(176 days)
The Imbibe Bone Marrow Aspiration Syringe is intended for use as a piston syringe for the aspiration of bone marrow, autologous blood, plasma or other blood components. Prior to use, the syringe can be filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). This syringe provides the surgeon with a convenient way to mix autologous blood or bone marrow with bone void filler (bone graft) and deliver the material to the orthopaedic surgical site.
The syringe consists of a calibrated hollow barrel and a movable plunger. At the distal end of the syringe there is a male connector (nozzle) for fitting the female connector (hub) of a single lumen aspiration needle. A luer-lock nozzle makes a stable connection between the syringe and needle. (Please note that the needle is not the subject of this 510(k).) A threaded screw cap (containing the luer-lock nozzle) at the distal end of the syringe can be removed to allow the user to fill the syringe with his or her choice of bone void filler. Alternatively, the plunger can be removed to add bone void filler from the proximal end of the syringe.
After filling the syringe with bone void filler, the user attaches a needle by way of the luer-lock, and percutaneously aspirates blood or marrow into the barrel of the syringe. Once the desired volume of blood or marrow has been collected, the threaded screw cap is removed and the contents of the syringe are delivered to the surgical site.
The provided text is related to a 510(k) premarket notification for the Imbibe™ Bone Marrow Aspiration Syringe. However, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The document primarily focuses on establishing substantial equivalence to a predicate device (K011087) by comparing physical characteristics and intended use. There is no study described that "proves the device meets the acceptance criteria" in the way you've outlined. Instead, the FDA's clearance is based on the new device being substantially equivalent to the previously cleared predicate.
However, I can extract what is available from the provided text based on your request.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the "acceptance criteria" are implied by the comparison to the predicate device's characteristics. The device "performance" is that it is reported as being "Identical" or having specific measurements that are presented as acceptable variations from the predicate.
| Characteristic / Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Modified Syringe) |
|---|---|
| Syringe Type: Piston Syringe | Piston Syringe |
| Intended Use: To collect blood components/bone marrow for mixing with bone graft and subsequent delivery to the surgical site. | Identical |
| Principle of Operation: Syringe used to collect blood, marrow; Removable cap allows syringe to be filled with graft material; Syringe provides for mixing of blood, marrow with graft material; Removable screw cap allows for delivery of blood, marrow filled graft to surgical site. | Identical |
| Barrel Length: 2.93 inches | 2.93, 3.25, 3.47, and 5.23 inches for the 10, 20, 30 and 60cc syringes, respectively |
| Barrel Diameter: 0.728 inches, OD | 0.728, 0.898, 1.038, and 1.186 inches OD for the 10, 20, 30 and 60cc syringes respectively |
| Tip Type: Gasket | Gasket |
| Volume: 10cc | 10cc, 20cc, 30cc, 60cc |
| Nozzle Type: Luer-lock | Luer-lock |
| Barrel Markings: Graduated scale | Graduated scale |
| Lubricant Composition: Silicone | Silicone |
| Lubricant amt/cm²: $100mg \pm 5mg$ | 25 mg maximum for all sizes |
| Barrel Transparency: Transparent, no radiopacifiers | Transparent, no radiopacifiers |
| Reuse: Single use only | Single use only |
| Biocompatibility: Established | Established by way of predicate device, K0111087 |
| Materials: Polycarbonate, ABS, Silicone | Polycarbonate, ABS, Silicone, PVC |
| Sterility: gamma radiation | gamma radiation |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document does not describe a specific "test set" or clinical study with sample sizes. The clearance is based on substantial equivalence, primarily through a comparison of design and specifications to a predicate device. There is no mention of data provenance.
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)
This information is not available in the provided text. The document does not describe a clinical study requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. 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
An MRMC study was not done. This is a medical device (a syringe), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical syringe and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available in the provided text. The regulatory clearance is based on substantial equivalence rather than a clinical trial with ground truth.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device.
Summary of the study that proves the device meets the acceptance criteria:
Based on the provided documentation, there was no independent clinical study or performance study described in the submission to "prove" the device meets acceptance criteria in a quantitative sense (e.g., through sensitivity/specificity, accuracy, etc.). Instead, the device received 510(k) clearance by demonstrating substantial equivalence to a previously cleared predicate device (K011087).
The "study" or justification for clearance primarily involved:
- Comparison of Device Design and Specifications: The submitting company, Orthovita, Inc., provided a detailed comparison table outlining the characteristics of the new Imbibe™ Bone Marrow Aspiration Syringe against the predicate device. This comparison included materials, dimensions, intended use, operating principle, and sterilization methods.
- Assertion of Identical Features: For many critical aspects like intended use, principle of operation, tip type, nozzle type, barrel markings, lubricant composition, barrel transparency, reuse, biocompatibility, and sterility, the new device was stated to be "Identical" or to achieve functionality in the same manner as the predicate.
- Reasonable Variations Justification: For parameters that differed (like barrel length, diameter, volume, and one material addition – PVC), these differences were implicitly considered within acceptable boundaries for substantial equivalence within the context of a piston syringe. For instance, the increase in available volumes (10cc, 20cc, 30cc, 60cc) and corresponding dimensional changes were presented as variations of the predicate's 10cc design. The mention of "Biocompatibility: Established by way of predicate device, K011087" indicates that no new biocompatibility testing was deemed necessary; the previous predicate's data was leveraged.
In essence, the "proof" for this 510(k) submission lies in the argument that the new device does not introduce new questions of safety or effectiveness when compared to the legally marketed predicate device, rather than explicit performance metrics from a clinical trial.
§ 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).