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510(k) Data Aggregation
(108 days)
The Synthes Zero-P is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P should be packed with autogenous bone graft and implanted via an anterior approach.
The purpose of this submission is to introduce an additional, larger footprint Zero-P spacer, as well as minor modifications to approved labeling.
The Synthes Zero-P is a radiolucent and radiopaque cervical intervertebral body fusion device. The Zero-P spacer is composed of PEEK Optima (ASTM F2026-02) with a radiopaque marker (ASTM F136-2a), and a titanium alloy anterior plate and screws (ASTM F F1295-01). The screws are inserted through the plate into the adjacent vertebral bodies and lock securely to the plate using a tapered-thread locking mechanism.
The Synthes Zero-P is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions.
The provided text describes a 510(k) summary for the Synthes Zero-P "Large Footprint" intervertebral fusion device.
This document focuses on establishing substantial equivalence to predicate devices based on design and mechanical performance, rather than clinical efficacy studies with specific acceptance criteria as you might see for novel medical diagnostics or AI/ML-driven devices.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable to a 510(k) submission for an intervertebral fusion device like the Synthes Zero-P. These types of studies are typically conducted for different types of devices, such as diagnostic imaging software or AI algorithms, where performance is measured against a ground truth and often involves human readers.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: Meet or exceed the performance of predicate devices in relevant mechanical tests. | Synthes performed static and dynamic compression shear and torsion testing in accordance with ASTM F2077. The summary states, "The enclosed information demonstrates the subject device is as safe, effective and performs as well as the predicate." This implies that the device met the mechanical performance requirements to be considered substantially equivalent to the predicate devices. Specific quantitative acceptance criteria (e.g., "yield strength > X N") and the exact results are not provided in this summary but would be detailed in the full submission. |
| Material Compatibility: Use materials proven safe and effective for intervertebral fusion devices. | The Zero-P spacer is composed of PEEK Optima (ASTM F2026-02) with a radiopaque marker (ASTM F136-2a), and a titanium alloy anterior plate and screws (ASTM F F1295-01). These are commonly used biocompatible materials in spinal implants, implicitly accepted through their use in predicate devices. |
| Design and Functionality: Comparable indications, fundamental scientific technology, surgical technique, screw fixation, and design to predicate devices. | "The modifications herein presented to Synthes Zero-P device are substantially equivalent to identified predicates, Synthes Zero-P System (K072981); Synthes Zero-P [sterile screws (K093762)]; Medtronic PEEK Prevail (K073285) in indications, fundamental scientific technology, material, mechanical performance, surgical technique, screw fixation and design." |
| Indications for Use: Align with predicate device indications. | The indications for use are clearly stated and align with those for intervertebral fusion devices for degenerative disc disease. This is implicitly accepted by the FDA's clearance of the device as substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable: This device is an implantable medical device, not a diagnostic or AI/ML device that would typically have a "test set" in the sense of clinical data points for performance evaluation against a ground truth. Performance is demonstrated primarily through non-clinical (benchtop) mechanical testing and comparison to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable: See point 2. Ground truth in this context would relate to the established mechanical standards (ASTM F2077) and engineering principles for implant design. The "experts" would be the engineers and biomechanical testing professionals performing and interpreting the tests.
4. Adjudication Method for the Test Set
- Not Applicable: See point 2.
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 an implantable device, not an AI-driven diagnostic tool. An MRMC study is not relevant to its clearance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is an implantable device; there is no algorithm or standalone performance study in this context.
7. The Type of Ground Truth Used
- For the non-clinical performance data, the "ground truth" is based on established engineering standards (ASTM F2077) for static and dynamic mechanical testing of intervertebral body fusion devices, and the mechanical performance characteristics of legally marketed predicate devices.
- For material composition, the ground truth is established by ASTM standards for medical-grade PEEK Optima and titanium alloy (ASTM F2026-02, ASTM F136-2a, ASTM F1295-01).
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" for this device. The design, materials, and mechanical properties are based on well-established engineering principles and existing predicate devices, not machine learning or AI models trained on data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: See point 8.
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(110 days)
The Synthes Zero-P VA is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P VA should be packed with autogenous bone graft and implanted via an anterior approach.
The Synthes Zero-P VA is a radiolucent and radiopaque intervertebral body fusion device. The Synthes Zero-P VA is composed of a spacer made from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with a single posterior titanium alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque marker. The marker allows accurate intra-operative radiographic assessment of the position of the implant. The spacer component is preassembled with a mating titanium alloy (Ti-6Al-7Nb; TAN; ASTM F1295) interbody plate. The device is implanted anteriorly by inserting two screws (TAN) through the plate, one screw per vertebral body. The interbody plate incorporates a lock-catch mechanism in each screw hole comprised of a TAV lock-screw and catch, as well as an Elgiloy (ASTM F1058) spring. The screws offered with the Zero-P VA system are 3.7mm in diameter.
This document describes the Synthes Zero-P VA device, which is an intervertebral body fusion device. The provided text outlines the device description, indications for use, and a comparison to predicate devices, including performance data. However, this document does not contain information about explicit acceptance criteria for a device's performance with numerical targets or a study validating those criteria in the context of device performance in terms of accuracy or efficacy metrics.
The "Performance Date (Nonclinical and/or Clinical)" section primarily discusses bench testing to demonstrate substantial equivalence to predicate devices in mechanical performance, not clinical outcomes or specific performance criteria like accuracy, sensitivity, or specificity that would be typical for an AI/ML-based device.
Therefore, for the information requested in the prompt:
1. A table of acceptance criteria and the reported device performance:
Based on the provided text, there are no explicit "acceptance criteria" for accuracy, sensitivity, specificity, or similar performance metrics as would be found for an AI/ML-based device. The performance data presented is for bench testing to demonstrate substantial equivalence in mechanical properties.
| Acceptance Criteria (Not explicitly stated for clinical efficacy/accuracy) | Reported Device Performance |
|---|---|
| Mechanical performance comparable to predicate devices (Implied) | Bench testing (ASTM F2077-03 and ASTM F2267-04) for: |
- Static Axial Compression
- Dynamic Axial Compression
- Static Compression Shear
- Dynamic Compression Shear
- Static Torsion
- Dynamic Torsion
- Subsidence
(Conclusions: Substantially equivalent in performance to Synthes Zero-P (K072981), Sulzer BAK™/Cervical IBF (P980048), and Medtronic PEEK Prevail (K073285)). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The document describes bench testing of the physical medical device, not a test set of data for an AI/ML system.
- Data Provenance: Not applicable in the context of clinical data. The performance data is from laboratory bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for an AI/ML system is not relevant for this device's submission which focuses on mechanical equivalence.
4. Adjudication method 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 a physical intervertebral fusion device, not an AI-assisted diagnostic or therapeutic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the bench testing, the "ground truth" would be the engineering specifications and established ASTM standards (ASTM F2077-03 and ASTM F2267-04) that dictate acceptable mechanical performance for intervertebral body fusion devices. This is not "ground truth" in the AI/ML sense.
8. The sample size for the training set:
- Not applicable. The device is not an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable.
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(121 days)
The Cervical Standalone Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Cervical Standalone Intervertebral Body Fusion Device implants are to be used with autogenous bone graft and implanted via an anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cervical Standalone Intervertebral Body Fusion Device is to be used with two titanium alloy screws which accompany the implant.
The Cervical Standalone Intervertebral Body Fusion Device is comprised of PEEK-OPTIMA® LT cages which are available in a variety of sizes. The cages include toothed spikes on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The cage shape and open center allow for bony in-growth in and around the implant. A single cage is sufficient to be used at each intervertebral level. Screws are inserted through the anterior titanium face and screwed into the vertebral bodies for bony fixation.
The acceptance criteria for the Cervical Standalone Intervertebral Body Fusion Device are based on demonstrating substantial equivalence to a predicate device, the COALITION™ Spacer Intervertebral Body Fusion Device (K083389). The study proving the device meets these criteria involved mechanical testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Technological Equivalence | Equivalent Indications for Use | Meets: Identical indications for use. |
| Equivalent Design Concepts | Meets: Same basic design. | |
| Equivalent Feature Comparisons | Meets: Similar features. | |
| Equivalent Biocompatible Materials | Meets: Uses established, known materials (PEEK-OPTIMA LT, Tantalum, Titanium 6AI-4V ELI), which are equivalent to the predicate. | |
| Equivalent Operating Principle | Meets: Same operating principle. | |
| Equivalent Manufacturing Environment | Meets: Same manufacturing environment. | |
| Equivalent Sterilization Process | Meets: Same sterilization process. | |
| Equivalent Packaging Configurations | Meets: Same packaging configurations. | |
| Mechanical Performance | Static Compression per ASTM F-2077 | Performed as designed and met or exceeded all product specifications. |
| Static Compression Shear per ASTM F-2077 | Performed as designed and met or exceeded all product specifications. | |
| Static Torsion per ASTM F-2077 | Performed as designed and met or exceeded all product specifications. | |
| Static Load Induced Subsidence per ASTM F-2077 | Performed as designed and met or exceeded all product specifications. | |
| Static Expulsion per ASTM F-2077 | Performed as designed and met or exceeded all product specifications. | |
| Dynamic Compression per ASTM F-2077 | Performed as designed and met or exceeded all product specifications. | |
| Dynamic Compression Shear per ASTM F-2077 | Performed as designed and met or exceeded all product specifications. | |
| Dynamic Torsion per ASTM F-2077 | Performed as designed and met or exceeded all product specifications. | |
| Wear Testing | Characteristics of particulate wear debris | The result from the wear testing was found to be substantially equivalent to legally marketed devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" in terms of patient data or
clinical samples. The testing described is primarily mechanical and wear testing of the device itself. - Data Provenance: Not applicable as the testing is non-clinical, mechanical testing of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The ground truth for this device's acceptance is based on adherence to engineering standards (ASTM F-2077 and F-2267) and comparison to a predicate device, not on expert clinical review of test data.
4. Adjudication method for the test set
- Not applicable. This was a non-clinical, mechanical testing study against established ASTM standards and
predicate device equivalence.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a
physical implant, not an AI-powered diagnostic or assistive tool.
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 algorithm. The "standalone" in the device name refers to its design as an intervertebral fusion device that does not require an anterior plate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the mechanical testing, the ground truth was defined by established engineering standards (ASTM F-2077 and F-2267) and the performance specifications of the device itself, with the aim of demonstrating that the device performed "as designed" and met/exceeded these specifications.
- For substantial equivalence, the ground truth was based on the characteristics and performance of the legally marketed predicate device (K083389).
8. The sample size for the training set
- Not applicable. This is a physical medical device undergoing mechanical validation, not a machine
learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable, as there was no training set for a machine learning model.
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(182 days)
The PEEK PREVAIL™ Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The PEEK PREVAIL™ Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is "I-Beam" shaped with a 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with bone graft.
The key difference between the predicate PEEK PREVAIL™ Cervical Interbody Device and the subject PEEK PREVAIL™ Cervical Interbody Device is the reduction of the device footprint by 2mm in the anterior/posterior dimension (i.e., adding a smaller footprint cage).
This product will be manufactured from PEEK Optima and will have tantalum radiopaque markers and a nitinol screw locking mechanism. The screw designed to be used with this device will be manufactured from titanium alloy.
Here's an analysis of the provided text regarding the PEEK PREVAIL™ Cervical Interbody Device, addressing your requested information:
This submission (K094042) is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to establish new safety and effectiveness. Therefore, many of your requested points regarding clinical study design, ground truth, and expert evaluation will not be directly relevant or available in this type of document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static axial torsion | In accordance with ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices," approved April 10, 2003. | The acceptance criteria was/were met. |
| Dynamic axial torsion | In accordance with ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices," approved April 10, 2003. | The acceptance criteria was/were met. |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "Non-Clinical Testing" and specifically mentions the mechanical tests performed.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. For mechanical testing of medical devices, sample sizes are typically determined by the relevant ASTM standard (ASTM F2077-03 in this case), often involving a small number of devices (e.g., 5-10) per test condition.
- Data Provenance: Not applicable in the context of this 510(k) submission, as it relies on non-clinical, in-vitro mechanical testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. The "ground truth" for mechanical testing is defined by the objective pass/fail criteria set forth in the ASTM standard, not by expert consensus on clinical findings.
4. Adjudication method for the test set
- This is not applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or image interpretation. Mechanical testing results are objectively measured against predefined criteria.
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 MRMC comparative effectiveness study was done. This device is a physical implant (interbody fusion device), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
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 algorithm, so standalone AI performance is not relevant.
7. The type of ground truth used
- The "ground truth" for this device's evaluation is defined by the objective, quantitative results of mechanical tests performed according to the specified ASTM standard (F2077-03). The standard itself outlines the methods and criteria for evaluating the mechanical properties of intervertebral body fusion devices.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device. No "training set" in that sense was used. The design and manufacturing processes are based on engineering principles and material science, validated through benchtop testing.
9. How the ground truth for the training set was established
- Not applicable. As no training set for an AI/ML model was used, there's no ground truth to establish for it. The design of the device is informed by engineering knowledge, material properties, and surgeon feedback (as mentioned, to accommodate variations in patient anatomies by providing a smaller footprint).
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