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The Newdeal Compression Plate is intended for fixation of bone fractures or for bone reconstruction.

Examples include:

• Arthrodesis in hand or foot surgery
• Fracture management in the foot or hand
• Mono or Bi-cortical osteotomies in the foot or hand
• Distal or proximal metatarsal or metacarpal osteotomies
• Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc)

The size and number of the plate(s) used should be adapted to the specific indication.

The Newdeal Compression Plate will offer the combination of two concepts:

• By widening the "eye" (diamond shaped opening) on the interaxis of the plate, mechanical deformation leads to narrowing of the interaxis of the two legs and thus provides compression between the two bone fragments to fuse. This is the same principle as the Newdeal Compression Plate (K070447), UNI-CLIP (K011716) and Newdeal Large UNI-CLIP (K061594).
• The rigidity of the "legs" is obtained using the Newdeal Locking System including a screw and a washer. This is the same principle as the Locking System of the following predicate devices: Surfix Knee Osteotomy System (K041601), Newdeal Lisfranc Plates (K060474), Newdeal Lapidus Plates (K060476), Newdeal TTC Plates (K060473 and Newdeal Compression Plate (K070447).

The provided text describes a submission for a medical device called the "Newdeal Compression Plate," not an AI/ML device. Therefore, the acceptance criteria and study described are related to the mechanical properties and substantial equivalence of a physical orthopedic implant, not to the performance of a software algorithm.

Based on the nature of the submission (510(k) for a medical device) and the content, there is no mention of an AI/ML device or any study that would typically be associated with evaluating AI/ML performance (e.g., diagnostic accuracy, reader study, standalone performance against ground truth).

The document focuses on establishing substantial equivalence to a previously approved predicate device (Newdeal Compression Plate, K070447) based on mechanical testing.

Here's a breakdown of why the requested information for an AI/ML device cannot be provided from this document:

• No AI/ML device: The device is a "Newdeal Compression Plate," a physical orthopedic implant.
• No acceptance criteria for AI/ML performance: The acceptance criteria are implicit in demonstrating substantial equivalence in mechanical properties.
• No study proving AI/ML performance: The study performed was "Mechanical tests" to show the equivalency of the modified plate to the unmodified predicate device.

However, I can extract the relevant information from the document regarding the medical device itself:

Acceptance Criteria and Study for the "Newdeal Compression Plate" (Medical Device - Not AI/ML)

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for the mechanical tests, but mechanical testing typically involves a set number of samples for various load, fatigue, and other biomechanical assessments.
• Data Provenance: Not specified, but generally refers to in-vitro laboratory testing of the physical device.

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

• Not applicable. For mechanical testing of a physical device, ground truth is established through standardized engineering test methods and measurements, not expert consensus in the clinical sense.

4. Adjudication method for the test set:

• Not applicable. Mechanical testing data is quantitative measurement, not subjective assessment requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. This is a medical device (implant) and not a diagnostic or screening tool that would involve human readers.

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.

7. The type of ground truth used:

• For the mechanical tests, the ground truth would be the quantitative measurements obtained from destructive and non-destructive mechanical tests (e.g., tensile strength, fatigue life, compression resistance, torsional resistance) against established engineering standards and comparison data from the predicate device.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is a physical device being evaluated for mechanical equivalence, not an AI/ML model being trained.

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

• Not applicable. See point 8.

In summary, the provided document details a 510(k) submission for a physical orthopedic implant. It does not pertain to an AI/ML device, and therefore, the specific questions related to AI/ML performance evaluation cannot be answered from this text.

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The Newdeal Compression Plate is indicated for fixation of bone fractures or for bone reconstruction.

Examples include:

• Arthrodesis in hand or foot surgery
• Fractures management in the foot or hand
• Mono or Bi-cortical osteotomies in the foot or hand
• Distal or proximal metatarsal or metacarpal osteotomies
• Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)

The size and number of plate(s) used should be adapted to the specific indication.

The Newdeal Compression Plate will offer the combination of two concepts:

• By widening the "eye" (diamond shaped opening) on the interaxis of the plate, mechanical deformation leads to narrowing of the interaxis of the two legs and thus provides compression between the two bone fragments to fuse. This is the same principle as the UNI-CLIP (K011716) and Newdeal Large UNI-CLIP (K061594).
• . The rigidity of the "legs" is obtained using the Newdeal Locking System including a screw and a washer. This is the same principle as the Locking system of the
• . following predicate device: Surfix Knee Osteotomy system (K041601), Newdeal Lisfranc Plates (K060474), Newdeal Lapidus Plates (K060476) and Newdeal TTC Plates (K060473).

The plate will be available with 2 or 4 holes and with interaxis of 20, 25 or 30 mm.

Fixation of the Newdeal Compression Plate is provided by two or four Screws & washers, which are the same as for the Lapidus Plate (K060474) and Lisfranc Plate (K060476).

Plates, screws and washers will be provided either sterile or non-sterile.

The Locking System (Screw + washer) will be made from Titanium alloy Ti-6Al-4V or 316L Stainless Steel.

The provided text describes a medical device, the "Newdeal Compression Plate," and its regulatory submission (510(k)) to the FDA. The document primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than an AI-powered device performance study.

Therefore, many of the requested categories about AI device performance will not be applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance (Not an AI Device)

Since this document describes a traditional medical device (compression plate) and not an AI-powered one, the concept of "acceptance criteria" for algorithms and their "reported device performance" in terms of metrics like sensitivity, specificity, or AUC is not applicable. The device's performance is assessed through mechanical tests to demonstrate its physical properties are compatible with its intended use.

Study Details (Mechanical Device, Not AI)

1. Sample size used for the test set and the data provenance: Not applicable for an AI device. For the mechanical tests, the specifics of the samples (e.g., number of plates tested, type of mechanical stress applied) are not detailed in this summary. Data provenance is not relevant in the context of mechanical testing of a physical device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to the physical properties of the device, established through engineering measurements, not expert interpretation.

3. Adjudication method for the test set: Not applicable.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI device, so MRMC studies involving human readers and AI assistance are not relevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.

6. The type of ground truth used: For the mechanical tests, the "ground truth" would be established by the physical and material science properties measured during testing and compared against established engineering standards or the predicate device's performance.

7. The sample size for the training set: Not applicable. There is no AI model to train.

8. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information for this Traditional Device:

• Device Type: Newdeal Compression Plate (a metallic bone fixation appliance).
• Purpose of the Submission: To demonstrate substantial equivalence to legally marketed predicate devices.
• Demonstration of Performance: Mechanical tests were carried out, and the results showed that the Newdeal Compression Plate has "mechanical properties compatible with their intended uses." These results were compared with a predicate device, the Large UNI-CLIP (K061594).
• Predicate Devices:
  • Wright Medical Technology Compression Plate, K051908
  • Newdeal Large UNI-CLIP Staple, K061594
• Conclusion: The device is substantially equivalent to the predicate devices and does not raise new issues of scientific technology, safety, or effectiveness.

This document clearly pertains to a physical medical device and its mechanical testing, not an AI-powered diagnostic or assistive tool.

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The Newdeal TTC Plates are intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantations of small bones in the foot and ankle.

The NEWDEAL® TTC Plates consists of a tibiotalocalcaneal plate, available in different sizes, dedicated to be fixed using NEWDEAL® locking system fixation screws and washers. It is available in different sizes, and is implanted using NEWDEAL® locking system fixation screws and washess. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates extemporaneously a single implant/screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socked at the top of each hole, thus blocking each screw head.

This document describes a 510(k) submission for the TTC Plates by Newdeal SAS. The submission is a "traditional" 510(k) given its age, and predominantly focuses on the substantial equivalence of modifications to an already cleared device.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study, formatted to your request:

Acceptance Criteria and Device Performance

Study Details:

This submission is for a modified medical device. The "study" here is a set of mechanical tests designed to demonstrate that the modified device is substantially equivalent to its predicate. It is not a clinical study involving human or animal subjects, nor is it related to AI/algorithm performance.

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

   • Sample Size: Not explicitly stated for the mechanical tests. The description indicates "mechanical tests have been carried out." For mechanical testing, samples typically refer to a specified number of physical units of the device tested under various conditions to ensure statistical significance, but this specific number is not provided in the summary.
   • Data Provenance: The tests were conducted to compare the modified device to the predicate device. The summary does not specify the country of origin for the testing, but the submitting company (Newdeal SAS) is based in France. The data is retrospective in the sense that it's comparing a new version to an existing one, but the mechanical testing itself is a prospective evaluation of the new device's properties.

2. 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 "study" involves mechanical testing, not a human-interpreted diagnostic or clinical outcome. Ground truth in this context would be engineering specifications and established testing methodologies.

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

   • Not applicable. Mechanical tests generally follow standardized procedures and results are objectively measured, rather than adjudicated by experts.

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 device is a bone fixation plate, not an AI or imaging diagnostic tool. No MRMC study was conducted.

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

   • Not applicable. This device is a bone fixation plate, not an AI or algorithm.

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

   • Mechanical Specifications/Engineering Standards: The ground truth for mechanical tests would be established engineering standards, material properties, and performance benchmarks derived from the predicate device and relevant international standards for bone fixation devices. The goal was to prove "similarity" to the predicate, implying the predicate's performance served as the benchmark.

7. The sample size for the training set:

   • Not applicable. This device is a bone fixation plate, not an AI system that requires a training set.

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

   • Not applicable. As above, no training set is relevant for this type of device.

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