(149 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.
Here's an analysis of the provided text regarding the EQUESTRA™ Fluid Delivery System, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than conducting a new clinical study with specific acceptance criteria for device performance as one might see for a novel, high-risk device or an AI/ML product. Therefore, many of the requested categories (like sample size, ground truth, MRMC studies, etc.) are not applicable to this type of submission.
The EQUESTRA™ Fluid Delivery System is a collection of general surgical instruments (bone tamps, stylets, and cannulas) designed to deliver legally cleared bone cement during orthopedic procedures. It does not contain any bone cement itself.
Since this is a submission based on substantial equivalence to existing Class I exempt instruments, the "acceptance criteria" are primarily related to general device safety and effectiveness as demonstrated by the predicate devices, rather than specific performance metrics measured in a new study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices: |
- Ability to provide a percutaneous means of delivering bone cement.
- Mechanical properties suitable for their intended use (e.g., bone tamps for tamping, stylets for guiding).
- Single-use disposable. | The submission asserts that the EQUESTRA™ Fluid Delivery System is substantially equivalent to various Class I exempt instruments including bone tamps, cannulas and stylets. This implicitly means it meets the functional capabilities and safety profiles of these predicate devices. Specific performance values (e.g., force required for tamping, flow rate through cannula) are not provided as this is not a de novo study. |
| Biocompatibility:
(Implied for patient contact devices) | While not explicitly stated as an "acceptance criteria," biocompatibility would be an inherent requirement for any surgical instrument. The substantial equivalence claim suggests it meets the same biocompatibility standards as its predicates. |
| Sterility:
(Implied for surgical instruments) | Also not explicitly stated as an "acceptance criteria," sterility is a fundamental requirement. The "single-use disposable" nature implies it is supplied sterile. |
| Material Safety:
(Implied for components) | The materials used would be expected to be safe for their intended use and consistent with materials used in predicate devices. |
2. Sample Size for the Test Set and Data Provenance
- Not Applicable. No explicit "test set" and corresponding sample size are mentioned for a new study. The demonstration of substantial equivalence relies on comparison to existing, already-marketed predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. Given the nature of a 510(k) for general instruments demonstrating substantial equivalence, there was no separate "ground truth" establishment for performance metrics by independent experts, as would be done for a diagnostic or AI device. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate devices.
4. Adjudication Method
- Not Applicable. No adjudication method is described as there was no study requiring expert consensus or adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is typically performed for imaging or diagnostic devices where human readers interpret results, sometimes with AI assistance. The EQUESTRA™ system is a set of physical surgical instruments, so an MRMC study is not relevant.
6. Standalone (Algorithm Only) Performance Study
- No. This device is hardware (surgical instruments), not an algorithm or software. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
- The "ground truth" in the context of this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The applicant is asserting that the EQUESTRA™ system is equivalent to these already-approved devices, rather than establishing new performance metrics.
8. Sample Size for the Training Set
- Not Applicable. There is no "training set" as this device does not involve an AI/ML algorithm or a new performance study that would require statistical training data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (As above, no training set).
§ 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.