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The JPS JuniOrtho Plating System™ is internal fixation and stabilization of fractures, osteotomies, mal-unions and non-unions of long bones of the lower limb.

The JPS JuniOrtho Plating System™ is indicated for internal fixation of femoral and tibial fractures, osteotomies, mal-unions and non-unions.

Indications include:

• Varus, valgus, rotational and/or shortening osteotomies
• Femoral neck and/or pertrochanteric fractures
• Proximal and distal metaphyseal fractures
• Pathological and impeding pathological fractures

Use of the JPS JuniOrtho Plating System™ is indicated in pediatric (excluding newborns) and small stature adult patients.

The JPS JuniOrtho Plating System™ consists of plate's sizes and shapes ranges, designed to accept locking and cortical bone screws, which are available in a variety of diameters and lengths, in order to support internal fixation and stabilization of fractures, osteotomies, mal-unions and non-unions in long bones of lower limbs. The JPS JuniOrtho Plating System™ is designed according to the anatomic region of clinical application: femur and tibia. The implants would be offered both in sterile and non-sterile packaging configurations.

The subject device implants, bone plates and bone screws, are made from Stainless steel AISI 316LVM, according to ASTM F138 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)".

Surgical procedures with the use of the subject implants may be performed with the support of general orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The instruments and accessories offered by Orthofix are classified as class I devices exempt from 510(k), under the product code LXH, according to 21 CFR 888.4540 Orthopedic Manual Surgical Instrument, and product code FSM according to 21 CFR 878.4800 Manual surgical instrument for general use.

These instruments are made by medical grade stainless steel (AISI 316LVM, AISI 630, AISI 420B, AISI 303, X15TN), Aluminum alloy (EN-AW 6082 T6), and plastic material (PP-H PROPILUX).

JPS JuniOrtho Plating System™ is designed to be used in the operating theatre only.

This is a medical device 510(k) summary, not a study report for an AI/ML powered device. As such, it does not contain any information about:

• Acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes or data provenance for a test set.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

This document describes a traditional medical device, the "JPS JuniOrtho Plating System™," which consists of physical plates and screws for internal fixation of bones. The performance analysis mentioned refers to bench testing and engineering assessments of the mechanical properties of the hardware, compared to predicate devices, to demonstrate substantial equivalence.

Therefore, I cannot provide the requested table and information based on the provided text.

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The ANTHEM™ Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulpa, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. Small fragment and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age).

The ANTHEM™ Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, sterile and non-sterile, with locking and non-locking screws. ANTHEM™ implants are manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel. All implants are for single use only.

This document is a 510(k) Summary for the ANTHEM™ Fracture System, a medical device. Based on the provided text, there is no study described that proves the device meets specific acceptance criteria based on AI/algorithm performance, nor is there any mention of an AI device. The document explicitly describes the ANTHEM™ Fracture System as a system of "plates and screws designed to be used for internal bone fixation."

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance related to AI/algorithmic accuracy.
• Sample size and data provenance for an AI test set.
• Number of experts and qualifications for AI ground truthing.
• Adjudication method for an AI test set.
• MRMC comparative effectiveness study for AI assistance.
• Standalone AI performance.
• Type of ground truth used for AI.
• Sample size for training set for AI.
• How ground truth for a training set was established for AI.

The document focuses on the mechanical and material performance of bone fixation devices, not on diagnostic or AI-driven performance.

Here's a summary of the performance data that is mentioned in the document, which pertains to the physical device itself:

1. Acceptance Criteria and Reported Device Performance (for the physical device):

• Acceptance Criteria (Implicit Standard Performance): The device's performance was evaluated in accordance with recognized ASTM standards for bone fixation devices. This implies that the device had to meet performance benchmarks defined by these standards to demonstrate substantial equivalence to predicate devices. While specific numerical acceptance criteria are not explicitly stated (e.g., "minimum bending strength of X N-m"), the adherence to these standards serves as the implicit acceptance criteria for mechanical performance.
• Reported Device Performance:
  • Tests Conducted: Engineering analysis, bending strength tests (for plates and screws), pullout strength tests (for screws), and insertion/removal torque tests (for screws).
  • Outcome: "Performance data demonstrates substantial equivalence to the predicate devices."
  • Bacterial Endotoxin Testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011 to ensure sterility or low endotoxin levels.

2. Sample Size and Data Provenance (for the physical device testing):

• The document does not specify the sample sizes used for the mechanical performance tests (e.g., how many plates or screws were tested for bending strength).
• The data provenance is not mentioned (e.g., where the tests were conducted, whether the materials were from specific batches, etc.).

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

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm requiring expert review for ground truth.

4. Adjudication method for the test set:

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.

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

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.

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

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

7. The type of ground truth used:

• For the physical device, "ground truth" would be the objective measurements obtained from standardized mechanical tests (e.g., actual force at failure, actual torque values) against the requirements of the ASTM standards.

8. The sample size for the training set:

• Not applicable, as this is not an AI/machine learning device.

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

• Not applicable, as this is not an AI/machine learning device.

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The OrthoPediatrics Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.

The OrthoPediatrics Blade Plate System will combine implants and instruments in one convenient system. This system will offer the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety.

This 510(k) premarket notification describes the OrthoPediatrics Blade Plate System. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Here's an analysis based on the provided text, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

• Plate thickness(s) and width(s) are substantially equivalent to predicates.
• Range of plate angles are substantially equivalent to predicates.
• Range of screw sizes and threads are substantially equivalent to predicates.
• The fundamental scientific principles and technological characteristics, including the intended use, material, sizes, and general design are the same as, or similar to the predicate devices. The technological characteristics of the subject device and the predicates are substantially equivalent to the predicates. |
  | Indications for Use Equivalence: Same or similar intended use as predicates. | Met: Indications for Use is substantially equivalent to predicates. The OrthoPediatrics Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies. Consistent with the predicate devices. |
  | Mechanical Strength & Resistance to Bending Moments: Equivalent or better mechanical properties compared to predicates. | Met: Engineering calculations with worst-case loading calculations of subject device and corresponding predicate device, confirmed that subject device has equivalent or better strength and resistance to bending moments. (This is a claim based on calculations, not a direct performance measurement against a benchmark from a study.) |
  | Safety and Effectiveness: No new questions of safety or effectiveness are raised. | Met (by inference): A review of the MAUDE complaint database of similar predicate devices supports the safety and effectiveness of the device. The FDA's substantial equivalence determination implies they found no new questions of safety or effectiveness. The fundamental scientific principles and technological characteristics, including the intended use, material, sizes, and general design are the same as, or similar to the predicate devices, leading to the conclusion that "safety and efficacy is expected to be equivalent." |

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

• Sample Size for Test Set: Not applicable. This submission relies on bench testing (engineering calculations) and comparison to predicates, not a clinical test set with human subjects or medical image data.
• Data Provenance: The "data" primarily comes from:
  • Specifications and material properties of the subject device.
  • Specifications and material properties of predicate devices.
  • Engineering calculations for mechanical properties.
  • MAUDE (Manufacturer and User Facility Device Experience) database – this is a post-market surveillance database for adverse events for marketed devices (predicates in this case), not a data set for a prospective study. Its provenance is from various healthcare facilities in the US reporting issues.

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

• Not applicable. There was no "test set" requiring ground truth established by experts in the context of clinical or diagnostic performance. This is a submission for a mechanical device, primarily demonstrating equivalence in design and materials.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring expert adjudication was used.

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 (bone plate system), not an AI/software as a medical device (SaMD) that would involve human readers or AI assistance.

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.)

• Not applicable in the conventional sense of clinical ground truth. The "ground truth" for this submission is implicitly based on:
  • Engineering Principles: Equations and models used for the strength calculations.
  • Material Standards: ASTM-F138 for 316L stainless steel.
  • FDA's Premarket Notification (510(k)) Process: The determination of "substantial equivalence" to legally marketed predicate devices, meaning the previous predicate devices serve as an established baseline for safety and effectiveness.

8. The sample size for the training set

• Not applicable. There is no machine learning or AI component requiring a training set.

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

• Not applicable. No training set.

Summary of the Study (Performance Analysis):

The "Performance Analysis" section clearly states: "Subject device has similar configuration, sizes and design as the predicate device(s). Engineering calculations with worst case loading calculations of subject device and corresponding predicate device, confirmed that subject device has equivalent or better strength and resistance to bending moments. A review of the MAUDE complaint data base of similar predicate devices support the safety and effectiveness of the device."

Essentially, the "study" demonstrating the device meets (implicit) acceptance criteria for safety and effectiveness is a bench-top engineering analysis (computational modeling/calculations) and a comparison to the established safety record (MAUDE data) of substantially equivalent predicate devices, rather than a clinical trial or diagnostic performance study. The core method is demonstrating substantial equivalence to legally marketed devices.

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