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The CanMINI Hand and Foot System is indicated for fixation of small bones and small bone fragments in the hand and foot. The devices are intended to be single-use and sterilized before use.

The CanMINI Hand and Foot System, manufactured by CANWELL MEDICAL CO. LTD., is an orthopedic fixation system designed to stabilize fractures or osteotomies of the small bones in the hand and foot. The system includes a variety of bone plates and screws made from high-quality titanium and titanium alloy, ensuring both strength and biocompatibility. The primary materials used in the CanMINI Hand and Foot System are pure titanium, conforming to ASTM F67 standards, and titanium alloy, conforming to ASTM F1472 standards.

The CanMINI Hand and Foot System consists of multiple components, each designed to address specific clinical needs in orthopedic surgery. The key components are bone plates and bone screws.

The bone plates include straight type bone plates such as models FZSQ01 Ⅰ, FZSQ12, FZSQ38, FZSQ39Ⅰ, FZSQ39Ⅱ, FZSQ39Ⅲ, FZSQ40Ⅰ, and FZSQ40Ⅱ, as well as supporting type non-locking bone plates like models FBC54Ⅰ, FBC54Ⅱ, FBC55, FBC56, and FBC58. Additionally, the system features supporting type locking bone plates including models FBCS29, FBCS57Ⅰ, FBCS57Ⅱ, FBCS59, FBCS60, FBCS86, FBCS87, FBCS88, FBCS89, FBCS96Ⅰ, FBCS96Ⅱ, FBCS99Ⅰ, FBCS99Ⅱ, FBCS132, FBCS134, and FBCS135. The bone screws are also categorized into different types, including metal non-locking bone screws with models FHAQ02 Ⅰ, FHAQ03 Ⅰ, FHAQ06 Ⅰ, metal locking screws with models FHAS04 Ⅰ, FHCS04 Ⅰ, and cannulated screws with model FGJYD Ⅹ. The bone plates and screws in the CanMINI Hand and Foot System come in a range of sizes to accommodate different anatomical and clinical requirements. For example, the 6-hole 1.5mm phalangeal metacarpal locking plate has dimensions of 29.7 mm in length, 4.7 mm in width, and 0.95 mm in thickness, while the 8-hole 2.4mm condylar locking plate has dimensions of 59.0 mm in length, 6.5 mm in width, and 1.4 mm in thickness.

The CanMINI Hand and Foot System is intended for the stabilization of fractures and osteotomies in the small bones of the hand and foot. It provides mechanical support to the bone during the healing process by maintaining proper alignment and stabilizing the fracture site. The system is designed to be used by orthopedic surgeons in various clinical scenarios involving bone fractures, including but not limited to, calcaneal fractures, fracture displacements, and non-union fractures. The clinical benefits of the system include providing critical stabilization and support during the healing of orthopedic fractures. This system aids in the proper alignment of fractured bones, enhances the healing process, and reduces the likelihood of complications such as malunion or delayed union.

The CanMINI Hand and Foot System is supplied in a non-sterile state and must be sterilized before use. It is intended for single use only.

The provided FDA 510(k) clearance letter and summary for the "CanMINI Hand and Foot System" do not describe acceptance criteria for an AI/software device nor a study proving it meets such criteria.

The document discusses a physical medical device (bone plates and screws) used for fixation of small bones, not a software or AI medical device. The "Non-Clinical Testing" section describes mechanical tests performed on the physical hardware components of the system (e.g., axial pullout strength, single cycle bend testing, driving torque), and material characterization tests for the titanium used in these components, against ASTM standards.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, ground truth establishment, MRMC studies, or standalone performance for an AI/software device from the provided text. The document explicitly states "Clinical Testing: Not Applicable." and focuses on the physical and material properties of an orthopedic implant system.

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Spinal fixation system is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.

Spinal fixation system is mainly constituted by pedicle screw, reduction pedicle screw, Set screw, Spine Hook, Rod and Transverse linking pole assembly. Through using the assembly of the screws, rods and/or poles, there will be established a firm frame structure on the Spinal (conforming to the bio-mechanics principle). The components of the system include: pedicle screw, reduction pedicle screw, set screw, spine hook, rod and transverse linking pole assembly and so on. According to the different specification of the rod's diameter and the different usage on the spinal segments, the system is classified: J2X03, J2X04, J2X07..

Here's an analysis of the provided text regarding the acceptance criteria and study for the described medical device:

The provided document (K161151) is a 510(k) summary for a "Spinal fixation system." It describes a traditional clearance pathway where the device is shown to be substantially equivalent to a legally marketed predicate device (Devine Spinal System K111690). This type of submission relies heavily on similarity in design, materials, and performance data to the predicate, rather than establishing de novo safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study provided to demonstrate the device meets acceptance criteria is primarily a non-clinical bench testing study focused on mechanical and material properties, along with a rationale for biocompatibility based on material standards and prior use.

• Mechanical Testing:

  • Tests conducted: Static compression bending test, Dynamic compression bending test, Static torsion test.
  • Standard followed: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model)
  • Results: For all mechanical tests, the reported performance is that the testing results show "no statistically significant difference" between the proposed device and the predicate device's performance. This implies the acceptance criterion was equivalence or non-inferiority to the predicate device's established mechanical properties.

• Biocompatibility Testing:

  • Rationale provided: The device is made of Ti-6Al-4V, a material conforming to ASTM F136. The document states this material has been "employed successfully in human implant applications in contact with soft tissue and bone for over a decade" and has been used as a "control material in Practice F 981." This serves as the "proof" that the material is biocompatible, rather than new primary biocompatibility testing specifically for this device.

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

• Sample Size for Test Set: The document does not explicitly state the exact sample size for the mechanical tests (e.g., how many screws, rods, or construct assemblies were tested for each mechanical property). It refers to "two sample groups" (presumably proposed device vs. predicate) for comparison.
• Data Provenance:
  • Country of Origin: Not explicitly stated for the testing itself, but the manufacturer (CANWELL MEDICAL CO., LTD.) is based in China. The predicate device manufacturer (Changzhou Orthmed Medical Instrument Co., Ltd) is also likely Chinese.
  • Retrospective or Prospective: The bench testing would be considered prospective for the specific tests performed on the proposed device, but the comparison relies on established data/performance of the predicate device.

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

Given this is a 510(k) submission for a physical implant (spinal fixation system) based on substantial equivalence and primarily on bench testing, the concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., expert consensus on image interpretation) is not applicable in the same way.

• Ground Truth for Mechanical Tests: The "ground truth" is effectively adherence to established ASTM standards and the performance characteristics of the predicate device. The experts involved would be engineers or testing personnel qualified to conduct and interpret the mechanical tests and compare them to the predicate's specifications/performance data. Their specific number or qualifications are not detailed in this document.
• Ground Truth for Biocompatibility: The "ground truth" is the established biocompatibility of the ASTM F136 Titanium alloy, as recognized by regulatory bodies and scientific literature.

4. Adjudication Method for the Test Set

Not applicable in the context of this type of mechanical and material testing. Adjudication methods like 2+1 or 3+1 are typically for resolving discrepancies in expert interpretations (e.g., in diagnostic studies). Here, the comparison is objective (numerical results from mechanical tests) and against a known standard or predicate performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study assesses human performance, often with and without AI assistance, and is common in diagnostic imaging devices. This device is a physical implant, not a diagnostic tool with human interpretation.

6. Standalone (Algorithm Only) Performance Study

• No standalone (algorithm only) performance study was done. This concept is relevant for AI algorithms. The device described is a physical medical implant (spinal fixation system).

7. Type of Ground Truth Used

• For Mechanical Performance: The ground truth is established through industry-recognized ASTM standards (ASTM F1717) and the established performance characteristics of the legally marketed predicate device (K111690).
• For Biocompatibility: The ground truth is based on material standards (ASTM F136) and the documented history of safe use of the material in medical implants.

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the computational sense. The design and manufacturing processes are informed by engineering principles, material science, and the existing predicate device, but not through a "training set" of data for an algorithm.

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

• Not Applicable (as there is no training set for an algorithm). The "ground truth" for the device's design and manufacturing is derived from established engineering principles, material science knowledge, and the performance history and specifications of the predicate device.

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The metallic locking bone plate and screw are intents with age above 21 as indicated fixation of fractures, including ulna, radius, humerus, femur, tibia, clavicle, and fibula for the following indications:

• ostcotomies, mal-unions, and non-unions;
• single, segmental, and comminuted fractures;
• normal bone density and osteopenic bone.

The proposed device, metallic Locking Bone Plate and Screw consists of bone plate and screw. The bone plates are used for internal fixation of bone fracture, including ulna, radius, humerus, femur and tibia. Implant is manufactured with Ti6Al4V Eli and titanium which conforms to ASTM F 136 and ASTM F67.
The proposed devices are provided un-sterilized. They shall be sterilized prior to use by healthcare provider. The proposed devices shall never be reused.

This document is a 510(k) premarket notification approval for a medical device: "Metallic Locking Bone Plate and Screw". It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and material biocompatibility, rather than providing details on a study proving the device meets acceptance criteria regarding clinical outcomes or diagnostic performance.

Therefore, many of the requested elements are not applicable to the information contained in this FDA letter and summary. However, I can extract the relevant information based on the document's content.

Device Name: Metallic Locking Bone Plate and Screw

Purpose of the Submission: To demonstrate substantial equivalence to legally marketed predicate devices.

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical or diagnostic performance data or sample sizes for mechanical testing. The performance data provided is based on non-clinical bench testing and material specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for mechanical performance is established by recognized engineering standards (ASTM). Biocompatibility is based on material science and established historical use, not expert consensus on a test set.

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

Not applicable. No clinical or diagnostic test set requiring expert adjudication was conducted.

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 device is a passive implantable device, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

The ground truth for this device's performance relies on:

• Engineering Standards: Bench testing results compared against established ASTM standards for metallic bone plates and screws.
• Material Specifications and Historical Use: Biocompatibility is established by the use of materials (pure titanium and Ti-6Al-4V) that conform to ASTM standards (F1472, F67) and have a long history of successful implantation in humans.

8. The sample size for the training set

Not applicable. No "training set" in the context of machine learning or clinical trials was used. The device design and performance are based on engineering principles and material science, informed by prior knowledge and testing of similar devices and materials.

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

Not applicable. There was no training set. The "ground truth" for the device's design and materials is derived from established engineering and material science principles, as well as the performance of predicate devices.

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