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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® PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metastarso-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 .

Addition of a screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.

The Newdeal HALLU® PLATES is a low profile Titanium plate dedicated to first metatarsophalangeal arthrodesis. The system includes both HALLU" -FIX C plates as well as HALLU -FIX S plates. The plates are used in conjunction with Newdeal SNAP-OFF® screws.

The provided document describes a Special 510(k) Summary for a medical device called "Modified Newdeal HALLU® PLATES." This type of submission is for modifications to a device already cleared by the FDA, relying on the substantial equivalence principle rather than extensive clinical efficacy studies.

Therefore, the "study" conducted is a mechanical equivalence test rather than a typical clinical study proving performance against acceptance criteria in a human population.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not specified. The document states "Mechanical tests have been carried out," but does not detail the number of plates tested or the specifics of the test setup (e.g., number of cycles, loads applied).
• Data Provenance: The tests were conducted by the manufacturer, Newdeal SAS, which is located in France. The data is thus prospective test data generated to support the 510(k) submission.

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

• This question is not applicable in this context. For mechanical equivalence testing, the "ground truth" is defined by established engineering and biomechanical principles and standards used to compare the mechanical properties of the modified device to its predicates. There are no "experts" establishing ground truth in the sense of clinical interpretation or diagnosis.

4. Adjudication Method for the Test Set

• This question is not applicable. Mechanical tests are typically analyzed objectively based on sensor readings and engineering calculations, not through an adjudication process like those used in clinical image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• This question is not applicable. This device is a bone fixation plate, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• This question is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is established through objective mechanical testing against the known mechanical properties of the legally marketed predicate devices. This involves comparing engineering parameters such as strength, fatigue resistance, and stiffness, as relevant to the device's function.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this is not an AI/ML device. The "training" for such a device would be the design and manufacturing processes guided by engineering principles.

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

• This question is not applicable for the same reason as above.

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The HALLU® -PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Examples include:
-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® -PLATES are available in two different designs :

• the HALLU®-C PLATE -
• the HALLU®-S PLATE -
  The HALLU®-C PLATE and the HALLU® -S PLATE are low profile Titanium plates dedicated to first metatarso-phalangeal arthrodesis. Those implants are pre-bent for optimal anatomical adaptation (10° valgus and 10°dorsiflexion). Their fixation is provided by Titanium SNAP-OFF® screws available in a two diameters: 3.0 and 2.7 mm. They exist in different colors for size identification. The bone contact surface is sand blasted in order to maximize plate stability. The range of HALLU -C PLATE and HALLUS S PLATE include 6 sizes ( 31eft/3right) for optimal anatomic fit. Moreover, the HALLU®-S PLATE has an anatomical design providing optimal bone coverage.

The provided text describes a medical device, the HALLU®-PLATES, and its regulatory clearance based on substantial equivalence to predicate devices, rather than a study proving performance against specific acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI/software device studies (e.g., sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, ground truth for training) is not applicable.

However, I can extract the information related to the device's testing and the standards it met.

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Breakdown of Applicable Information:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated as this was a physical device test, not a data-driven software evaluation. The document mentions "Test 1" and "Test 2," implying multiple samples of the plate were tested for bending and fatigue.
• Data Provenance: The tests were conducted to comply with French Standard ISO 9585 and ASTM Standard F-382-99. This implies the tests were performed in a controlled laboratory setting, likely in the country of origin of the sponsor (France) or a qualified testing facility. The study type is experimental/bench testing, not retrospective or prospective human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable as the "ground truth" for a physical device test like this is defined by established engineering standards (ISO 9585 and ASTM F-382-99) and the physical properties of the materials and design, not by expert human interpretation.

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

• This question is not applicable for a physical device test. The compliance is determined by measurements against predefined standard thresholds.

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, a MRMC comparative effectiveness study was not done. This is a physical bone plate, not an AI or imaging device that would involve human readers.

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

• Yes, a standalone test was done. The device's performance (bending strength, stiffness, fatigue strength) was evaluated independently against established physical standards. This is analogous to a "standalone" test for a physical product.

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

• The ground truth was based on established engineering standards for bone plates: French Standard ISO 9585 and ASTM Standard F-382-99.

8. The sample size for the training set:

• Not applicable. This device underwent physical bench testing, not a machine learning training process.

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

• Not applicable. As above, there was no training set for a machine learning model.

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