(93 days)
PISCES™-SA ALIF Spacers (Standalone Use, With Integrated Fixation)
The PISCES™ SA (Standalone) ALIF Interbody System are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™-SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
PISCES™-SA Used with Screws and/or Anchors:
When used with three (3) anchors, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 level without the need for supplemental fixation.
When used with three (3) screws, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels without the need for supplemental fixation.
Hyperlordotic interbody devices (>20° lordosis) used with screws and/or anchors must always be used with supplemental fixation and may be used at 1 or 2 contiguous levels.
PISCES™ ALIF Spacers (Without Integrated Fixation)
PISCES™ ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>= 20 lordosis) must be used with at least anterior supplemental fixation.
PISCES™-SA Standalone ALIF Interbody System is an interbody fusion device for the lumbar spine that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws and/or anchors, these devices are standalone interbody fusion devices. The integrated fixation anchors may not provide adequate stability for all situations. The surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g., anterior plate, posterior pedicle screws) may be needed. When used without screws and/or anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The PISCES™ SA interbodies are manufactured from titanium alloy (Ti-6AI-4V ELI) per ASTM F3001. The spacers are available in multiple sizes. The spacers are single use devices, which are sterilized via gamma radiation and are provided to the user in sterile packages. The screws, and locking plates are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and must be sterilized prior to use. The instruments used to insert the cage are manufactured from medical grade stainless steel and must be sterilized prior to use. The screws, anchors, locking plates, and instruments are supplied in a re-usable tray for steam sterilization.
The provided text is related to a 510(k) premarket notification for a medical device called the "PISCES™-SA STANDALONE ALIF Interbody System". This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing, rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically seen for AI/ML device evaluations. As such, many of the requested elements (like sample size for test sets, data provenance, ground truth establishment, expert qualifications, MRMC studies, standalone performance for AI, and training set details) are not applicable or available in this document because it describes a traditional hardware medical device clearance, not an AI/ML software device.
However, I can extract information related to the non-clinical testing performed to demonstrate substantial equivalence, which serves a similar purpose to meeting acceptance criteria for this type of device.
Here's a summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics that would be directly comparable to the reported device performance in the way you might expect for an AI/ML model. Instead, it refers to a battery of non-clinical mechanical tests and cadaveric studies. The "reported device performance" is implicitly that the device performs equivalently to the predicate and meets the requirements of the standards cited.
| Criteria Category (Implied) | Specific Test/Study | Method | Performance (Implicitly Met) |
|---|---|---|---|
| Mechanical Strength & Stability | Static Compression | ASTM F2077 | Equivalent to predicate |
| Dynamic Compression | ASTM F2077 | Equivalent to predicate | |
| Static Compression Shear | ASTM F2077 | Equivalent to predicate | |
| Dynamic Compression Shear | ASTM F2077 | Equivalent to predicate | |
| Subsidence | ASTM F2267 | Equivalent to predicate | |
| Expulsion Testing | Not specified standard | Equivalent to predicate | |
| Cantilever Anchor Bending | Not specified standard | Equivalent to predicate | |
| Anchor Impaction Testing | Not specified standard | Equivalent to predicate | |
| Functional Equivalence | Cadaveric Implantation | Not specified standard | Equivalent to predicate |
| Cadaveric Range of Motion (ROM) | Not specified standard | Equivalent to predicate | |
| Cadaveric Fatigue Studies | Not specified standard | Equivalent to predicate | |
| Void Analysis | Not specified standard | Equivalent to predicate |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated for each test. For cadaveric studies, the sample size (number of cadavers or specimens) is not provided. For mechanical tests, the number of samples tested is not given but would typically follow the requirements of the ASTM standards or internal protocols.
- Data Provenance: The cadaveric studies originate from cadaveric specimens. Mechanical testing data comes from laboratory experiments. There is no mention of country of origin or whether the data is retrospective or prospective, as this is typically not relevant for this type of non-clinical device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Ground truth as typically understood for AI/ML (e.g., expert consensus) is not applicable here. The "ground truth" for this device comes from the physical and mechanical properties measured in the laboratory and cadaveric settings, compared against established standards (like ASTM) and the performance of a predicate device.
4. Adjudication method for the test set
- Adjudication methods like 2+1 or 3+1 are not applicable for this type of non-clinical testing. Performance is determined by direct physical measurement and comparison to predefined acceptance criteria within engineering and anatomical studies.
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
- A Multi Reader Multi Case (MRMC) comparative effectiveness study is not applicable as this is a physical interbody fusion device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- "Standalone performance" in the context of an algorithm is not applicable. This is a physical implant, not an algorithm. Its performance is inherent to its design and material properties.
7. The type of ground truth used
- The "ground truth" for justifying substantial equivalence is based on engineering standards (ASTM F2077, ASTM F2267) and direct experimental measurements (mechanical tests, cadaveric studies) demonstrating that the device performs functionally and safely in a manner equivalent to its predicate device. This is a form of empirical ground truth based on physical and biomechanical properties, rather than expert consensus or pathology reports.
8. The sample size for the training set
- A "training set" as defined for AI/ML models is not applicable. This device is a physical product, not a software algorithm that undergoes a training phase.
9. How the ground truth for the training set was established
- As a training set is not applicable, the method of establishing its ground truth is also not applicable.
In conclusion, this FDA 510(k) clearance document is for a traditional medical device (an interbody fusion system). The "acceptance criteria" and "study" described are primarily non-clinical evaluations to confirm the device's mechanical and functional equivalence to a legally marketed predicate device, rather than a clinical trial or AI/ML performance study.
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February 10, 2023
Osseus Fusion Systems % Ms. Jennifer Palinchik President JALEX Medical LLC 27865 Clemens Rd Suite 3 Westlake, Ohio 44145
Re: K223413
Trade/Device Name: Pisces™-SA STANDALONE ALIF Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX, PHM Dated: January 18, 2023 Received: January 30, 2023
Dear Ms. Palinchik:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223413
Device Name PISCESTM-SA Standalone ALIF Interbody System
Indications for Use (Describe) PISCESTM-SA ALIF Spacers (Standalone Use, With Integrated Fixation)
The PISCES™ SA (Standalone) ALIF Interbody System are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be sketally mature and have had at least six (6) months of non-operative treatment. PISCES™ SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
PISCESTM-SA Used with Screws and/or Anchors:
When used with three (3) anchors, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 level without the need for supplemental fixation.
When used with three (3) screws, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels without the need for supplemental fixation.
Hyperlordotic interbody devices (>20° lordosis) used with screws and/or anchors must always be used with supplemental fixation and may be used at 1 or 2 contiguous levels.
PISCESTM ALIF Spacers (Without Integrated Fixation)
PISCES™ ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>= 20 lordosis) must be used with at least anterior supplemental fixation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/1 description: The image shows the word "OSSEUS" in a stylized font. The first letter "O" is a square with a dot in the center. The rest of the letters are in a sans-serif font with rounded edges. The color of the letters transitions from purple to blue. There is a trademark symbol next to the last letter.
510(k) Summary
| Submitted By: | Osseus Fusion Systems1931 Greenville Ave.Suite 200Dallas, TX 75206 |
|---|---|
| Date: | 02/08/2023 |
| Contact Person: | Jennifer Palinchik, JALEX Medical, President (consultant) |
| Contact Telephone: | (440) 935-3282 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | PISCES™-SA STANDALONE ALIF Interbody System |
| Device Classification Name: | Intervertebral Body Fusion Device with Integrated Fixation, Lumbar |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Product Code: | OVD, MAX, PHM |
| Predicate Device: | K213935- PISCES™-SA STANDALONE ALIF Interbody SystemThe predicate device has not been subject to any design related recalls. |
Device Description:
PISCES™-SA Standalone ALIF Interbody System is an interbody fusion device for the lumbar spine that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws and/or anchors, these devices are standalone interbody fusion devices. The integrated fixation anchors may not provide adequate stability for all situations. The surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g., anterior plate, posterior pedicle screws) may be needed. When used without screws and/or anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The PISCES™ SA interbodies are manufactured from titanium alloy (Ti-6AI-4V ELI) per ASTM F3001. The spacers are available in multiple sizes. The spacers are single use devices, which are sterilized via gamma radiation and are provided to the user in sterile packages. The screws, and locking plates are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and must be sterilized prior to use. The instruments used to insert the cage are manufactured from medical grade stainless steel and must be sterilized prior to use. The screws, anchors, locking plates, and instruments are supplied in a re-usable tray for steam sterilization.
Intended Use:
PISCESTM-SA ALIF Spacers (Standalone Use, With Integrated Fixation) .
The PISCES™S A (Standalone) ALIF Interbody System are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-Sl). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™-SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
PISCESTM-SA Used with Screws and/or Anchors:
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- When used with three (3) anchors, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 level without the need for supplemental fixation. -When used with three (3) screws, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels without the need for supplemental fixation.
-Hyperlordotic interbody devices (>20° lordosis) used with screws and/or anchors must always be used with supplemental fixation and may be used at 1 or 2 contiguous levels.
PISCESTM ALIF Spacers (Without Integrated Fixation) .
PISCES™ ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (TI-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (LI-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20 lordosis) must be used with at least anterior supplemental fixation.
Summary of Technological Characteristics:
PISCES™-SA Standalone ALIF Interbody System and the predicates have the same intended use and fundamental scientific technology. All devices compare similarly in:
- Design features
- Intended use
- Materials ●
- Dimensions
- . Function
Please see Table 1 Below for a comparison of the devices.
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തടടലടച
Summary of Technological Characteristics:
| Table 1: Technological Characteristics Comparison | ||
|---|---|---|
| -- | --------------------------------------------------- | -- |
| Feature | Subject Device:PISCES™-SAStandalone ALIFInterbody System | Primary Predicate:K213935 -PISCES™-SA Standalone ALIFInterbody System | Comparison |
|---|---|---|---|
| Regulation | 888.3080 | 888.3080 | Equivalent |
| Product Code | OVD, MAX, PHM | OVD, MAX, PHM | Equivalent |
| Indications for Use | PISCES™-SA ALIFSpacers (Standalone Use,With Integrated Fixation)The PISCES™-SA(Standalone) ALIFInterbody System arelumbar interbody fusiondevices intended for usein patients withdegenerative disc disease(DDD) at one or twocontiguous levels of thelumbosacral spine (L2-S1). DDD is defined asdiscogenic back pain withdegeneration of the discconfirmed by history andradiographic studies. Inaddition, these patientsmay have up to Grade 1spondylolisthesis orretrolisthesis at theinvolved level(s). Thesepatients should beskeletally mature andhave had at least six (6)months of non-operativetreatment. PISCES™-SA(Standalone) ALIFSpacers are to be filledwith autograft boneand/or allogenic bonegraft composed ofcancellous and/orcorticocancellous bone. | PISCES™-SAStandalone ALIFInterbody System is afamily of integratedinterbody fusion devicesindicated for one ormore contiguous levelsof the thoracic spine(T1-T12, thoracolumbarjunction (T12-L1), orlumbosacral spine (L1-S1), as an adjunct tofusion in patients withthe followingindications: degenerativedisc disease (DDD), discherniation (withmyelopathy and/orradiculopathy), up toGrade 1spondylolisthesis orretrolisthesis at involvedlevel(s), deformity(degenerative scoliosisor kyphosis), spinalstenosis, and failedprevious fusion(pseudarthrosis). DDD isdefined as a discogenicback pain withdegeneration of the discconfirmed by historyand radiographic studies.These patients should beskeletally mature andhave had at least (6)months of non-operativetreatment.PISCES™-SAStandalone ALIF | Equivalent |
| PISCES™-SA Used withScrews and/or Anchors:-When used with three (3)anchors, interbody deviceswith a lordotic angle ≤20° |
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.
| can be used asstandalone interbodyfusion devices at 1 levelwithout the need forsupplemental fixation.-When used with three (3)screws, interbody deviceswith a lordotic angle ≤20°can be used as standaloneinterbody fusion devicesat 1 or 2 contiguous levelswithout the need forsupplemental fixation.-Hyperlordotic interbodydevices (>20° lordosis)used with screws and/oranchors must always beused with supplementalfixation and may be usedat 1 or 2 contiguouslevels.PISCES™ ALIF Spacers(Without IntegratedFixation)PISCES™ ALIF Spacersare lumbar interbodyfusion devices indicatedat one or more levels ofthe thoracic spine (Tl-T12), thoracolumbarjunction (T12-Ll), orlumbosacral spine (Ll-Sl)as an adjunct to fusion inpatients with thefollowing indications:degenerative disc disease(DDD), disc herniation(with myelopathy and/orradiculopathy),spondylolisthesis,deformity (degenerativescoliosis or kyphosis),spinal stenosis, and failedprevious fusion(pseudarthrosis). DDD isdefined as discogenicback pain withdegeneration of the discas confirmed by historyand radiographic studies. | Interbody System isintended to be used withor without three screwsor anchors whichaccompany theinterbodies. When usedwith screws, thesedevices are standaloneinterbody fusion devicesfor one or twocontiguous levels of thelumbosacral spine (L1-S1). When used withanchors, these devicesare stand-aloneinterbody fusion devicesfor one level of thelumbosacral spine (L1-S1). When used withoutscrews or anchors, thesedevices are intended foruse with supplementalfixation (e.g. facetscrews or posteriorfixation) for one or morecontiguous levels of thethoracic spine (T1-T12,thoracolumbar junction(T12-L1), orlumbosacral spine (L1-S1). When used withoutscrews or anchors, thesedevices with ≥ 20°lordosis must be usedwith at least anteriorsupplemental fixation.PISCES™-SAStandalone ALIFInterbody System isdesigned for use withautograft and/orallogenic bone graftcomposed of cancellousand/or corticocancellousbone graft to facilitatefusion. |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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തടടലടന
| These patients should beskeletally mature andhave had at least six (6)months of non-operativetreatment. PISCESTMALIF Spacers are to befilled with autograft boneand/or allogenic bonegraft composed ofcancellous and/orcorticocancellous bone.These devices areintended to be used withsupplemental fixationsystems that have beencleared for use in thethoracolumbosacral spine(e.g., posterior pediclescrew and rod systems,anterior plate systems,and anterior screw androd systems).Hyperlordotic interbodydevices (≥20 lordosis)must be used with at leastanterior supplementalfixation. | |||
|---|---|---|---|
| Device Description | PISCESTM-SA | PISCESTM-SA | Equivalent |
| Standalone ALIF spacers | Standalone ALIF | ||
| are interbody fusion | spacers are interbody | ||
| devices for the lumbar | fusion devices for the | ||
| spine that may be used | lumbar spine that may | ||
| with three titanium alloy | be used with three | ||
| screws or anchors which | titanium alloy screws or | ||
| accompany the implants. | anchors which | ||
| When used with screws | accompany the implants. | ||
| and/or anchors, these | When used with screws | ||
| devices are standalone | and/or anchors, these | ||
| interbody fusion devices. | devices are standalone | ||
| When used without | interbody fusion | ||
| screws and/or anchors, | devices. When used | ||
| these devices are intended | without screws and/or | ||
| for use with supplemental | anchors, these devices | ||
| fixation (e.g. facet screws | are intended for use with | ||
| or posterior fixation). The | supplemental fixation | ||
| PISCESTM-SA spacers | (e.g. facet screws or | ||
| are manufactured from | posterior fixation). The | ||
| titanium alloy (Ti-6Al-4V | PISCESTM-SA spacers | ||
| ELI) per ASTM F3001. | are manufactured from | ||
| in multiple sizes. Thespacers are single usedevices, which aresterilized via gammaradiation and areprovided to the user insterile packages. Thescrews, anchors, andlocking plates aremanufactured fromtitanium alloy (Ti-6Al-4VELI) per ASTM F136 andmust be sterilized prior touse. The instruments usedto insert the cage aremanufactured frommedical grade stainlesssteel and must besterilized prior to use.The screws, anchors,blocking plates, andinstruments are suppliedin a re-usable tray forsteam sterilization. | 4V ELI) per ASTMF3001. The spacers areavailable in multiplesizes. The spacers aresingle use devices,which are sterilized viagamma radiation and areprovided to the user insterile packages. Thescrews, anchors, andlocking plates aremanufactured fromtitanium alloy (Ti-6Al-4V ELI) per ASTMF136 and must besterilized prior to use.The instruments used toinsert the cage aremanufactured frommedical grade stainlesssteel and must besterilized prior to use.The screws, anchors,blocking plates, andinstruments are suppliedin a re-usable tray forsteam sterilization. | ||
| Interbody Heights | 9-19 mm in 2 mmincrements | 9-19 mm in 2 mmincrements | Equivalent |
| Footprints | 23x29 mm, 26x35 mm,29x39 mm | 23x29 mm, 26x35 mm,29x39 mm | Equivalent |
| Lordotic Angles | 8°, 16°, 20°, 24° | 8°, 16°, 20°, 24° | Equivalent |
| Standalone FixationTechnology | Screws or Anchors | Screws or Anchors | Equivalent |
| Screw Diameters | Ø4.8 mm and Ø5.25 mm | Ø4.8 mm and Ø5.25 mm | Equivalent |
| Screw Lengths | 15-52.5 mm in 2.5 mmincrements | 15-52.5 mm in 2.5 mmincrements | Equivalent |
| Screw Types | Fixed, Variable, Self-tapping, Self-drilling | Fixed, Variable, Self-tapping, Self-drilling | Equivalent |
| Anchor Diameter | Ø4.8 mm | Ø4.8 mm | Equivalent |
| Anchor Lengths | 22.5 mm, 25 mm, 27.5mm | 22.5 mm, 25 mm, 27.5mm | Equivalent |
| Materials | Ti-6Al-4V ELI perASTM F3001 and ASTMF136 | Ti-6Al-4V ELI perASTM F3001 andASTM F136 | Equivalent |
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Oss=us™
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Non-clinical Testing:
Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression per ASTM F2077, static and dynamic compression shear per ASTM F2077, subsidence per ASTM F2267, expulsion testing, cantilever anchor bending, and anchor impaction testing. Substantial equivalence is also supported by performing cadaveric implantation, cadaveric Range of Motion (ROM), cadaveric fatigue studies, and void analysis compared to a previously cleared predicate device.
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.