performed according to ISO 10993-1, 3, 5, 6, 10, 11, 12, and 33.
• MR Conditional labeling: A non-clinical worst-case MRI review was conducted using scientific evidence and published literature (Woods, Terry O., et al., 2019). Titanium alloy (Ti-6A1-4V, ELI) properties were assessed according to magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119).

In summary, the provided text describes the regulatory filing for a dental implant and focuses on demonstrating substantial equivalence, not on providing the results of a performance study with acceptance criteria.

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The S-Monovette® EDTA K2-Gel provides a means for collection, processing and transportation of a plasma specimen in a closed system. Following collection of the blood, the S-Monovette® EDTA K2-Gel is to be centrifuged such that the gel creates a barrier between the plasma and cellular components. The plasma specimen can then be removed for testing or the specimen can be transported for testing at another location without the plasma mixing with the cellular components.

The plasma specimen produced by the S-Monovette® EDTA K2-Gel can be used for Nucleic Acid Testing (NAT) by methods such as PCR - Polymerase Chain Reaction or for other procedures where the laboratory has determined that a plasma specimen is appropriate.

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This document is a 510(k) premarket notification for a medical device, specifically a "S-Monovette EDTA K2-Gel" blood collection tube. It outlines the FDA's decision regarding substantial equivalence to a predicate device and provides information on the intended use of the device.

However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with performance evaluations of AI/ML-driven or diagnostic/screening devices for which the requested information (e.g., sample size for test set, number of experts, adjudication method, AI vs. human performance) would be relevant.

This document pertains to a blood specimen collection device, which is a Class II medical device. The FDA's review for such devices primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, ensuring safety and effectiveness through comparisons of design, materials, performance, labeling, and intended use. Performance testing for a blood collection device would typically involve demonstrating its ability to properly collect, store, and process blood specimens according to its stated indications, and to ensure the blood components (e.g., plasma) are suitable for subsequent laboratory testing. This would involve chemical stability, sterility, and physical integrity studies rather than diagnostic accuracy studies with ground truth.

Therefore, I cannot extract the requested information (Table of acceptance criteria, sample size, expert qualifications, etc.) because it is not present in this type of FDA 510(k) summary for a blood collection device. The information requested is more relevant for diagnostic devices that analyze patient data to make a clinical determination.

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The TAC-S™ Monopolar Cautery Probes are disposable electrosurgical devices intended to be used in arthroscopic procedures where electro-coagulation of soft tissues is desired. They are intended to be used with Oratec™ Interventions ElectroThermal™ Generators.

The ORATEC Interventions TAC-S, MiniTAC-S, and MicroTAC-S Monopolar Cautery Probes are single-use electrosurgical devices designed for use in arthroscopic procedures where electro-coagulation of soft tissues is desired. They are designed to provide minimally invasive access to the targeted tissue, and to deliver radiofrequency energy in a controlled fashion. The modified probes consist of the following features:

• . a shaft with a radiofrequency-energized tip for percutaneous or intraoperative access to perform tissue coagulation;
• . a thermocouple at the distal end of the shaft for measuring tip temperature during RF energy delivery;
• handle and cable connection receptacle at the proximal end;
• accessory connector cables which are designed to fit standard RF control units with temperature and impedance feedback.

The provided text is a 510(k) summary for a medical device called the TAC-S™ Monopolar Cautery Probe Family. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through novel clinical studies designed for that purpose. The "study" here is essentially the comparison to the predicate and the data supporting substantial equivalence.

Therefore, many of the requested elements (like sample size for test sets, number of experts for ground truth, MRMC studies, specific acceptance criteria beyond "intended use," etc.) are typically not found directly in a 510(k) summary focused on substantial equivalence for this type of device. The "acceptance criteria" for a 510(k) is primarily the FDA's determination of substantial equivalence based on the provided comparison.

Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations of a 510(k) summary for these specific details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for 510(k) Submission): The primary "acceptance criterion" for this submission is demonstrating substantial equivalence to the predicate device (TAC-S™ Monopolar Cautery Probe, K963157) regarding safety and effectiveness for the stated intended use. This is achieved by showing that the modified devices (MiniTAC-S and MicroTAC-S) are as safe and effective as the predicate.

Reported Device Performance:
The document does not provide specific performance metrics in a quantitative sense (e.g., coagulation time, tissue impedance, temperature range achieved) against explicit numerical acceptance criteria. Instead, it asserts equivalence based on:

Summary of "Performance": The performance reported is that the modified devices are deemed "substantially equivalent" to the predicate, meaning they are expected to perform safely and effectively for their intended use despite minor design changes. The document does not provide a study with quantitative performance metrics against specific benchmarks, but rather a justification of equivalency.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not describe a clinical "test set" in the context of a prospective study with human subjects. The evaluation is primarily a design comparison and likely bench/pre-clinical testing to support the modified features.

• Sample Size for Test Set: Not applicable or not specified in this type of submission. There is no mention of a clinical trial or a "test set" from such a trial.
• Data Provenance: The data provenance implicitly comes from the manufacturer's internal testing (likely bench testing for material changes and dimension checks) used to support the substantial equivalence claim. There is no mention of country of origin for clinical data, as no clinical data (in the sense of human trials) is presented. It is a retrospective comparison to an existing device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This element is not applicable to this 510(k) submission. There is no mention of a specific "test set" requiring expert ground truthing, as this is not a diagnostic device or a device whose performance is assessed by expert interpretation of outputs.

4. Adjudication Method for the Test Set

This element is not applicable to this 510(k) submission. There is no mention of a "test set" requiring 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

This element is not applicable to this 510(k) submission. This is an electrosurgical device, not a diagnostic imaging device with AI components. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

This element is not applicable to this 510(k) submission. This is a physical electrosurgical probe, not an algorithm or software-only device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For a 510(k) submission of this nature, the "ground truth" is implicitly established by the predicate device's safety and effectiveness. The manufacturers typically demonstrate through engineering analysis, bench testing, and sometimes cadaveric or animal studies (if relevant) that the modified device performs comparably to the predicate for critical parameters. There's no mentioned independent "ground truth" derived from expert consensus, pathology, or outcomes data for a new clinical study.

8. The Sample Size for the Training Set

This element is not applicable to this 510(k) submission. There is no "training set" in the context of machine learning. The device is a physical instrument.

9. How the Ground Truth for the Training Set Was Established

This element is not applicable to this 510(k) submission, as there is no "training set" or AI component.

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