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The Mondeal® HAND CONTOUR System is intended to be used for the internal fixation of small bones including the hand and the foot.

The Mondeal® Hand Contour System consists of titanium plates with shapes and sizes designed for internal fixation of small bones including the hand and foot, and screws of varying lengths from 4 to 23 mm and 1.2 , 1.7, and 2.3 mm in diameter, supplied nonsterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include straight, "T" shaped and condylar configurations. Manual reusable surgical instruments are supplied to facilitate implantation

This document is a 510(k) summary for the Mondeal® Hand Contour System. It does not describe a study involving device performance metrics related to acceptance criteria in the typical sense of a diagnostic or AI-driven device. Instead, it demonstrates substantial equivalence to a predicate device based on material, design, and intended use.

Therefore, the following information is not directly extractable from the provided text in the context of a "study that proves the device meets the acceptance criteria" in terms of clinical performance or accuracy:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method
• If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

However, I can extract information related to the acceptance criteria and the "study" (in this case, a comparative analysis) that led to the device's market clearance based on substantial equivalence.

Here's the information that can be extracted or inferred from the provided text regarding the "acceptance criteria" for 510(k) clearance:

Acceptance Criteria and Reported Device Performance (for 510(k) Substantial Equivalence)

Study Information (for 510(k) Pre-market Notification):

This submission is a 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, not a diagnostic accuracy study or a clinical trial.

1. Sample size used for the test set and the data provenance: Not applicable. The "test" here involves comparing characteristics of the subject device to a predicate device. This is a comparison of manufacturing specifications and intended use, not a performance study on a particular data set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" is established by the specifications and regulatory status of the predicate device. The FDA reviews the submitted comparison.
3. Adjudication method: Not applicable.
4. 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 a medical device (surgical implant) for internal fixation, not an AI-driven diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
6. The type of ground truth used:
   • Basis for "Ground Truth": The "ground truth" in this context is the established safety and effectiveness of the predicate device (Howmedica Profyle® Hand and Small Fragment System, K961497) as determined by its prior market clearance.
   • The "study" here involves a comparison table highlighting that the subject device (Mondeal® Hand Contour System) has identical or similar characteristics (materials, design, performance specifications like corrosion resistance and mechanical properties, sterilization method, packaging) and substantially similar indications for use to the predicate device.
7. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the "study" described in this document is a comparative analysis demonstrating that the Mondeal® Hand Contour System is substantially equivalent to a previously cleared predicate device, the Howmedica Profyle® Hand and Small Fragment System, based on:

• Identical or similar fundamental technology (titanium plates and screws).
• Similar materials (CP Titanium Grade 2 plates and Ti-6Al-4V ELI screws).
• Comparable performance specifications (corrosion resistance, mechanical properties like hardness, yield/tensile strength, elongation).
• Identical sterilization methods and similar packaging.
• Substantially similar Indications for Use (internal fixation of small bones of the hand and foot).

The acceptance criteria are met by demonstrating this substantial equivalence across these characteristics.

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The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.

The Mondeal® Distal Radius System consists of titanium volar and dorsal plates with shapes and sizes designed for internal fixation of distal radius fractures and osteotomies, and screws of varying lengths from 8 to 38 mm and 2.7 or 3.0 mm in diameter, supplied non-sterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include dorsal and volar "T" shaped right and configurations. Manual reusable surgical instruments may be supplied to facilitate implantation.

This submission describes a medical device, the Mondeal® Distal Radius System, which is a set of plates and screws for fixing distal radius fractures. The document is a 510(k) summary, which aims to demonstrate substantial equivalence to a previously cleared device. Therefore, the "study" conducted is a comparison to a predicate device, rather than a clinical trial or a performance study with acceptance criteria in the typical sense for an AI/software device.

Here's an analysis of the provided text in the format you requested:

Acceptance Criteria and Study for Mondeal® Distal Radius System

The "acceptance criteria" and "study" for the Mondeal® Distal Radius System are based on demonstrating substantial equivalence to a predicate device (Mondeal® Radius HO System, K050655), as per 510(k) requirements. There is no performance study against specific, quantified acceptance criteria in the context of an AI/software device. Instead, the "performance" here refers to material and mechanical properties, as well as intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" are implied by the 510(k) process, which requires demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This means the new device must have the same intended use, and the same technological characteristics, or, if different, any differences must not raise new questions of safety and effectiveness.

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

• Sample Size for Test Set: Not applicable. This is not a study involving a "test set" of patients or data in the typical sense. The evaluation is a comparison of device specifications and characteristics against a predicate device.
• Data Provenance: Not applicable. The data is descriptive information about the device's design, materials, and performance specifications.

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

• Not applicable. There is no "ground truth" in the context of expert consensus on patient data or images. The "ground truth" for this submission would be industry standards for material properties and manufacturing, as well as the specifications of the predicate device.

4. Adjudication Method for the Test Set

• Not applicable. There is no test set or adjudication process as described in the context of clinical studies or AI algorithm evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is not an MRMC study. It is a comparison of a new medical device to a predicate device based on its physical and mechanical properties.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

• The "ground truth" is based on accepted engineering and material science standards, as well as the specifications and regulatory clearance of the predicate device (Mondeal® Radius HO System, K050655). The submission relies on the established safety and effectiveness of the existing predicate device as the benchmark for comparison.

8. Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. There is no training set for this device.

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The SIS Sinus Implant Stabilizer is intended to provide a fixed anchorage point to stabilize dental implants in the sinus region, enabling sinus augmentation and implantation to be carried out in one session.

The SIS Sinus Implant Stabilizer consists of a titanium plate provided with 3 large perforations for screw fixation of implants for premolars and first molars. It may be additionally secured in place with titanium microscrews and is provided in two sizes for use with different implant systems.

This appears to be a 510(k) premarket notification for a medical device called the "SIS Sinus Implant Stabilizer." This type of document is a submission to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.

Unfortunately, the provided text does not contain specific acceptance criteria, detailed study designs, or performance metrics in the way you've outlined for a clinical study proving a device meets acceptance criteria. Instead, it states:

"Performance Data: Testing was performed to support substantial equivalence to the predicate devices. The SIS Sinus Implant Stabilizer met all specified design and performance requirements."

This is a general statement indicating that the device passed internal testing to support its substantial equivalence claim, rather than a detailed report of a study designed to evaluate its performance against pre-defined acceptance criteria with specific metrics.

Therefore, I cannot fill in the table or answer most of your detailed questions based solely on the provided text. The 510(k) summary typically doesn't include the granular details of performance testing or clinical studies unless they are novel or significant. The focus here is on demonstrating equivalence to existing predicate devices.

Here's what I can extract and state based on the provided text, and where information is missing:

Acceptance Criteria and Device Performance (Based on provided text)

Detailed Study Information (Based on provided text)

1. A table of acceptance criteria and the reported device performance

   • As noted above, the document only states that the device "met all specified design and performance requirements." It does not provide a table with specific quantitative acceptance criteria (e.g., specific tensile strength, fatigue life, or biocompatibility pass/fail criteria) nor detailed performance values.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not specified.
   • Data Provenance: Not specified, but likely from Mondeal Medical Systems GmbH in Germany given their address.
   • Retrospective/Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable. This device is a physical implant. Performance testing would likely involve bench testing (mechanical, material, biocompatibility) rather than expert-established ground truth on a 'test set' in the context of diagnostic AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Applicable. See point 3.

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

   • No. This is a physical medical implant device, not an AI/diagnostic software.

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

   • No. This is a physical medical implant device, not an AI/diagnostic software.

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

   • Not applicable in the typical sense for an AI/diagnostic device. Performance was assessed against design and performance requirements (e.g., mechanical properties, biocompatibility). The "ground truth" is that the device must meet these engineering and regulatory specifications.

8. The sample size for the training set

   • Not Applicable. This is a physical medical implant device; it does not involve a "training set" in the context of machine learning.

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

   • Not Applicable. See point 8.

Conclusion based on provided text:

The provided 510(k) summary is for a physical medical implant (SIS Sinus Implant Stabilizer). The performance data section broadly states that "Testing was performed to support substantial equivalence to the predicate devices. The SIS Sinus Implant Stabilizer met all specified design and performance requirements." This indicates that the device underwent necessary engineering and possibly biological testing (e.g., biocompatibility) to demonstrate its safety and effectiveness, likely by meeting recognized standards and internal specifications similar to its predicate devices. However, the document does not elaborate on the specific acceptance criteria, quantitative results, or detailed study designs that would typically be found in a clinical study report for a diagnostic AI device.

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The Lin/Liou Orthodontic Mini Anchor System (LOMAS) (Sterile) is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the Lin/Liou Orthodontic Mini Anchor System (LOMAS). This type of document establishes substantial equivalence to a predicate device and permits marketing. It does not contain information on acceptance criteria, a study proving device performance, or any of the detailed study parameters requested in your prompt.

The letter is a regulatory approval document and not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

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The Lin/Liou Orthodontic Mini Anchor System (LOMAS) is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only

Lin/Liou Orthodontic Mini Anchor System (LOMAS)

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study design, or ground truth establishment. The document is an FDA 510(k) clearance letter for the "Lin/Liou Orthodontic Mini Anchor System (LOMAS)," confirming its substantial equivalence to a predicate device and outlining regulatory information. It does not include details about device testing or specific performance metrics.

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