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The Newdeal Ankle Nail 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 ioints
• rheumatoid arthritis -
• revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
• revision of failed total ankle arthroplasty with subtalar intrusion ー
• talar deficiency conditions (requiring a tibiocalcaneal arthrodesis) -
• avascular necrosis of the talus -
• Neuroarthropathy or neuropathic ankle deformity ー
• 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 Newdeal Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 11mm, 12mm and 13mm, and lengths of 150mm and 180mm. It allows for proximal and distal locking, using locking cortical screws 5mm diameter, 20 to 110mm long by 5mm increment. The nail, the end cap and the locking screws are all made from Ti-6Al-4V ELI alloy.

Based on the provided text, the device in question is the Newdeal Ankle Nail, an intramedullary fixation rod. The document is a 510(k) Summary, which is a premarket notification demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study establishing efficacy or safety against acceptance criteria in the same way a new drug or novel medical device might.

Therefore, the "acceptance criteria" and "device performance" in this context refer to demonstrating that the Newdeal Ankle Nail's technological characteristics and intended use are substantially equivalent to existing predicate devices, not that it meets specific numeric clinical performance metrics through new studies. The "study" mentioned is a "Summary of Studies" meant to support this substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for a 510(k) submission are based on demonstrating "substantial equivalence" to one or more legally marketed predicate devices. The "reported device performance" here describes how the new device matches the characteristics of those predicates. The document states, "The technological characteristics of the Newdeal Ankle Nail are the same as the predicate devices in terms of intended use and design."

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

• The document does not report on a test set in the traditional sense of a clinical or ex-vivo performance study with a specific sample size. The "Summary of Studies" section only states "Summary of Studies. Ankle Nail meets our acceptance criteria," without detailing any specific studies, their methodology, or data provenance. The assessment is based on comparing technological characteristics and intended use to predicate devices, not on a new performance study.

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. As noted above, there is no disclosed "test set" or independent clinical study requiring expert ground truth establishment for a novel device performance claim. The claims are based on substantial equivalence to existing devices.

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

• Not applicable. There is no disclosed "test set" or independent clinical study requiring adjudication.

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 medical implant (an ankle nail), not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant to this submission.

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

• Not applicable. This device is a medical implant, not an algorithm, and does not operate as a standalone AI system.

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

• Not applicable. For a 510(k) submission focused on substantial equivalence for an implantable medical device, the "ground truth" is typically established by the regulatory history and accepted performance of the predicate devices already on the market, combined with engineering and biocompatibility testing (which are not detailed in this summary). There's no new "ground truth" established for clinical outcomes in this document for the Newdeal Ankle Nail itself.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device submission.

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

• Not applicable. This is not a machine learning or AI device submission.

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Intramedullary Hip Screws are indicated for intracapsular fractures of the femoral neck; trochanteric or subtrochanteric fractures; osteotomies for patients with diseases or deformities of the hip; hip arthrodesis; supracondylar fractures and distal femoral fractures using a supracondylar plate; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; femoral neck fractures; subcapital fractures; comminuted neck and shaft fractures; femur reconstruction following tumor resection; leg length discrepancies secondary to femoral inequality; and prophylactic nailing of impending pathologic fractures. Smith & Nephew, Inc. Intramedullary Hip Screws are for single use only.

Intramedullary Hip Screw

The provided text does not describe a study to prove acceptance criteria for a device using an AI algorithm.

Instead, it is a 510(k) premarket notification summary for a medical device called an "Intramedullary Hip Screw" manufactured by Smith & Nephew, Inc. This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of design features, indications for use, and material composition.

Therefore, I cannot populate the requested table and answer the study-related questions (2-9) because the information is not present in the provided text.

Here's a breakdown of what the document does provide:

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

The document states:

• Acceptance Criteria (Implied): Mechanical test data showed the device is "capable of withstanding expected in vivo loading without failure."
• Reported Device Performance: "A review of the mechanical test data indicated that the Intramedullary Hip Screw is equivalent to predicate devices currently used clinically and is capable of withstanding expected in vivo loading without failure."

Missing Information (as per your request, because it's an AI-related prompt and this document is not AI-related):

2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs. without AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures. The Smith & Nephew, Inc. Trochanteric Antegrade Nail is for single use only.

Not Found

The provided text describes a 510(k) premarket notification for the "TriGen Trochanteric Antegrade Nail." This document focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria in a clinical study for a
new device.

Here's an analysis based on your requirements and the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not applicable. The document describes a 510(k) submission based on mechanical testing and substantial equivalence to predicate devices, not a clinical study with a "test set" of patients.
• Data Provenance: Not applicable. The data primarily comes from mechanical test data and comparisons to existing predicate devices. No patient-specific data is mentioned, thus no country of origin or retrospective/prospective nature is indicated.

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

• Number of Experts: Not applicable. As there was no clinical test set for this 510(k) submission, no ground truth was established by experts in this context. The "ground truth" for the submission is the regulatory determination of substantial equivalence based on engineering and design comparisons.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No clinical test set or human interpretation was involved in the data presented in this summary.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this summary. This is a premarket notification for a medical device (intramedullary nail), which typically relies on mechanical testing and substantial equivalence to existing devices rather than reader studies.
• Effect Size of AI Improvement: Not applicable, as no AI component or reader study was performed.

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

• Standalone Study: No, a standalone algorithm performance study was not done. The device is a physical implant (intramedullary nail), not an algorithm or software.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The "ground truth" in this context is the mechanical equivalence to established devices, as determined by engineering tests, and the regulatory determination of substantial equivalence by the FDA based on design, materials, and intended use as compared to predicate devices. It is not pathology, outcomes data, or expert consensus from a clinical trial.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable. There is no mention of a training set as this is not a machine learning or AI-based device.

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

• Ground Truth Establishment: Not applicable. No training set was used.

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aap Biorigid Nail Femur (BNF) is intended to use in fractures of the femoral bone.

The indications are:
Types of Fractures: Simple closed fractures, Comminuted fractures, Open fractures of first, second or third degree, Crush fractures
Antegrade Indications: Femur shaft fractures, Distal femur shaft fractures, Pathological fractures, e.g. tumor osteolysis, Periprosthetic femur fracture in the middle to third part with knee replacement in situ
Retrograde Indications: Supracondylary fractures, Simultaneous nailing of femur and tibia, Distal femur fracture with osteosynthesis or hip prosthesis in situ, Periprosthetic femur fracture at knee arthroplasty
Borderline Indications: Percondylar femur fracture, Pseudarthrosis (only reamed method), Osteoporosis

Intramedullary rods are used for the stabilisation of fractures or correction of deformity of ong bones with or without interlocking screws. The connection between the nail and the interlocking screw is realised with central holes or grooves. Reamed and unreamed intramedullary nailing and for the femoral bone the antegrade and retrograde entrance are standard methods today.

agp Bioriqid Nail Femur (BNF) is the consistent development of the Biorigid Nail Tibia for the femoral bone. The BNF is a full material nail. The interlocking of the nail happens with solid Ø 5.3 mm screws through central holes and grooves.

The central holes on the nail protect against rotational forces. The grooves are designed for interlocking possibility over the whole length of the nail and a defined reduction of the rigidity because of the full material nail.

The BNF permits the execution of different implantation techniques and interlocking with only one nail. Therefore it meets the different injury manners and necessity for individual solutions.

aap Biorigid Nail Femur (BNF) incorporates

• Nail in different diameters .
• Interlocking screws in different lenghts ●
• Interlocking nut ●
• Protection cap in different lengths ●
• CondyLock ●
• Accessories, like targeting devices etc. ●

This 510(k) summary does not contain information about specific acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided document. The document primarily establishes the device's intended use, materials, and comparison to existing devices.

Here's a breakdown of why the information is missing:

• Acceptance Criteria & Device Performance: The document does not define specific performance metrics (e.g., strength, durability, biocompatibility targets) or report test results against such criteria. The "Performance Standards" section refers generally to cGMP's, ASTM requirements, and harmonized standards like ISO 9001 / EN 46001, but these are quality management and material specification standards, not specific device performance acceptance criteria.
• Study Details: Since there's no mention of specific performance testing, there's no information on:
  • Sample sizes for test sets
  • Data provenance
  • Number or qualifications of experts
  • Adjudication methods
  • MRMC comparative effectiveness studies
  • Standalone performance studies
  • Type of ground truth used
  • Training set sample size or ground truth establishment

This document is a regulatory submission for a Class II medical device (intramedullary fixation rod) seeking 510(k) clearance by demonstrating substantial equivalence. For such devices, rigorous clinical trials or extensive performance studies with explicit acceptance criteria are often not required if substantial equivalence to a legally marketed predicate device can be shown. The FDA's letter explicitly states that the device is "substantially equivalent... to legally marketed predicate devices."

What the document does provide in lieu of a performance study:

• Predicate Devices: A list of several similar intramedullary nails from other manufacturers that serve as the basis for demonstrating substantial equivalence (e.g., Howmedica Osteonics Corp. T2 Femoral Nail System, Synthes Ti Distal Femoral Nail).
• Comparison of Technological Characteristics: It states that the aap Biorigid Nail Femur (BNF) is "substantially equivalent to the predicate devices with respect to physical/technical and material characteristics." This implies that the device is expected to perform similarly to those already on the market without needing to re-prove fundamental performance through new studies.
• Material Composition: Specifies the use of Titanium Alloy (Ti 6Al 4V E.L.I. = ASTM F136), a well-established and approved material for such implants.
• Intended Use: Clearly outlines the types of fractures and anatomical locations for which the device is indicated, which aligns with the predicate devices.

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