(146 days)
The SPEEDTRAP suture construct is indicated for use in soft tissue approximation in orthopedic procedures.
The SPEEDTRAP graft preparation system consists of a suture construct provided on a disposable delivery device. The SPEEDTRAP Graft Preparation system is offered in long and short configurations with white (undyed) and green/white (undyed) color options, including single and multi-pack (Qty. 4) offerings.
This document is a 510(k) summary for the SPEEDTRAP Graft Preparation System, a medical device for soft tissue approximation. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study demonstrating the device meets those criteria, as typically found in an AI/software medical device submission.
However, it does describe the types of tests performed to establish equivalence.
Here's an analysis based on the provided text, highlighting the absence of the requested information for AI/software devices and interpreting the available data in the context of a traditional medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a formal table of acceptance criteria with corresponding performance data in the way one would expect for an AI/software medical device. Instead, it states that "Performance data equivalence was established using non-clinical testing, including suture diameter and suture tensile strength testing." It also mentions "bacterial endotoxin testing."
While not explicitly called "acceptance criteria," the regulatory standards and testing performed for substantial equivalence imply certain thresholds must have been met for these non-clinical tests.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Non-Clinical Testing: | |
| Suture Diameter | Data established equivalence to predicate devices. |
| Suture Tensile Strength | Data established equivalence to predicate devices. |
| Bacterial Endotoxin | Device met requirements. |
| Material/Design Equivalence | "Comprised of the same materials and is similar in design to the predicate Size 2 ORTHOCORD (K040004; K043298) and ETHIBOND EXCEL (K946173), sutures." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified. The document states "non-clinical testing" was performed, but the number of sutures or tests conducted for diameter, tensile strength, or endotoxin is not provided.
- Data Provenance: Not applicable in the context of human data. These are non-clinical (laboratory/bench) tests on the physical device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. Ground truth, in the context of AI/software devices, refers to expert labeling or pathology. For this physical medical device, "ground truth" would be established by standardized measurement techniques and laboratory protocols for the non-clinical tests. No human experts are mentioned for establishing ground truth for these device performance metrics.
4. Adjudication Method for the Test Set:
Not applicable. This concept is for human expert review of cases, typically for AI/software validation. The performance tests described (suture diameter, tensile strength, bacterial endotoxin) are objective laboratory measurements, not subjective expert assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, usually in diagnostic imaging. The SPEEDTRAP Graft Preparation System is a physical surgical suture system, not an AI/software diagnostic tool.
6. If a Standalone Performance Study (Algorithm Only) was done:
No, a standalone (algorithm only) performance study was not done. This is specific to AI/software devices operating without human intervention. The SPEEDTRAP system is a manually implanted surgical device.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" would be the objective, measured values obtained through standardized laboratory testing methods. For instance, for suture diameter, the ground truth would be the measurement obtained using a calibrated micrometer; for tensile strength, it would be the force at break measured by a tensile testing machine according to a standard. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
In summary: The provided document is a 510(k) summary for a physical medical device (suture system). It details regulatory information and establishes substantial equivalence based on material, design, and non-clinical performance (suture diameter, tensile strength, bacterial endotoxin). The questions provided are primarily geared towards the validation of Artificial Intelligence/Software as a Medical Device (AI/SaMD), and thus, most of them are not directly applicable to the content presented in this document.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.