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Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

The ALPS Small Bone Locked Plating System Line Extension consists of three Titanium alloy plates offered to be used with non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr for bone fixation and the management of fractures, fusions, revisions and reconstructive surgeries.

The provided text is related to a 510(k) submission for a medical device called the "ALPS Small Bone Locked Plating System Line Extension." This submission focuses on establishing substantial equivalence to existing predicate devices, primarily through pre-clinical data. There is no information in the provided text about acceptance criteria or a study that proves the device meets specific performance criteria in terms of a clinically relevant outcome (e.g., diagnostic accuracy, patient outcomes).

The document is a 510(k) summary, which is a regulatory submission to the FDA for medical devices that are substantially equivalent to already legally marketed devices. The "study" mentioned for demonstrating substantial equivalence is pre-clinical and focuses on mechanical properties, not an evaluation of how humans or algorithms perform with the device.

Therefore, for the information requested, I can only provide what is explicitly stated or can be inferred, and will indicate where information is not present in the provided text.

Here's a breakdown based on your request:

Acceptance Criteria and Study for ALPS Small Bone Locked Plating System Line Extension

The provided 510(k) summary primarily demonstrates substantial equivalence through pre-clinical testing, rather than studies involving human or AI performance. The "acceptance criteria" and "reported device performance" are framed in terms of mechanical and material properties, aligning with the regulatory pathway of demonstrating equivalence to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable / Not Provided. This device is a bone fixation system, not a diagnostic or AI-driven device that would typically involve a "test set" of patient data or data provenance in the context of diagnostic accuracy. The "test set" in this context refers to components or constructs used in pre-clinical mechanical testing. The sample sizes for these pre-clinical tests are not specified in the provided text.

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 / Not Provided. As this is a pre-clinical evaluation of a bone implant, there is no "ground truth" established by clinical experts (like radiologists for image interpretation) for a "test set" of clinical data. The "ground truth" for mechanical testing is based on engineering principles and established standards.

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

• Not Applicable / Not Provided. Adjudication methods are typically used to resolve discrepancies in expert interpretations of clinical data or images. This concept does not apply to the pre-clinical mechanical testing performed for this device.

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, an MRMC comparative effectiveness study was not done. This device is an implantable bone fixation system, not an AI-based diagnostic tool. Therefore, MRMC studies involving human readers or AI assistance are not relevant to this submission.

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 device is a physical implant, not an algorithm.

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

• Mechanical and Material Standards: The "ground truth" for the substantial equivalence claim is based on engineering principles, material science standards, and the performance characteristics of the predicate devices. This includes demonstrating equivalent axial load construct strength and galvanic corrosion potential.

8. The sample size for the training set

• Not Applicable / Not Provided. There is no "training set" in the context of this device. A training set is typically used for machine learning algorithms, which are not part of this device submission.

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

• Not Applicable / Not Provided. As there is no training set, there is no ground truth established for one.

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The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as: - Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus - Lisfranc arthrodesis - Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.

The NEWDEAL® Lapidus Plate consists of an osteosynthesis plate designed to bridge the 1* tarsometatarsal joint, available in different sizes, which will be fixed using NEWDEAL® locking system fixation screws and washers. 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 a single plate/screw unit fixed into the bone. The ostedsynthesis screws must be driven into the bone through the holes in the mo one. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.

The provided text describes a 510(k) summary for Lapidus Plates and a letter from the FDA. It does not contain information about acceptance criteria, device performance metrics, or details of a study that would demonstrate the device meets such criteria in the way typically seen for AI/ML medical devices (e.g., sensitivity, specificity, AUC).

Instead, this document pertains to a traditional medical device (bone fixation plates) and its equivalence to a predicate device based on mechanical testing.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

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. "Mechanical tests" were performed, but the number of plates tested is not mentioned.
• Data Provenance: Not applicable. This refers to mechanical testing, not clinical data or patient data.

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. Ground truth as typically defined for AI/ML devices (e.g., expert labels on images) is not relevant for mechanical testing of bone plates. The "truth" here is the physical measurement of mechanical properties.

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

• Not applicable. This concept is for resolving disagreements among human readers or labelers in diagnostic studies.

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 mechanical device, not an AI/ML diagnostic aid.

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

• Not applicable. This is a mechanical device.

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

• Ground Truth: For mechanical testing, the "ground truth" would be the objectively measured physical properties (e.g., strength, stiffness, fatigue resistance) of the devices, compared against the known properties of the predicate device.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it's not a machine learning model.

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

• Not applicable. This device does not involve a training set.

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The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as:

• arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus,
• Lisfranc arthrodesis -
• mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.

The NEWDEAL® Lapidus Plate consists of an osteosynthesis plate designed to bridge the 1st tarsometatarsal joint, available in different sizes, which are implanted using NEWDEAL® locking system fixation screws and washers. 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 oreates a single /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 socket at the top of each hole, thus blocking each screw head.

The provided 510(k) premarket notification for the Newdeal SAS Lapidus Plates describes a medical device, not an AI/ML-enabled device. Therefore, the questions related to AI/ML device performance, such as acceptance criteria for AI models, sample sizes for test sets in AI studies, expert qualifications for AI ground truth, multi-reader multi-case studies, and training set details, are not applicable.

The document demonstrates the device's substantial equivalence through mechanical testing and comparison to predicate devices, rather than clinical efficacy against acceptance criteria derived from AI performance metrics.

Here's an analysis of the provided text in the context of the device's regulatory submission:

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

• Acceptance Criteria: The document does not explicitly state numerical acceptance criteria in the way an AI/ML device would. Instead, the primary acceptance criterion for this 510(k) submission is substantial equivalence to legally marketed predicate devices. This means that the device must perform at least as well as or be equivalent in function and safety to the predicate devices.
• Reported Device Performance:

  Performance Metric	Reported Device Performance
  Bending Resistance	"greater than predicate devices (Synthes Modular Foot System)"
  Equivalence	"substantially equivalent to commercially marketed devices" (Acumed K033639, Synthes K010321, Synthes K001941)
  Novel Issues	"do not raise any new issues of scientific technology, safety or effectiveness"

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

• Not Applicable (N/A): This is a mechanical device, not an AI/ML device that uses data for performance evaluation. The "test set" here refers to the physical devices tested.
• Sample Size: Not explicitly stated as "sample size" in relation to a patient cohort. The "Testing and Test Results" section refers to an "evaluation of the bending resistance based upon mechanical calculations." This implies a mechanical engineering analysis, likely involving a limited number of physical prototypes or simulations.
• Data Provenance: N/A for this type of device. The "data" pertains to mechanical properties.

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 (N/A): As this is not an AI/ML device, there's no need for experts to establish a "ground truth" for a test set in the conventional sense of image or data interpretation. The "ground truth" for mechanical performance criteria would be established through engineering standards and testing protocols.
• Qualifications of Experts: Not specified, but would typically involve mechanical engineers or materials scientists for the design and testing of such implants.

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

• Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI evaluations to resolve discrepancies in expert opinions on ground truth. This is a mechanical device submission. The "adjudication" for mechanical testing would involve engineering verification against established test standards.

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 multi-reader multi-case (MRMC) study is typically performed for imaging or diagnostic devices where human readers interpret data, often with or without AI assistance. This is a bone fixation plate, a passive implant, and such a study is irrelevant for its clearance.

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

• No: This question is specifically for AI/ML algorithms. The Lapidus Plate is a physical surgical implant, not an algorithm.

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

• Mechanical Engineering Standards and Predicate Device Performance: The "ground truth" for this device's performance relies on established mechanical engineering principles, calculations, and the safety and effectiveness profile of the legally marketed predicate devices. The "Conclusion" explicitly states that the device "do not raise any new issues of scientific technology, safety or effectiveness," implying its performance meets accepted industry benchmarks and regulatory requirements for similar devices.

8. The sample size for the training set

• Not Applicable (N/A): This is a mechanical device, not an AI/ML device that requires a training set.

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

• Not Applicable (N/A): This is a mechanical device, not an AI/ML device that requires a training set or ground truth in this context.

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