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The intended use/indications for use of the predicate devices identified remain the same as previously cleared in their respective 510(k)s. The respective 510(k)s for the devices can be referenced in the predicate device section above.

The purpose of this submission is the addition of MR Conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization.

This is a 510(k) summary for a submission that adds MR Conditional information to the labeling of several existing medical devices. The submission does not introduce new devices or changes to the fundamental design, materials, or indications for use of the listed devices. Therefore, the "acceptance criteria" and "device performance" in this context relate to the MR compatibility of the devices according to established standards.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the provided text. For MR compatibility testing, the "sample size" typically refers to the number of device models/configurations tested. It's implied that "the devices" (referring to the listed product lines and their components) were tested.
• Data Provenance: The nature of this testing (MR compatibility) suggests it was conducted in a controlled environment as a prospective evaluation of the devices. The country of origin of the data is not specified but would likely have been where the testing laboratory is located, presumably in a country with recognized testing standards (e.g., USA or Europe).

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

• This type of submission (MR compatibility of implants) does not typically involve human expert "ground truth" derived from clinical images. The "ground truth" here is objective measurements against engineering standards for MR safety and compatibility. The "experts" would be the engineers and physicists conducting the tests and interpreting the results according to ASTM standards and FDA guidance. Their qualifications would be expertise in MR safety testing and relevant engineering fields.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study requiring adjudication of human-interpreted data. The results are based on objective physical measurements and adherence to specified test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This submission is for device labeling updates based on physical properties (MR compatibility), not for evaluating the clinical effectiveness of a diagnostic or therapeutic algorithm with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone algorithm performance study was not done. This submission is about the physical properties of medical implants in an MRI environment, not about an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" used is defined by internationally recognized engineering standards for MR compatibility: ASTM F2052 (displacement force), ASTM F2213 (torque), ASTM F2182 (RF-induced heating), and ASTM F2119 (image artifact). The FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" also serves as a framework for the "ground truth" criteria.

8. The Sample Size for the Training Set

• Not applicable. This submission is about MR compatibility testing of existing devices, not about developing or training an AI algorithm. Therefore, there is no "training set."

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

• Not applicable, as there is no training set.

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The HALLU® Lock Plates are intended for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Including cases of:

• Hallux rigidus
• Severe hallux valgus (IM angle >20° and HV angle >40°)
• Deformity from rheumatoid arthritis
• Failed previous surgical procedure
• Traumatic arthritis
• Neuromuscular instability.
  The HALLU® Lock plates must be fixed with the SURFIX® fixed angle locking system and with the SURFTX®-Alpha variable angle locking system of 2.7mm or 3.0mm diameter (screws and lock-screws).
  Addition of a Newdeal® QWIX® screw crossing the joint is strongly recommended for optimal arthrodesis consolidation

The Newdeal HALLU® Lock Plate System is a low profile Titanium plate dedicated to first metatarso-phalangeal arthrodesis. The HALLU Lock C plates are pre-bent with 10° valgus and 10° dorsiflexion. The HALLU Lock S plates are available with 10° valgus and 10° or 5° dorsiflexion. Pre-operative bending is possible to completely fit to the anatomical shape of the joint. Their fixation is provided by SURFIX and SURFIX ALPHA locking screws.

The provided text describes a medical device, the "Newdeal HALLU® Lock Plate System," which is a bone fixation appliance. It is a 510(k) summary, indicating that it aims to demonstrate substantial equivalence to an existing device rather than presenting entirely new clinical trial data for novel acceptance criteria.

Therefore, the structure of the response will reflect the information available in a 510(k) summary for a substantially equivalent device, focusing on mechanical testing rather than extensive clinical studies.

Here's the information as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text describes mechanical testing, not a clinical study involving human subjects or data related to patient outcomes. Therefore, information regarding "sample size used for the test set" in the context of clinical data, "data provenance (e.g. country of origin of the data, retrospective or prospective)," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth (e.g., pathology, outcomes data)," "training set sample size," and "how ground truth for training set was established" are not applicable to this type of submission.

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

Not applicable (as per explanation in point 2). The ground truth for mechanical testing is typically based on established biomechanical standards and measurements, not expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable (as per explanation in point 2).

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 a bone fixation plate, and the submission focuses on mechanical equivalence. An MRMC study is relevant for diagnostic imaging AI, which is not the subject here.

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

Not applicable. This device is a physical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the mechanical testing performed, the ground truth would be established through objective physical measurements and engineering analyses under controlled laboratory conditions, demonstrating that the new device's mechanical properties (e.g., strength, stiffness, fatigue resistance) fall within acceptable predefined limits or are equivalent to the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable (as per explanation in point 8).

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