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The Newdeal Interphalangeal Implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes.

Examples include:

• rigid or semi-rigid hammertoe deformity .
• revision of failed arthroplasty or arthrodesis .
• 2nd toe shortening .

The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of:

• . Fixed or semi-fixed hammer toe
• Revision of failed arthrodesis or arthroplasty ●
• . Shortening due to length excess of the second toe

This interphalangeal implant configuration will be offered in two different sizes.

The provided text describes the Newdeal® Interphalangeal implant and its substantial equivalence to other devices. It focuses on the regulatory submission (510(k) summary) for this medical device. As such, the information required to populate the table (acceptance criteria and device performance based on a study of AI/algorithm performance) and subsequent questions about AI/algorithm-related studies are not present in the document. This document is a regulatory submission for a physical medical implant, not an AI or algorithm-based device.

Therefore, I cannot provide the requested information.

Here's why:

• Acceptance Criteria & Device Performance: The document mentions "Static and Fatigue Bending tests were performed comparing the mechanical properties" but does not detail specific quantitative acceptance criteria or the reported device performance against those criteria. It only states that the results "helped to support substantial equivalence."
• AI/Algorithm Related Questions (2-7): The entire submission is for a physical orthopedic implant. It does not involve an AI or algorithm. Therefore, there are no test sets, data provenance, experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types related to AI.
• Training Set (8-9): Similarly, the concept of a "training set" and establishing ground truth for it is irrelevant for a physical mechanical implant.

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The Newdeal Compression Plates are 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 Newdeal Uni-CP™ U-Plate is intended for arthrodesis of the second and third cuneo-metatarsal and the inter-cuneiform second and third joints.
  The size and number of the plate(s) used should be adapted to the specific indication.

The Newdeal Compression Plates 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.
• . The rigidity of the "legs" is obtained using the Newdeal Locking System including a screw and a washer.

This document describes a 510(k) premarket notification for a medical device, the "Modified Newdeal® Compression Plates." This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving novel effectiveness or meeting specific performance acceptance criteria through clinical studies. Therefore, many of the requested elements for describing acceptance criteria and a study proving device adherence are not directly applicable to this type of regulatory filing.

Here's an analysis based on the provided text, addressing the points where information is available and explaining why other points are not applicable:

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

For a 510(k) submission, the primary acceptance criteria for the modified device are demonstrating mechanical performance at least equivalent to the predicate device.

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: The document does not specify the exact number of plates or tests performed during the static and dynamic 4-point bending mechanical tests. It only states that tests "have been carried out."
• Data provenance: The document does not explicitly state the country of origin of the mechanical test data. Given the submitter's address is in France (Newdeal SAS), it is likely the testing was conducted in Europe. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission, not by analyzing past clinical data. This is a pre-clinical (bench-top) study, not a clinical study involving patients.

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)

This point is not applicable. The "ground truth" concept (e.g., expert consensus on clinical diagnoses) is relevant for studies involving human interpretation or clinical outcomes. This submission is based on mechanical (bench-top) testing, where the "ground truth" is established by engineering standards and measurements, not expert clinical interpretation.

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

This point is not applicable. Adjudication methods are used in clinical trials or studies where human assessment of outcomes or conditions requires agreement or arbitration. Mechanical testing does not involve such human adjudication in the same way.

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

This point is not applicable. This submission is for a medical implant (bone plate), not an AI-powered diagnostic device. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this device.

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

This point is not applicable. This is not an algorithm or software device.

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

The "ground truth" in this context refers to the established mechanical properties and performance standards for bone fixation plates, as generally understood in the orthopedic device industry and often guided by international standards (though not explicitly mentioned here) for such testing. The comparison is made against the measured mechanical properties of the predicate device.

8. The sample size for the training set

This point is not applicable. There is no "training set" as this is a physical medical device undergoing mechanical testing, not a machine learning model.

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

This point is not applicable for the same reason as point 8.

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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 PANTA® Nail system is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include:

• Post-traumatic and degenerative arthritis involving both ankle and subtalar joints
• Rheumatoid arthritis
• Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
• Revision of failed total ankle arthroplasty with subtalar intrusion
• Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis)
• Avascular necrosis of the talus
• Neuroarthropathy or neuropathic ankle deformity
• Severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
• Severe pilon fractures with trauma to the subtalar joint.

The modified Panta® Nail (dia. 10mm and XL) is ideally suited for tibiotalocalcaneal fusion indications. These Nails affords rigid, load sharing fixation that incorporates a simple nailmounted, in-line method of compression across the arthrodesis site.
The Panta® Nail (dia. 10mm and XL) affords even more torsional rigidity and better calcaneal purchase through its two transcalcaneal locking screws that are inserted from posterior to anterior, using a nail-mounted targeting device. Calcaneal screws eliminate significant rotation, preventing the calcaneus from "rocking" on the nail during weight-bearing. Some screws allow a sufficient stability for the fixation between calcaneus, talus and tibia.
The Panta® Nail (dia. 10mm and XL) is provided with sterile end caps which sit flush to the end of the nail and protect the internal threads from tissue ingrowth.

The provided text describes a 510(k) premarket notification for a medical device called the "Newdeal Panta® Nail (dia. 10mm) Newdeal Panta® Nail XL." This submission primarily focuses on establishing substantial equivalence to existing predicate devices based on mechanical testing, rather than clinical performance or AI algorithm effectiveness. Therefore, many of the requested categories related to AI performance, expert consensus, and human-in-the-loop studies are not applicable or cannot be extracted from this document.

Here's the information that can be extracted and a clear indication where information is not available:

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": [
      "Mechanical properties equivalent to the unmodified device Newdeal Ankle Nail, [K050882](https://510k.innolitics.com/search/K050882)."
    ],
    "Reported Device Performance": [
      "Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified Panta® Nail (dia. 10mm and XL) is equivalent to the properties of the unmodified device Newdeal Ankle Nail, [K050882](https://510k.innolitics.com/search/K050882)."
    ]
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "This information is not provided in the document. The study involved mechanical tests, not a clinical test set with 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. The study involved mechanical testing, not expert consensus on medical images or patient outcomes.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The study involved mechanical testing.",
  "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 is a medical device for surgical fixation, not an AI-powered diagnostic tool.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This is a medical device for surgical fixation, not an AI algorithm.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The 'ground truth' for the mechanical testing was the established mechanical properties of the predicate device (Newdeal Ankle Nail, [K050882](https://510k.innolitics.com/search/K050882)).",
  "8. The sample size for the training set": "Not applicable. This document describes mechanical testing for a physical medical device, not an AI model requiring a training set.",
  "9. How the ground truth for the training set was established": "Not applicable. This document describes mechanical testing for a physical medical device, not an AI model requiring a 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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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 TIBIAXYS System is indicated for fixation of bone fractures or for bone reconstruction, including Arthrodesis, Osteotomies and fractures of ankle joint, distal tibia and fibula.

The Newdeal TIBIAXYS Plates are fixed with the SURFIX ALPHA Locking System 3.5mm diameter screws and Lock screws. Anterior Plates for ankle Arthrodesis have to be fixed with the TIBIAXYS cortical 4mm diameter screws.

The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fractures of ankle joint, distal tibia and fibula. All plates and screws are manufactured from titanium alloy and are provided either sterile or non-sterile.

The provided 510(k) summary for the Newdeal TIBIAXYS System describes a medical device, a bone plate fixation system, and does not involve AI/ML components typically associated with the requested criteria. Therefore, most of the requested information regarding AI/ML device performance, ground truth, and expert evaluation is not applicable.

However, I can extract the information related to the device's performance based on the general mechanical testing described.

Non-AI/ML Device Acceptance Criteria and Study Details:

The summary states that the device was tested for its mechanical properties to ensure compatibility with its intended uses and compared to predicate devices. The acceptance criteria are implicitly that the device's mechanical properties are compatible with its intended uses and substantially equivalent to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample size (number of mechanical tests or units tested) or the provenance (e.g., country of origin, retrospective/prospective) for the mechanical testing performed. This information is typically detailed in the full test reports, not usually summarized in this section of a 510(k) submission.

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

Not applicable. This device is a mechanical implant, and its performance is evaluated through engineering tests, not human expert interpretation of data or images. "Ground truth" in this context refers to engineering specifications and performance standards.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements and do not require expert adjudication in the way clinical diagnostic interpretations would.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, often with AI assistance. The Newdeal TIBIAXYS System is a surgical implant.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The ground truth or performance standard for this device is based on engineering specifications and established mechanical performance criteria for bone fixation plates, along with comparison to the performance of legally marketed predicate devices. This includes properties like strength, fatigue resistance, and biocompatibility (though the summary only explicitly mentions "mechanical properties").

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the AI/ML sense.

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

Not applicable. As there is no AI/ML training set, this question is not relevant.

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The QWIX Positioning Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

• Mono or Bi-cortical osteotomies in the foot or hand (including Hallux Valgus treatment)
• Fractures management in the foot or hand -
• Fixation of bone fragments in long bones or small bones fractures -
• Arthrodesis in hand, foot or ankle surgery -

The size of the chosen screw should be adapted to the specific indication.

The QWIX® Positioning Screw is a cannulated fully threaded screw. It also has a self-tapping screw tip. It is provided in diameters 5.5 mm and 7.5 mm and in length from 30 mm to 80 mm for the 5.5 mm and from 40 mm to 120 mm for the 7.5 m. The QWIX® Positioning Screw is made from Titanium alloy (Ti-6Al-4V ELI).

The provided text describes a 510(k) premarket notification for the QWIX® Positioning Screw. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than establishing new performance criteria through efficacy studies with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be fully provided from the given text.

Here's an analysis of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion	Reported Device Performance
   Mechanical Properties	"Mechanical tests have been carried out. Results have shown that the mechanical properties of the QWIX® Positioning Screw staples have similar to properties of predicate devices, such as Newdeal ICOS screws (K011821) and Synthes 7.3 screw (K962011)."
   Substantial Equivalence	"The new QWIX® Positioning Screws are substantially equivalent to the commercially marketed device, Stabilization Screw, K050346."

   Note: The document states "similar to properties" and "substantially equivalent" rather than specific quantitative acceptance criteria or numerical performance metrics. The 510(k) process is about demonstrating equivalence, not necessarily meeting a predefined performance target in the same way a de novo or PMA would require.

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

   • No specific sample size for a "test set" (in the context of clinical or algorithmic performance evaluation) is mentioned.
   • The study referenced is "Mechanical tests," which typically involves material and component testing, not human or patient data. Therefore, data provenance relevant to clinical outcomes is not applicable here.

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

   • Not applicable. Ground truth in a clinical or diagnostic sense is not established for this type of submission. The comparison is mechanical properties against existing devices.

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

   • Not applicable. There is no "test set" requiring expert adjudication in this context.

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 screw, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant.

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

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

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

   • The "ground truth" or reference for the mechanical tests would be the established mechanical properties of the predicate devices (Newdeal ICOS screws (K011821) and Synthes 7.3 screw (K962011)) and relevant material standards. This is not "expert consensus, pathology, or outcomes data" in a clinical sense.

8. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/ML device.

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

   • Not applicable.

Summary of what the document does provide:

• Device: QWIX® Positioning Screw, a cannulated fully threaded screw for bone fixation.
• Indicated Use: Fixation of bone fractures or bone reconstruction in the foot or hand, including osteotomies, Hallux Valgus treatment, fracture management, fixation of bone fragments, and arthrodesis.
• Basis for Approval: Substantial equivalence to predicate device Stabilization Screw, K050346.
• Supporting Evidence for Equivalence: Mechanical tests showing "similar" mechanical properties to other predicate devices (Newdeal ICOS screws K011821 and Synthes 7.3 screw K962011). The submission also asserts same intended use, materials, basic design, instructions for use, and manufacturing process as previously cleared devices.

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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 Basal Dorsal Plate is intended for fixation of osteotomy of the basis of the first metatarsal. Examples include: Moderate to severe Hallux Valgus, Hallux varus

The Basal Dorsal Plate is designed for fixation of basal osteotomy of the 1st metatarsal. Characteristics of the plate have taken into account all the requirements associated with basal osteotomy: Anatomical shape adapted to the dorsal curve of the basis of the 1st metatarsal, in two different lengths for better adaptation to the specific anatomy of the patient. Fixation with CALCANEA 3.5mm screws in variable angle design for easier positioning and grip into the bone, and a locking design for better stability of the system. The Basal Dorsal Plate and CALCANEA screws are made from titanium alloy (Ti-6AI-4V ELI), which are color-coded for ease of identification. Fixation of the Basal Dorsal Plate is provided by four CALCANEA screws, already cleared with the CALCANEA Plate and Screws system (510(k) K041786). The plates and screws are provided sterile with the Basal Dorsal Plate.

Here's an analysis of the provided text regarding the Basal Dorsal Plate, focusing on acceptance criteria and supporting studies:

It is important to note that the provided text is a 510(k) summary for a medical device (Basal Dorsal Plate). Such summaries are typically a declaration of substantial equivalence to a predicate device, rather than a detailed report of clinical or advanced performance studies. Therefore, direct "acceptance criteria" as one might see for an AI algorithm or a clinical trial endpoint, and "study that proves the device meets the acceptance criteria" in that context, are not fully present. Instead, the document focuses on mechanical testing and comparison to predicate devices to demonstrate equivalence for market clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Mechanical tests were carried out, and all results show that the Basal Dorsal Plates have mechanical properties compatible with their intended uses. |
| Material Compatibility:
Manufactured from biocompatible and known materials appropriate for implantation. | Made from titanium alloy (Ti-6AI-4V ELI). This is a standard and well-understood material for implants, implicitly meeting biocompatibility and material strength requirements. |
| Fixation Mechanism Stability:
Screws provide stable fixation and a locking design for system stability. | Fixation with CALCANEA™ 3.5mm screws in variable angle design for easier positioning and grip into the bone, and a locking design for better stability of the system. These screws are already indicated for use with the CALCANEA™ Plate and Screws system (510(k) K041786), implying their established performance. |
| Substantial Equivalence:
Comparable in intended use, technological characteristics, and safety/effectiveness to predicates. | Substantially equivalent to Newdeal B-BOP Plate, K052152, and Acumed Lower Extremity Congruent Bone Plate System, K033639. The device "do not raise any new issues of scientific technology, safety or effectiveness." |

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

• Sample Size: The document does not specify a "sample size" in terms of number of physical plates tested for the mechanical evaluation. It refers to "mechanical calculations" and "mechanical tests." For medical implants, this typically involves a set number of units tested to destruction or to defined limits under various load conditions, following recognized ASTM or ISO standards. However, the exact number is not stated.
• Data Provenance: The mechanical testing data would be generated internally by Newdeal SAS or a contracted testing facility. The country of origin for the device developer is France. The data itself is prospective in the sense that the tests were specifically conducted to support this 510(k) submission.

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

This information is not applicable to this type of 510(k) submission. For mechanical testing of an implant, "ground truth" is established by engineering specifications, validated test methods (e.g., ASTM standards), and material properties, not by human expert consensus on images or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are used in studies involving human interpretation or clinical endpoints where there might be disagreement among experts. For mechanical testing, test results are typically objective measurements, and any "adjudication" would refer to expert engineering review and interpretation of the raw data against predetermined pass/fail criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) summary. This type of study is relevant for diagnostic imaging AI, where human readers interact with AI assistance. The Basal Dorsal Plate is a surgical implant, not a diagnostic tool requiring human interpretation.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This concept is not applicable to the Basal Dorsal Plate. It is a physical medical device, not an algorithm. The "performance" is its mechanical integrity and function as an implant in the body, which is evaluated through mechanical testing and clinical experience of substantially equivalent predicate devices.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on:

• Engineering specifications and material properties: For aspects like bending resistance and material compatibility. These are defined by established biomechanical principles and regulatory standards.
• Performance of predicate devices: The "expected in vivo specifications performance" is benchmarked against the known safe and effective performance of legally marketed predicate devices. This implicitly means that the clinical outcomes and performance data of those predicates serve as the "ground truth" for what constitutes an acceptable device.

8. The Sample Size for the Training Set

This concept is not applicable. There is no "training set" for a physical medical implant like a Basal Dorsal Plate in the context of an AI algorithm. The design and manufacturing process are informed by general engineering principles, biomechanical understanding, and lessons learned from previous similar devices, but not through a formal "training set" like one created for machine learning.

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

As there is no "training set" in the AI sense, this is not applicable. The design decision-making relies on established engineering principles, biomechanical requirements for the specific anatomical location (1st metatarsal), and understanding of surgical procedures like basal osteotomy.

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