(111 days)
The implants of the Foot and Hand Motion are intended for the fixation of bone fractures and for arthrodeses of the foot and hand in adults.
The Foot and Hand Motion consists of screws designed for the fixation of bone fractures, for arthrodeses and for osteotomies of foot and hand in adults. The implants of the Foot and Hand Motion will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Foot and Hand Motion will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization (Initial S single use kits).
This document is a 510(k) summary for a medical device called "Foot and Hand Motion" by NEWCLIP TECHNICS. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics. Therefore, many of the requested elements for describing acceptance criteria and a study are not directly available in the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in a quantitative format within the document. The document primarily focuses on establishing substantial equivalence through non-clinical testing and similarity to predicate devices. There are no explicit performance acceptance criteria (e.g., minimum pullout strength in Newtons) or reported device performance values in a table.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of number of screws tested. The non-clinical tests mention "Comparative pullout tests," "Torsional tests," and "Driving torque tests," but the number of samples used for these tests is not quantified.
- Data Provenance: The tests are non-clinical (laboratory tests). There is no mention of country of origin of data or whether it's retrospective or prospective, as these terms typically apply to clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The tests mentioned are non-clinical engineering and material tests (e.g., pullout, torsional strength), not diagnostic or clinical studies that would require expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable, as there is no human-involved "test set" requiring adjudication in the context of this 510(k) summary.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical studies were performed." Therefore, an MRMC study was not conducted.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. The device is a physical bone fixation system (screws), not an algorithm or AI system.
7. Type of Ground Truth Used
Not applicable. For the non-clinical tests mentioned, the "ground truth" would be established by the testing protocols and measurements of physical properties (e.g., force, torque) of the device.
8. Sample Size for the Training Set
Not applicable. There is no mention of a "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 mentioned.
Summary of Available Information from the Document:
The document establishes that the "Foot and Hand Motion" device is substantially equivalent to predicate devices based on:
- Intended Use: Fixation of bone fractures and arthrodeses of the foot and hand in adults.
- Design, Materials, Mechanical Safety, and Performance.
- Materials: Titanium alloy Ti-6Al-4V (conform to ASTM F 136 and/or ISO 5832-3).
- Non-Clinical Tests Conducted:
- Comparative pullout tests
- Torsional tests
- Driving torque tests
- Engineering analyses
- Endotoxins testing using LAL quantitative kinetic chromogenic method.
- Clinical Studies: None were performed.
The conclusion is that the device is equivalent based on similarities in principles of operation, technology, materials, and indications for use with the listed predicate devices. The "acceptance criteria" appear to be implicit in the demonstration of substantial equivalence through these non-clinical tests and comparison to the predicate devices, rather than explicit numerical performance targets.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.