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Specific Indications:

1. 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate
   2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate is intended for treating of Intraarticular Fracture of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus.
2. 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support
   2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support is intended for treating of Intraarticular fractures of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus.
3. 2.7/3.5mm Wise-Lock Dorsolateral Medial Distal Humerus Plate
   2.7/3.5mm Wise-Lock Dorsolateral Medial Distal Humerus Plate are indicated for treating of Intraarticular fractures of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus.
4. 3.5mm Wise-Lock Extra-Articular Distal Humerus Plate
   3.5mm Wise-Lock Extra-Articular Distal Humerus Plate are indicated for fractures of the distal humerus.
5. PHEELOS-3.5mm Wise-Lock Proximal Humerus Plate, Short
   PHEELOS Short Indications

• · Dislocated two-, three-, and four-fragment fractures of the proximal humerus
• · Pseudarthroses in the proximal humerus
• · Osteotomies in the proximal humerus

6. PHEELOS-3.5mm Wise-Lock Proximal Humerus Plate, Long
   • As for PHEELOS Short, but for fractures extending to the shaft or without medial support.
7. 3.5mm Wise-Lock Proximal Humerus Plate
   The 3.5mm Wise-Lock Proximal Humerus Plate is intended for fractures and fracture dislocations, and nonunions of the proximal humerus.
8. 3.5mm Wise-Lock Periarticular Proximal Humerus Plate
   3.5mm Wise-Lock Periarticular Proximal Humerus Plate are indicated for fracture dislocations, osteotomies, and nonunions of the proximal humerus.
9. 3.5mm Wise-Lock Olecranon Plate
   3.5mm Wise-Lock Olecranon Plate is indicated for fixation of fractures and non-unions of the olecranon.
10. 3.5mm Wise-Lock Hook Plate
    3.5mm Wise-Lock Hook Plate is indicated for fractures, osteotomies of small bones including the ulna, radius, tibia and fibula.
11. 2.7mm Wise-Lock Screw, Self-Tapping (Hex Head)
    This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
12. 3.5mm Wise-Lock Screw, Self-Tapping (Hex Head)
    This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
13. 3.5mm Wise-Lock Screw, Self-Drilling, (Hex Head)
    This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
14. 3.5mm Wise-Lock Cancellous Screw, Full Thread, Self-Tapping, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
15. 3.5mm Wise-Lock Cancellous Screw, Short Thread, Self-Tapping, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
16. 3.5mm Cortical Screw, Self-Tapping, (Hex Head)
    This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
17. 4.0mm Cancellous Screw, Short Thread
    This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
18. 4.0mm Cancellous Screw, Full Thread
    This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
19. 2.7mm Cortical Screw, Self-Tapping, (Hex Head)
    This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.

The Humerus and Ulna System consists of various types of bone plates, Screws for implantation in the humerus and ulna bone to treat humerus and ulna bone fractures.
The Humerus and Ulna System consists of medial and postero-lateral distal humerus plates of various lengths and 2.7 mm locking screws. The plates are pre-contoured to match the anatomy of the distal humerus with a limited contact low profile design. The plate features locking compression holes which accept 2.4, 3.5, & 4.0 mm cortex screws, 2.4, 2.7 & 3.5 mm locking screws, and 4.0 mm cancellous screws. The System is available in Stainless Steel and Titanium.
These implants are sold in both non-sterile and sterile conditions.
Note- Non sterile products have to be sterilized before use.
The system is indicated for use in adult patients only. All implants are for single use only.
The humerus and Ulna System contains several plates and each plate has its intended uses.

The provided 510(k) summary describes a medical device, the "Humerus & Ulna System" by Auxein Medical Private Limited, which consists of various bone plates and screws for humerus and ulna bone fracture fixation. The document states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain information related to software or AI/ML components. Therefore, it is impossible to extract the acceptance criteria for an algorithm, the details of a study proving a device meets those criteria, or other AI/ML-specific information like sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

The document primarily focuses on demonstrating substantial equivalence through:

• Comparison of technological characteristics: Product code, regulation number, regulatory class, indications for use, material, performance standards, sterilization, shelf-life, single use/reuse, operating principle, and dimensional verification are compared to predicate devices.
• Non-clinical (bench) testing: This includes material standards (ASTM F136/ISO 5832-3, ASTM F899-12, ASTM F138/ISO 5832-1), biocompatibility (ISO 10993), and mechanical performance (ASTM F382 for plates, ASTM F543 for screws, including driving torque, torsion, and axial pull-out tests).
• Sterilization, shelf-life, and packaging standards: (ISO 11137 series, ISO 17665 series, ISO 11140-1, ISO 11737 series, ISO 11607 series, ASTM F1980, ASTM F88, ASTM F1929).
• Bacterial Endotoxin testing: (USP <85>, USP <161>).

All of these tests are standard for orthopedic implants and confirm the physical and biological safety and performance of the hardware, but they do not involve any AI/ML algorithm evaluation.

Therefore, based solely on the provided text, I cannot answer the specific questions related to acceptance criteria and studies for an AI/ML component. The device described is a physical implant system, not a software-driven diagnostic or treatment planning tool that would typically involve the type of AI/ML evaluation metrics requested.

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The Humerus Locking Plating System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The Humerus Locking Plating System consists of plates designed for various fracture modes of the humerus bone. The system is used with locking screws, smooth locking pegs, threaded locking peg, locking cortical screws and standard cortical screws. The locking screws, threaded pegs and pegs could be supplied cannulated or not. Each device is manufactured from titanium alloy Ti-6A1-V4 ELI (conforms to ASTM F 136-02a and/or ISO 5832-3) or stainless steel (conforms to ASTM F 138 and/or ISO 5832-1). Each device can be supplied color anodized or non-anodized. The Humerus Locking Plating System will be provided non-sterile for steam sterilization by health care professionals prior to use.

This looks like a 510k submission for a medical device. These types of submissions typically don't include studies demonstrating device performance against specific acceptance criteria in the way a clinical trial or AI/software validation study would. Instead, they focus on demonstrating substantial equivalence to a legally marketed predicate device.

Therefore, the information requested in your prompt (especially regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI/software) is not present in this 510(k) summary.

A 510(k) summary focuses on:

• Device Description: What the device is.
• Intended Use: What the device is meant to do.
• Predicate Device: A legally marketed device with similar characteristics and intended use.
• Technological Comparison: How the new device is similar to (and sometimes different from) the predicate device.
• Performance Data: Often bench testing (mechanical, material, sterilization efficacy) to ensure the device meets established standards or performs comparably to the predicate, but not necessarily clinical performance against specific acceptance criteria with expert ground truth.

If you are looking for details on studies proving device performance against acceptance criteria, that information would be found in a more comprehensive premarket approval (PMA) application or a different type of regulatory submission, or in a separate clinical study report, depending on the device's risk class and novelty.

To directly answer your prompt based only on the provided text, I must state that the requested information is not available in the given document.

However, I can extract the information that is present:

Key Information from the Document:

• Device Name: Humerus Locking Plating System
• Intended Use: For fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.
• Predicate Devices:
  • Modified Shoulder Fixation System of HAND INNOVATIONS (K051728)
  • SYNTHES LCP® Proximal Humerus Plates, long of SYNTHES (K041860)
  • Proximal Humerus Plate of ACUMED (K012655)
  • Stryker Plating System of HOWMEDICA OSTEONICS CORP. (K060798)
• Materials: Titanium alloy Ti-6A1-V4 ELI (ASTM F 136-02a and/or ISO 5832-3) or stainless steel (ASTM F 138 and/or ISO 5832-1).

Regarding your specific questions, as they relate to AI/software performance, none of the following can be answered from this document:

1. A table of acceptance criteria and the reported device performance: Not provided. This is a mechanical orthopedic implant, not typically evaluated with "performance criteria" in the AI sense for a 510(k). The "performance" would be related to mechanical strength, biocompatibility, and sterilization, which are confirmed through engineering tests, not clinical studies in this context.
2. Sample sized used for the test set and the data provenance: Not applicable in the AI/software sense. Bench testing would have its own sample sizes.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. Ground truth for an orthopedic implant refers to its physical and material properties, not diagnostic accuracy by experts.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for an orthopedic implant, not a diagnostic imaging device or AI assistance tool.
6. If a standalone performance was done: "Standalone performance" in this context would refer to mechanical testing (fatigue, torsion, bending), not AI algorithm-only performance. Such tests are usually part of the submission to demonstrate compliance with standards, but specific results and acceptance criteria are not detailed in this summary.
7. The type of ground truth used: For a mechanical implant, ground truth typically refers to scientific standards (e.g., ASTM/ISO for material properties, mechanical load capabilities).
8. The sample size for the training set: Not applicable (no AI/ML component).
9. How the ground truth for the training set was established: Not applicable (no AI/ML component).

In summary, the provided document is a 510(k) summary for an orthopedic implant, not an AI/software device. The regulatory pathway is based on substantial equivalence, and the detailed performance study information you're asking for, especially regarding AI-specific validation, is not part of this type of submission summary.

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The Humerus Wires device is intended to be implanted in the humerus for internal fixation of fractures and/or reconstruction of the humeral bone.

The Humerus Wires device is an internal wire fixation device to be used in the fixation of humeral fractures.

I am sorry, but the provided text only contains basic descriptive and classification information about a medical device called "Humerus Wires." It is a 510(k) summary from 1996 for a fixation wire.

The document does not contain any information about:

• Acceptance criteria for performance.
• A study proving the device meets acceptance criteria.
• Reported device performance metrics.
• Sample sizes for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Types of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Therefore, I cannot fulfill your request for this specific document. This document is related to regulatory clearance (510(k)) and focuses on substantial equivalence to predicate devices, not detailed performance studies or AI-related metrics.

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