FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

GPS Advanced is a sterile, single use dispenser for the delivery of FIBERGRAFT™ BG Putty GPS bone graft substitute. The dispenser has a ratcheted plunger that advances with each squeeze of its handle. The 5 cc GPS Advanced Cannula ("GPS Advanced Cannula") is available individually packaged and can be attached to the dispenser.

GPS Advanced is provided sterile via irradiation and GPS Advanced Cannula is provided sterile via ethylene oxide.

The GPS Advanced Cannula is provided empty and needs to be filled with FIBERGRAFT™ BG Putty GPS prior to use. FIBERGRAFT™ BG Putty GPS is a bioactive synthetic bone graft substitute in putty format made from 45S5 bioactive glass and has been previously cleared under K170306 (FIBERGRAFT™ BG Putty – Bone Graft Substitute) and K222276 (CONDUIT™ Cages and FIBERGRAFT™ BG Putty). FIBERGRAFT™ BG Putty GPS is not included in the GPS Advanced dispensing system.

AI/ML Overview

Based on the provided FDA 510(k) clearance letter for "GPS Advanced and GPS Advanced Cannula," it's important to understand that this device is a piston syringe used for delivering a bone graft substitute. As such, the "acceptance criteria" and "study that proves the device meets acceptance criteria" are focused on the mechanical and functional performance of the syringe as a medical device, rather than the performance of an AI/ML algorithm or diagnostic tool.

Therefore, many of the typical questions asked about AI/ML device studies (like MRMC studies, standalone algorithm performance, AI training/test sets, ground truth establishment for AI) are not applicable to this type of device.

Here's a breakdown of the acceptance criteria and performance data as inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance (Inferred)
Biological Safety	Biocompatibility and safety of materials in contact with body fluids/tissue.	Met through Biological Risk Assessment.
Sterilization Efficacy	Device is sterile.	Met through Sterilization Validation (Irradiation for GPS Advanced, Ethylene Oxide for GPS Advanced Cannula).
Packaging Integrity	Packaging maintains sterility and protects device integrity over shelf-life.	Met through Packaging and Shelf-Life Testing.
Functional Performance	Device delivers the intended substance (FIBERGRAFT™ BG Putty GPS) effectively and reliably to the bone grafting site.	Met through functional evaluation (likely as part of Packaging and Shelf-Life Testing, and implicitly through similarity to predicate). The ratcheted plunger advances with each squeeze, allowing delivery.
Shelf-Life Stability	Device maintains its functional and sterile properties for its specified shelf-life.	Met through Shelf-Life Testing.
Design & Material Conformity	Design features, materials, and principle of operation are consistent with predicate devices and suitable for intended use.	"The technological characteristics, including design, materials, principle of operation and performance as well as intended use of GPS Advanced and GPS Advanced Cannula are consistent with those of the primary predicate and reference device."

Explanation of Inferences:

The document explicitly states that "The performance data for the subject devices consists of the following evaluations: Biological Risk Assessment, Sterilization Validation, Packaging and Shelf-Life Testing, including functional evaluation." These evaluations implicitly define the acceptance criteria for those aspects.
The statement about "consistent with those of the primary predicate and reference device" implies that the new device must perform comparably to previously cleared devices in terms of its core technological characteristics and function.

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

This information is not explicitly detailed in the provided 510(k) summary. For a mechanical device like a syringe, "sample size" typically refers to the number of units tested for various validations (e.g., how many syringes were subjected to sterilization, packaging, or functional tests). The document does not specify these numbers.

Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" here refers to test results from various engineering and biological validations of the device itself.

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

This concept is not applicable to this device. "Ground truth" in this context is established through engineering specifications, validated test methods (e.g., sterility testing, material biocompatibility standards), and direct functional testing, not by expert consensus on clinical images or interpretations.

4. Adjudication Method for the Test Set

This concept is not applicable to this device, as there's no "interpretation" or "diagnosis" being made that requires human adjudication. Device performance is determined by objective measurements and validation against established standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The GPS Advanced and GPS Advanced Cannula is a delivery device, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This concept applies to AI/ML algorithms that perform a task independently (e.g., detecting a lesion on an image). The GPS Advanced and GPS Advanced Cannula is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective scientific and engineering standards and tests:

Sterility Validation: Demonstration that the device meets established sterility assurance levels (e.g., SAL of 10^-6).
Biocompatibility Standards: Compliance with ISO 10993 series for medical device biocompatibility.
Functional Specifications: Ability to successfully deliver the specified volume of material, maintain pressure, resist leakage, and operate smoothly.
Packaging Integrity Standards: Ability of the packaging to maintain sterility and physical integrity under specified conditions.
Shelf-Life Parameters: Demonstration that the device retains its functional and sterile properties over its specified shelf-life.

8. The Sample Size for the Training Set

This concept is not applicable for this device. "Training set" refers to data used to train AI/ML algorithms. The GPS Advanced and GPS Advanced Cannula is a mechanical device, not an AI/ML system.

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

This concept is not applicable for this device, as there is no "training set" in the AI/ML sense.

Summary

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).