(77 days)
HEALOS Bone Graft Material ("HEALOS"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.
Addition of dimensional and volumetric configurations to the HEALOS Bone Graft Material
This FDA 510(k) K043308 document for the HEALOS® Bone Graft Material is a premarket notification for a Class II medical device. It focuses on demonstrating substantial equivalence to a legally marketed predicate device (K012751).
Crucially, this type of submission (510(k) for a bone graft material) typically does not involve the kind of performance studies or acceptance criteria that would utilize algorithms, AI, or human readers in the way your detailed request implies.
Here's a breakdown of why your specific questions about acceptance criteria, study design, multi-reader multi-case studies, and ground truth for AI models are not directly applicable to this document:
- Device Type: The HEALOS Bone Graft Material is a physical medical device (filler, calcium sulfate preformed pellets) for bone void filling, not a diagnostic imaging device or an AI-powered diagnostic/assistance tool.
- 510(k) Process: A 510(k) aims to establish substantial equivalence. For a device like this, the "performance data" referred to (if any) would typically involve biocompatibility testing, material characterization, mechanical properties, and perhaps animal studies to show resorption and new bone formation. It would not involve a "device performance" in terms of diagnostic accuracy or a human-AI interaction study.
- "Performance Data" Section: The document explicitly states: "PERFORMANCE No performance standards have been established for DATA: this type of device." This further reinforces that there are no pre-defined quantitative or qualitative metrics for "device performance" in the sense of diagnostic accuracy that would be assessed in a clinical trial with human readers or AI.
Therefore, most of your requested information cannot be extracted from this document because it pertains to types of studies and evaluations that are not relevant to a 510(k) for a bone graft material.
However, I can address the spirit of some of your questions based on what might be implied by the substantial equivalence process for such a device, and explicitly state what is missing.
Acceptance Criteria and Study for HEALOS® Bone Graft Material (K043308)
Based on the provided K043308 document for HEALOS® Bone Graft Material, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI/diagnostic device is not applicable. This submission is for a physical bone graft material seeking Substantial Equivalence (SE) to a predicate device. The "acceptance criteria" here would implicitly relate to demonstrating safety, effectiveness, and substantial equivalence to the predicate device, often through material characterization, biocompatibility, and potentially animal studies, rather than performance metrics for an algorithm or diagnostic accuracy.
Information Not Found (and why):
Most of the requested information (points 1-9) relates to the evaluation of AI/diagnostic algorithms. This 510(k) is for a physical bone graft material, and therefore, these types of studies were not conducted or reported in this document.
Detailed Response to Your Specific Questions in the Context of a Bone Graft Material 510(k):
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity/specificity for a diagnostic device. For a bone graft material 510(k), acceptance criteria implicitly revolve around demonstrating substantial equivalence to the predicate device (HEALOS Bone Graft Material K012751) in terms of materials, intended use, and general safety/effectiveness characteristics. This would involve showing similar biocompatibility, resorption profiles, and mechanical properties.
- Reported Device Performance: The document states: "PERFORMANCE No performance standards have been established for DATA: this type of device." This means there aren't quantitative performance metrics like those for diagnostic devices reported here. Performance would be inferred from material characterization and comparison to the predicate.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable: This type of test set is relevant for diagnostic or AI algorithm evaluation, not for a bone graft material device. Data provenance (country, retrospective/prospective) would be for clinical data, which is not detailed in this 510(k) for a physical device. Any "testing" would be laboratory-based (material, mechanical) or potentially animal studies, not human subject test sets in the diagnostic sense.
-
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):
- Not Applicable: Ground truth for a test set (e.g., disease presence) is not relevant for a bone graft material device. This question applies to diagnostic evaluations.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: Adjudication methods are used to establish a consensus ground truth for diagnostic decisions, which is irrelevant for a bone graft material.
-
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:
- Not Applicable: MRMC studies and the concept of "human readers improving with AI assistance" are specific to diagnostic support systems incorporating AI. This device is a physical bone graft material.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: "Standalone algorithm performance" is not relevant as this is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable: The concept of "ground truth" in this context is for diagnostic confirmation. For a bone graft material, "ground truth" in a very loose sense might refer to histological evidence of bone formation in an animal model or mechanical testing results meeting specifications, but not in the diagnostic sense.
-
The sample size for the training set:
- Not Applicable: "Training set" is a concept for machine learning algorithms. This device is a physical product.
-
How the ground truth for the training set was established:
- Not Applicable: As with training sets, establishing ground truth for them is an AI/ML concept, not relevant to a bone graft material.
In summary, the K043308 document demonstrates substantial equivalence for a bone graft material by comparing it to an existing predicate device, primarily focusing on materials, safety, and intended use. It does not involve the type of performance studies, acceptance criteria, or evaluation metrics that would be used for an AI-powered diagnostic device, and therefore, the information requested in your specific questions is not present in this document.
{0}------------------------------------------------
Ko43308
FEB 1 6 2005
IX. 510(k) Summary
DePuy Spine, Inc. SUBMITTER: 325 Paramount Drive Raynham, MA 02780
Sharon Starowicz CONTACT PERSON:
November 5, 2004 DATE PREPARED:
CLASSIFICATION NAME: Filler, calcium sulfate preformed pellets
PROPRIETARY NAME: HEALOS Bone Graft Material
PREDICATE DEVICES: HEALOS Bone Graft Material (K012751)
Addition of dimensional and volumetric configurations DEVICE DESCRIPTION: to the HEALOS Bone Graft Material
HEALOS Bone Graft Material ("HEALOS"), combined INTENDED USE: with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.
The principal components of HEALOS are Type I MATERIALS: bovine collagen and hydroxyapatite.
PERFORMANCE No performance standards have been established for DATA: this type of device.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
FEB 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sharon Starowicz Director of Regulatory Affairs DePuv Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K043308
Trade/Device Name: HEALOS® Bone Graft Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: January 21, 2005 Received: January 24, 2005
Dear Ms. Starowicz:
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 r ou may) after or visions 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 may oe subject to back acceral 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{2}------------------------------------------------
Page 2 - Ms. Starowicz
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin mailing of substantial equivalence of your device to a legally premaired notification: The PPA mailing of 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 If you desire specific advice ion Jour (240) 276-0120. Also, please note the regulation entitled, Comact the Office of Compullion as (21 notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
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
{3}------------------------------------------------
lll. Indications for Use
510(k) Number (if known):
HEALOS® Bone Graft Material Device Name:
Indications For Use:
HEALOS Bone Graft Material ("HEALOS"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _
Mark A. Milam
General, Restorative. and Neurological Devices
510(k) Number K043308
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.