(59 days)
Synthes RIA System is intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis.
Synthes RIA System is a flexible reaming device that consists of a series of disposable tube assemblies, disposable reamer heads and reusable drive shafts. The device is designed for expedited reaming of the medullary canal in preparation for internal fixation. The free-rotating reamer head attaches to the distal end of the tube assembly. Ports in the manifold of the tube assembly allow simultaneous irrigation and aspiration through the tube assembly during the reaming process. Irrigating fluid is passed through the cannula of the drive shaft and reamer head and aspiration is drawn through ports of the retainer and aspiration tube. The RIA device is available in reaming diameters ranging from 10 to 19 mm and effective reaming lengths ranging from 200 to 580 mm.
Here's an analysis of the provided text regarding the Synthes Reamer Irrigator Aspirator (RIA) System, focusing on acceptance criteria and study information:
Analysis of Acceptance Criteria and Device Performance Study
The provided document is a 510(k) summary for the Synthes (USA) Reamer Irrigator Aspirator (RIA) System (K013527). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific performance metrics and acceptance criteria as might be seen for novel high-risk devices.
Therefore, the document does not contain explicit acceptance criteria or a study demonstrating the device meets those criteria in the way envisioned by the prompt's structured questions. Instead, the "study" is the comparison to the predicate device, K993335 (Synthes (USA) Reamer Irrigator Aspirator (RIA) System). The primary "acceptance criteria" in a 510(k) context for a device like this are that it is substantially equivalent in terms of intended use, technological characteristics, and safety and effectiveness information to the predicate device.
Given this, I will address the prompt's questions based on the information available and clarify what is not present in a standard 510(k) for a device of this type.
1. Table of Acceptance Criteria and Reported Device Performance
As explained above, explicit, quantitative acceptance criteria with specific performance metrics are not typically found in a 510(k) summary for devices like the Synthes RIA System, which relies on substantial equivalence to a predicate. The "performance" demonstrated is that the modified device performs as intended and is substantially equivalent to its predecessor.
| Acceptance Criteria Category (Implied by 510(k)) | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|
| Intended Use | "clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis." - Identical to predicate. |
| Technological Characteristics | "flexible reaming device that consists of a series of disposable tube assemblies, disposable reamer heads and reusable drive shafts." Device is "available in reaming diameters ranging from 10 to 19 mm and effective reaming lengths ranging from 200 to 580 mm." - Equivalent to predicate, indicating no significant changes that would alter safety or effectiveness. |
| Safety and Effectiveness | The FDA’s clearance of K013527 indicates that the agency found the device to be as safe and effective as the predicate device (K993335) for its stated intended use. No new safety or effectiveness concerns were raised in comparison to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this 510(k) submission. There was no "test set" of patients or cases in a clinical study sense. The demonstration of substantial equivalence is based on device description, technical specifications, and comparison to the predicate.
- Data Provenance: Not applicable. No clinical data or patient data is mentioned or used for this 510(k) clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No "test set" or external experts were used to establish ground truth for a performance study. Clinical expertise during the FDA review process would be from FDA reviewers evaluating the submission.
4. Adjudication Method for the Test Set
- Not applicable. No "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. The Synthes RIA System is a mechanical surgical instrument, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or assessment of human improvement with AI assistance is entirely irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. As noted above, this device is a mechanical surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Not applicable in the clinical study sense. The "ground truth" for a 510(k) in this context is the established safety and effectiveness of the predicate device, which the new device is compared against.
8. The Sample Size for the Training Set
- Not applicable. As a mechanical surgical instrument, there is no "training set" in the machine learning or AI context. Device design and engineering principles, along with manufacturing standards, guide its development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set for this type of device.
§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.