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Quick - Radius Disposable Set is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate and screw systems is suited for treatment of fractures in osteopenic bone.

Quick - Radius Disposable Set are plate and instruments kit, for osteosynthesis procedures of the distal radius, in sterile condition, single use and disposable instruments after use. This sterile set must be used with 2.4mm screws, also sterile and individually packaged. The surgeon selects the best combination of plate size, left or right and screw designs and quantities, as needed. Single use and sterile templates are available, individually packed, for determining the size of the plate to be used. Also, as an option, individually packed plates, instruments only kit, and instruments with plates and screws kit, are available in sterile condition.

The plates and screws are produced with Titanium Alloy, according with standard ASTM F136, and the instruments are made of Stainless Steel, according with standard ASTM F899.

The provided text describes a 510(k) submission for a medical device, the "Quick - Radius Disposable Set." The document primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study against specific acceptance criteria for a novel device or an AI/algorithm-based diagnostic tool.

Therefore, the information required to populate the fields related to acceptance criteria, specific performance metrics, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/algorithm-based device is not present in the provided text.

The document states:

• "The proposed device is a line extension to the predicate device with new presentation forms." (Page 3, Section VI)
• "The proposed and predicate devices have the same basic design, intended use and biocompatibility profile." (Page 3, Section VI)
• "Difference between the proposed device and the predicate includes addition of a presentation form in a sterile condition." (Page 3, Section VI)
• "The subject Quick - Radius Disposable Set components possess the same technological characteristics as the predicate devices. These include: performance, shape and dimensions, material and manufacturing, sizes, biocompatibility and device usage." (Page 3, Section VII)
• "The EO sterilization has been validated to a sterility assurance level (SAL) of 10-6, according to ISO 11135" (Page 3, Section VII)
• "Any differences between the proposed device and the predicate device are considered minor and do not raise new or different questions concerning safety or effectiveness." (Page 3, Section VI and Page 4, Section VIII)

In conclusion, this submission is for a physical medical device (bone plates and screws set) seeking 510(k) clearance based on substantial equivalence to predicate devices, mainly through demonstrating equivalent design, materials, and a validated sterilization process. It does not involve software, AI, or diagnostic claims that would necessitate the types of performance studies and acceptance criteria typically associated with those technologies.

Therefore, I cannot fill in the requested table and answer the specific questions about "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm, as the provided text does not contain such information. The "performance data" section in the document (Section VII) refers to the performance of the physical components (e.g., mechanical performance, biocompatibility) rather than diagnostic accuracy metrics.

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The ANTHEM™ Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulpa, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. Small fragment and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age).

The ANTHEM™ Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, sterile and non-sterile, with locking and non-locking screws. ANTHEM™ implants are manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel. All implants are for single use only.

This document is a 510(k) Summary for the ANTHEM™ Fracture System, a medical device. Based on the provided text, there is no study described that proves the device meets specific acceptance criteria based on AI/algorithm performance, nor is there any mention of an AI device. The document explicitly describes the ANTHEM™ Fracture System as a system of "plates and screws designed to be used for internal bone fixation."

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance related to AI/algorithmic accuracy.
• Sample size and data provenance for an AI test set.
• Number of experts and qualifications for AI ground truthing.
• Adjudication method for an AI test set.
• MRMC comparative effectiveness study for AI assistance.
• Standalone AI performance.
• Type of ground truth used for AI.
• Sample size for training set for AI.
• How ground truth for a training set was established for AI.

The document focuses on the mechanical and material performance of bone fixation devices, not on diagnostic or AI-driven performance.

Here's a summary of the performance data that is mentioned in the document, which pertains to the physical device itself:

1. Acceptance Criteria and Reported Device Performance (for the physical device):

• Acceptance Criteria (Implicit Standard Performance): The device's performance was evaluated in accordance with recognized ASTM standards for bone fixation devices. This implies that the device had to meet performance benchmarks defined by these standards to demonstrate substantial equivalence to predicate devices. While specific numerical acceptance criteria are not explicitly stated (e.g., "minimum bending strength of X N-m"), the adherence to these standards serves as the implicit acceptance criteria for mechanical performance.
• Reported Device Performance:
  • Tests Conducted: Engineering analysis, bending strength tests (for plates and screws), pullout strength tests (for screws), and insertion/removal torque tests (for screws).
  • Outcome: "Performance data demonstrates substantial equivalence to the predicate devices."
  • Bacterial Endotoxin Testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011 to ensure sterility or low endotoxin levels.

2. Sample Size and Data Provenance (for the physical device testing):

• The document does not specify the sample sizes used for the mechanical performance tests (e.g., how many plates or screws were tested for bending strength).
• The data provenance is not mentioned (e.g., where the tests were conducted, whether the materials were from specific batches, etc.).

3. Number of experts used to establish the ground truth... and qualifications of those experts:

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm requiring expert review for ground truth.

4. Adjudication method for the test set:

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done...:

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.

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

• Not applicable. This document describes a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the physical device, "ground truth" would be the objective measurements obtained from standardized mechanical tests (e.g., actual force at failure, actual torque values) against the requirements of the ASTM standards.

8. The sample size for the training set:

• Not applicable, as this is not an AI/machine learning device.

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

• Not applicable, as this is not an AI/machine learning device.

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