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510(k) Data Aggregation
(78 days)
The GraftGun Universal Graft Delivery System (GDS®) is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site, via direct visualization or minimally invasive.
The GraftGun Universal Graft Delivery System (GDS®) consists of a sterile, single-use, disposable device, and non-sterile reusable Adapter Tips intended for the delivery of prepared allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. The GraftGun Universal Graft Delivery System (GDS®) includes the GraftGun Dispensing Unit, Loading Device, Graft Tubes, and Adapter Tips.
The provided text describes a medical device, the GraftGun Universal Graft Delivery System (GDS®), and its 510(k) clearance process. However, this document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) system.
The device described is a piston syringe used for delivering bone graft material. The performance testing mentioned (Compatibility Assessments, Sterilization Validations, Cleaning Validations, Biocompatibility Assessment, Package Performance, Shelf-Life Testing) are standard tests for mechanical medical devices to ensure their safety, functionality, and sterility. They are not related to AI/ML performance metrics such as sensitivity, specificity, AUC, or reader studies.
Therefore, I cannot fulfill your request for the specific details about AI/ML acceptance criteria and study data based on the provided text. The document is for a non-AI/ML device.
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(30 days)
The Graftgun Universal Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
The Graftgun Universal Graft Delivery System is a sterile, single-use, disposable piston type syringe intended for the delivery of prepared allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
This document describes the FDA's 510(k) premarket notification for the SurGenTec Graftgun Universal Graft Delivery System (K180937). The submission seeks to prove substantial equivalence to a previously cleared device (K170675), with the only modification being that the 5cc graft or syringe tubes can now be supplied preloaded with graft material by a registered graft facility, packaged, sterilized, and shipped to the surgical facility.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of acceptance criteria and the reported device performance:
The document details a series of potential failure modes and the corresponding tests performed to ensure the device's functionality and integrity are not compromised by the new pre-loading and sterilization process. While explicit numerical acceptance criteria are not presented in a table format, the "Action Taken" column describes the tests conducted and implies that the device passed these tests, thus meeting implicitly defined acceptance criteria. The document states that the "results of that analysis showed that after mitigation and characterization of each remaining risk's severity and probability, all remaining risks were ranked as Acceptable."
| Potential Effects of Failure | Potential Cause | Action Taken (Reported Device Performance) |
|---|---|---|
| The bone graft loaded by the Bone Graft Manufacturer cannot be pushed through the Graft tube | The bone graft loaded is too viscous to be pushed through the tube. | Functionality Test -Specific material (GGDVT15 Rev A) performed on tubes after they have gone through the Bone Graft manufacturer's entire process. - 12.5 (Implied: Passed, graft can be pushed through) |
| Device's physical properties are diminished by the Bone Graft company's manufacturing process (Ex: filling, freezing storage temperatures, etc.) | Tube was weakened from Bone Graft manufacturer's process and the user bending the tube to reach desired graft dispensing location. | Tube Bend Test (GGDVT05 Rev A) performed on tubes after they have gone through the Bone Graft manufacturer's entire process. - 12.3 (Implied: Passed, tube integrity maintained after bending) |
| Marking on tube are rubbed off from bone graft manufacturer's process. | Markings rubbed off during Bone Graft manufacturer's process. | Ink scratchoff test (GGDVT01 Rev A) performed after they have gone through the Bone Graft manufacturer's entire process. - 12.1 (Implied: Passed, markings remain visible) |
| Marking on tube are rubbed off during use | Markings were affected during the Bone Graft manufacturer's process so they can be rubbed off easier. | Ink scratchoff test (GGDVT01 Rev A) performed after they have gone through the Bone Graft manufacturer's entire process. - 12.1 (Implied: Passed, markings remain visible during use) |
| Device's physical properties are diminished by the Bone Graft company's manufacturing process (Ex: filling, freezing, storage temperatures, etc.). | Tube was weakened from Bone Graft manufacturer's process so when the user squeezes handle to dispense graft it breaks the tube. | Tube burst test (GGDVT11 Rev A) and Functionality -Specific Material test (GGDVT15 Rev A) performed on tubes after they have gone through the Bone Graft manufacturer's entire process. - 12.4 and 12.5 (Implied: Passed, tube does not break during dispensing) |
| Device's physical properties are diminished by the Bone Graft company's manufacturing process (Ex: filling, freezing, storage temperatures, etc.). | Connection with tube was weakened from Bone Graft manufacturer's process which allowed the ring to fall off. | Ring Pull Off Test (GGDVT02 Rev A) performed on tubes after they have gone through the Bone Graft manufacturer's entire process. - 12.2 (Implied: Passed, ring remains attached) |
| Cracks. Breaks. Handles on syringe break. | The assembly was weakened from Bone Graft manufacturer's process so the device breaks before it can load the Graft Tube | Functionality Test-Specific material test (GGDVT16 Rev A) performed on prototype and production validation. - 12.6 (Implied: Passed, handles and assembly maintain integrity) |
| Reduction of components in the kit causes a reduction of sterility | Less components in the tray affects the way the componentsare sterilized | The gamma sterilizer (Sterigenics) advised that removing components at this scale is no issue for gamma sterilization. Because the density was decreased and packaging configuration did not change significantly, the validated gamma sterilization process should not have affect on sterility. (Implied: Sterility is maintained) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document provides test identification numbers (e.g., GGDVT15 Rev A, GGDVT05 Rev A) but does not specify the sample size used for each test. The number "12.5" which appears after some tests codes is not clearly defined but could potentially be a sample size (e.g., 12.5 units or batches). This is not explicitly stated.
- Data Provenance: The tests were performed on "tubes after they have gone through the Bone Graft manufacturer's entire process." This indicates the tests were conducted prospectively on devices subjected to the new pre-loading and sterilization conditions. The document does not specify the country of origin of the data, but the context implies it relates to the US FDA submission process.
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):
The provided text does not mention the use of experts to establish ground truth for the device's functional and physical property tests. These are engineering and performance validation tests, not diagnostic or clinical interpretation tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As the tests are focused on physical and functional properties and not on subjective interpretation, an adjudication method like 2+1 or 3+1 is not applicable and not mentioned in the document. The tests seem to have pass/fail criteria based on objective measurements or observations.
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:
This is a device for delivering bone graft material, not a diagnostic imaging or AI-assisted device. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not an algorithm-only device. It is a physical medical device. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests appears to be based on engineering specifications and established functional requirements for a graft delivery system. For example, for the "Ink scratchoff test," the ground truth would be that the markings must remain legible, and for the "Tube burst test," the tube must not burst under anticipated stress. For sterility, the ground truth is a sterility assurance level (SAL) of 10-6, which is an industry standard.
8. The sample size for the training set:
This is a physical medical device, not an AI/Machine Learning algorithm. Therefore, the concept of a "training set" in the context of data for model training is not applicable and no such sample size is mentioned.
9. How the ground truth for the training set was established:
As above, this is not an AI/ML device, so the concept of a training set and its ground truth establishment is not applicable.
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(135 days)
The Graftgun Universal Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
The Graftgun Universal Graft Delivery System is a sterile, single-use, disposable device intended for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. The device system consists of: a graft tube for containing and delivering the desired graft material to the surgical site; a plunger to express the graft material from the graft tube; an actuating handle to advance the plunger down the length of the graft tube via a ratcheting mechanism; and an end cap to retain the graft material in the graft tube until ready for use. The system also contains a syringe style loading device for loading the graft tube with graft material. The system is designed such that the graft tube can be filled with the desired graft material, attached to the actuating handle and plunger for use, then removed and refilled or replaced with a new graft tube. The kit comprises two graft tubes. One graft tube is capable of containing 5.0 cc of graft material and the second can contain up to 7.5 cc. Both graft tubes are marked with a graduated scale to measure the volume of graft placed. The graft tube does not have a Luer lock mechanism; the device does not require a needle or similar attachment, the graft tube contents being expressed directly from the tip of the graft tube into the graft site. Components are made of one or more of the following materials: polycarbonate, polypropylene, self-lubricating silicone, stainless steel, acrylonitrile butadiene styrene, and silicone elastomer. The device is packaged in a thermoformed tray with a Tyvek lid. Each tray is then packaged individually in a Tyvek-PE film pouch and an outer paperboard carton. The packaged device system is sterilized via gamma irradiation.
The provided text is a 510(k) Premarket Notification Summary for the Graftgun Universal Graft Delivery System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed acceptance criteria table and a comprehensive study report with the requested specifications for a new medical device.
Therefore, much of the information requested in your prompt (e.g., sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for AI/algorithm-based devices) is not applicable to this type of regulatory submission because the Graftgun is a physical medical device, not an AI or software-intensive device requiring such detailed performance study data.
However, I can extract the information relevant to this specific device based on the principles of substantial equivalence.
Here's the breakdown of what can be inferred or explicitly stated from the document:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal "acceptance criteria" table with numerical performance targets and reported results in the way a clinical study for a drug or an AI diagnostic device would. Instead, substantial equivalence is demonstrated by comparing the new device's technological characteristics and indications for use to those of legally marketed predicate devices. The "performance" being evaluated is whether these characteristics do not raise new questions of safety or effectiveness.
| Characteristic / Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (Graftgun Universal Graft Delivery System) |
|---|---|---|
| Intended Use | Delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. | "Intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site." (Matches predicates) |
| Mechanism of Operation | Graft material expressed from graft tube via a plunger (similar to predicates, but specific actuation mechanism can differ without raising new safety/effectiveness concerns). | Graft material expressed from graft tube via a plunger, operated by a ratchet-actuated handle. Material expressed from graft tube directly to graft site. (Differs from predicates in specific actuation but similar function) |
| Sterility | Sterile, single use only, SAL 10^-6 (similar to predicates). | Sterile, single use only; SAL 10^-6; sterilized via γ radiation. (Different sterilization method than predicates (EO gas) but determined not to raise new safety/effectiveness issues) |
| Patient-Contact Materials | Polypropylene, polycarbonate (similar to predicates). | Polypropylene, polycarbonate. (Matches predicates) |
| Volume Capacity | Comparable to predicate devices (range from 4.0ml to 14.0ml). | Up to 7.5ml in graft tube (within range of predicates) |
The "study" that proves the device meets the acceptance criteria (of substantial equivalence) is the 510(k) submission process itself, which involves a detailed comparison of the new device to existing legally marketed predicate devices. The conclusion statement explicitly states: "The Graftgun Universal Graft Delivery System is substantially equivalent in intended use, principal of operation, and materials to the Bone Solutions Mixing and Delivery System and Bi-Portal Bone Graft Delivery System predicate devices. The difference in plunger actuation and method of sterilization are minor and do not raise any new safety or effectiveness issues for the Graftgun Universal Graft Delivery System for its intended indications."
2. Sample sized used for the test set and the data provenance
- Not applicable / not provided. For a physical device like a syringe, this type of regulatory submission typically relies on bench testing, material testing, and design verification/validation (D/V) activities to ensure functionality, sterility, biocompatibility, and mechanical integrity, rather than large-scale clinical "test sets" of patient data. The document does not detail specific sample sizes for these engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / not provided. Establishing "ground truth" using experts for a test set is relevant for diagnostic or AI-driven devices. For a bone graft delivery system, the "ground truth" is defined by its engineering specifications, material properties, and intended mechanical function.
4. Adjudication method for the test set
- Not applicable / not provided. Adjudication methods are typically for resolving discrepancies in expert interpretations, primarily in diagnostic imaging or clinical evaluations.
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, this was not done. MRMC studies are specific to evaluating diagnostic performance, often for AI-assisted systems, comparing human performance with and without AI. This device is a physical delivery system, not a diagnostic or AI-assisted tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not have an algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's safety and effectiveness is established through engineering specifications, material biocompatibility standards, sterilization validation, and mechanical performance testing (e.g., force to express graft, integrity of components). This is not derived from expert consensus on patient outcomes or pathology, but rather from adherence to recognized standards for medical device design and manufacturing.
8. The sample size for the training set
- Not applicable / not provided. "Training sets" are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable / not provided.
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