(48 days)
TheriLink™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriLink™ parts create a network within the defect site that resorbs during healing and is replaced by bone.
The TheriLink™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate (ß-TCP), a commonly found mineral in bone. The porosity and geometric features of ß-tricalcium phosphate create a network within the defect site that resorbs during healing and is replaced by native bone.
The provided text describes the TheriLink™ Bone Void Filler, a synthetic beta-tricalcium phosphate (ß-TCP) device for filling bone voids but does not include information about acceptance criteria or a study proving the device meets them in the context of performance metrics like sensitivity, specificity, or AI-assisted improvements. This is mainly because the document is a 510(k) summary for a medical device which relies on demonstrating substantial equivalence to a predicate device rather than clinical trial performance metrics as would be typical for an AI/ML diagnostic.
Based on the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" in the traditional sense of performance targets for an AI/ML device (e.g., minimum sensitivity, specificity). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "performance" described relates to the physical and chemical characteristics of the TheriLink™ Bone Void Filler, comparing it to a predicate device (TheriFil™).
| Characteristic | Acceptance Criteria (Implied for Substantial Equivalence via Predicate Range) | Reported TheriLink™ Performance | Predicate (TheriFil™) Performance |
|---|---|---|---|
| Porosity (%) | Similar to TheriFil™ (59 ± 5.3) | 58 ± 2.2 | 59 ± 5.3 |
| Pore Area (µm²) - Mean | Similar to TheriFil™ (3000 ± 1200) | 2500 ± 900 | 3000 ± 1200 |
| Pore Area (µm²) - Min* | Similar to TheriFil™ (40) | 40 | 40 |
| Pore Area (µm²) - Max | Similar to TheriFil™ (3.5 x10^5 ± 2.1 x10^5) | 4.9 x10^5 ± 1.9 x10^5 | 3.5 x10^5 ± 2.1 x10^5 |
| Pore Diameter (µm) - Mean | Similar to TheriFil™ (60 ± 12) | 55 ± 11 | 60 ± 12 |
| Pore Diameter (µm) - Min* | Similar to TheriFil™ (7) | 7 | 7 |
| Pore Diameter (µm) - Max | Similar to TheriFil™ (640 ± 220) | 770 ± 170 | 640 ± 220 |
| True Density (grams/mL) | Similar to TheriFil™ (1.5) | 1.5 | 1.5 |
| Crystallinity | Similar to TheriFil™ (ß-TCP > 75%) | ß-TCP > 75% | ß-TCP > 75% |
Note: The "acceptance criteria" here are implied by the substantial equivalence argument, meaning the device's characteristics must be sufficiently similar to the predicate to not raise new questions of safety or effectiveness. There are no explicit numerical acceptance thresholds stated in the document beyond the comparative data.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "SEM images (n = 18)" were used for estimating porosity and pore area. This constitutes the "test set" for physical characteristic evaluation.
- Sample Size (Test Set): 18 (for SEM images)
- Data Provenance: Not explicitly stated, but it would be from manufacturing batches of the TheriLink™ and TheriFil™ devices. This is a retrospective analysis of manufactured products. Country of origin not specified, but the company is US-based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For physical/chemical characteristic measurements, the "ground truth" is typically established by standardized laboratory testing procedures performed by qualified technicians or engineers, rather than medical experts.
4. Adjudication Method for the Test Set
Not applicable. The measurements are objective physical characteristics, not expert interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No, an MRMC comparative effectiveness study was not done. This device is a bone void filler, not an AI/ML diagnostic tool meant to assist human readers. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done.
No, this is not an AI algorithm. Its "performance" is based on its physical and chemical properties and biological host response (resorption and replacement by bone), not an algorithmic output.
7. The Type of Ground Truth Used
For the physical and chemical characteristics, the ground truth is established by objective laboratory measurements using methods such as SEM imaging and pycnometry. For the biological performance (resorption and replacement by bone), the implicitly accepted ground truth is the known biological behavior of ß-TCP and the predicate device, as well as the intended biological response described for TheriLink™ ("resorbs during healing and is replaced by bone").
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The manufacturing process and formulation are based on scientific principles of material science and known biocompatibility of ß-TCP, not a data-driven training approach.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there's no training set for an AI/ML model.
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KO40134 THERICS' ャートは1人を見える11、そのために1本に1人に
THERICS, INC. I 15 Campus Drive PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 609-514-7219 FAX: E-MAIL: therics@therics.com
MAR - 9 2004
510(k) SUMMARY
Therics' TheriLink™ Bone Void Filler
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Submitter's Name:
Umberto V. Parrotta 609.514.7237 or 609.514.7200 (main) Telephone: Facsimile: 609.514.7219 Contact Person: Umberto V. Parrotta
Date Prepared: January 19, 2004
Name of Device and Name/Address of Sponsor
TRADE/PROPRIETARY NAME OF DEVICE:
TheriLink™ Bone Void Filler
ADDRESS:
115 Campus Drive Princeton, New Jersey 08540
Common or Usual Name:
Bone Void Filler. Synthetic Bone Void Filler. Synthetic Cancellous Bone Void Filler. Bone Graft Substitute. Synthetic Bone Substitute. Synthetic Cancellous Bone Substitute
Classification Name
Bone Void Filler
Predicate Devices
Therics' TheriFil™ Bone Void Filler Orthovita's Vitoss™
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THERICS, INC. 115 CAMPUS DRIVE PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 609-514-7219 FAX: E-MAIL: therics@therics.com
Image /page/1/Figure/1 description: The image shows a logo for a company called "THERICS". The logo features a stylized letter "T" above the company name. Below the company name, the text "LASER ENGINEERING SPECIALISTS" is present, indicating the company's area of expertise.
Intended Use / Indications for Use
cu ose / Indications is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriLink™ parts create a network within the defect site that resorbs during healing and is replaced by bone.
Technological Characteristics and Substantial Equivalence
The TheriLink™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate (ß-TCP), a commonly found mineral in bone. The porosity and geometric features of ß-tricalcium phosphate create a network within the defect site that resorbs during healing and is replaced by native bone.
A summary of the physical and chemical characteristics of both TheriLink™ and TheriFil™ is below in Table 1.
| Characteristic | TheriLink™ | TheriFil™ |
|---|---|---|
| Porosity (%) | 58 ± 2.2 | 59 ± 5.3 |
| Pore Area (µm²) | Mean2500 ± 900 | 3000 ± 1200 |
| Min*40 | 40 | |
| Max$4.9 x10^5 ± 1.9 x10^5$ | $3.5 x10^5 ± 2.1 x10^5$ | |
| Pore diameter (µm) | Mean55 ± 11 | 60 ± 12 |
| Min*7 | 7 | |
| Max770 ± 170 | 640 ± 220 | |
| True Density (grams/mL) | 1.5 | 1.5 |
| Crystallinity | β-TCP > 75% | β-TCP > 75% |
Table 1. Physical and chemical characteristics of the TheriLink™ and TheriFil™ .
Percent porosity and pore area (um') were estimated using SEM images (n = 18) and are described in Attachment - 13A, I crosity Characterization. Data are shown as ave ± sidev. The pore diameter was estimated from the pore area by assuming r circular shaped pores. * All finite (< 40 um') pore structures were excluded from the analysis and therefore the minimum porc e realis represented by 40um and the pore diameter by 7um. The true density was measured using a pycnometer.
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THERICS, INC. 115 Campus Drive PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 609-514-7219 FAX: E-MAIL: therics@therics.com
Image /page/2/Figure/1 description: The image shows a logo with the word "THERICS" in a stylized font. Below the word "THERICS" is the text "VISCOR ENGINEERING SPECIALISTS". Above the word "THERICS" is a symbol that looks like a "T" made of plus signs.
The risk assessment comparing the design of TheriLink™ to TheriFir™ indicates I he TISK assessment comparing the design, appearing consistent with similar FDA cleared and marketed products (i.e. Orthovita's Vitoss™).
The TheriLink™ implants have the same intended use and indications, the same THE THENDS - Implants nation and technological characteristics, and equivalent of simmal principals or operepriate bench studies, and risk assessment. performance of characteristics in appeared in substantially equivalent to the predicate device.
Attachment - 6
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem consisting of three stylized horizontal lines that appear to be flowing or waving.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 2004
Therics, Inc. C/o Jonathan S. Kahan Hogan & Hartson, LLP 555 13th St. NW Washington, DC 20004
Re: K040134
Trade/Device Name: TheriLink™ Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: January 21, 2004 Received: February 9, 2004
Dear Mr. Kahan:
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 (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.
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Page 2 - Jonathan S. Kahan
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). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
R. Mark A. Millerson
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CONFIDENTIAL
Attachment - 11
Indications for Use Form
510(k) Number (if known):
Device Name:
TheriLink™ Bone Void Filler
Indications for Use:
TheriLink™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e., the extremities, spine and pelvis). TheriLink™ parts create a network within the defect site that resorbs during healing and is replaced by bone.
v 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) Division of General, Restorative, and Neurological Devices Koy 0134
File: Attachment-11-TheriLink-IndicationsForUseStatementForm.doc
"10()) Nirmher
§ 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.