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The Baby Gorilla/Gorilla Bone Plates and Bone Screws of the Baby Gorilla/Gorilla Plating System are indicated for use in stabilization of fractures or osteotomies; intra and extra articular fractures, ioint depression, and multi-fragmentary fractures: revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The system can be used in both and pediatric patients. Specific examples include: Forefoot: Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion), Metatarsal or phalangeal fractures and osteotomies, Lesser metatarsal shortening osteotomies (e.g. Weil), Fifth metatarsal fractures (e.g. Jones Fracture). Mid/Hindfoot: LisFranc Arthrodesis and/or Stabilization, 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions, Intercuneiform Fusions, Navicular-Cuneiform (NC) Fusion, Talo-Navicular (TN) Fusion, Calcaneo-Cuboid (CC) Fusion, Subtalar Fusion, Medial Column Fusion, Cuneiform Fracture, Cuboid Fracture, Navicular Fracture. Ankle: Lateral Malleolar Fractures, Syndesmosis Injuries, Medial Malleolar Fractures and Osteotomies, Bi-Malleolar Fractures, Tri-Malleolar Fractures, Posterior Malleolar Fractures, Distal Anterior Tibia Fractures, Vertical Shear Fractures of the Medial Malleolus, Pilon Fractures, Distal Tibia Shaft Fractures, Distal Fibula Shaft Fractures, Distal Tibia Periarticular Fractures, Medial Malleolar Avulsion Fractures, Lateral Malleolar Avulsion Fractures, Tibiotalocalcaneal Joint Arthrodesis, Tibiotalar Joint Arthrodesis, Tibiocalcaneal Arthrodesis, Supramalleolar Osteotomy, Fibular Osteotomy, First metatarsal osteotomies for hallux valgus correction including: Opening base wedge osteotomy, Closing base wedge osteotomy, Crescentic Osteotomy, Proximal Osteotomy (Chevron and Rotational Oblique), Distal Osteotomy (Chevron/Austin), Arthrodesis of the first metatarsophalangeal joint (MTP) including: Primary MTP Fusion due to hallux ridgidus and/or hallux valgus, Revision MTP Fusion, Revision of failed first MTP Arthroplasty implant. Flatfoot: Lateral Column Lengthening (Evans Osteotomy), Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy), Calcaneal Slide Osteotomy. Charcot: Medial column fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot), Lateral column fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot). In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device. The Monster Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the device. Specific examples include: Fractures and Osteotomies: Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc), Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture), Talar fractures, Ankle fractures, Navicular fractures, Fractures of the fibula, malleolus, and calcaneus, Metatarsal and phalangeal osteotomies, Weil osteotomy, Calcaneal osteotomy. Hallux Valgus Correction: Fixation of osteotomies (i.e. Akin, Scarf, Chevron), Interphalangeal (IP) arthrodesis, Proximal, midshaft, or distal osteotomy, Lapidus arthrodesis. Arthrodesis/Deformity Correction: 1st MTP arthrodesis, Metatarsal deformity correction, Tarsometatarsal joint arthrodesis, Naviculocuneiform joint arthrodesis, Talonavicular arthrodesis, Subtalar joint arthrodesis, Triple arthrodesis, Medial column arthrodesis, Subtalar joint distraction arthrodesis, Ankle arthrodesis, Lateralizing calcaneal osteotomy, Lateral column lengthening, Hammertoe. Fusion resulting from neuropathic osteoarthropathy (Charcot) such as: Medial and lateral column, Subtalar, talonavicular, and calcaneocuboid.

Baby Gorilla/ Gorilla Plating System: The Baby Gorilla/Gorilla Plating System is comprised of bone plates, threaded bone screws, and washers. Gorilla Plates are offered in “mini” and “standard” set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in “mini” and “standard” sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non-locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw. The Baby Gorilla/Gorilla Plating System implants are manufactured from medical grade titanium (per ASTM F67), stainless steel (per ASTM E138) and titanium alloy (per ASTM. Monster Screw System: The Monster Screw System is comprised of threaded bone screws (Ti Alloy or Stainless Steel) offered in 2.0mm to 9.5mm diameters (in 0.5mm increments). In addition, a 2.7mm diameter is also part of the system. The overall screw length ranges from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are available in a variety of designs including fully or partially threaded, self-drilling or blunt, cannulated or solid, and headed or headless. Sized-matched washers are also available.

The provided text is a 510(k) summary for medical devices (Baby Gorilla/Gorilla Plating System and Monster Screw System), which are orthopedic implants. This type of FDA submission focuses on demonstrating substantial equivalence to previously cleared devices rather than proving performance based on clinical studies or AI algorithm performance.

Therefore, the document does not contain any information about acceptance criteria for an AI device, nor does it describe a study involving AI performance metrics, ground truth establishment, expert adjudication, or MRMC studies. The performance testing mentioned specifically refers to "Bacterial endotoxin testing, sterilization validation, and a cleaning Performance validation," which are standard tests for demonstrating the safety and effectiveness of the physical device itself (implants) and its sterility, not for evaluating an AI algorithm.

Since the request is to describe the "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI device, and the provided document is entirely about physical orthopedic implants and their substantial equivalence to predicates, I cannot fulfill the request using only the given input.

The document implicitly states that the acceptance criteria relate to demonstrating substantial equivalence for the new sterile-packed offerings of the screws, plates, and washers to the previously cleared non-sterile or differently-packaged versions of the same devices. The study proving this is the submission itself, which likely included documentation of the manufacturing process changes (sterilization, packing) and the performance testing mentioned (endotoxin, sterilization, cleaning validation) to show that these changes do not raise new issues of safety or effectiveness.

However, none of this relates to AI, machine learning, or image analysis, which the prompt heavily implies with terms like "AI vs without AI assistance," "standalone algorithm performance," "ground truth," and "expert concensus."

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The Baby Gorilla®/Gorilla® Bone Plates and Bone Screws of the Baby Gorilla®/Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, The system can be used in both adult and pediatric patients. Specific examples include:

Forefoot:

• · Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
• · Metatarsal or phalangeal fractures and osteotomies
• · Lesser metatarsal shortening osteotomies (e.g. Weil)
• · Fifth metatarsal fractures (e.g. Jones Fracture)

Mid/Hindfoot:

• · LisFranc Arthrodesis and/or Stabilization
• · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
• Intercuneiform Fusions
• · Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• · Calcaneo-Cuboid (CC) Fusion
• · Subtalar Fusion
• Medial Column Fusions
• · Cuneiform Fracture
• · Cuboid Fracture
• Navicular Fracture

Ankle:

• · Lateral Malleolar Fractures
• · Syndesmosis Injuries
• · Medial Malleolar Fractures and Osteotomies
• Bi-Malleolar Fractures
• Tri-Malleolar Fractures
• Posterior Malleolar Fractures
• Distal Anterior Tibia Fractures
• · Vertical Shear Fractures of the Medial Malleolus
• Pilon Fractures
• Distal Tibia Shaft Fractures
• Distal Fibula Shaft Fractures
• Distal Tibia Periarticular Fractures
• Medial Malleolar Avulsion Fractures
• · Lateral Malleolar Avulsion Fractures
• Tibiotalocalcaneal Joint Arthrodesis
• Tibiotalar Joint Arthrodesis
• Tibiocalcaneal Arthrodesis
• · Supramalleolar Osteotomy
• Fibular Osteotomy

First metatarsal osteotomies for hallux valgus correction including:

• Opening base wedge osteotomy
• · Closing base wedge osteotomy
• Crescentic Osteotomy
• · Proximal Osteotomy (Chevron and Rotational Oblique)
• Distal Osteotomy (Chevron/Austin)

Arthrodesis of the first metatarsophalangeal joint (MTP) including:

• Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
• Revision MTP Fusion
• · Revision of failed first MTP Arthroplasty implant

Flatfoot:

• · Lateral Column Lengthening (Evans Osteotomy)
• · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
• · Calcaneal Slide Osteotomy

Charcot:

• · Medial column fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot)
• · Lateral column fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot)

In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the device.

The Baby Gorilla®/Gorilla® Plating System implants are internal fixation systems. Gorilla® Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "min" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non-locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw. The Baby Gorilla®/Gorilla® Plating System implants are manufactured from medical grade titanium (per ASTM F67), stainless steel (per ASTM F138), and titanium alloy (per ASTM F136).

The provided text is a 510(k) summary for a medical device (Baby Gorilla®/Gorilla® Plating System) and does not contain information about the acceptance criteria and study proving an AI/ML powered device meets those criteria. The document describes a new version of an existing plating system and demonstrates its substantial equivalence to a predicate device through engineering analysis, rather than clinical study data for an AI/ML algorithm.

Therefore, I cannot provide the requested information based on the given input. The categories requested, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "standalone performance," are relevant to the evaluation of AI/ML medical devices, which this document does not describe.

Ask a specific question about this device

The Baby Gorilla®/Gorilla® Bone Plates and Bone Screws of the Baby Gorilla®/Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, The system can be used in both adult and pediatric patients. Specific examples include:

Forefoot:

• · Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
• · Metatarsal or phalangeal fractures and osteotomies
• · Lesser metatarsal shortening osteotomies (e.g. Weil)
• · Fifth metatarsal fractures (e.g. Jones Fracture)

Mid/Hindfoot:

• · LisFranc Arthrodesis and/or Stabilization
• · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
• · Intercuneiform Fusions
• · Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• Calcaneo-Cuboid (CC) Fusion
• · Subtalar Fusion
• · Medial Column Fusions
• · Cuneiform Fracture
• · Cuboid Fracture
• Navicular Fracture

Ankle:

• · Lateral Malleolar Fractures
• · Syndesmosis Injuries
• · Medial Malleolar Fractures and Osteotomies
• Bi-Malleolar Fractures
• Tri-Malleolar Fractures
• · Posterior Malleolar Fractures
• Distal Anterior Tibia Fractures
• · Vertical Shear Fractures of the Medial Malleolus
• Pilon Fractures
• Distal Tibia Shaft Fractures
• Distal Fibula Shaft Fractures
• Distal Tibia Periarticular Fractures
• Medial Malleolar Avulsion Fractures
• · Lateral Malleolar Avulsion Fractures
• Tibiotalocalcaneal Joint Arthrodesis
• Tibiotalar Joint Arthrodesis
• Tibiocalcaneal Arthrodesis
• · Supramalleolar Osteotomy
• Fibular Osteotomy

First metatarsal osteotomies for hallux valgus correction including:

• · Opening base wedge osteotomy
• Closing base wedge osteotomy
• Crescentic Osteotomy
• · Proximal Osteotomy (Chevron and Rotational Oblique)
• · Distal Osteotomy (Chevron/Austin)

Arthrodesis of the first metatarsophalangeal joint (MTP) including:

• · Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
• Revision MTP Fusion
• · Revision of failed first MTP Arthroplasty implant

Flatfoot:

• · Lateral Column Lengthening (Evans Osteotomy)
• · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
• · Calcaneal Slide Osteotomy

Charcot:

• · Medial column fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot)
• · Lateral column fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot)

In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the device.

The Baby Gorilla®/Gorilla® Plating System implants are internal fixation systems. Gorilla® Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "min" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non-locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw. The Baby Gorilla®/Gorilla® Plating System implants are manufactured from medical grade titanium (per ASTM F67), stainless steel (per ASTM F138), and titanium alloy (per ASTM F136).

This FDA 510(k) Premarket Notification document describes a medical device, the Baby Gorilla®/Gorilla® Plating System, which is a system for internal fixation of bones. The application is for substantial equivalence to a previously cleared device, not for a novel AI or diagnostic device. Therefore, many of the requested elements for an AI/diagnostic device study (like MRMC studies, effect size of AI assistance, specific ground truth methods for algorithm training, and detailed expert qualifications) are not applicable to this type of submission.

However, I can extract the relevant information regarding acceptance criteria and performance data as presented in the document for a medical device seeking substantial equivalence.

Acceptance Criteria and Reported Device Performance

The core of a 510(k) submission for substantial equivalence is demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily achieved by showing that the new device has the same (or substantially similar) indications for use and technological characteristics, and that any differences do not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

• Basic Design
• Material
• Manufacturing
• Sizes (dimensions are comparable) | Same technological characteristics as the predicate:
• Performance
• Basic design
• Material (medical grade titanium, stainless steel, titanium alloy)
• Manufacturing
• Sizes (dimensions are comparable to those offered by predicate systems). |
  | Safety and Effectiveness | Differences do not raise new questions of safety and effectiveness. | Differences between the subject and predicate devices were shown not to raise new questions of safety and effectiveness through engineering analysis. |

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

• Not applicable (N/A) in the context of an AI/diagnostic device study. This submission is for a bone plating system, not a diagnostic algorithm. The "test set" here refers to the device itself and its components.
• Data Provenance: The performance data is derived from "engineering analysis." This typically involves laboratory testing of materials and designs, not clinical data from patients in a specific country.

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

• N/A. This information pertains to establishing ground truth for diagnostic or AI algorithm performance. For a bone plating system, the "ground truth" is adherence to established material properties, mechanical strength requirements, and manufacturing standards. This is evaluated by engineers and regulatory bodies against recognized standards, not by clinical experts establishing diagnostic ground truth.

4. Adjudication method for the test set:

• N/A. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in diagnostic studies. This is not relevant for the engineering analysis of a bone plating system.

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:

• N/A. This is a device for internal fixation, not an AI or diagnostic tool. No human readers or AI assistance are involved in its primary function.

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

• N/A. This is not an algorithm. The device is a physical bone plating system.

7. The type of ground truth used:

• For this type of medical device (bone plating system), the "ground truth" is primarily based on engineering standards, material specifications (e.g., ASTM F67 for medical grade titanium, ASTM F136 for titanium alloy, ASTM F138 for stainless steel), and mechanical performance requirements. The performance data section states, "Engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices." This means the device's mechanical properties, biocompatibility, and intended function are assessed against established benchmarks and industry standards for similar devices. There is no "pathology" or "outcomes data" in the sense of a clinical trial used here to establish ground truth for a diagnostic context.

8. The sample size for the training set:

• N/A. This device is not an AI algorithm, so there is no "training set."

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

• N/A. As there is no training set for an AI algorithm, this question is not applicable.

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The Baby Gorilla®/Gorilla® Bone Plates and Bone Screws of the Baby Gorilla®/Gorilla® Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The system can be used in both adult and pediatric patients. Specific examples include: Forefoot: Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion) Metatarsal or phalangeal fractures and osteotomies Lesser metatarsal shortening osteotomies (e.g. Weil) Fifth metatarsal fractures (e.g. Jones Fracture) Mid/Hindfoot: LisFranc Arthrodesis and/or Stabilization 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions Intercuneiform Fusions Navicular-Cuneiform (NC) Fusion Talo-Navicular (TN) Fusion Calcaneo-Cuboid (CC) Fusion Subtalar Fusion Medial Column Fusions Cuneiform Fracture Cuboid Fracture Navicular Fracture Ankle: Lateral Malleolar Fractures Syndesmosis Injuries Medial Malleolar Fractures and Osteotomies Bi-Malleolar Fractures Tri-Malleolar Fractures Posterior Malleolar Fractures Distal Anterior Tibia Fractures Vertical Shear Fractures of the Medial Malleolus Pilon Fractures Distal Tibia Shaft Fractures Distal Fibula Shaft Fractures Distal Tibia Periarticular Fractures Medial Malleolar Avulsion Fractures Lateral Malleolar Avulsion Fractures Tibiotalocalcaneal Joint Arthrodesis Tibiotalar Joint Arthrodesis Tibiocalcaneal Arthrodesis Supramalleolar Osteotomy Fibular Osteotomy First metatarsal osteotomies for hallux valgus correction including: Opening base wedge osteotomy Closing base wedge osteotomy Crescentic Osteotomy Proximal Osteotomy (Chevron and Rotational Oblique) Distal Osteotomy (Chevron/Austin) Arthrodesis of the first metatarsophalangeal joint (MTP) including: Primary MTP Fusion due to hallux ridgidus and/or hallux valgus Revision MTP Fusion Revision of failed first MTP Arthroplasty implant Flatfoot: Lateral Column Lengthening (Evans Osteotomy) Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy) Calcaneal Slide Osteotomy Charcot: Medial column fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot) Lateral column fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot) In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.

The Baby Gorilla®/Gorilla® Plating System implants are internal fixation systems. Gorilla® Plates are offered in “mini” and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "mini" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non-locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw.

Here's an analysis of the provided text regarding the Baby Gorilla®/Gorilla® Plating System, focusing on the acceptance criteria and study information:

This document is a 510(k) Summary for a medical device (K190365), seeking clearance for substantial equivalence to previously marketed devices. In these types of submissions for orthopedic implants, the "acceptance criteria" are not clinical performance outcomes like sensitivity/specificity but rather engineering and material testing standards. The "study" refers to the engineering analyses and tests conducted to demonstrate that the modified device meets the performance characteristics of its predicates.

Based on the provided text, a table of acceptance criteria and reported device performance, and details about studies are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as this is not a clinical study with patients. For engineering analysis, the "sample size" would refer to the number of physical samples tested or the scope of the computational models used. This information is typically detailed in the full test reports, which are not included in this summary.
• Data Provenance: The data comes from engineering analyses and testing conducted by the manufacturer, Paragon 28, Inc. It is not patient or clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in the usual sense for clinical studies. It is internal company data, likely from laboratory testing.

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

• This type of information is not applicable to this submission. "Ground truth" established by experts (e.g., radiologists) is relevant for AI/imaging device clearances where clinical accuracy is being assessed. For a 510(k) for an orthopedic implant like the Baby Gorilla®/Gorilla® Plating System, the "ground truth" is based on established engineering principles, material science, and the functional performance of the device against recognized standards and predicate devices. No external expert panel is typically used for this type of "ground truth" establishment in engineering testing for substantial equivalence.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations in clinical studies, particularly for diagnostic accuracy. Since this submission relies on engineering analysis and comparison to predicate devices rather than clinical interpretation of data, an adjudication method is not relevant.

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 study is relevant for AI-powered diagnostic devices. This submission pertains to an orthopedic implant, which is a physical device used in surgery, not a diagnostic tool where human readers assess images. Therefore, no MRMC study was conducted, and the concept of "human readers improving with AI assistance" does not apply.

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. Therefore, "standalone algorithm performance" is not a relevant concept for this 510(k) submission.

7. The Type of Ground Truth Used

• The "ground truth" for this medical device's claims of safety and effectiveness, for the purpose of a 510(k), is based on:
  • Engineering Standards: Compliance with recognized ASTM standards for materials (e.g., ASTM F67, F138, F136).
  • Mechanical Testing Results: Data from physical tests (e.g., fatigue, static strength, push-out/pull-out forces) that demonstrate the device's mechanical performance is equivalent to or better than predicate devices and suitable for its intended anatomical use.
  • Comparison to Predicate Devices: The foundational "ground truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate devices. The new device must demonstrate it is "substantially equivalent" to these predicates in terms of intended use, technological characteristics, and performance.

8. The Sample Size for the Training Set

• Not applicable. A "training set" refers to data used to train machine learning models. This device is an orthopedic implant, not an AI/ML product. Therefore, no training set was involved.

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

• Not applicable. As no training set was involved, this question is not relevant.

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