Search Results

The MINNE TIES™ MMF Suture System is an adjustable flexible plastic band that wraps between and around a tooth to create an anchorage point for maxilla-mandibular fixation and immobilization. MINNE TIES™ MMF Suture System is suitable for:

• Pre-operative fixation
• Per-operative fixation
• Short-term (up to 3 weeks) fixation for minimally displaced fractures
• Splintage post jaw dislocation

The MINNE TIES™ MMF Suture System contains:

• Four (4) 1.0mm sized sutures
• Seven (7) 0.7mm sized sutures
• One (1) 0.5mm Sized suture
  and are used to establish maxilla-mandibular fixation (MMF) and immobilization by applying independently balanced series of sutures bilaterally between and/or around the teeth in the interdental space (i.e. triangular apical embrasure). The sutures provide a stabilizing occlusive force allowing for short term (up to 3 weeks) fixation for minimally displaced fractures for pre-operative and per-operative fixation and splintage post jaw dislocation. An Introducer is used to advance sutures between and/or around the teeth. A cheek retractor is included with the system to organize the ties during the procedure.
  The MINNE TIES™ MMF Sutures are made of polypropylene, polyester and stainless steel. The cheek retractor is made of polypropylene.

The provided text describes a 510(k) premarket notification for the "MINNE TIES™ MMF Suture System". This document indicates the device's substantial equivalence to a legally marketed predicate device rather than a ground-up study proving its performance against acceptance criteria for a novel AI/ML device.

Therefore, the information required to answer the prompt for an AI/ML device (e.g., acceptance criteria for AI performance, sample sizes for AI training/test sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not present in the provided document.

The document focuses on:

• Device Description: The components and general use of the MINNE TIES™ MMF Suture System.
• Intended Use/Indications for Use: What the device is intended for (maxilla-mandibular fixation).
• Predicate Device Comparison: A detailed comparison to a previously cleared device (Rapid IMF™ - K030605) to demonstrate substantial equivalence.
• Non-Clinical Testing: Physical and material tests (tensile strength, fatigue, biocompatibility, sterilization, packaging, shelf life, corrosion resistance, system handling/cadaver test) to show that the new device performs similarly and safely to the predicate.
• Clinical Testing: Explicitly states that clinical data was not required for this device, which further indicates the absence of human-in-the-loop performance studies or deep learning-based performance evaluations.

In summary, this document is for a medical device that does not involve artificial intelligence or machine learning, and thus the specific metrics and study methodologies requested in the prompt related to AI/ML device acceptance criteria are not applicable or provided.

Ask a specific question about this device

The Erich Arch Bar is indicated for use in intermaxillary and maxillo-mandibular fixation.

The Erich Arch Bar is made of fully annealed electro polished stainless steel which is affixed temporarily to the teeth by an oral surgeon or dentist with ligature wire. The installed device provides temporary jaw immobilization.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria or quantitative performance metrics are mentioned in this 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance criteria.

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

No information is provided regarding a "test set" or a study designed to evaluate the performance of the Erich Arch Bar. The submission relies on demonstrating substantial equivalence to pre-existing, legally marketed devices.

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

Not applicable, as no test set or ground truth establishment process is described for this specific device.

4. Adjudication Method for the Test Set

Not applicable, as no test set or adjudication process is described.

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

No MRMC comparative effectiveness study is mentioned. This 510(k) submission does not present data on human reader improvement with or without AI assistance, as it pertains to a physical medical device (arch bar) and not an AI/software device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable, as this is a physical medical device and not an algorithm or software.

7. The Type of Ground Truth Used

Not applicable, as the submission does not involve the establishment of ground truth for performance evaluation; it focuses on substantial equivalence to existing devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

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

Not applicable, as this device is not an AI/machine learning model.

Summary of the K061271 Submission and Lack of Performance Data:

The provided 510(k) summary for the KLS-Martin Erich Arch Bar describes a submission focused on demonstrating substantial equivalence to predicate devices. This type of regulatory submission primarily relies on showing that the new device has "identical in application and indications for use" and similar "material composition and application" to devices already legally marketed.

Therefore, the document does not include:

• Specific acceptance criteria for performance.
• Results from a formal study (test set, training set).
• Details about expert ground truth, adjudication, or MRMC studies.

The FDA's letter (pages 2-4) confirms that they reviewed the submission and determined substantial equivalence, allowing the device to be marketed based on this comparison, rather than requiring new clinical performance data demonstrating its efficacy or safety against pre-defined performance criteria.

Ask a specific question about this device

Casey Surgical Safety Release ™ Arch Bar Kit is indicated for use in intermaxillary and maxillo-mandibular fixation.

The Casey Surgical Safety Release ™ Arch Bar Kit is made of four components which are installed by an oral surgeon or dentist along with ligature wires. The installed device provides temporary jaw immobilization. The device incorporates a safety release mechanism.

The provided text is a 510(k) summary for the Casey Surgical Safety Release™ Arch Bar Kit. It describes the device, its intended use, and comparison to predicate devices. However, this document does not contain any information regarding clinical studies, acceptance criteria, or performance data beyond stating substantial equivalence to predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided text. The document focuses on regulatory compliance through substantial equivalence, rather than detailing a specific performance study against defined acceptance criteria.

The 510(k) summary indicates that the device's substantial equivalence is based on:

• Comparison of Technical Characteristics to Predicate Device: "Similar to predicate devices K991004 Synthes Quick Lock™ IMF system and K8200944 Dental Arch Bar in materials of construction and indications for use. The Casey Surgical Safety Release ™ Arch Bar Kit has the additional safety release feature."

This implies that the acceptance criteria were implicitly met by demonstrating that the device is as safe and effective as the predicate devices, likely through engineering analysis, functional testing, and material characterization, rather than a clinical study with specific performance metrics like accuracy, sensitivity, or specificity.

To directly address your numbered points based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not available in the provided text.
2. Sample size used for the test set and the data provenance: Not applicable, as no performance study is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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. This device is not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable, as no performance study with ground truth is detailed. The ground for substantial equivalence is comparison to predicate devices and their established safety and effectiveness.
8. The sample size for the training set: Not applicable, as no machine learning algorithm is involved.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Rapid IMF is an adjustable flexible plastic band that wraps around a tooth to create an anchorage point for maxillo-mandibular fixation and immobilisation (similar to an orthodontic band). Rapid IMF is suitable for:

• Pre-operative fixation
• Per-operative fixation
• Short-term (up to 3 weeks) fixation for minimally displaced fractures
• Splintage post jaw dislocation

The Rapid IMF is an adjustable flexible plastic band that wraps around a tooth to create an anchorage point for maxillo-mandibular fixation and immobilisation (similar to an orthodontic band).

I am sorry, but the provided text does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for a medical device called "RAPID IMF™", stating that the device is substantially equivalent to legally marketed predicate devices and outlining regulatory compliance requirements. It also includes the indications for use of the device.

Ask a specific question about this device

The DRG LockJaw™ 15 Minute Intermaxillary Fixation System is intended for secondary intermaxillary fixation in the treatment of maxillary and mandibular fractures, in elective orthognathic surgery and in the stabilization of dental and dentoalveolar injuries.

DRG LockJaw™ 15 Minute Intermaxillary Fixation System

This is a scanned FDA letter for a 510k submission for the DRG LockJaw™ 15 Minute Intermaxillary Fixation System. Unfortunately, the letter does not contain the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.).

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. It grants permission to market the device subject to general controls. The letter also includes the stated indications for use of the device.

Therefore, I cannot provide the detailed information you requested based solely on the provided text. To get this information, you would typically need to review the full 510(k) summary or submission documents, which are not included here.

Ask a specific question about this device

Synthes Quick Lock TM IMF System is indicated for use in intermaxillary and maxillo-mandibular fixation.

The Synthes Quick Lock ™ IMF System consists of brackets, arch bars and instrumentation which are used to facilitate temporary jaw immobilization. The Synthes Quick Lock ™ Bracket is a dental bracket that provides an attachment point for MMF wires and elastics. It incorporates a high tensile strength fiber that circumdentially attaches the bracket to the dentition. The Quick Lock ™ Arch Bar and Arch Bar Bracket provide additional support to the dental arch.

This document is a 510(k) summary for the Synthes Quick Lock™ IMF System, a device used for temporary jaw immobilization. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a detailed study for acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The document does not describe specific acceptance criteria (e.g., performance metrics, thresholds) or present a study with performance data against such criteria.
• Sample size used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth establishment process is mentioned.
• Adjudication method for the test set: No test set or adjudication method is mentioned.
• 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 is not an AI device, and no such study is mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI device, and no such study is mentioned.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): No ground truth is mentioned.
• The sample size for the training set: No training set is mentioned.
• How the ground truth for the training set was established: No training set or ground truth establishment is mentioned.

Summary of the Document's Information:

The document is a "Summary of Safety and Effectiveness Information [510(k) Summary]" for the Synthes Quick Lock™ IMF System. This system consists of brackets, arch bars, and instrumentation for temporary jaw immobilization.

Key conclusions from the document:

• Device Classification: Class II, 21 CFR 872.4700 (Lock, Wire, and Ligature, Intraoral).
• Predicate Devices: Dimac Medical, Inc. Dimac Wires (K910090), W. Lorenz Traditional Wire and Arch Bars, Unisplint (K820944), Wall-Omnisplint Maxillofacial Fracture Kit (K number unknown).
• Intended Use: Indicated for use in intermaxillary and maxillo-mandibular fixation.
• Materials: 316L Stainless Steel, Ti-6Al-7NB, Vectran fiber, and Nylon.
• Regulatory Decision: The FDA reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This allows the company to market the device subject to general controls provisions of the Act.

The document does not detail specific acceptance criteria or performance studies in the way one might expect for a novel device proving its effectiveness. Instead, the "acceptance criteria" here is met by demonstrating substantial equivalence to already approved predicate devices, implying that the safety and effectiveness are comparable.

Ask a specific question about this device