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.

Device Description

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.

AI/ML Overview

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.

Summary

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K023014

Imbibe™ Bone Marrow Aspiration Syringe Special 510(k)

MAR 11 2003

501(k) Summary

Submitted by	Address	Telephone	Contact Person
Orthovita, Inc.	45 Great Valley ParkwayMalvern, PA 19355	(610) 640-1775	Andreina IdeSr. Director, RegulatoryAffairs
September 2002
Trade Name	Imbibe™ Bone MarrowAspiration Syringe	Imbibe™ Bone MarrowAspiration Syringe, K011087
Common Name	Bone Graft Delivery Syringe	Bone Graft Delivery Syringe
Classification Name	Piston Syringe	Piston Syringe

Device Description:

Intended Use:

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.

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K023.74

Orthovita, Inc. Imbibe™ Bone Marrow Aspiration Syringe Special 510(k)

COMPARISON TO PREDICATE (Original) SYRINGE

Predicate Syringe, K011087

Modified Syringe

Syringe Type	Piston Syringe	Piston Syringe
Intended Use	To collect blood components/bone marrowfor mixing with bone graft and subsequentdelivery to the surgical site.	Identical
Principle of Operation	Syringe used to collect blood, marrowRemovable cap allows syringe to befilled with graft material Syringe provides for mixing of blood,marrow with graft material Removable screw cap allows fordelivery of blood, marrow filled graftto surgical site	Identical
Barrel Length	2.93 inches	2.93, 3.25, 3.47, and 5.23 inches forthe 10, 20, 30 and 60cc syringes,respectively
Barrel Diameter	0.728 inches, OD	0.728, 0.898, 1.038, and 1.186 inchesOD for the 10, 20, 30 and 60ccsyringes 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 predicatedevice, K011087
Materials	Polycarbonate, ABS, Silicone	Polycarbonate, ABS, Silicone, PVC
Sterility	gamma radiation	gamma radiation

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the three branches of government. The eagle is enclosed in a circle, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the top of the circle. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 11 2003

Orthovita, Inc. Andreina Ide Senior Director, Regulatory Affairs 45 Great Valley Parkway Malvern, Pennsylvania 19355

Re: K023074

Trade/Device Name: IMBIBE™ Bone Marrow Aspiration Syringe Regulation Number: 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: February 10, 2003 Received: February 11, 2003

Dear Ms. Ide:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general' controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing

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Page 2 – Ms. Andreina Ide

(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Orthovita, Inc. Imbibe™ Bone Marrow Aspiration Syringe Special 510(k)

INDICATIONS FOR USE STATEMENT

510(k) NUMBER (IF KNOWN): [ ¿ 2 ≤ ~14

DEVICE NAME: Imbibe™ Bone Marrow Aspiration Syringe

INDICATIONS FOR USE:

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 1X (Per 21 CFR 801.109) OR

Over-The-Counter-Use

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological ( evices

510(k) Number K023074

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).