Search Results

(1) Femur Reconstruction Interlocking Nail System
The Femur Reconstruction Interlocking Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.

(2) Femur Retrograde Interlocking Nail System
The Femur Retrograde Interlocking Nail System is indicated for simple long bone fractures: severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grating; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.

(3) Humerus Interlocking Nail System
The Humerus Interlocking Nail System indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures with diaphyseal extension, diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.

(4) Tibia Interlocking Nail System
The Tibia Interlocking Nail System is intended to stabilize fractures of the proximal and distal thatt; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions.

(5) Compression Hip Nail System
The Compression Hip Nail System is intended to treat stable proximal femoral fracture including Pertrochanteric fractures, Intertrochanteric fractures and High sub trochanteric fractures and combination of these fractures.

This intramedullary fixation rod is used for stabilization of shaft fracture in humeral bone, femoral bone and tibial bone. It is implanted into medullary cavity inside of the long bone (humeral bone, femoral bone and tibial bone) with a fracture and the fractured long bone (humeral bone, femoral bone and tibial bone) is fixed to the nail by using the locking screw at the upper and lower parts of the fractured part.
The nailing system consists of the Femur Reconstruction Interlock Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, and Compression Hip Nailing System.

The provided document is a 510(k) premarket notification FDA clearance letter for an intramedullary fixation rod system. It does not contain any information about acceptance criteria, device performance, study design, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is concerned with demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical characteristics, rather than reporting on a clinical or performance study with defined acceptance criteria.

The relevant sections explicitly state:

• "Clinical Test Conclusion: Clinical testing was not required for this submission."
• "Non-clinical Test Conclusion: The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices." (lists biological and mechanical standards).

To answer your questions, I would need a different document, such as a summary of safety and effectiveness data or a clinical study report.

Ask a specific question about this device

The Adaptable Ortho Innovations Intramedullary Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions.

The Adaptable Ortho Innovations Intramedullary Nail System consists of an adjustable length intramedullary nail, locking screws, and end caps. All implants are manufactured from Ti-6Al-4V ELI per ASTM F136. The nail system is available in a range of lengths and diameters to accommodate varying patient anatomy.

This FDA 510(k) Premarket Notification is for a medical device (intramedullary nail system), not an AI/ML software device. Therefore, the typical acceptance criteria and study designs associated with AI/ML systems (such as those involving sensitivity, specificity, AUC, human reader studies, and ground truth establishment) are not applicable.

The document demonstrates substantial equivalence to predicate devices through mechanical testing and comparison of technological characteristics, not through clinical performance metrics related to diagnostic accuracy or human interpretation.

Here's an analysis based on the provided document, but understand that the questions about AI/ML performance metrics are not relevant to this type of device clearance:

1. Table of acceptance criteria and the reported device performance:

Since this is a mechanical device, the "acceptance criteria" revolve around demonstrating comparable mechanical properties to predicate devices, ensuring safety and performance in a biological and mechanical context. The document states that testing was performed per ASTM standards.

Regarding the AI/ML specific questions:

2. Sample sizes used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI/ML diagnostic. Testing involves physical samples of the nail system for mechanical property evaluation. The number of samples tested would be dictated by the relevant ASTM standards (e.g., F1264, F543).
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 a mechanical device is established through engineering and material science standards (e.g., ASTM standards for material properties, strength, fatigue).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus among human readers for image interpretation, which is not relevant here.
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/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on engineering standards, material specifications, and validated mechanical performance data (e.g., yield strength, fatigue life, torsional rigidity) obtained from physical testing of the device and its components.
8. The sample size for the training set: Not applicable. This is a hardware device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary:

The acceptance criteria for the Adaptable Ortho Innovations Intramedullary Nail System focused on demonstrating substantial equivalence to legally marketed predicate devices through robust mechanical testing (adhering to ASTM standards), material characterization, sterilization validation, and packaging/shelf-life validation. The FDA's clearance is based on the premise that these non-clinical tests are sufficient to establish that the device is as safe and effective as its predicates.

Ask a specific question about this device

The indications for use of this internal fixation device include:

• Open and closed tibial fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Fractures involving osteopenic and osteoporotic bone
• Nonunion and malunion
  The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System.

The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The T2 Alpha Tibia Nailing System is a fracture fixation system and includes sterile implants (tibial nails in various diameters, compression screw tibia and end caps) as well as non-sterile instruments (targeting devices). The sterile implants are made of titanium alloy (Ti6A14V ELI) per ASTM F136. The adapters and nail holding screws are manufactured from stainless steel. The Targeting Arm Tibia and Adjusting Device Tibia are made of stainless steel. PEEK unreinforced as well as PEEK with 30% and 50% carbon fibers. The Distal Targeting Arm Tibia is made of PEEK with 30% and 50% carbon fibers.

The IMN Screws System includes bone screws (locking screws and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. All screws are made of titanium allov (Ti6Al4V ELI) per ASTM F136.

The provided FDA 510(k) summary (K193308) for the Stryker T2 Alpha Tibia Nailing System and IMN Screws System does not contain information related to software-based medical devices, AI/ML performance, or human-reader studies. Therefore, I cannot extract the acceptance criteria and study details as requested for such systems.

The document discusses implantable medical devices (intramedullary rods and bone screws) and focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and material compatibility analyses.

Here’s a breakdown of what is available in the document, which falls under traditional medical device clearance, not AI/software:

1. Table of Acceptance Criteria and Reported Device Performance

This table would typically be relevant for software performance metrics (e.g., sensitivity, specificity, AUC). For this device, the "acceptance criteria" are implied by the mechanical testing standards and successful demonstration of substantial equivalence.

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

This information is not applicable. The "test set" here refers to physical samples for mechanical and biological testing, not a dataset for an AI model.

• Sample Size: Not specified in terms of number of devices tested, but mechanical tests were performed.
• Data Provenance: Not applicable in the context of clinical data for AI. These are laboratory-based mechanical and material test results.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. "Ground truth" in this context would be the physical properties confirmed by mechanical tests and material analyses, not human interpretation of medical images or data.

4. Adjudication Method

Not applicable. There is no adjudication process described for the mechanical test results.

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

No. The document explicitly states: "No clinical testing of the T2 Alpha Tibia Nailing System has been conducted." and "No clinical testing of the IMN Screws System has been conducted."

6. Standalone (Algorithm Only) Performance

Not applicable. This device is not an algorithm or software.

7. Type of Ground Truth Used

For mechanical testing, the "ground truth" is defined by the physical behaviors and material properties measured according to established ASTM standards (e.g., ASTM F1264 for intramedullary fixation rods, ASTM F543 for metallic bone fixation fasteners). For MR compatibility, it relates to the measured displacement, torque, heating, and artifact characteristics in an MR environment. For bacterial endotoxin, it refers to a specified endotoxin limit.

8. Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the context of AI/ML.

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

Not applicable.

Ask a specific question about this device

The intended use of the I.T.S. CONNEXX Locking Tibia Nail is to stabilize fractures of the proximal and distal tibia and the tibial shaft in a pediatric or adult patient. Indications for use include open and closed tibial shaft fractures; certain pre and post-isthmic fractures, tibial malunions and non-unions, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, metaphyseal and epiphyseal fractures, transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, bone support, and fractures with bone loss.

The I.T.S. CONNEXX Locking Tibia Nail is a fracture fixation intramedullary rod with locking/nonlocking cross-screw fixation for repairing long bone tibia fractures of a patient. The I.T.S. CONNEXX Locking Tibia Nail System is composed of a cannulated 9mm and 10mm diameter nail in various lengths (255mm to 420mm in 15mm increments) and two styles of cross-screw attachments, a 4.7mm standard cortical screw as a non-locking feature and a 4.7mm Bolt Double Thread as a non-locking feature (two thread diameters on the screw for thread engagement into the proximal and distal cortex of the tibial shaft when inserted). A cannulated 'locking key sleeve' and 'end cap' combination function to firmly fix the above two cross-screw attachments to the 9mm or 10mm nail for 'locking' the cross-screws to the tibia nail - thus making the entire IM rod/cross-screw assembly 'angle-stable locking'. All tibial rods and cross-screws are composed of high strength 6-4 ELI Titanium Alloy to ASTM F-136. A full compliment of instrumentation is available for use with the system.

The provided text is a 510(k) summary for the I.T.S. CONNEXX Locking Tibia Nail. It outlines the device's description, intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead of performance criteria and a study to prove it, the document focuses on demonstrating substantial equivalence to existing legally marketed devices. This is a common pathway for medical device approval in the United States, where a new device is shown to be as safe and effective as a predicate device already on the market, rather than necessarily performing a specific quantitative benchmark study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample size used for the test set and the data provenance: No specific test set or study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set is described.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "proof" and "acceptance":

The "proof" for this device's safety and effectiveness, as per the 510(k) process, is its substantial equivalence to existing, legally marketed predicate devices. The acceptance criteria, in this context, are implicitly that the device's design, materials, and intended use are comparable to these predicate devices.

Basis of Substantial Equivalence (from the text):

• "The I.T.S. CONNEXX Locking Tibia Nail is substantially equivalent to the Synthes, DePuy/ACE, Zimmer, Stryker, and Biopro IM Tibia Nail systems."
• The comparison likely involves:
  • Intended Use: The indications for use are very similar to those of the predicate devices.
  • Technology/Design Principles: It's an intramedullary rod with locking/nonlocking cross-screw fixation, a common design for such devices.
  • Materials: High strength 6-4 ELI Titanium Alloy (ASTM F-136) is a standard material for orthopedic implants.
  • Performance Characteristics: While not explicitly detailed, the equivalence would imply that its mechanical performance (e.g., strength, fatigue resistance) is comparable to the predicate devices, likely demonstrated through bench testing as part of the 510(k) submission (though not described in this summary).

Conclusion:

This 510(k) summary does not describe a study with explicit acceptance criteria and device performance metrics in the way one might expect for a diagnostic or AI device. Instead, it leverages the concept of substantial equivalence to predicate devices as its primary justification for safety and effectiveness. The "acceptance criteria" are met by demonstrating that the new device is sufficiently similar to already approved devices.

Ask a specific question about this device