(29 days)
The EQUESTRA™ Delivery System is intended to provide surgeons with a percutaneous means of delivering legally cleared bone cement to the surgical site in orthopedic procedures.
The EQUESTRA™ Fluid Delivery System is designed to provide surgeons with a means to inject commercially cleared bone cement to the surgical site in orthopedic procedures. The EQUESTRA™ Fluid Delivery System does not contain any bone cement material, as this system only consists of general instruments.
The EQUESTRA™ Fluid Delivery System consists of a variety of general surgical instruments. The system reservoirs are supplied empty as the system itself does not include any bone cement. Included in the system are bone tamps and stylets. All of the system components are manual, single-use disposable instruments.
The purpose of this submission was to add modified instruments to the EQUESTRA™ Fluid Delivery System.
This document describes the K043568 EQUESTRA™ Fluid Delivery System, which is a set of instruments used to deliver legally cleared bone cement in orthopedic procedures.
Based on the provided text, there is no acceptance criteria or study data presented that proves the device meets specific performance metrics.
The submission is a 510(k) Pre-market Notification seeking substantial equivalence. The core of this type of submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than proving its performance against specific, quantifiable acceptance criteria through an independent study.
Here's a breakdown based on your requested information:
1. A table of acceptance criteria and the reported device performance:
- Not applicable. The document does not describe acceptance criteria for specific performance metrics (e.g., flow rate, pressure, volume delivery accuracy) nor independent performance results against such criteria. The submission relies on demonstrating substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No test set or associated data provenance is described for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring adjudication is described.
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 manual surgical instrument and does not involve AI or human "readers" in the context of image interpretation or diagnostic performance. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical instrument and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The submission focuses on substantial equivalence based on device design and intended use compared to a predicate, not on a ground truth for a diagnostic or performance outcome.
8. The sample size for the training set:
- Not applicable. This device is a manual surgical instrument; there is no "training set" in the context of machine learning or statistically powered performance studies.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
In summary:
The K043568 submission for the EQUESTRA™ Fluid Delivery System is a pre-market notification (510(k)) that established substantial equivalence to an already cleared predicate device (K040483). This means the device was determined to be as safe and effective as the predicate without necessarily conducting independent, de novo performance studies with acceptance criteria, test sets, or ground truth establishment. The "proof" of meeting any "criteria" is the demonstration that the new instruments are sufficiently similar to the previously cleared ones.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.