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The Nextremity Solutions Nextra® CH Cannulated Hammertoe System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

The Nextra® CH Cannulated Hammertoe System consists of a two-part cannulated bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implant diameters range from 2.75mm to 4.2mm. The middle screw implant diameters range from 2.75mm to 5.0mm in increments of 0.75mm. The proximal and distal screw implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The system offers an optional fixation method using a Kirschner wire (K-wire) in conjunction with the screw implants for additional fixation and temporary stabilization. The K-Wire is intended to be removed at the discretion of the physician upon joint fusion. The k-wires provided are manufactured from 316 Stainless Steel conforming to ASTM F138. The system includes the necessary surgical site preparation and insertion instruments, including implant specific drivers. The implants and instruments of the system are provided sterile for single use.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "Nextra® CH Cannulated Hammertoe System." It is not a document assessing the performance of an AI/ML medical device. Therefore, the information requested about acceptance criteria, study details, human reader performance, AI standalone performance, and ground truth establishment is not present in this text.

The document focuses on demonstrating substantial equivalence of the new device to a legally marketed predicate device (K213530). This process typically relies on comparing indications for use, technological characteristics (materials, design, sizes, mechanical properties), and performance data (often non-clinical) to show that the new device is as safe and effective as the predicate.

Here's a breakdown of what can be extracted from the document, and what cannot:

What is present in the document:

• Device Name: Nextra® CH Cannulated Hammertoe System
• Indicated Use: Small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.
• Predicate Device: Nextra® CH Cannulated Hammertoe System (K213530)
• Basis for SE: "There are no differences between the subject device system and the predicate device systems. The Nextra CH Cannulated Hammertoe system is substantially equivalent to the predicate device regarding the intended use and indications, material, design, sizes, and mechanical properties."
• Non-Clinical Testing Mentioned:
  • Endotoxin testing (Limulus Amebocyte Lysate (LAL) method) - Results met the Endotoxin limit of ≤20 EU per device.
  • Clinically representative cadaver study: "evaluated by varying levels of surgeon proficiency is confirmed to produce repeating successful outcomes with equal or greater fixation compared to the standard of care." (No specific sample size or detailed outcomes provided).
  • Verification bench test: "evaluate implant assembly/disassembly force... results demonstrated the average assembly force of the implants threaded into bone foam by the subject device driver is greater than the average assembly force of implants threaded into bone foam by the predicate driver." (No specific quantitative acceptance criteria or results beyond "greater than" provided).
• Absence of Clinical Testing: "Clinical testing was not necessary to demonstrate substantial equivalence of the Nextra CH Cannulated Hammertoe System to the predicate device."

What is NOT present in the document (and therefore cannot be answered from the provided text):

1. A table of acceptance criteria and the reported device performance (in the context of AI/ML evaluation): The document refers to "acceptance criteria" only implicitly through "meeting the Endotoxin limit" and "greater than" for assembly force, but these are not specific quantitative values for a device performance study in the way you've outlined for an AI/ML system. There are no detailed tables of performance metrics.
2. Sample size used for the test set and the data provenance: While a "clinically representative cadaver study with statistically relevant sample size" is mentioned, the specific sample size is not disclosed. Data provenance (country, retrospective/prospective) is also not stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML system is not relevant here. The cadaver study involved "varying levels of surgeon proficiency," but not for establishing ground truth as you've defined it.
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. This device is a physical medical implant, not an AI/ML diagnostic system.
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 (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/ML system's evaluation. For the cadaver study, "successful outcomes" and "fixation" were evaluated, but the method for establishing "ground truth" (e.g., a definitive measure of fusion success) for that study is not detailed here.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided text is an FDA 510(k) clearance letter and summary for a physical orthopedic implant. It does not contain the information requested about the evaluation of an AI/ML medical device.

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The Nextremity Solutions CalcShift™ Displacement Calcaneal Osteotomy System is indicated for osteotomies, nonunions, malunions, revisions, fusions, and reconstruction of the calcaneus requiring a medial or lateral displacement osteotomy.

The CalcShift Displacement Calcaneal Osteotomy System is a foot and ankle plate and screw system consisting of a plate and screw implants. The plate is 1.6mm thick, 19.75mm long, and 11.5mm wide. The plate has 4 screw holes. The system provides locking and non-locking screws that are 3.5mm in diameter and range in length from 10mm to 70mm. The system includes cannulated compression screws and cannulated stability screws that are 5.0mm in diameter and range from 30mm to 100mm in length. The plate and screws are provided sterile. The plates and screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.

This document is a 510(k) premarket notification for a medical device called the CalcShift™ Displacement Calcaneal Osteotomy System. It details the device's indications for use, description, and the non-clinical testing performed to demonstrate its substantial equivalence to predicate devices. Crucially, the document explicitly states that clinical testing was not necessary for this device. Therefore, a study proving the device meets acceptance criteria, as defined by a clinical study with an AI component, was not performed or submitted for this specific 510(k) clearance.

Given this, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (as these are typically derived from clinical study outcomes)
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size regarding human reader improvement with AI assistance
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document's "Non-Clinical Testing" section describes mechanical tests performed on the device (e.g., axial pullout strength, torque to failure, 4-point bend tests) to ensure its performance and safety are comparable to existing predicate devices. The acceptance criteria for this device are therefore primarily based on these mechanical test results meeting established ASTM standards (ASTM F543-17 and ASTM F382) and demonstrating substantial equivalence to the predicate devices in terms of strength and adequacy for intended use.

In summary, this 510(k) relies on non-clinical bench testing for device acceptance, not clinical testing, and definitely not a study involving AI performance or human-in-the-loop evaluation as would be typical for an AI/ML medical device.

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The StealthFix Intraosseous Fixation System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:

• · Arthrodesis in hand or foot surgery
• · Mono or bi-cortical osteotomies in the foot or hand
• · Fracture management in the foot or hand
• · Distal or proximal metatarsal or metacarpal osteotomies
• · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.

The StealthFix Intraosseous Fixation System is an orthopedic intraosseous staple system consisting of staple and screw implants. The staples consist of two legs or posts connected by a bridge. The staples are available in post diameters of 2.5mm(mini), 3.5mm(small) and 4.5mm(standard). The 2.5mm staples are provided with a bridge span of 10mm and range in post length from 8mm to 12mm. The 3.5mm staples are provided with a bridge span of 15mm and range in post length from 14mm to 20mm. The 4.5mm staples are available in bridge spans of 15mm and 20mm and range in post length from 14mm to 32mm. The system provides crossing screws for optional fixation with the standard staple implants. Standard staples are designed with a screw slot to accept a crossing screw. The screws are 3.5mm in diameter with lengths ranging from 16mm to 38mm in 2mm increments. The system provides accessory instruments designed for preparation of the implant site and insertion of implants into bone, including implant specific inserters and targeting arms. The implants of the system are available packaged both sterile and non-sterile for single use. The instruments are provided non-sterile, reusable or non-sterile, single use and must be cleaned and sterilized by the end user prior to use. The system also provides some instruments sterile packaged, individually and in sets.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "StealthFix Intraosseous Fixation System." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the context of an AI/software device.

Therefore, many of the requested categories related to AI/software performance studies are not applicable to this type of regulatory submission. This document describes a traditional hardware medical device.

Here's the breakdown based on the provided information, with explanations for why certain sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not provide specific quantitative acceptance criteria or device performance metrics in the way an AI/software device would (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating equivalence through material, design, and mechanical properties.

   Acceptance Criteria Category	Specific Criteria (Not explicitly stated as quantitative values for a software device)	Reported Device Performance
   Biocompatibility	Endotoxin limit ≤ 20 EU per device	Met the Endotoxin limit
   Mechanical Properties	Not creating a new worst-case for:	Engineering analysis performed; modified staples/screws do not create a new worst case for these tests.
   	- Static and dynamic 4-point bend testing (staples)
   	- Pullout force (staples) (ASTM F564)
   	- Torsional strength (screws) (ASTM F543)
   	- Pullout strength (screws) (ASTM F543)
   	- Insertion performance (screws) (ASTM F543)
   Substantial Equivalence	Equivalence in intended use, indications, material, design, sizes, mechanical properties to predicate device.	Achieved; differences do not raise new safety/effectiveness questions.

2. Sample sizes used for the test set and the data provenance: Not applicable. This is a hardware device. The "tests" mentioned were engineering analyses and biocompatibility testing, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set with ground truth established by experts is described for this hardware device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the same reason as above.

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 an orthopedic fixation system, not an AI/software diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance relies on engineering principles and biocompatibility standards, not clinical outcomes or expert consensus on diagnostic interpretations.

8. The sample size for the training set: Not applicable. No training set is involved for this hardware device.

9. How the ground truth for the training set was established: Not applicable. No training set or associated ground truth.

Study Proving the Device Meets Acceptance Criteria (as described in this 510(k) submission):

The primary "study" that proves this device meets the regulatory acceptance criteria for 510(k) clearance is a demonstration of Substantial Equivalence to a legally marketed predicate device (K163440 - Stealth Staple System, First Ray LLC).

• Non-Clinical Testing:

  • Biocompatibility: Endotoxin testing was performed using the Limulus Amebocyte Lysate (LAL) method according to AAMI ST72, USP 161, and USP 85. The results met the endotoxin limit of ≤20 EU per device.
  • Mechanical Performance: An engineering analysis was conducted. This analysis ensured that modifications made to the subject device (increased internal thread length in staple posts, non-cannulated screws) did not create a new worst-case scenario for several mechanical tests that would typically be performed on such devices. These tests include:
    • Static and dynamic 4-point bend testing (for staples)
    • Pullout force (for staples, according to ASTM F564)
    • Torsional strength (for screws, according to ASTM F543)
    • Pullout strength (for screws, according to ASTM F543)
    • Insertion performance (for screws, according to ASTM F543)

• Clinical Testing: The submission explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the StealthFix Intraosseous Fixation System to the predicate device." This is a common aspect of 510(k) submissions where non-clinical data is deemed sufficient to establish equivalence.

• Conclusion: The submission concludes that "The StealthFix Intraosseous Fixation System is substantially equivalent to the predicate devices regarding its intended use, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise different types of safety and effectiveness questions." This statement is the ultimate proof that the device, for the purposes of this FDA submission, "meets the acceptance criteria" of being substantially equivalent to a predicate.

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The Nextremity Solutions InCore® Subtalar System is intended for reduction and internal fixation of arthrodeses, osteotomies, and nonunions of the bones and joints of the foot. The three-part construct is specifically intended for internal fixation for Subtalar Joint Arthodesis (also known as Subtalar Joint Fusion).

The InCore® Subtalar System consists of a post and two headless compression screws. Posts are available with an 8.0 mm diameter, in an 28mm length, and in right and left orientations. Screws are available in a 5.5 mm diameter and lengths of 50 to 120mm. The post is inserted into the talus and compression screws are inserted into the calcaneus and into the post to maintain apposition of the bones during fusion. A post plug screw is threaded into the top of the post after all components have been implanted to prevent tissue ingrowth into the post and facilitate removal, if needed. All implants are manufactured from color anodized Ti-6Al-4V alloy conforming to ASTM F-136.

The system is provided with a set of accessory instruments, including an implant specific targeting guide, designed for preparation of the implant site and insertion of the implants into bone.

The provided text describes a 510(k) premarket notification for a medical device called the InCore® Subtalar System. This document does not include information about AI/ML device performance, acceptance criteria for an algorithm, or a study that proves a device meets such criteria.

The information provided is typical for a medical device clearance, focusing on:

• Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.
• Device Description and Intended Use: What the device is and what it's used for (internal fixation of bone arthrodeses, osteotomies, and nonunions in the foot, specifically subtalar joint arthrodesis).
• Non-Clinical Testing: Mechanical and biocompatibility tests (e.g., torque to failure, three-point bend tests, endotoxin testing) to ensure the device's physical properties and safety.
• Clinical Testing: The document explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of the InCore® Subtalar System to the predicate device." This means no human clinical trials were conducted for this submission.

Therefore, I cannot extract the requested information regarding acceptance criteria, AI/ML study performance, sample sizes, expert involvement, or ground truth establishment for an AI/ML device from this document. The device described is a physical implant (bone screw system), not an AI algorithm.

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The Nextremity Solutions Nextra CH Cannulated Hammertoe System is intended for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

The Nextra® CH Cannulated Hammertoe System (originally cleared as DuoHex™ CH Cannulated Hammertoe System- K200840) consists of a two-part cannulated bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implant diameters range from 2.75mm to 4.2mm. The middle screw implant diameters range from 2.75mm to 5.0mm in increments of 0.75mm. The proximal and distal screw implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The system offers an optional fixation method using a Kirschner wire (K-wire) in conjunction with the screw implants for additional fixation and temporary stabilization. The K-Wire is intended to be removed at the discretion of the physician upon joint fusion. The k-wires provided are manufactured from 316 Stainless Steel conforming to ASTM F138. The system includes the necessary surgical site preparation and insertion instruments, including implant specific drivers. The implants and instruments of the system are provided sterile for single use.

This FDA submission is for the Nextra® CH Cannulated Hammertoe System, a medical device, not an AI/ML algorithm. Therefore, the questions regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets are not applicable in the context of an AI/ML device.

Here's why and what information is available in the provided document:

Why the questions are not applicable:

The provided text is a 510(k) premarket notification for a physical medical device (implants and instruments for Hammertoe surgery). The questions in your prompt are specifically designed to evaluate the performance and validation of Artificial Intelligence (AI) or Machine Learning (ML) algorithms, which require different types of testing and validation compared to hardware medical devices.

What is available in the document regarding device performance and criteria:

The FDA letter and 510(k) summary pertain to demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria for an AI model.

Here's a breakdown of what the document does provide in relation to traditional medical device clearance:

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

   • Acceptance Criteria (Implied by Substantial Equivalence): The primary "acceptance criteria" for this type of device clearance is demonstrating substantial equivalence to a predicate device in terms of:
     • Intended Use
     • Materials
     • Design
     • Sizes
     • Mechanical Properties
   • Reported Device Performance (as demonstrated for substantial equivalence):
     • Non-Clinical Testing: Endotoxin testing was performed using the Limulus Ameebocyte Lysate (LAL) method (AAMI ST72, USP 161 and USP 85). Results met the Endotoxin limit of ≤20 EU per device. This is a safety criterion, not a functional performance criterion in the AI sense.
     • Mechanical Properties: The summary states that differences in mechanical properties do not raise new safety or effectiveness concerns, implying that the mechanical properties are considered equivalent or acceptable. Specific numerical performance values are not given in this summary.

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 for an AI/ML device. For this physical device, there wasn't a "test set" in the AI sense. The evaluation was based on engineering principles, materials science, and a 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 for an AI/ML device. Ground truth establishment by experts pertains to diagnostic or analytical AI systems.

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

   • Not applicable for an AI/ML device.

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 for an AI/ML device. This type of study is relevant for AI-assisted diagnostic tools.

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

   • Not applicable for an AI/ML device.

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

   • Not applicable for an AI/ML device. For a physical implant, "ground truth" relates to its physical and biological performance, which is assessed through material testing, biocompatibility studies (like endotoxin testing), and clinical experience with the predicate device.

8. The sample size for the training set:

   • Not applicable for an AI/ML device. There is no "training set" for a physical implant.

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

   • Not applicable for an AI/ML device.

In summary, the provided document details the regulatory clearance of a physical medical device based on substantial equivalence, not the validation of an AI/ML algorithm.

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The Stratum Ankle Fusion Plating System is indicated for use in stabilization of fractures or osteotomies, intra and extra articular fractures, and multi-fragmentary fractures, non-union and malunion, joint fusion and reconstruction of small bones of the feet and ankles including the distal tibia, talus, and calcaneus.

The Stratum Ankle Fusion Plating System is a foot and ankle plating system consisting of plates and screw implants. The plates are 3.5mm thick, range in length from 73.66mm to 107.70mm, and range in width from 22.10mm to 40.64mm. The plates have between 10 and 13 locking screw holes and 1 to 2 slots. The plates are provided sterile. The system provides locking and nonlocking screws that are available in diameters of 3.5mm and range in length from 10mm to 80mm. The screws are provided sterile and non-sterile. The system includes cannulated crossing screws that are 6.5mm in diameter and range from 26mm to 90mm in length. The cannulated screws are provided sterile. The plates and screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136.

The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.

This document is lacking the essential information requested in the prompt, such as acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy, AUC), sample sizes for test and training sets, details on expert ground truth establishment, adjudication methods, and explicit mention of standalone or MRMC studies.

The provided text describes a 510(k) premarket notification for a medical device called the "Stratum Ankle Fusion Plating System." This is a metallic bone fixation appliance, and the FDA has determined it is substantially equivalent to legally marketed predicate devices. The document focuses on regulatory compliance, device description, indications for use, and non-clinical testing to demonstrate mechanical equivalence. It explicitly states that clinical testing was not necessary for substantial equivalence.

Therefore, I cannot fulfill the request as the provided text does not contain the required information about acceptance criteria, performance studies (clinical or AI-related), sample sizes, expert ground truth, or adjudication methods. The device is a physical bone fixation system, not a software or AI-based diagnostic device that would typically undergo such performance evaluation.

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The Nextremity Solutions Nextra PEEK Hammertoe Correction System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

The Nextra PEEK Hammertoe Correction System consists of a two-part mating bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implants are available in diameters of 3.2mm and 4.2mm. The middle screw implant is available in diameters of 3.5mm, 4.25mm, and 5.0mm, with 0° and 10° angled options. The proximal and distal screw implants are manufactured from polyetheretherketone (PEEK) conforming to ASTM F2026. The system includes implant specific drivers and taps, and other necessary surgical site preparation instruments. The implants and instruments of the system are provided sterile for single use.

Here's a breakdown of the acceptance criteria and study information for the Nextra® PEEK Hammertoe Correction System, based on the provided FDA 510(k) summary:

This device did not undergo clinical testing to demonstrate substantial equivalence. Instead, the submission relies on non-clinical testing to compare its performance to predicate devices. This means that many of the typical elements of an AI/medical device performance study (like sample size, ground truth, expert adjudication, MRMC studies) are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not detail specific sample sizes for the non-clinical tests beyond "worst-case implant construct" for mechanical testing. Data provenance is not applicable as this was non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for non-clinical testing (like material properties and mechanical strength) is established through standardized testing procedures and material specifications, not expert interpretation.

4. Adjudication method 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
No, a multi-reader multi-case comparative effectiveness study was not done. This device is an implant, not an AI-assisted diagnostic or treatment planning tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation was based on:

• Standardized Endotoxin Limits: Defined by AAMI ST72, USP 161, and USP 85.
• Standardized Mechanical Testing Protocols: Defined by ASTM F2193-18a and comparison to the mechanical properties of legally marketed predicate devices.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established
Not applicable.

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The Nextremity Solutions Stratur " Reduced Size Foot Plating System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the foot and ankle, particularly in ostopenic bone.

The Stratum™ Reduced Size (RS) Foot Plating System is a foot and ankle plating system consisting of plate and screw implants. The plates range in length from 25.5mm and in width from 6.35mm to 18mm and feature between 2 and 10 screw holes. There is one diameter, 2.4mm, for all screw types including locking, non-locking, and MDS screws. The screws range in length from 8mm to 50mm and are provided sterile. The system also includes a sterile set of accessory instruments along with individually packaged drill guides / drill bits, screw driver shafts, threaded wire with nut, and olive wires designed for preparation of the implant site and insertion of devices into the bone. The plates, screws, instrument kits, drill guide / drill bits, screw driver shafts, threaded wire with nut, and olive wires are all packaged individually in separate sterile packaging. The plates, non-locking and locking screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The multi-directional locking screws are manufactured from Co-Cr-Mo conforming to ASTM F1537.

This document is a 510(k) premarket notification for the Stratum™ Reduced Size Foot Plating System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against defined acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, and training set information is not applicable or available in this document.

Here's an analysis of what can be extracted:

Acceptance Criteria and Device Performance

A formal table of acceptance criteria and reported device performance, as one would see in a detailed performance study, is not provided in this 510(k) submission.

Instead, the submission states that:

• Mechanical Testing: "The strength of the worst-case Stratum Reduced Size Foot Plating System plates and screws is substantially equivalent to predicate devices with similar indications and is adequate for their intended use."
• Bacterial Endotoxin Testing: "Endotoxin levels meet the requirement of **

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The Nextremity Solutions DuoHex™ CH Cannulated Hammertoe System is intended for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

The DuoHex™ CH Cannulated Hammertoe System consists of a two-part cannulated bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implant diameters range from 2.75mm to 4.2mm. The middle screw implant diameters range from 2.75mm to 5.0mm in increments of 0.75mm. The proximal and distal screw implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The system offers an optional fixation method using a Kirschner wire (K-wire) in conjunction with the screw implants for additional fixation and temporary stabilization. The K-Wire is intended to be removed at the discretion of the physician upon joint fusion. The k-wires provided are manufactured from 316 Stainless Steel conforming to ASTM F138. The system includes the necessary surgical site preparation and insertion instruments.

This document describes a medical device, the DuoHex™ CH Cannulated Hammertoe System, and its clearance by the FDA based on substantial equivalence to predicate devices. It does not present clinical performance data or studies against specific acceptance criteria for AI/ML-driven medical devices.

Therefore, I cannot provide the details requested in your prompt for acceptance criteria and study data for an AI/ML device. The provided text is a 510(k) summary for a non-AI/ML medical device (bone screw system) and primarily relies on mechanical testing and comparison to existing products for substantial equivalence.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the DuoHex™ CH Cannulated Hammertoe System to the predicate device." This means no clinical study was performed to "prove the device meets the acceptance criteria" in the way you've described for an AI/ML system.
• The device is a "Bone Screw System" for hammertoe correction, a mechanical implant, not an AI/ML diagnostic or therapeutic guidance tool.
• The "Non-Clinical Testing" section describes mechanical and material tests (axial pull-out strength, torque to failure, static/dynamic 3-point bend tests) and endotoxin testing, not performance metrics like sensitivity, specificity, or AUC as would be relevant for an AI/ML system.

To answer your request, if this were an AI/ML device, and assuming a hypothetical scenario where the document would contain the necessary information, a typical response would look like this (but again, this is NOT supported by the provided text):

Hypothetical Acceptance Criteria and Study for an AI/ML-Driven Hummer Toe Diagnostic System (Illustrative - NOT based on the provided document)

Let's imagine, for the sake of demonstrating the structure, that the DuoHex™ CH system included an AI component that diagnosed hammertoe severity from medical images.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The actual document does not contain any such performance metrics as it's for a mechanical device.

2. Sample Size and Data Provenance

• Test Set Sample Size: 500 patient cases (e.g., foot X-rays)
• Data Provenance: Retrospective data collected from multiple clinical sites across the United States and Europe (e.g., Germany, UK).

Note: The actual document does not mention any test set or data provenance in this context.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: 3 independent orthopedic radiologists.
• Qualifications: Each radiologist had at least 15 years of experience specializing in musculoskeletal imaging, with a focus on foot and ankle pathologies. All were board-certified in their respective countries.

Note: The actual document does not mention any experts for ground truth establishment.

4. Adjudication Method for Test Set

• Adjudication Method: 2+1 Adjudication. If at least two out of three experts agreed on a diagnosis (e.g., severity of hammertoe), that was considered the provisional ground truth. In cases of disagreement (e.g., 1-1-1 split), a fourth senior orthopedic surgeon (with 25+ years experience) acted as a tie-breaker/final adjudicator.

Note: The actual document does not mention any adjudication method.

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

• Was an MRMC study done? Yes.
• Effect Size of Human Reader Improvement:
  • Without AI assistance: Average diagnostic accuracy of human readers was 78%.
  • With AI assistance (AI-assisted read): Average diagnostic accuracy of human readers improved to 89%.
  • Effect Size: The AI assistance led to an average increase of 11 percentage points in diagnostic accuracy for human readers (p

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The Nextremity Solutions InCore® MPJ System is a three-part construct intended for internal fixation for First Metatarsophalangeal Joint Arthrodesis (also known as 1st MPJ Fusion).

The InCore MPJ System consists of a post and two headless compression screws. Posts are available with a 4.9mm diameter, in an 18mm length, and left orientations. Screws are available in a 2.7mm diameter and lengths of 16 to 52mm. The post is inserted into the metatarsal head and compression screws are inserted into the phalange and into the post to maintain apposition of the bones during fusion. A post plug screw is threaded into the top of the post after all components have been implanted to prevent tissue ingrowth into the post and facilitate removal, if needed. All implants are manufactured from color anodized Ti-6Al-4V alloy conforming to ASTM F-136. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.

The provided document (K200124) is a 510(k) summary for a medical device called the "InCore MPJ System," which is a bone fixation fastener. This document describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.

It explicitly states:

• Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the InCore MPJ System to the predicate device.

Therefore, there is no information available within this document regarding acceptance criteria, device performance from a clinical study, sample sizes for test or training sets, expert roles, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to an AI/ML-based medical device.

The document covers:

1. A table of acceptance criteria and the reported device performance: Not applicable, as this is a mechanical fastener, and performance is shown through mechanical testing against standards, not clinical metrics like sensitivity/specificity for an AI device. The document mentions "axial pull-out strength, torque to failure, and 3-point bend tests" conforming to ASTM standards, confirming strength and equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance: Not applicable in the context of clinical AI/ML studies. Mechanical testing was performed on "worst case compression screws" and "worst case constructs," but specific sample sizes for these mechanical tests are not detailed beyond "worst case."

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 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 the performance against established ASTM F543-13 and ASTM F1264-16 standards for strength.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In summary, this document pertains to a traditional medical device (a mechanical implant) and relies on non-clinical, biomechanical testing for substantial equivalence, not clinical studies or AI/ML performance metrics.

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