(59 days)
These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
These devices are bone paste products made by combining gelatin and demineralized bone matrix.
The provided text is a 510(k) Summary for several bone graft substitute devices. It describes the devices, their indications for use, and a summary of technological characteristics. However, it does not include detailed acceptance criteria or a study proving that the device meets specific performance metrics in the way your request outlines for AI/software devices (e.g., sensitivity, specificity, or reader improvement).
This document pertains to a medical device submitted for FDA clearance under the 510(k) pathway, which establishes substantial equivalence to a predicate device, rather than a novel study with clearly defined acceptance criteria and performance data for a diagnostic algorithm.
Therefore, I cannot populate the requested table or answer most of the specific questions about standalone performance, MRMC studies, sample sizes, or ground truth establishment in the context of an AI-based device, as this information is not present in the provided document.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criterion implicitly for a 510(k) is "substantial equivalence" to a predicate device.
- Reported Device Performance:
- The document states: "Results from studies in animal models indicate that these products can be used as a bone graft substitute with equivalent or better healing results when compared to the predicate device."
- "Healing was evaluated radiographically, histologically, and mechanically."
- "DBM and finished product were screened for osteoinductivity in a rat assay."
- Limitation: No specific quantitative performance values (e.g., percentage of improved healing, specific radiographic scores) are provided.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Pro Osteon™ Implant 500R) in terms of safety and effectiveness as a bone graft substitute. | Animal model studies indicate "equivalent or better healing results" compared to the predicate. Healing evaluated radiographically, histologically, and mechanically. Osteoinductivity screened in a rat assay. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "animal models" and "a rat assay" but does not give the number of animals or cases.
- Data Provenance: Animal models (rats).
- Retrospective or Prospective: Not explicitly stated, but typically animal model studies are conducted prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The evaluation of healing in animal models would likely involve animal pathologists, histologists, and veterinary radiologists, but the number and qualifications are not disclosed. This is not a human expert-based ground truth for a diagnostic AI.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This relates to expert consensus for diagnostic decisions, which is not described here.
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 is not an AI/software device. The document describes a bone graft substitute.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/software device.
7. The type of ground truth used:
- Animal Outcomes/Pathology: Based on the "radiographically, histologically, and mechanically" evaluation of healing in animal models, the ground truth would be based on these biological and physical measures in animals.
8. The sample size for the training set:
- Not applicable. This is for a physical medical device, not a machine learning algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
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Image /page/0/Picture/0 description: The image shows the logo for Regeneration Technologies, Inc. The word "Regeneration" is in large, bold, black letters. Below it, in smaller letters, is the phrase "TECHNOLOGIES, INC."
11621 Research Circle Post Office Box 2650 Alachua. FL 32616-2650 USA
Tel 386.418.8888 Toll Free 877 343.6832 Fax 386.413.0542 www.rtix.com
510(K) Summary
February 2, 2005 Date:
Submitted by: Carrie Hartill Regeneration Technologies, Inc. 11621 Research Circle P.O. Box 2650 Alachua, FL 32616-2650 386-418-8888 Telephone: 386-462-3821 Facsimile:
Proprietary Name: REGENAFIL® Allograft Paste REGENAFIL® RT Allograft Paste OPTEFILTM Allograft Paste, Syringe OPTEFIL™ RT Allograft Paste, Syringe OSTEOFIL® DBM Paste OSTEOFIL® RT DBM Paste RTI Allograft Paste
Common Name: Bone Void Filler, Bone Graft Substitute
Classification Name: Filler, Calcium Sulfate Preformed Pellets (per 21CFR section 888.3045)
Predicate Devices:
The current devices have the same indications as and are substantially equivalent to the Pro Osteon™ Implant 500R Resorbable Bone Graft Substitute.
Description:
These devices are bone paste products made by combining gelatin and demineralized bone matrix.
Indications for Use:
REGENAFIL® Allograft Paste; REGENAFIL® RT Allograft Paste; OPTEFIL™ Allograft Paste, Syringe; OPTEFIL™ RT Allograft Paste, Syringe; OSTEOFIL® DBM Paste; OSTEOFIL® RT DBM Paste; and RTI Allograft Paste are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are
K Ö43420
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Image /page/1/Picture/0 description: The image is a black and white abstract design. It features a dark background with lighter, curved lines and dots scattered throughout. The lines appear to be brushstrokes or scribbles, creating a sense of movement and texture. The overall impression is one of chaos and randomness.
indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremittes, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
Summary of Technological Characteristics:
These devices are composed of allograft demineralized bone in a gelatin carrier matrix. These devices have been screened for osteoinductivity in an in vivo assay and also provide a scaffold for osteoconduction. The processed coral in the Pro Osteon® Implant 500R Resorbable Bone Graft Substitute provides a scaffold for osteoconduction.
Non-Clinical Performance Data Supporting Substantial Equivalence Determination: Results from studies in animal models indicate that these products can be used as a bone graft substitute with equivalent or better healing results when compared to the predicate device. Healing was evaluated radiographically, histologically, and mechanically.
1 DBM and finished product were screened for osteoinductivity in a rat assay. Findings from an animal model are not necessarily predictive of human clinical results.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the eagle.
FEB 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Regeneration Technologies, Inc C/o Ms. Carrie Hartill 11621 Research Circle P.O. Box 2650 Alachua, Florida 32616-2650
Re: K043420
Ro43420
Trade Name: REGENAFIL® Allograft Paste, REGENAFIL® RT Allograft Paste, OPTEFILTM Allograft Paste, Syringe, OPTEFIL™ RT Allograft Paste, OP TEFIL™ Anografi Paste, Syrings, OF FEFIL® - TEFFE - Tell Frances
Syringe, OSTEOFIL® DBM Paste, OSTEOFIL® RT DBM Paste and RTI Allograft Paste Regulation Number: 21 CFR 888.3045 Regulation Name: Reabsorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: December 9, 2004 Received: December 13, 2004
Dear Ms. Hartill:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becareer and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatives to the enactment date of the Medical Device Amendments, or to conninered phor to May 20, 1978, the ecordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic rear (110.) that the device, subject to the general controls provisions of the Act. The I ou may, merelore, mannet 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 your device is etablifical controls. Existing major regulations affecting your device it may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA oun of the firther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be deviloed that I 19 mination that your device complies with other requirements of the Act that I DI has intass and regulations administered by other Federal agencies. You must or any I catal statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quand provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Carrie Hartill
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse organ finding of substantial equivalence of your device to a legally premarce issues 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 11 you desire specific at (240) 276-0120. Also, please note the regulation entitled, Connect the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general michinal 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 vours,
Sincerely yours,
Mark A. Millam
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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Indications for Use
510(k) Number (if known): K043420
Device Name:
REGENAFIL® Allograft Paste REGENAFIL® RT Allograft Paste OPTEFIL™ Allograft Paste, Syringe OPTEFILTM RT Allograft Paste, Syringe OSTEOFIL® DBM Paste OSTEOFIL® RT DBM Paste RTI Allograft Paste
Indications for Use:
These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Minh M
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number
§ 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.