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The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

The Healix Compression Screw (HCS) System consists of cannulated, solid titanium allov. headless, headed screws and specialized instrumentation. This submission expands the Healix offering and includes longer screws ranging from 31 to 130mm in length for the 2.0 to 7.5mm diameters.

The provided text is a 510(k) summary for the Nvision Biomedical Technologies' Healix Compression Screw System. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML or diagnostic performance.

Instead, this document is a regulatory submission for a physical medical device (bone fixation screws) and relies on mechanical performance characteristics and a comparison to existing predicate devices.

Therefore, I cannot extract the requested information (items 1-9) as it pertains to AI/ML device performance from the provided text. The document clearly states:

• "No FDA performance standards have been established for the Healix Compression Screw System."
• "The following was performed to demonstrate safety per methods of the previous submission: . Engineering analysis comparison of mechanical performance characteristics"
• "The results of the engineering analysis indicate that the Healix Compression Screw System is substantially equivalent to the predicate devices."

This indicates the evaluation was based on engineering analysis and comparison against physical predicate devices, not on a study proving a device meets acceptance criteria related to diagnostic performance, human-in-the-loop improvements, or ground truth establishment for AI/ML.

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The MECRON™ Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the device.

The MECRON™ Cannulated Screw System consists of headed and headless bone screws and corresponding washers. The screws are offered in diameters from 2.0mm thru 7.0mm (in 0.5 mm increments) and overall lengths from 8 mm (for smaller diameters) thru 120 mm (for larger diameters). The cannulated screws have self-tapping and self-drilling features and are manufactured from medical grade titanium alloy (per DIN EN ISO 5832-3 and ASTM F136).

This document is a 510(k) premarket notification for a medical device (MECRON™ Cannulated Screw System). It does not describe acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML or diagnostic device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through mechanical testing for a physical orthopedic implant.

Therefore, I cannot extract the information required by your request about acceptance criteria, device performance, sample sizes, expert involvement, ground truth, or MRMC studies, as these concepts are not applicable or detailed in this specific type of regulatory submission for this device.

The document states:

• "Clinical Data were not needed for these devices to show substantial equivalence."
• "Merete has conducted mechanical analysis and functional worst case tests to demonstrate that the MECRON™ Cannulated Screw System has the mechanical properties necessary to perform as well or better than the predicate device... These tests have been performed in accordance with ASTM F543-13."

This indicates that the "study" proving the device met its criteria was a series of mechanical and functional worst-case tests, not a clinical study involving human data, AI models, or expert human readers. The "acceptance criteria" were likely performance benchmarks derived from the predicate device and established standards like ASTM F543-13.

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The Tornier ForeFoot STP Screw System is indicated for fixation of fractures, fusions, and osteotomies of bones of the hand and foot.

The submission is regarding the ForeFoot STP System. This system consists of screws of various diameters, lengths and thread configurations.

This document is a 510(k) premarket notification for the Tornier ForeFoot STP System, a medical device. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. Based on the provided text, a "study" in the context of device performance refers to mechanical testing rather than a clinical study or a study involving AI/software analysis of data.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated table format for this 510(k) submission. However, it mentions the types of tests performed and the conclusion that the device is substantially equivalent based on these tests.

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

This document describes mechanical testing of a physical medical device (screws), not a study analyzing data (like images or patient records). Therefore, the concept of a "test set" in the context of data provenance (country of origin, retrospective/prospective) and sample size for data analysis does not directly apply.

• The "sample size" would refer to the number of physical screws tested in the mechanical evaluations. This information is not provided in the document.
• "Data provenance" is not applicable as this concerns mechanical properties of the device itself, not clinical or image data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This is not applicable. The "ground truth" for mechanical testing of screws is defined by the physical properties of the materials and the engineering standards for such devices. It does not involve expert interpretation in the way clinical or imaging studies do.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical testing results are objective measurements based on engineering principles and test protocols, not subjective interpretations requiring adjudication.

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

This is not applicable. This submission is for a physical medical device (fixation screws), not an AI or software-based medical device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This is not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the mechanical testing of the ForeFoot STP System would be based on engineering standards and established material properties for bone fixation devices. The performance is compared against the known performance of the predicate devices, which also comply with these engineering standards. The focus is on demonstrating equivalent mechanical strength and characteristics.

8. The Sample Size for the Training Set

This is not applicable. This refers to a physical medical device, not an AI or software-based system that uses a "training set."

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

This is not applicable. This refers to a physical medical device, not an AI or software-based system.

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The Monster Screw System™ is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device.

The Monster Screw System™ is comprised of bone screws and washers. The Monster Screw is a threaded bone screw offered in 2.0mm to 9.5mm diameters (in 0.5 mm increments) having overall lengths from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are offered having a variety of features with respect to head, thread, tip, cannulation and material. Size-matched washers are also available.

This document is a 510(k) summary for the Paragon 28 Monster Screw System™. It describes the device and its intended use, but it does not contain the kind of detailed performance study data you're asking for regarding acceptance criteria, sample sizes, ground truth (which is typically for diagnostic devices), or comparative effectiveness studies.

This submission is for a bone fixation fastener, which is a hardware device, not a diagnostic AI/ML device. Therefore, the questions about "acceptance criteria and study that proves the device meets the acceptance criteria" are typically addressed through mechanical testing and equivalence to predicate devices, rather than clinical performance metrics, ground truth established by experts, or AI-specific study designs like MRMC or standalone performance.

However, I can extract the information that is present and note where the requested information is not applicable or not provided in this type of document.

Here's the relevant information based on the provided text:

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

This document does not specify formal "acceptance criteria" in terms of clinical performance metrics, as would be common for diagnostic devices. Instead, the performance is demonstrated through theoretical comparisons to predicate devices for mechanical equivalence.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a mechanical device. The "test set" here refers to theoretical comparisons and bench testing, not a clinical study with a patient sample size.
• Data Provenance: Not applicable. The "theoretical comparisons" would be based on engineering principles and potentially prior testing data of predicate devices.

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. This is not a diagnostic device where "ground truth" would be established by experts interpreting images or clinical outcomes. The equivalence is based on engineering and material science.

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

• Not applicable. There is no adjudication needed for mechanical equivalence testing as described 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 a hardware bone fixation device, not an AI-powered diagnostic tool. An MRMC study is not relevant.

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

• Not applicable. This is a hardware device; there is no algorithm or AI component.

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

• Not applicable. As noted, "ground truth" as typically defined for diagnostic performance is not relevant for this type of device submission. The "truth" is established through engineering specifications and mechanical testing to demonstrate equivalence.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" or "ground truth" in this context.

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