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The ULTiMAX™ brand Trochanteric Intramedullary Rod System is indicated for single use to stabilize intertrochanteric and subtrochanteric fractures of the proximal femur.

ULTiMAX™ Trochanteric Intramedullary Rod System II

The provided text is an FDA 510(k) clearance letter for a medical device called the "ULTiMAX™ Trochanteric Intramedullary Rod System II". This letter confirms that the device has been found substantially equivalent to a predicate device and can be marketed.

However, the letter does not contain any information about acceptance criteria or the study that proves the device meets specific performance criteria. It is a regulatory clearance document, not a detailed technical report or a clinical study summary.

Therefore, I cannot provide the requested information based only on the provided input. The document's purpose is to grant market authorization based on substantial equivalence, not to detail the specific performance validation results.

To answer your request, I would need a different type of document, such as:

• A pre-market submission summary (e.g., a 510(k) summary or an IDE report)
• A clinical study report
• A peer-reviewed publication about the device's performance

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The ULTiMAX™ brand Distal Radial (Volar) Locking Plate System is indicated for single use to stabilize distal fractures of the radius.

ULTIMAX™ Distal Radial (Volar) Locking Plate System

Unfortunately, the provided text is a 510(k) clearance letter from the FDA for a medical device called the "ULTIMAX™ Distal Radial (Volar) Locking Plate System." This document primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device.

It does not contain information about:

• Specific acceptance criteria for device performance (e.g., in terms of biomechanical properties, clinical outcomes, etc.).
• Any detailed study that proves the device meets such criteria. The "substantial equivalence" determination is typically based on comparing the new device's design, materials, and intended use to a device already on the market (the predicate device), rather than requiring new, comprehensive performance studies with acceptance criteria.
• Sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how training ground truth was established.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details based on the given document. The letter indicates that the device is cleared for marketing based on its equivalence to previously approved devices, but it does not detail the specific performance metrics or studies you're asking for.

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The ULTiMAX™ brand Cortical Bone Screws are indicated for single use for osteotomy fixation, interfragmentary fixation, and for stabilizing fractures in metaphyseal and diaphyseal bone in long bones. Uses include arthrodesis of joints; stabilizing fractures of the medial malleolus and distal tibia; patella fractures; metatarsal fractures and fractures of the calcaneus and other bones in the foot; fractures of bones in the hand; proximal, distal and intercondylar fractures of the humerus; use with the BTI ULTiMAX™ Humeral Intramedullary Rod System.

Not Found

This document is a 510(k) clearance letter from the FDA for the ULTIMAX™ Cortical Bone Screws. It states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, this document does not contain information about acceptance criteria or a study that proves the device meets those criteria. Such information would typically be found in the 510(k) submission itself, not the clearance letter.

To fully answer your request, I would need access to the actual 510(k) submission for K990513, which is not provided in your input.

Based on the provided text, I can only state that the document does not contain the information requested in your bulleted list.

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The ULTiMAX™ brand Distal Femoral Intramedullary Rod System is indicated for single use to stabilize distal femoral fractures, including supracondylar fractures, severely comminuted supracondylar fractures with difficult intra-articular extension, fractures that require stabilization of the femoral condylar segment, distal fractures in osteoporotic bone, pathologic fractures, pseudoarthrosis, malunions and failed distal femoral osteosynthesis.

ULTiMAX™ Distal Femoral Intramedullary Rod System

I am sorry, but based on the provided document, I cannot extract information about the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the ULTiMAX™ Distal Femoral Intramedullary Rod System, which primarily discusses the substantial equivalence of the device to a predicate device and its indications for use. It does not contain details about specific performance acceptance criteria or performance study results.

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The BT™ Humeral Intramedullary Rod device is indicated for fractures of the humerus.

BTI™ Humeral Intramedullary Rod System

This looks like a 510(k) clearance letter from the FDA for a medical device (BTI™ Humeral Intramedullary Rod System). It doesn't contain the kind of detailed study information you're asking for regarding acceptance criteria, sample sizes, expert involvement, and ground truth.

This document primarily states:

• The device name: BTI™ Humeral Intramedullary Rod System
• Its intended use: Fractures of the humerus
• Its regulatory class: II
• The FDA's determination of substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information based on the provided text.

To answer your questions, I would need a detailed study report or clinical trial documentation, which would typically accompany a 510(k) submission but is not included in this FDA clearance letter.

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The BTI™ brand Large (7.0 mm) Cannulated Transfixing Screw is indicated for single use with the BTI brand Proximal Humeral Intramedullary Rod, the BTI brand Mid-Shaft Humeral Intramedullary Rod and the BTI brand Tod, the Britishedullary Rod Systems to stablifize fractures.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "BTI Large (7.0 mm) Transfixing Screw." It does not describe the acceptance criteria or a study that proves the device meets those criteria. Instead, it indicates that the FDA has determined the device to be "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory clearance and provides instructions on labeling and permissible uses of the device, particularly regarding its non-use for pedicular screw fixation.

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The BTI™ brand Cortical Bone Screws are indicated for single use for osteotomy fixation, interfragmentary fixation, and for stabilizing fractures in metaphyseal and diaphyseal bone in long bones. Uses include arthrodesis of joints; stabilizing fractures of the medial malleolus and distal tibia; patella fractures; metatarsal fractures and fractures of the calcaneus and other bones in the foot; fractures of bones in the hand; proximal, distal and intercondylar fractures of the humerus; use with the BTI Compression Hip Screw System, BTI Humeral Intramedullary Rod Systems, and the BTI Distal Femoral Intramedullary Rod System.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the BTI™ Cortical Bone Screws. It does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI assistance or human-in-the-loop performance.

The letter primarily focuses on:

• The FDA's determination of substantial equivalence for the BTI™ Cortical Bone Screws to previously marketed devices.
• The device's regulatory classification (Class II).
• Important disclaimers and warnings regarding the unapproved use of the device for pedicular screw fixation/attachment, stating that such use would be considered investigational and would require specific regulatory approvals.
• General controls and regulations applicable to the device.
• The indications for use for which the device is approved.

Therefore, I cannot provide the requested information, as it is not present in the given document.

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indicated for single use to stabilize intracapsular, certain cervical and subcapital fractures of the femur; fractures of the distal femur and proximal tible: pelvis and acetabular fractures and certain fractures of the shoulder and elbow. They are contraindicated for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, lumbar spine.

The EZ-Fix™ Cannulated Screws are fabricated from titanium allov (Ti-BAL-4V ELI). They are tested per ASTM standards and have a thread diameter and length of 7.3 mm and 20 mm respectively and a shaft diameter of 5.3 mm. They accept a 3.2 mm guide pin through the 3.45 mm cannulation. They are self reaming and tapping and have reverse cutting flutes. The EZ-Fix™ Cannulated Screws are available in 35 mm to 125 mm lengths are supplied non-sterile.

The EZ-Fix™ Cannulated Screw System is a medical device, and its acceptance criteria as well as the study proving its compliance are primarily focused on demonstrating substantial equivalence to predicate devices. This type of regulatory submission (510(k)) relies on showing that the new device is as safe and effective as a legally marketed predicate device.

Here's an analysis of the provided text in relation to your questions:

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

For a 510(k) submission like this, acceptance criteria typically revolve around demonstrating similarity to predicate devices across various attributes. The "Comparison Table" provided in the document serves as the primary evidence for meeting these criteria. The "SE" column (Substantial Equivalence) indicates whether the EZ-Fix™ Cannulated Screw is considered equivalent to the predicate for that specific characteristic.

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

The document does not describe a specific test set in the traditional sense of a clinical trial or a large-scale performance study. This is typical for a Class II device submitted under a 510(k) based on substantial equivalence. Instead, the "testing" mentioned refers to:

• Compliance with ASTM standards: "They are tested per ASTM standards." This implies manufacturing and material testing, not necessarily a clinical outcomes study with a "test set" of patients.
• Pyrogenicity testing: "Pyrogenicity testing of the EZ-Fix™ to determine level of endotoxin performed using LAL (Limulus Amebocyte Lysate) method." This is a laboratory test on device samples, not a clinical test set.
• Equivalence to referenced equivalent: "These test values are identical to those obtained on the referenced equivalent." This suggests comparative engineering or material testing against the predicate devices' specifications, not human subject data.

Therefore, there is no explicit sample size for a test set of patient data, nor is information provided on data provenance (country, retrospective/prospective).

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)

Given that there isn't a traditional "test set" of patient data in this submission focused on clinical outcomes, there are no experts mentioned for establishing ground truth in the context of clinical interpretation or diagnosis. The "ground truth" here is compliance with engineering standards and similarity to predicate devices as determined by the manufacturer's testing and comparison.

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

Since there is no "test set" in the context of clinical image interpretation or patient outcomes, there is no adjudication method described.

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 MRMC study was done or described. This device is a bone fixation screw, not an AI-powered diagnostic tool, so such a study would not be applicable.

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

No standalone performance study for an algorithm was done. This device is a physical implant, not an algorithm.

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

The "ground truth" in this submission is established through:

• Manufacturer specifications and design parameters: For characteristics like material, thread diameter, screw lengths.
• ASTM standards: For performance (e.g., ASTM F117 for material properties or mechanical strength).
• Laboratory testing: For pyrogenicity (LAL method).
• Comparison to predicate devices: The core of a 510(k) is demonstrating that the new device's characteristics and performance are "substantially equivalent" to legally marketed devices. So, the established characteristics and performance of the predicate devices implicitly serve as a form of "ground truth" for comparison.

8. The sample size for the training set

No training set is described or applicable as this is a physical medical device, not a machine learning model.

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

Not applicable as there is no training set.

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