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MBA Biotech Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture System is intended to be used in the molar region.

The MBA Biotech Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of teeth. It is two stage endosseous screw type implant with internal hexagonal connection.

This system consists of the fixture, cover screw, and various abutments. Only the subject abutments can be used with the subject fixtures.

The Fixture is made of Pure Titanium of ASTM F67 and the surface of the fixture is treated with the SLA(Sand-blasted, Large grit, Acid-etched surface). Fixture is provided sterile.

The provided FDA 510(k) Clearance Letter for the MBA Biotech Implant System does not contain information related to a study proving the device meets acceptance criteria for an AI/ML medical device.

The document discusses the substantial equivalence of the MBA Biotech Implant System (a dental implant, a hardware device) to a predicate device, focusing on material, dimensions, surface treatment, sterilization, and non-clinical testing (fatigue, shelf-life, biocompatibility). It explicitly details how tests for the predicate device were leveraged for the subject device due to similar characteristics.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance data for an algorithm.
7. Type of ground truth used.
8. Sample size for a training set.
9. Ground truth establishment for a training set.

These points are relevant for the development and regulatory clearance of AI/ML-based medical devices, which are typically software devices. The MBA Biotech Implant System is a physical dental implant, and its clearance process relies on demonstrating substantial equivalence to existing physical devices through bench testing and material comparisons, not AI/ML performance studies.

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The EMI mBath and eBath is a Product that consists of water agitators and a tub that is used in the bathing of an individual, by an attendee, in either a commercial or residential setting.

The eBath uses a microprocessor to control water filling and emptying, while the mBath uses manual gages. The eBath offers temperature monitoring, with an integrated AC powered hydraulic lift and transport chair in which an attendant can use to assist an individual. The Product is available in both 60" and 70" lengths along with an optional door and weight scale.

This document is a 510(k) clearance letter from the FDA for a medical device called the "EMI Bath." It does not contain any information about acceptance criteria, device performance testing, or studies that prove the device meets acceptance criteria.

The letter primarily states that the FDA has reviewed the premarket notification and determined the device to be substantially equivalent to legally marketed predicate devices. It lists the trade name, regulation number, regulatory class, and product code, and then outlines the general controls and regulations that the manufacturer must comply with.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval, not a technical report detailing performance studies.

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The MBAResorb Implant is indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing.

The MBAResorb Implant consists of a soft-threaded implant designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The design differs from the predicate Subtalar MBA device only in that the material is reabsorbed into the body.

This document describes a 510(k) premarket notification for a medical device called the MBAResorb Implant. It is not a study proving the device meets acceptance criteria. The document is an application to the FDA seeking clearance to market the device based on its substantial equivalence to previously cleared devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies cannot be extracted from the provided text. These elements are typically found in clinical study reports or detailed performance data submissions, which are not present here.

Summary of what can be extracted related to the device and its intended use:

• Device Name: MBAResorb Implant
• Intended Use: "The MBAResorb Implant is indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing."
• Material: Poly L-Lactide (PLLA), described as bioresorbable.
• Predicate Device: KMI Subtalar MBA Orthopedic Foot Implant (K960692), cleared Jul 23, 1996.
• Regulatory Clearance: The FDA letter (SEP - 6 2005) indicates that the device was deemed substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. This is a regulatory clearance, not a performance study outcome.

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The MBA Hemostasis Valves are designed for use during percutaneous transluminal angioplasty (PTA) and other intravascular therapeutic procedures that utilize a guiding catheter.

The MBA™ is a Dual Seal Hemostasis Valve with an integral introducer

The provided text describes a 510(k) summary for the MBA™ Hemostasis Valves and a letter from the FDA regarding its clearance. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or adjudication methods that would typically be found in a study proving a device meets acceptance criteria.

The document primarily focuses on:

• Identifying the device and its predicate.
• Stating its intended use and device use.
• Confirming biocompatibility.
• Asserting substantial equivalence to a predicate device (Merit Passage Hemostasis Valves, K925419).
• The FDA's clearance of the device based on substantial equivalence.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or comparative effectiveness. The text explicitly states, "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act," which further indicates that specific performance criteria and a study to meet them are not detailed in this submission.

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