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The PK High Tibial Osteotomy Correction System is an external fixation device, which is intended for use in the treatment of the following indications in the tibia:

• Temporary fracture fixation
• Correction of deformity
• Osteotomy
• Bone union
• Bone reconstruction
• Fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality
• Leg lengthening

The PK High Tibial Osteotomy Correction System is a single-use external fixator which consisting of the following components: fixation plate, cortex pin and cancellous pin. Pins are available in various lengths and diameters according to practical requirements. These pins and other components are manufactured from 316L stainless steel (ASTM F138/ ISO 5832-1) and aluminum alloy. These devices are intended to be used in the tibia. Adjustment of the fixator is possible during the course of treatment. All components are provided sterile.

The provided document is a 510(k) premarket notification for a medical device called the "PK High Tibial Osteotomy Correction System." This document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing details of an AI/ML algorithm's performance.

Therefore, the information required to answer your questions regarding acceptance criteria, study data, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details for an AI/ML device is NOT present in this submission.

This 510(k) submission confirms that:

• The device is a medical device (external fixator), not an AI/ML algorithm.
• The approval is based on substantial equivalence to predicate devices, not on a clinical performance study of an AI/ML algorithm.
• Non-clinical performance data (mechanical testing) was conducted, referring to ASTM F1541, to demonstrate substantial equivalence, but this is physical device testing, not AI/ML algorithm performance.
• "Clinical testing was not required for this submission." This explicitly states that no clinical performance data was gathered or submitted for this device, which would be crucial for evaluating an AI/ML algorithm.

In summary, the provided document does not contain the information requested in your prompt because it is about a physical medical device clearance, not an AI/ML algorithm's regulatory approval.

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The AOS Anterolateral Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non- unions of the proximal humerus

The AOS Anterolateral Proximal Humeral plates are open reduction internal fixation devices for the temporary fixation of various types of fractures of the humerus and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Anterolateral Proximal Humeral System consists of titanium plates, and proximal and distal locking and non-locking screws. 16 and 18 hole plates are being added to the system. The 16 hole plates are 9.4 inches long. The 18 hole plates are 10.4 inches long.

The provided text describes a medical device, the "AOS Anterolateral Proximal Humeral Plate," which is a metallic bone fixation appliance. The document is a 510(k) premarket notification for modifications being added to the existing system. Crucially, the document explicitly states under the "CLINICAL DATA" section: "There is no clinical data referenced in this special 510(k)."

This means that no clinical study was conducted as part of this specific 510(k) submission to prove the device meets acceptance criteria. The claim of substantial equivalence for the modifications (adding 16 and 18-hole plates) is based on similarities to predicate devices and preclinical testing (though the document states mechanical testing was not necessary due to no anticipated decrease in strength or increase in risk).

Therefore, I cannot provide information on acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for this specific submission because the document explicitly states no clinical data was referenced.

The relevant information is:

• Acceptance Criteria and Reported Device Performance: Not applicable, as no clinical study was referenced for this submission. The submission relies on substantial equivalence to predicate devices and the absence of a need for new mechanical testing for the additions.
• Sample size for test set and data provenance: Not applicable, as no clinical study was referenced.
• Number of experts used to establish ground truth and qualifications: Not applicable.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No, not applicable.
• Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable, as no clinical study was referenced.
• How the ground truth for the training set was established: Not applicable.

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The Phantom™ Small Bone Intramedullary Nail System is indication and fixation of the small bones of the feet and ankle for the treatment of fractures, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.

The PhantomTM Small Bone Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.

The PhantomTM Small Bone Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The PhantomTM nails are offered in a variety of lengths to accommodate variations in patient anatomy. The PhantomTM threaded pegs and locking screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.

This document is a 510(k) summary for the Phantom™ Small Bone Intramedullary Nail System, a medical device. It does not describe an AI/ML powered device, therefore the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly with respect to AI/ML specific aspects (like sample size for test/training set, expert ground truth, MRMC studies, standalone performance), is not present in the provided text.

However, I can extract information regarding the device's mechanical performance testing and its acceptance criteria as implied by the comparison to a predicate device.

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

The document does not explicitly state numerical acceptance criteria, but it describes the type of testing performed and the conclusion drawn from it. The acceptance is implied by the "substantially equivalent" determination.

Regarding the other requested information, the document does not contain:

2. Sample size used for the test set and the data provenance: Not applicable as this is a mechanical device, not an AI/ML system tested on data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For mechanical testing, the "ground truth" is measured physical properties and performance under specific conditions as defined by ASTM standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary based on available information:

The study proving the device meets acceptance criteria was a series of mechanical tests on the worst-case configurations of the Phantom™ nail, locking screws, and threaded pegs. These tests were conducted according to ASTM F382 (for static and dynamic bending of the nail) and ASTM F543 (for torsion, insertion/removal, and pullout of the screws/pegs). The acceptance criteria were met by demonstrating substantial equivalence in mechanical performance and technological characteristics to the predicate device, the ParaLock Plating System™ (K140397). The document does not specify the exact number of units tested for mechanical properties, or the numerical thresholds for passing, but rather states that the comparison demonstrated substantial equivalence.

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The AOS Anterolateral Proximal Humeral Plate is indicated for fracture dislocations, osteotomies, and nonunions of the proximal humerus.

The AOS Anterolateral Proximal Humeral plates are open reduction internal fixation devices for the temporary fixation of various types of fractures of the humerus and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Anterolateral Proximal Humeral System consists of titanium plates, and proximal and distal locking and non-locking screws.

The provided text describes a 510(k) premarket notification for the "AOS Anterolateral Proximal Humeral Plate." This document is an FDA letter recognizing the device as substantially equivalent to a legally marketed predicate device. As such, it does not contain acceptance criteria or a study proving the device meets those criteria, as these are typically part of a performance study, not a substantial equivalence claim.

Substantial equivalence is established primarily by demonstrating that the new device has the same intended use and the same technological characteristics as the predicate device, or if there are differences, that they do not raise new questions of safety and effectiveness. The document explicitly states: "physical testing was deemed unnecessary, and substantial equivalence was determined in strength and geometry between the proposed plates and predicate plates."

Therefore, based on the provided text, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because such a study was not deemed necessary for this 510(k) submission.

Specifically, I cannot extract:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses on explaining that the new device (AOS Anterolateral Proximal Humeral Plate) is substantially equivalent to a previously cleared predicate device (AOS Proximal Humeral Plate, K080590) because they share the same indications for use, similar geometry and design, fundamental scientific technology, and material.

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The Orthofix Contours Proximal Humeral Plate (PHP) is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.

The Orthofix Contours Proximal Humeral Plate (PHP) is a modified version of the Orthofix Titanium Humeral Plating System "LSP", cleared under 510(k) K062920. Like the predicate device, the Orthofix Contours Proximal Humeral Plate (PHP) is a locking titanium plate intended for the treatment of fractures. osteotomies and non-unions of the proximal humerus. The Orthofix Contours Proximal Humeral Plate (PHP) consists of a left and a right plate that has to be used in combination with at least two Diaphyseal Screws, a main locking screw and at least two titanium hexagonal Fine Threaded Screws. In addition titanium/polymeric cerclage wires can be used to achieve further stabilization of the bone fragments. Instrumentation is available for the insertion of the plates and screws. The modifications introduced with the Orthofix Contours Proximal Humeral Plate (PHP) are summarized below: - Dimensional changes, concerning width and central part height of the plate, diameter of some fixation points and lengths of the revision screws. - Sterilization configuration: Orthofix Contours Proximal Humeral Plate (PHP) will be sold in a sterile configuration while the predicate device, Orthofix Titanium Humeral Plating System "LSP" is sold in a non-sterile configuration. - Packaging configuration: as the Orthofix Contours Proximal Humeral Plate (PHP) will be sold in a sterile configuration, the packaging will be modified with respect to the predicate device.

This document describes a 510(k) premarket notification for the Orthofix Contours Proximal Humeral Plate (PHP). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) would.

Therefore, the requested information regarding acceptance criteria, specific device performance metrics, sample sizes for test and training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable in this context.

Here's an explanation based on the provided document:

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

• Not Applicable. This document does not describe acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI-driven device. It's for a medical implant and focuses on mechanical equivalence.

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

• Not Applicable. No test set for clinical performance is mentioned. The study referenced (mechanical testing) would involve physical samples of the device, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. Ground truth for clinical interpretation by experts is not relevant to this submission for a bone plate.

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

• Not Applicable. Clinical adjudication methods are not relevant to this submission.

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 not an AI-driven device and no MRMC study was performed or is relevant.

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

• Not Applicable. This is not an algorithm or AI device.

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

• Not Applicable. The "ground truth" in this context is the mechanical performance standards set by ASTM (American Society for Testing and Materials) for bone plates.

8. The sample size for the training set:

• Not Applicable. There is no training set mentioned, as this is not an AI/ML device.

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

• Not Applicable. There is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the 510(k) document):

The "study" in this context is mechanical testing to demonstrate substantial equivalence to a predicate device, rather than a clinical trial.

• Acceptance Criteria (Implicit): The implicit acceptance criteria are that the mechanical strength of the Orthofix Contours Proximal Humeral Plate (PHP) must be equivalent or better than the predicate device, Orthofix Titanium Humeral Plating System "LSP". This is based on specific ASTM standards.

• Study Description:

  • Type of Study: Non-clinical (mechanical) testing.
  • Standards Used: The testing was conducted in accordance with ASTM F384-06 (Standard Specification for Metallic Bone Plates) and ASTM F382-99 (Standard Specification for Metallic Bone Plates). These standards specify methods for evaluating the mechanical properties of bone plates.
  • Reported Device Performance: "Testing in accordance with ASTM F384-06 and ASTM F382-99 shows the mechanical strength of the Orthofix Contours Proximal Humeral Plate (PHP) to be equivalent or better than the predicate devices." (Page 2, Section 6 and Page 3, Section 7)
  • Comparison: The results were compared directly against the mechanical performance of the predicate device, the Orthofix Titanium Humeral Plating System "LSP" (K062920).
  • Conclusion: Based on these mechanical test results, alongside similarities in design, materials, and intended uses, Orthofix concluded that the Contours Proximal Humeral Plate (PHP) is substantially equivalent to the predicate device.

Key takeaway for this document: The focus of a 510(k) for a medical implant like a bone plate is primarily on demonstrating substantial equivalence to a previously cleared device through comparisons in design, materials, intended use, and non-clinical performance (like mechanical strength) rather than extensive clinical efficacy or diagnostic performance studies.

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The AOS Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The AOS Proximal Humeral Plate is an internal fixation device for the fixation of fractures of the humeral head and is intended as a load sharing device which may be removed once the fracture has healed.

The plate is manufactured in multiple lengths with the overall length of the plate ranging from 97mm to 236mm. The proximal portion has eight 135° angled holes to accept 4.0mm locking screw. The distal portion has 3, 5, 8, 11 and 14 hole configurations which will accept a 4.0mm locking screw or a 3.5mm cortical screw. There are three associated screws for the AOS Proximal Humeral Plate; the 4.0mm fully threaded locking screws, the 4.0mm partially threaded locking screw and the 3.5mm cortical screw. The AOS Proximal Humeral Plates and screws are manufactured from titanium alloy.

The overall length of the AOS Proximal Humeral Plate ranges from 97mm to 236mm while the proximal portion is consistent for all plates at 48mm. The proximal portion of the plate contains 8 threaded holes that accept the 4.0mm partially threaded cancellous locking screw. The proximal portion of the plate also contains six suture holes and a 2.0mm hole for positioning.

The distal shaft of the plate is manufactured in 3, 5, 8, 11 and 14 hole configurations with the first hole being a slot. These threaded holes are staggered through the length of the plate and accept a 4.0mm fully threaded cancellous locking screw or the 3.5mm cortical screw.

The provided document is a 510(k) premarket notification for a medical device called the "AOS Proximal Humeral Plate." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a new clinical study. Therefore, the information requested about acceptance criteria, study details, and performance metrics for the device itself (like AI performance) is not directly present in this document, as it outlines a comparison to a predicate device.

Specifically, the document states: "The AOS Proximal Humeral Plate and the predicate Synthes (USA) Proximal Humeral Plate have the same indication for use, similar design geometry and are manufactured from similar material. Therefore, mechanical testing to support Substantial Equivalence was not necessary." This means the assessment was primarily based on design and material similarity to an already approved device, rather than new performance testing.

Here's an attempt to answer the questions based on the information provided, highlighting what is not applicable:

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

• Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission relying on similarity to a predicate device. The "acceptance criteria" here is that the device is substantially equivalent to the predicate.
• Reported Device Performance: Not reported in terms of specific numeric performance metrics, as direct performance testing was deemed unnecessary due to substantial equivalence.

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

• Not applicable. This is not a study that involved a test set with patient data. It's a regulatory submission based on comparison to an existing device.

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. No ground truth was established by experts for a test set in this context. The "ground truth" for substantial equivalence is the predicate device and its established safety and effectiveness.

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

• Not applicable. No test set requiring 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 for internal fixation, not an imaging device or AI-assisted diagnostic tool.

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

• Not applicable. This is a physical orthopedic implant, not an algorithm.

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

• The "ground truth" in the context of a 510(k) submission for substantial equivalence is the safety and effectiveness profile of the predicate device. This profile is established through its own prior approvals, clinical use, and potentially pre-market or post-market studies of the predicate. No new ground truth, in the sense of expert consensus, pathology, or outcomes data for the AOS Proximal Humeral Plate, was generated for this submission.

8. The sample size for the training set

• Not applicable. There was no training set for a study described in this document.

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

• Not applicable. There was no training set for a study described in this document.

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The Synthes (USA) Modular Blade Plate System is indicated for fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

The Synthes (USA) Modular Blade Plate System is comprised of a spiral blade that attaches to one end of a side plate, secured with a coupling screw to create a fixed angle construct. The Modular Plates are available in various configurations - 90°, 110°, 120° and 130° plates with off-sets, and 95° or 130° plates without off-sets. The Modular Plates have standard locking-compression holes (LCP) in the shaft and are available in a variety of lengths to accommodate varying injury, patient anatomy and size. The Modular Plates are available to be used with 4.5 mm Cortex screws or 5.0 mm Locking screws. The Spiral Blades rotate 90° clockwise or counterclockwise over the length of the blade. A variety of lengths are available to accommodate varying patient anatomy. The coupling screw is one size fits all plate and blade configurations.

This document is a 510(k) summary for the Synthes (USA) Modular Blade Plate System. It describes the device, its intended use, and states that it is substantially equivalent to predicate devices. However, this submission does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The provided text from K080109 mainly consists of:

• 510(k) Summary: Manufacturer contact, device name, classification, predicate device, device description, and intended use.
• FDA Letter: Formal notification from the FDA regarding the 510(k) clearance, confirming substantial equivalence and outlining regulatory responsibilities.
• Indications for Use Form: A standard FDA form reiterating the intended use of the device.

There is no mention of performance data, clinical trials, or any studies designed to establish acceptance criteria or demonstrate the device's efficacy or safety against such criteria. The FDA clearance is based on substantial equivalence to a predicate device, meaning it is deemed as safe and effective as a legally marketed device, not necessarily on performance against specific, pre-defined acceptance criteria demonstrated through a new study.

Therefore, I cannot populate the requested table and information as the input text does not contain this data.

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The Orthofix Titanium Humeral Plating System is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.

The Orthofix Titanium Humeral Plating System consists of bone plates and locking screws, made of a titanium alloy. The bone plate included in the system is designed to treat fractures of the proximal humerus and come in a right and left version.

The plate has several locking options for the insertion of Fragment Fixations System implants (FFS), thus allowing a customized fragment adapted approach. Accessories include a cover to protect the ends of the FFS and a screw to lock this cover on the plate.

Instrumentation is available for the insertion of the plates and screws.

The provided document is a 510(k) summary for the Orthofix Titanium Humeral Plating System "LSP". This document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria related to AI or algorithm performance.

Instead, it's a submission for a medical device (bone plate system) seeking marketing clearance based on substantial equivalence to a predicate device. This type of regulatory submission primarily focuses on demonstrating that the new device is as safe and effective as another legally marketed device, rather than on proving performance against a set of quantitative metrics for an AI system.

Therefore, I cannot provide the requested information from the given text because it is not present in this 510(k) summary.

Here's why and what kind of information is present:

• Type of Device: The device is a "Orthofix Titanium Humeral Plating System 'LSP'", which consists of bone plates and locking screws. This is a physical orthopedic implant, not an AI/software device.
• Regulatory Pathway: The submission is a 510(k) for substantial equivalence. This pathway typically compares a new device's design, materials, and intended use to an existing predicate device to demonstrate similar safety and effectiveness.
• Lack of Performance Study for AI: The document does not describe any AI/algorithm component, nor does it refer to any studies evaluating AI or algorithmic performance, acceptance criteria for such, or involvement of experts for ground truth establishment.

The document primarily states:

• Intended Use: For fractures, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
• Substantial Equivalence: The device is considered substantially equivalent to a predicate device based on similarities in design, materials, and intended uses.

To directly answer your request based on the absence of the information in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance: Not present for AI/algorithm performance. The document focuses on substantial equivalence to a predicate device, not on specific quantitative acceptance criteria for an AI system.
2. Sample size used for the test set and the data provenance: Not applicable or not provided, as no AI performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth for an AI assessment is described.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) document is for a traditional medical device (bone plate system) and does not contain any information related to AI or algorithmic performance, acceptance criteria, or studies as requested.

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The device is used for internal fracture fixation of small bone (toe, finger etc) and reconstruction of Mandible & Maxilla. (Craniomaxillofacial Skeleton).

Leforte system bone plate is made of unalloyed Titanium (ASTM F67-95 G1) and is manufactured and intended for internal fixation of small bones (toc, foot, finger, hand etc.) and reconstruction of Mandible & Maxilla. (Craniomaxillofacial Skeleton). Jeil Medical Co., Ltd. utilizes the state of the art technology and apply the essential requirement of MDD (93/42/EEC) and ISO 14630. 1997 from the device design to manufacturing and QC..

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, the document is a 510(k) summary for the "Leforte System Bone Plate," a medical device used for internal fracture fixation. The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device already on the market, not to prove specific performance against acceptance criteria in a study.

The document focuses on:

• Device Identification: Proprietary and classification names, product code.
• Equivalent legally marketed devices (predicates): Osteo BOS™ System, Lorenz Small Fragment System, and Syntec-Taichung Non-sterile Titanium Mimi Plate.
• Indications for Use: Internal fracture fixation of small bones (toe, finger) and reconstruction of Mandible & Maxilla.
• Description of the Device: Material (unalloyed Titanium, ASTM F67-95 G1) and manufacturing standards (MDD 93/42/EEC and ISO 14630.1997).
• Potential Adverse Effects and Complications: A list of common adverse effects associated with bone fixation devices.
• Safety and Effectiveness, comparisons to predicate devices: A table comparing the Leforte System Bone Plate to its predicates based on classification, applicant, 510(k) number, material, and intended use. The key takeaway from this section is the conclusion of substantial equivalence.
• Conclusion: States that the Leforte System Bone Plates are equivalent to currently marketed devices, made of the same materials, and have similar dimensions and characteristics, with identical potential adverse effects.
• FDA Clearance Letter: A letter from the FDA confirming the substantial equivalence determination for the K023360 submission.
• Indications for Use Statement (from FDA): Reconfirms the intended uses.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, study design, sample sizes, expert qualifications, or ground truth, as this information is not present in the provided text. The document is an FDA submission for substantial equivalence, which is a regulatory pathway that relies on demonstrating similarity to existing devices rather than new performance studies against predefined acceptance criteria.

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Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation oand treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.

External fixation devices are specially designed frames, clamps, rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.

The provided text describes a 510(k) submission for "Reprocessed External Fixation Devices" by Alliance Medical Corporation. This submission focuses on demonstrating substantial equivalence to predicate devices, not on a new, AI-powered diagnostic or therapeutic device. As such, many of the requested criteria (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, AI improvement effect size) are not applicable to this type of submission.

The core of this submission is about proving that reprocessing existing external fixation devices does not alter their safety and effectiveness compared to new, predicate devices.

Here's an analysis of the available information based on your request:

Description of Acceptance Criteria and Study to Prove Device Meets Them

The acceptance criteria for the "Reprocessed External Fixation Devices" are implicitly tied to demonstrating that the reprocessed devices perform identically to their original, new counterparts, and to the predicate devices, in terms of safety and effectiveness. The study described focuses on proving that the reprocessing procedure maintains these critical performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for the devices tested as part of the "bench and laboratory testing."
• Data Provenance: The data comes from "bench and laboratory testing" conducted by Alliance Medical Corporation. No country of origin is specified for the data itself, but the submitter is based in Phoenix, Arizona, USA. The testing is retrospective in the sense that it evaluates the performance of reprocessed versions of already existing devices. It is not prospective clinical trial data.

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

• Not Applicable. This submission does not involve a diagnostic device or a study requiring expert readers to establish ground truth for a test set in the traditional sense (e.g., radiology interpretation). The "ground truth" here is the established performance and safety of the original, new devices and the predicate devices. The study aims to show the reprocessed device meets these existing standards, rather than defining a new ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. There is no mention of an adjudication method as it relates to expert reader interpretation. The testing is bench and laboratory-based.

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 not an AI-powered device.

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

• Not Applicable. This is not an AI-powered device or algorithm.

7. The type of ground truth used

• The "ground truth" for this submission is implicitly the established performance specifications, material properties, biocompatibility, and intended use of the original, new, and predicate external fixation devices. The study aims to demonstrate that the reprocessed devices meet these existing, well-defined standards. This is akin to using established engineering standards and material science data as a basis for comparison.

8. The Sample Size for the Training Set

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

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

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