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The SmartJet Grafting Liquid Applicator is intended for the application of fluids, as deemed necessary by the surgeon's determination of the clinical use requirements, to facilitate the preparation of soft tissue autograft or allograft material prior to the application of the graft material to a repair site.

The Harvest SmartJet Grafting Liquid Applicator is provided sterile in a sealed pouch and is intended for a single use. The device consists of the following components:
Two commercially available disposable medical piston syringes.
Applicator Tip (spray or dual cannula)
Handle Frame, and
Plunger Clip

This 510(k) summary for the Harvest SmartJet Grafting Liquid Applicator indicates that the device has been found substantially equivalent to a predicate device (Harvest SmartJet Bone Grafting Liquid Applicator, cleared under 510(k)011032) based on technological characteristics and design. It states that the proposed device has the same technological characteristics and is identical in design and configuration to the predicate device, and the materials of manufacture have been demonstrated to be suitable for the intended use.

This implies that the acceptance criteria for this 510(k) submission were primarily based on demonstrating substantial equivalence to the predicate device, rather than explicit performance metrics from an independent study in the current filing. The FDA's letter confirms substantial equivalence without requiring a new clinical study.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

No explicit test set or clinical study data is provided in this 510(k) summary for the Harvest SmartJet Grafting Liquid Applicator to demonstrate performance against specific criteria. The submission relies on the established substantial equivalence to the predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable, as no new test set requiring expert ground truth establishment for performance evaluation against specific metrics is described in this 510(k) summary.

4. Adjudication Method for the Test Set:

Not applicable, as no new test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned for this 510(k) submission.

6. Standalone (Algorithm Only) Performance Study:

Not applicable, as this device is a manual surgical instrument, not an algorithm.

7. Type of Ground Truth Used:

Not applicable, as no new study requiring ground truth is described. The "truth" in this context is the FDA's acceptance of substantial equivalence to a previously cleared device.

8. Sample Size for the Training Set:

Not applicable, as this device is a manual surgical instrument and does not involve a "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as this device is a manual surgical instrument and does not involve a "training set" or ground truth establishment in this manner.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria is the 510(k) review process itself, which concluded that the Harvest SmartJet Grafting Liquid Applicator is substantially equivalent to its predicate device, the Harvest SmartJet Bone Grafting Liquid Applicator (K011032). This determination was based on:

• Comparison of Technological Characteristics/Performance Data: The submission explicitly states, "The proposed device has the same technological characteristics and is identical in design and configuration compared with the predicate device. The materials of manufacture have been demonstrated to be suitable for the intended use specified."
• Predicate Device Equivalence: The predicate device had already undergone FDA clearance, meaning its safety and effectiveness for its intended use were established. By demonstrating that the new device is essentially the same in terms of design, materials, and intended purpose (with an expanded indications for use that was also deemed acceptable), the need for new, extensive performance studies was circumvented.

The FDA's decision to clear the device "based upon the information you supplied, we have determined the device is substantially equivalent" confirms that this comparison was sufficient to meet their regulatory requirements for acceptance. No new independent performance studies or clinical trials specific to this 510(k) for this device are described in the provided text.

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