(266 days)
The PUMA System is intended as an adjunct in fracture repair involving metaphyseal, and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
The PUMA System when used for fixation of bone-to-bone or soft tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.
Specifically, the PUMA System is indicated to provide fixation during the healing process for the following:
- . Fixation of Syndesmosis disruptions in connection with Weber B and C ankle fractures.
- Fixation of Syndesmosis disruptions in connection with dorsal distal radioulnar ligament (DRUL) disruptions.
- Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc Injury.
- Hallux Valgus reconstruction by providing for the reduction of 1st and 2nd metatarsal intermetatarsal angle.
The PUMA System comprises three components: one suture (PUMA Body) made of a nickel titanium alloy (nitinol), and two anchors (PUMA Anchors) made of polyether-ether-ketone (PEEK). The PUMA Body is inserted through bones or soft tissues that need to be stabilized. Once placed, the device secures the bone and/or tissue by means of the PUMA Anchors affixed to each side of the Body. The elastic/superelastic shape characteristic of the nitinol confers some flexibility while maintaining the stability of the PUMA System.
This document is a 510(k) Summary for the PUMA System, a medical device intended for fracture repair and fixation. It describes the device, its indications for use, and a summary of non-clinical testing performed to demonstrate its substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states, "No FDA performance standards have been established for the PUMA System." Therefore, there are no specific, quantitative acceptance criteria listed that the device's performance needs to meet against a defined numerical threshold. Instead, the "acceptance criteria" are implicitly to demonstrate safety and effectiveness based on current industry standards and equivalence to predicate devices through the following non-clinical tests:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility (per ISO 10993-1) | Pass: "Biocompatibility risk assessment per ISO 10993-1" was performed. Conclusion: "does not raise new issues of safety or effectiveness compared to the predicate devices." |
| Sterility/Endotoxin Absence (per ANSI/AAMI ST72) | Pass: "Bacterial Endotoxin Testing per ANSI/AAMI ST72" was performed. Conclusion: "does not raise new issues of safety or effectiveness compared to the predicate devices." |
| Material Safety - Chemical Analysis (Extractables/Leachables) | Pass: "Extractable/Leachable Chemical Analysis and Toxicological Risk Assessment" was performed. Conclusion: "does not raise new issues of safety or effectiveness compared to the predicate devices." |
| Mechanical Stability - Pull-out Force | Pass: "Pull-out Force" testing was performed. Conclusion: "performance data demonstrate substantial equivalence to the predicates," and "does not raise new issues of safety or effectiveness compared to the predicate devices." The specific numerical outcome is not provided. |
| Mechanical Durability - Cyclic Fatigue | Pass: "Cyclic Fatigue Testing" was performed. Conclusion: "performance data demonstrate substantial equivalence to the predicates," and "does not raise new issues of safety or effectiveness compared to the predicate devices." The specific numerical outcome is not provided. |
| Material Strength - Tensile Testing (pre- and post-cyclic) | Pass: "Tensile Testing (pre- and post-cyclic fatigue testing)" was performed. Conclusion: "performance data demonstrate substantial equivalence to the predicates," and "does not raise new issues of safety or effectiveness compared to the predicate devices." The specific numerical outcome is not provided. |
| Material Integrity - Corrosion | Pass: "Corrosion Testing (on the final trimmed device)" was performed. Conclusion: "performance data demonstrate substantial equivalence to the predicates," and "does not raise new issues of safety or effectiveness compared to the predicate devices." The specific numerical outcome is not provided. |
| Substantial Equivalence (Overall) | Achieved: "The subject device is considered as safe and effective for its intended use as the predicate device." "The results of these tests indicate that the PUMA System is substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical testing (bench testing), not a clinical trial with a "test set" of patients. Therefore, information regarding "sample size used for the test set" in the context of human subjects or "data provenance" (country of origin, retrospective/prospective) is not applicable or provided. The tests mentioned (Biocompatibility, Pull-out Force, Cyclic Fatigue, etc.) would have involved specific numbers of device samples or materials, but these sample sizes are not detailed in this summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable as the summary describes non-clinical (bench) testing, not a clinical study involving human patients where expert readers would establish ground truth for a diagnostic or interventional outcome.
4. Adjudication Method:
This information is not applicable as the summary describes non-clinical (bench) testing, not a clinical study involving human patients where adjudication of expert readings would be required.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document does not mention any MRMC comparative effectiveness study or any study involving human readers with or without AI assistance. The testing performed was non-clinical.
6. Standalone (Algorithm Only) Performance Study:
No. The PUMA System is described as comprising physical components (suture, anchors). It is a mechanical device, not an algorithm or AI system. Therefore, a standalone algorithm-only performance study is not relevant or mentioned.
7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" would be established by engineering and material science standards and measurements. For example:
- Biocompatibility: Conformance to ISO 10993-1.
- Pull-out Force: Measured force applied to the device until failure, compared against expected mechanical properties or predicate device performance.
- Tensile Strength: Measured force to achieve specified elongation or fracture, compared against material specifications or predicate device performance.
- Corrosion: Visual inspection or other analytical methods to detect material degradation.
The document implicitly uses these established engineering and material science "ground truths" to determine if the device performed as expected and equivalently to its predicates.
8. Sample Size for the Training Set:
This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning. The device design and manufacturing processes are developed through engineering principles, not statistical learning from data in a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.