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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.

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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

• 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).

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