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510(k) Data Aggregation
(121 days)
The Stable-C Interbody System is an anterior cervical interbody fusion system. The Stable-C Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is to be used with supplemental fixation cleared for use in the cervical spine. The system is intended to be used with autogenous or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.
The Stable-C Interbody System is an anterior cervical interbody device comprised of a cage (lordotic angles of 0 , 6°, and 12°) made from Ti-6Al-4V per ASTM F3001 and two fixation anchors made from Ti-6-Al-4V ELI per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.
The provided text is a 510(k) premarket notification FDA letter for a medical device called the "Stable-C Interbody System." This document primarily focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices.
It does NOT describe a study involving an AI/Medical Device that uses machine learning, nor does it provide details about acceptance criteria and performance data in the context of an algorithm's accuracy or effectiveness.
The "Performance Data" section in the document refers to mechanical testing of the physical implant device to prove its structural integrity and safety, not the performance of an AI algorithm.
Therefore, I cannot extract the requested information (acceptance criteria, details of a study proving algorithm performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from the provided text because it is not relevant to an AI/ML medical device.
To answer your request, I would need a document describing the validation and performance of an AI/ML-based medical device.
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(17 days)
The Irix-C Cervical Integrated Fusion System is a stand-alone cervical fusion device intended for spinal fusion procedures at one level (C2 – T1 inclusive) in skeletally mature patients for treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies).
Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
Patients should receive at least six (6) weeks of non-operative treatment with a cervical intervertebral fusion device.
The Irix-C Cervical Integrated Fusion System is a stand-alone intervertebral fusion device designed to restore biomechanical height and act as an aid in fusion of the cervical spine in anterior discectomy procedures. The device is generally boxed shaped with teeth on the superior and inferior faces of the device. The Irix-C implant will be manufactured in either a composite construction of titanium alloy (Ti6AI4V) in accordance with ASTM F136 and Invibio PEEK Optima LT1 in accordance with ASTM F2026, or from Ti6Al4V titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580.
The intervertebral fusion device is intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The device is then secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6AI4V) per ASTM F136.
The devices are available in various sizes, and screws are offered in multiple lengths to adjust for variations in patient anatomy. The single-use implants are provided clean and non-sterile. These devices are intended to be sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave.
A series of manual surgical instruments, provided clean and non-sterile, intended to assist with the insertion and placement of the implants, is included in an instrument tray, which is used for instrument sterilization and storage.
The system does not contain software/firmware.
This document is a 510(k) premarket notification for a medical device called the "Irix-C Cervical Integrated Fusion System." It is a submission to the FDA seeking clearance to market the device.
Based on the provided text, the device is an intervertebral body fusion device intended for spinal fusion procedures. It is classified as a Class II device with product code OVE.
Crucially, this document states: "No substantial technological changes were made to the existing Irix-C System, nor were any new components added to the Irix-C System. The only change is the expanded Indications for Use. Therefore, no additional testing was required or performed."
This means there is NO EVIDENCE OF A STUDY to prove the device meets acceptance criteria related to its performance for this particular 510(k) submission. Instead, the submission relies on the substantial equivalence principle, arguing that the device is equivalent to previously cleared predicate devices for its expanded indications for use.
Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria, as no such study is described in this document for the current submission.
However, I can extract the proposed Indications for Use (the acceptance criteria in terms of clinical application) for the device and clarify why no performance study was conducted.
1. A table of acceptance criteria and the reported device performance
As stated above, this 510(k) submission did not involve new performance testing. The "acceptance criteria" for this submission are essentially the expanded "Indications for Use," which are compared to predicate devices for substantial equivalence, rather than being demonstrated through new performance data.
| Acceptance Criteria (Expanded Indications for Use) | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|
| Intended Use: Stand-alone cervical fusion device for spinal fusion. | Substantially equivalent to predicate devices (K131951, K161280, and other reference devices). |
| Level: One level (C2 – T1 inclusive) | Substantially equivalent to predicate devices for cervical levels, with an expansion from C3-T1 to C2-T1 deemed non-unique based on other cleared devices. |
| Patient Population: Skeletally mature patients. | Substantially equivalent to predicate devices. |
| Condition: Treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). | Substantially equivalent to predicate devices. |
| Implantation Method: Open, anterior approach. | Substantially equivalent to predicate devices. |
| Graft Material: Packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. | This is the primary expansion of the indication from the previous clearance, which presumably only included autograft. The inclusion of allograft is deemed substantially equivalent based on predicate devices from Orthofix and other reference devices that already have this indication. |
| Pre-operative Treatment: Patients should receive at least six (6) weeks of non-operative treatment with a cervical intervertebral fusion device prior to treatment. | Substantially equivalent to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No new performance study (test set) was conducted for this 510(k) submission.
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)
- Not applicable. No new performance study requiring expert ground truth establishment was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new performance study requiring adjudication was conducted.
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
- Not applicable. This device is a physical implant, not an AI/software device. The submission explicitly states "The system does not contain software/firmware."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No new performance study requiring ground truth was conducted. The ground for substantial equivalence is based on comparisons of design, materials, and established indications for use of predicate devices.
8. The sample size for the training set
- Not applicable. No new performance study (training set) was conducted as there is no algorithm or AI component.
9. How the ground truth for the training set was established
- Not applicable. No new performance study (training set) was conducted.
Summary of the document's approach:
The manufacturer, X-Spine Systems, Inc., submitted a 510(k) for their Irix-C Cervical Integrated Fusion System. The core of this submission is substantial equivalence to existing predicate devices. They are seeking to expand the device's "Indications for Use" to include:
- The use of allograft (in addition to autograft) as bone graft material.
- An expanded anatomical region for use, specifically including level C2 (whereas the previous clearance was for C3-T1 inclusive).
The document explicitly states that no new performance data or testing was required or performed because "No substantial technological changes were made to the existing Irix-C System, nor were any new components added to the Irix-C System. The only change is the expanded Indications for Use."
They argue that the expanded indications are not "unique" and are already covered by other legally marketed devices, thus demonstrating substantial equivalence.
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(149 days)
The Shoreline ACS device is a stand-alone device interior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease of the cervical spine at a single level (C2-T ). The Shoreline ACS implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and implanted via an anterior approach. The cervical device is to be used in patients who have had at least six (0) weeks of nonoperative treatment. The cervical device is to be used with Shoreline bone screw fixation and the Shoreline locking cover.
The SeaSpine Shoreline™ ACS (Anterior Cervical Standalone) System consists of the implant assembly, associated instrumentation as well as caddies and trays that may be used for storage and organization. The implant assembly is composed of a PEEK cervical spacer (ASTM F2026) and a titanium alloy (ASTM F136) plate with titanium alloy variable angle or fixed bone screws and a titanium alloy locking cover. Shoreline ACS is offered in a variety of footprints and heights to accommodate variations in patient anatomy and is generally box-shaped with surface teeth and a central canal for receiving autograft bone graft material and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The system is implanted via an anterior approach.
The system offers spacers in low profile and no profile versions. Low profile versions have minimal profile anterior to the disc space (1.6mm), while no profile versions have zero profile. Both low profile and no profile spacers are available with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene® (NM). Alternatively, the no profile spacer is available without a NanoMetalene® coating. Both low profile and no profile versions of the spacers are available in a standard lordotic angle. The Low Profile spacer will also be offered in multiple lordosis versions. The SeaSpine Shoreline™ ACS spacers include radiographic markers manufactured from either titanium alloy (ASTM F136) or tantalum (ASTM F560).
No profile implant versions are offered in a two-screw construct and the low profile versions in two. three, and four-screw constructs to accommodate a range of surgeon preference. For all spacer, plate and screw variations, the locking cover attaches to the device and physically blocks the screw heads to prevent screw back out from the construct.
The provided text refers to a 510(k) premarket notification for the SeaSpine Shoreline™ ACS - Anterior Cervical Standalone System, an intervertebral body fusion device. The focus of this document is to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria as you might find for a novel AI/software device.
Therefore, many of the requested sections related to acceptance criteria, ground truth, expert opinions, and AI performance studies are not applicable to this particular document. This is a medical device approval based primarily on mechanical testing and material equivalence to existing devices.
Here's an analysis based on the information provided and what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance equivalent to predicate device per ASTM standards | Demonstrated equivalent performance to the Globus predicate through static and dynamic compression shear, and torsion testing per ASTM F2077, subsidence testing per ASTM F2267, and wear particle analysis per ASTM F1877. |
| Intended Use | Single level cervical spinal fusion via anterior approach for skeletally mature patients with Degenerative Disc Disease (DDD) (Matches predicate) |
| Materials | Equivalent or similar materials: PEEK-OPTIMA per ASTM 2026, Titanium alloy (ASTM F136), Tantalum, (ASTM F560), CP Titanium Surface (ASTM F67) (Matches or similar to predicate) |
| Design | Equivalent or similar spacer height, footprint, lordotic angle, and screw/plate dimensions (Matches or similar to predicate) |
Notes:
- The document explicitly states that the device demonstrated equivalent performance to the predicate device in specific mechanical tests. The "acceptance criteria" here are implicitly that the device performs at least as well as the predicate device in these tests, adhering to the specified ASTM standards. Specific numerical thresholds for acceptance are not detailed in this summary but would be part of the underlying test reports.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the document. Mechanical testing typically involves a set number of samples of the device components, but the specific quantity is not mentioned here. Data provenance (country, retrospective/prospective) is not relevant for this type of mechanical comparison testing.
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)
- Not applicable. This study is not evaluating expert interpretation or diagnostic performance. It's focused on the physical and mechanical properties of the device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" requiring adjudication in the context of expert review or diagnostic outcomes.
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
- Not applicable. This is a medical device, not an AI/software product that assists human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For mechanical testing, the "ground truth" is defined by the ASTM standards (e.g., F2077, F2267, F1877) themselves, which specify the methodology and expected performance characteristics against which the device is measured. There is no expert consensus or pathology involved in establishing this ground truth for a mechanical test.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
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(159 days)
The ArcadiusXP C Spinal System is intended to be used as an intervertebral body fusion device as a standalone system used with the supplied bone screws and requires no additional supplementary fixation system. It is intended for spinal fusion procedures at one level in the cervical spine from the C2/C3 disc space for the treatment of cervical degenerative disc discogenic pain with degeneration ofthe disc confirmed by history and radiographic studies) using autograft bone.
Patients should be skeletally mature and must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the ArcadiusXP C Spinal System.
The Arcadius X C spinal system is a stand-alone cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy procedures. The system consists of a PEEK cage and two bone screws. The PEEK cages are manufactured from a radiolucent material medical grade LT1 polyetheretherketone (PEEK) per ASTM F2026, with a titanium layer and a vacuum titanium plasma spray coating (PlasmaporeXP). The Arcadius N C implants are offered in various heights and geometrical options to fit the anatomical needs of a wide variety of patients. The Arcadius C implant is available in two footprints. The wide central opening holds optimal graft material. The screws are 4mm in diameter and offered in three lengths. The fixation screws and radiographic markers are manufactured of titanium alloy, (Ti6Al4V) according to ISO 5832/3.
The provided text is a 510(k) Summary for the Arcadius C Spinal System, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance testing. It does not contain information about studies involving human readers, AI assistance, or the establishment of ground truth for a test set in the context of diagnostic or interpretive tasks.
Therefore, many of the requested items cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
The document states that the Arcadius C Spinal System "meets or exceeds the performance of the predicate devices" for various tests. However, it does not provide specific acceptance criteria (e.g., minimum load values, maximum wear rates) or detailed reported device performance values for these tests. It only lists the types of tests performed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified directly in the document. The implication is that the system must perform at least as well as predicate devices in the listed tests. | "meets or exceeds the performance of the predicate devices" for the following tests: |
| - Static and dynamic torsion per ASTM F2077 | |
| - Static and dynamic axial compression per ASTM F2077 | |
| - Static and dynamic shear compression testing per ASTM F2077 | |
| - Subsidence per ASTM F2267 | |
| - Wear Debris per ASTM F1877 | |
| - Expulsion per ASTM Draft Standard F-04.25.02.02 | |
| - Microstructure of the coating per ASTM F1854 | |
| - Static Tensile Strength per ASTM F1147 | |
| - Static Shear Strength per ASTM F1044 | |
| - Shear Fatigue Test per ASTM F1160 | |
| - Abrasion Resistance per ASTM F1978 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document describes non-clinical (mechanical) testing of a medical implant, not a study involving a test set of data (like images or patient records) for an AI device.
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)
Not applicable. Ground truth for non-clinical mechanical testing is established by measurement instruments and scientific standards, not human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance data, the "ground truth" is based on established ASTM standards and methodologies for mechanical testing of implants, utilizing precise measurement devices and engineering principles.
8. The sample size for the training set
Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
Not applicable.
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