Search Results

Ask a specific question about this device

The BPS Wrist Fracture System is indicated for the fixation of simple and complex intra-articular and extra-articular fractures, and for osteotomies of the distal radius in adults. The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.

The BPS Wrist Fracture System includes bone plate and bone screw implants designed for fixation of certain fractures, fusions, or osteotomies in the distal radius. To meet various patient anatomical needs, the BPS Wrist Fractures several sizes of distal radius plates as well as various styles of locking, non-locking, and cortical bone screws. The plates are manufactured from Commercially Pure Titanium Grade 4 per ASTM F67. The screws are manufactured from Titanium Alloy Grade 5 (Ti-6Al-4V ELI) per ASTM F136.

I'm sorry, but based on the provided FDA 510(k) clearance letter for the "BPS Wrist Fracture System," this device is a physical medical implant (a metallic bone fixation appliance) and not an AI or software-based medical device.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/software performance metrics (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, etc.) is not present in this document.

The 510(k) summary explicitly states:

• "The BPS Wrist Fracture System includes bone plate and bone screw implants designed for fixation of certain fractures, fusions, or osteotomies in the distal radius."
• "The plates are manufactured from Commercially Pure Titanium Grade 4 per ASTM F67. The screws are manufactured from Titanium Alloy Grade 5 (Ti-6Al-4V ELI) per ASTM F136."
• The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section only mentions "cleaning, sterilization, biocompatibility, mechanical and performance characteristics," which are typical for physical implants, not AI/software.

None of the provided text suggests any AI or software component requiring the kind of study details you've asked for.

To answer your specific questions related to AI/software, I would need a 510(k) clearance letter or similar documentation for an AI/software medical device.

Ask a specific question about this device

The OrthoNovis bones plates and screws system are intended to be used for internal fixation of bone fractures, fusions or osteotomies in the ankle, foot, hand, wrist, clavicle, scapula, pelvis, long bone (such as humerus, ulna, radius, femur, tibia, and fibula, and small bones (such as metacarpals, metatarsals, phalanges). The washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large bone and bone fragments.

The bone fragment fixation plates and washers of various sizes, consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones, including the clavicle, acetabulum, pelvis, scapula, humerus, radius, ulna, femur, tibia,phalanges, carpals, metacarpals, tarsals, metatarsals and fibula. The washers are to function with screw head from breaking through the cortex of the bone by providing additional surface area during screw placement. The plates s are a one-piece device made of commercially pure titanium alloy or stainless steel.

I am sorry, but the provided text does not contain information about an AI/ML-based device or a study proving its performance against acceptance criteria. The document is a 510(k) premarket notification for a traditional medical device: "BPS - Bone Fragment Fixation Plates, Screws and Washers."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them for an AI/ML device, as this information is not present in the given text.

The document primarily discusses:

• The FDA's review and determination of substantial equivalence for the BPS device.
• Regulatory requirements for medical devices.
• The identity of the applicant and correspondent.
• The device name, common name, classification, and product codes.
• Legally marketed predicate devices.
• A summary description of the BPS device.
• Indications for Use for the BPS device.
• A comparison of intended use and technological characteristics to predicate devices, noting the introduction of additional material options and minor modifications to screw geometry.
• A statement that engineering justifications were provided to demonstrate adequate mechanical properties, and that the device is substantially equivalent to the primary predicate.

There is no mention of acceptance criteria, test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth was established, as these are typically relevant for AI/ML device evaluations, not for the type of traditional bone fixation device described.

Ask a specific question about this device

The BPS Wrist Fracture System is indicated for the fixation of simple and complex intra-articular and extra-articular fractures, and for osteotomies of the distal radius in adults. The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.

The BPS Wrist Fracture System includes bone plate and bone screw implants designed for fixation of certain fractures, fusions, or osteotomies in the distal radius. To meet various patient anatomical needs, the BPS Wrist Fracture System features several sizes of distal radius plates as well as various styles and sizes of locking, nonlocking, and cortical bone screws. The plates are manufactured from Commercially Pure Titanium Grade 4 per ASTM F67. The screws are manufactured from Titanium Alloy Grade 5 (Ti-6AI-4V ELI) per ASTM F136.

This 510(k) summary does not contain information about software, AI, or any studies related to human reader performance or ground truth establishment. It focuses on the mechanical performance of a bone fixation system. Therefore, I cannot provide the details you requested regarding acceptance criteria and studies that prove a device meets criteria related to AI or diagnostic performance.

The document describes the BPS Wrist Fracture System, a device for bone fixation, and its performance data relates to mechanical testing.

Here's the information that is available based on the provided text, formatted as closely as possible to your request for clarity:

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

Regarding your other requested information:

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The "test set" here refers to mechanical samples of the device components (plates and screws), not patient data. The provenance of these mechanical tests is not specified beyond being "conducted per ASTM" standards.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are mechanical tests, not clinical studies requiring expert ground truth for interpretation.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a clinical study requiring adjudication.
• 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 bone fixation system, not an AI or imaging device, so MRMC studies are irrelevant.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for mechanical tests is the quantitative measurement against the established ASTM standards.
• The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI or machine learning device.
• How the ground truth for the training set was established: Not applicable for the same reason as above.

Ask a specific question about this device

The ONX Large External Fixation System is indicated for the following:

• Stabilization/fixation of:
  • Long bone fractures in tibia and femur
  • Fractures of pelvis and ankle
  • Peri-articular and intra-articular fractures of knee and ankle
• Joint arthrodesis
• Non-unions and mal-unions
• Osteotomies

The ONX Large External Fixation System is an external fixation device consisting of bone pins, connecting rods, clamps, posts, and related accessories used for the management of bone fractures and reconstructive orthopedic surgery. The device is a modular system designed to provide a broad range of frame construction options. The connecting rods are made from unidirectional carbon fiber reinforced epoxy. Pins, components, and posts are made from materials conforming to ASTM F136 and ASTM F138.

The provided text is a 510(k) summary for the ONX Large External Fixation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria in the context of AI/ML device performance. Therefore, most of the requested information regarding AI/ML device performance metrics, study design, and data provenance cannot be extracted from this document.

However, I can extract information related to the device type and the type of performance data provided for this specific medical device, which is a physical external fixation system, not an AI/ML diagnostic tool.

Here's what can be extracted:

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

The document does not explicitly state "acceptance criteria" in a tabular format for clinical performance or diagnostic accuracy. Instead, it relies on demonstrating substantial equivalence in mechanical performance to a predicate device.

• Construct fatigue testing under axial load per ASTM F1541 Annex 7 was performed.
• The results show that the subject device is substantially equivalent to the predicate in mechanical performance.
• The overall technology characteristics and mechanical performance data lead to the conclusion that the ONX Large External Fixation System is substantially equivalent to the predicate device. |
  | Intended Use | - Has the same intended use as the predicate device. |
  | Operating Principle | - Uses the same operating principle as the predicate device. |
  | Design | - Incorporates the same design as the predicate device. |
  | Materials | - Incorporates the same or very similar materials as the predicate device (connecting rods from unidirectional carbon fiber reinforced epoxy; pins, components, and posts from ASTM F136 and ASTM F138 conforming materials). |
  | Packaging & Sterilization | - Has similar packaging and is sterilized using the same materials and processes as the predicate device. |

Regarding the other points, the provided document does not contain the requested information as it pertains to an orthopedic hardware device, not an AI/ML-based diagnostic or assistive device:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here would refer to the physical devices tested for mechanical properties, not a dataset of medical images or patient records. The document only mentions "engineering analysis" and "construct fatigue 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 mechanical testing is established through physical measurements and engineering specifications, not expert interpretation.
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, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical performance, the ground truth is based on engineering standards (ASTM F1541, ASTM F1541 Annex 7) and physical measurements of material properties and construct strength/fatigue.
8. The sample size for the training set: Not applicable. This device does not use a training set in the AI/ML sense.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) pertains to a physical orthopedic device and its substantial equivalence based on mechanical, material, and design comparisons, not on AI/ML performance metrics.

Ask a specific question about this device