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The Omnia Medical PsiF DNA™ System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions. The PsiF DNA™ may be implanted via a transverse or inline approach. When PsiF DNA™ is implanted inline, it must be used with a PsiF DNA™ screw implanted transversely across the same sacroiliac joint.

The Omnia Medical PsiF DNA™ System consists of screws and washers manufactured from Ti-6Al-4V ELI per ASTM F3001 and ASTM F136, respectively. The screws are available in one diameter and a variety of lengths to accommodate varying patient anatomy. The system includes instrumentation for implantation that is manufactured from surgical grade stainless steel or aluminum. During the procedure, the implant is inserted through the ilium to pierce its medial cortex, across the sacroiliac joint and into the sacrum to pierce its lateral cortex, and bone graft material is placed in the barrel of the implant to facilitate additional bone incorporation after surgery. The implants and instruments are provided in two surgical kit options. In one kit, the implants and instruments are provided non-sterile and sterilized by the end user. In the other kit, the implants and instruments are single-use and provided sterile.

Based on the provided FDA 510(k) clearance letter for the Omnia Medical PsiF DNA™ System, there is no information about specific acceptance criteria or a study that proves the device meets those criteria in the context of AI/Software performance.

The clearance letter focuses on the device being a physical medical device (a bone fixation fastener) and its substantial equivalence to predicate devices based on mechanical and cadaveric testing.

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria for a device, a test set, expert ground truth, MRMC studies, or training sets, as these concepts are typically applied to the evaluation of software as a medical device (SaMD) or AI-enabled medical devices, not to a physical implant like the Omnia Medical PsiF DNA™ System.

The document explicitly states:

• "Clinical testing was not required to support a substantial equivalence determination for the PsiF DNA™ device." This confirms that there was no clinical study, let alone one focused on human-in-the-loop performance or AI assistance.
• The non-clinical testing listed consists entirely of mechanical and cadaveric tests, which are standard for orthopedic implants to assess their structural integrity, strength, and biomechanical compatibility.

In summary, none of the requested information (table of acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, ground truth types) is present in this 510(k) document because the cleared device is a physical implant, not an AI/software product requiring such performance evaluation.

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The TiBrid™ SA system is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have six months of nonoperative therapy. This device is intended for use with autogenous bone graft and/or allograft compromised of cancellous and/or corticocancellous bone graft and integrated fixation.

The TiBrid™ -SA is a standalone device and must be used with the internal bone screws or TiBrid™. SA plate and bone screws provided.

The Omnia Medical TiBrid™-SA System is a standalone intervertebral body fusion system used in the spine to replace a collapsed, damaged, or unstable disc. The implantable devices are manufactured from PEEK-OPTIMA™ HA Enhanced, titanium alloy, and tantalum for radiographic visualization. Each device is available in multiple footprints, heights, and angles. The implants feature a hollow center to accommodate autograft or allograft and include anti-migration features. All devices are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and integrated fixation.

The provided document is a 510(k) premarket notification from the FDA for a medical device called the "Omnia Medical TiBrid™-SA System." This notification approves the device based on its substantial equivalence to previously cleared predicate devices. It does not describe a study conducted by the applicant to prove the device meets acceptance criteria, but rather summarizes how the device compares to predicate devices based on certain performance data.

Therefore, the requested information, specifically regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details, is not present in the provided text. The document states that "Clinical Studies were not applicable to support a substantial equivalence determination for this device."

However, I can extract the non-clinical performance data type and the conclusion regarding substantial equivalence.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and explicit statements about what is not available:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable/not provided. The document refers to non-clinical (mechanical) testing, not a clinical test set with human or animal subjects.
• Data Provenance: Not applicable/not provided.

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/not provided. Ground truth establishment by experts is typically associated with clinical studies involving human interpretation or diagnoses, which were not performed for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/not provided. This relates to clinical study methodology, which was not performed.

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, an MRMC comparative effectiveness study was not done. The device mentioned (Omnia Medical TiBrid™-SA System) is an intervertebral body fusion device (an implant), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. The device is an implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical performance data, the "ground truth" would be the engineering specifications and established ASTM standards for implantable devices. Compliance with these standards confirms the device's mechanical integrity.

8. The sample size for the training set

• Not applicable. No training set for an algorithm was used as this is an implant device, not an AI/ML product.

9. How the ground truth for the training set was established

• Not applicable. No training set for an algorithm was used.

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The Coupler-ATM and Coupler-LTM Lumbar Plate Systems are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the vessels or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies):

• · Pseudoarthrosis;
• · Spondylolysis;
• · Spondylolisthesis;
• · Spinal stenosis;
• Tumors;
• · Trauma (i.e. Fractures or Dislocation)
• · Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
• · Failed Previous Fusion

The Coupler-ATM and Coupler-L™ Lumbar Plate Systems provide stabilization to the lumbar spine during spinal fusion. These systems include plates, screws, and an instrument set used in the surgical insertion of the implants. The implants are composed of Ti6Al4V ELI Titanium per ASTM F136. The screws are inserted into the vertebral body through corresponding holes in the plate to achieve fixation. A screw locking system is incorporated in the plate allowing the surgeon to lock the screws into place with cam screws after insertion. The plates are available in multiple lengths to allow for utilization in fusion operations across L1 to S1 of the lumbar spine. The system instrumentation is manufactured from surgical grade stainless steel and other surgical grade materials. The instrumentation is used in the placement and fixing of the device.

This document describes the Omnia Medical Coupler-A™ Anterior Lumbar Plate System and Omnia Medical Coupler-L™ Lateral Lumbar Plate System, which are spinal intervertebral body fixation orthoses. The document primarily focuses on demonstrating the substantial equivalence of these devices to a predicate device (Stryker LITe® Plate System K221728) through mechanical testing.

Here's the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the provided text. The mechanical testing refers to "subject device" and "predicate device," implying samples of both were tested, but no specific number of units or tests is given.
• Data Provenance: Not explicitly stated. Mechanical testing is generally conducted in a laboratory setting. There is no indication of country of origin for this data or if it's retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable as the study described is mechanical testing of medical devices, not a clinical study involving ground truth established by expert consensus. The "ground truth" here is the physical performance of the devices under specific forces, measured by laboratory equipment against industry standards (ASTM F1717).

4. Adjudication Method for the Test Set

• This information is not applicable as the study is mechanical testing and does not involve human interpretation or adjudication.

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 MRMC comparative effectiveness study was not done. This document pertains to the mechanical safety and performance of spinal implants, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No, this is not an algorithm. This document describes the mechanical testing of a physical medical device (spinal plates and screws).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" in this context is established by engineering standards and physical measurements. Specifically, the performance of the devices is evaluated against ASTM F1717, an industry standard for "Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model." The acceptance criteria are implicitly derived from the performance of the legally marketed predicate device and the requirements of this standard.

8. The Sample Size for the Training Set

• This information is not applicable. There is no "training set" as this is not an AI/machine learning study.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable. There is no "training set" or corresponding ground truth establishment process for a mechanical testing study of this nature.

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The Omnia Medical Coupler-C Anterior Cervical Plate is indicated for use in temporarily stabilizing the anterior spine from C2 to T1 during the development of cervical spinal fusion in patients with degenerative disc disease (DD), neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities (i.e., scoliosis, kyphosis, and/or lordosis), tumors, pseudoarthrosis, or failed previous fusion.

The Omnia Medical Coupler-C Anterior Cervical Plate system includes plates, screws, and an instrument set used to insert the implants. The implants are composed of Ti-6Al-4V ELI per ASTM F136. The screws are inserted into the vertebral body through corresponding holes in the plate to achieve fixation. A screw locking system is incorporated in the plate, allowing the surgeon to lock screws into place with anti-backout mechanisms after insertion. The plates are available in multiple lengths and levels to allow for utilization in fusion operations across 1 to 4 levels of the cervical spine. The system instrumentation is manufactured from surgical grade stainless steel (17-4 PH per ASTM F899) and other surgical grade materials. The instrumentation is used to prepare the site and to implant the device.

This is a 510(k) premarket notification for a medical device, the Omnia Medical Coupler-C Anterior Cervical Plate. This document primarily focuses on establishing "substantial equivalence" of the new device to existing legally marketed predicate devices, rather than a diagnostic device that requires clinical performance studies based on acceptance criteria for accuracy metrics.

Therefore, the provided text does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to the performance of a diagnostic or AI-powered device.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to mechanical testing which demonstrates the device's physical properties are comparable to legally marketed predicate devices.

Here's the relevant information that can be extracted:

1. A table of acceptance criteria and the reported device performance:

The document states:
"Substantial equivalence is supported by the results of mechanical testing, including static and dynamic compression bending, and static torsion per ASTM F1717. Results support that the subject device has demonstrated substantial equivalence."

Acceptance Criteria: Demonstrated "substantial equivalence" based on mechanical testing according to ASTM F1717 guidelines. (The specific numerical criteria for static and dynamic compression bending, and static torsion are not detailed in this document but would be defined by ASTM F1717 and the comparison to predicate devices.)

Reported Device Performance:

• Static and dynamic compression bending per ASTM F1717: Results support "substantial equivalence."
• Static torsion per ASTM F1717: Results support "substantial equivalence."

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical units of the device subjected to mechanical testing, not a dataset of patient images or clinical data. The provenance of these physical samples is not specified but would typically be manufactured units of the Omnia Medical Coupler-C Anterior Cervical Plate.

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 a diagnostic device is not relevant for this type of mechanical testing.

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 spinal implant device, not a diagnostic imaging device with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used: Not applicable. For mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices.

8. The sample size for the training set: Not applicable. This is not a machine learning or diagnostic device.

9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a physical medical device (a spinal implant), not a software or diagnostic device. Therefore, the questions related to acceptance criteria for diagnostic accuracy, study design for clinical performance, expert adjudication, or AI performance are not relevant to this specific K223321 submission. The "acceptance criteria" and "study" refer to mechanical testing validating the structural integrity and performance compared to existing devices.

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The TiBrid™ SC standalone cervical fusion device is indicated for use in anterior cervical interbody procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. The implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The device is to be used is patients who have had six weeks of non-operative treatment. The cervical standalone intervertebral body fusion device is to be used with either two bone screws and a screw locking cover or a connecting plate. If the connecting plate is chosen, the number of screws should correspond to the number of holes in the plate.

The TiBrid™-SC system consists of a standalone hybrid PEEK OPTIMA™ HA Enhanced and titanium alloy cervical interbody device with 3 titanium plate options (two, three, and four screws) that can be connected to the standalone device. The standalone cages are available in multiple footprints and heights, and have a lordotic angle of 6°. The plates are available in multiple heights. The cages feature a hollow center to accommodate autograft or allograft and include anti-migration features. All devices are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

The provided text describes a 510(k) premarket notification for a medical device (Omnia Medical TiBrid™-SC) and does not contain information about the acceptance criteria or a study proving the device meets those criteria for an AI/ML product.

The document is a submission to the FDA for an intervertebral body fusion device, which is a physical implant used in spinal surgery, not a software or AI/ML-based device. The "acceptance criteria" discussed in the document are about demonstrating substantial equivalence to existing predicate devices based on design, materials, dimensions, function, and mechanical testing results (e.g., static and dynamic compression, subsidence, expulsion testing).

Therefore, I cannot extract the requested information regarding an AI/ML device's acceptance criteria and study from this document. The questions posed in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are relevant to the evaluation of AI/ML products, but not to the type of medical device described in this 510(k) submission.

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The TiBrid™-SA system is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have six months of nonoperative therapy. This device is intended for use with autogenous bone graft and/or allograft compromised of cancellous and/or corticocancellous bone graft and integrated fixation.

The TiBrid™-SA is a standalone device and must be used with the internal bone screws provided.

The Omnia Medical TiBrid™-SA System is a standalone intervertebral body fusion system used in the spine to replace a collapsed, damaged, or unstable disc. The implantable devices are manufactured from PEEK-OPTIMA™ HA Enhanced, titanium alloy, and tantalum for radiographic visualization. Each device is available in multiple footprints, heights, and angles. The implants feature a hollow center to accommodate autograft or allograft and include anti-migration features. All devices are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and integrated fixation.

The provided document is a 510(k) Pre-market Notification from the FDA regarding the Omnia Medical TiBrid™-SA. It pertains to a medical device (an intervertebral body fusion device), not an Artificial Intelligence (AI) or machine learning (ML) device. Therefore, the document does not contain information about acceptance criteria or studies related to AI/ML device performance, such as sensitivity, specificity, or reader studies.

The "acceptance criteria" discussed in this document refer to the criteria for demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance. This section:

1. A table of acceptance criteria and the reported device performance: Not applicable in the context of an AI/ML device. The document mentions mechanical testing according to ASTM standards for the physical intervertebral body fusion device.
2. Sample sized used for the test set and the data provenance: Not applicable for AI/ML device performance. Mechanical testing is described, but specific sample sizes for these tests are not provided in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for AI/ML device performance.
4. Adjudication method: Not applicable for AI/ML device performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is not an AI-assisted diagnostic device.
6. If a standalone performance study was done: Not applicable for AI/ML device performance. The device itself (the fusion device) undergoes mechanical testing.
7. The type of ground truth used: Not applicable for AI/ML device performance. For the mechanical device, "ground truth" would be related to compliance with ASTM standards in laboratory testing.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

The document primarily focuses on demonstrating that the Omnia Medical TiBrid™-SA System is substantially equivalent to legally marketed predicate devices based on:

• Indications for Use
• Technological Characteristics (design features, intended use, materials, dimensions, function)
• Results of mechanical testing (static and dynamic compression, static and dynamic torsion, static and dynamic compression shear per ASTM F2077, subsidence per ASTM F2267, and expulsion testing).

The document is a regulatory approval letter for a physical medical implant, not a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool.

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The Omnia Medical Trauma Screws are intended for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

The Omnia Medical Trauma screws are manufactured from Ti-6A1-4V ELI per ASTM F136. The screws are available in a variety of lengths and diameters to accommodate varying patient anatomy.

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML medical device.

The document pertains to the 510(k) premarket notification for Omnia Medical Trauma Screws, which are physical medical devices (metallic bone fixation fasteners), not an AI/ML software device.

Therefore, I cannot provide an answer that includes:

1. A table of acceptance criteria and reported device performance (for an AI/ML device)
2. Sample size and data provenance for a test set (for an AI/ML device)
3. Number and qualifications of experts for ground truth (for an AI/ML device)
4. Adjudication method (for an AI/ML device)
5. Multi-reader multi-case (MRMC) comparative effectiveness study data (for an AI/ML device)
6. Standalone performance data (for an AI/ML device)
7. Type of ground truth (for an AI/ML device)
8. Sample size for the training set (for an AI/ML device)
9. How ground truth for the training set was established (for an AI/ML device)

The document focuses on the substantial equivalence of the physical trauma screws to a predicate device based on intended use, technological characteristics, and engineering rationale, rather than performance data from clinical studies in the way you'd expect for an AI/ML algorithm.

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The Omnia Medical TiBrid™ Cervical Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have had at least six weeks of non-operative treatment with intervertebral cages. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

The Omnia Medical TiBrid™ ALIF, PLIF, TLIF and Lateral Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis 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. Patients should have had at least six months of non-operative treatment with intervertebral cages. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

Not Found

This document is a 510(k) clearance letter for the Omnia Medical TiBrid™ Cervical Cage, Omnia Medical TiBrid™ Lateral Cage, Omnia Medical TiBrid™ ALIF Cage, Omnia Medical TiBrid™ PLIF Cage, and Omnia Medical TiBrid™ TLIF Cage. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does NOT contain any information about acceptance criteria, device performance testing, study details (sample size, data provenance, ground truth, expert qualifications, adjudication methods), or multi-reader multi-case comparative effectiveness studies. These types of details are typically found in the 510(k) summary or the full submission, not in the clearance letter itself.

Therefore, I cannot provide the requested information from this document.

To answer your request, I would need to analyze a different part of the 510(k) submission, specifically the sections that detail the performance data and testing conducted to demonstrate substantial equivalence.

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The Omnia Medical VBR is a vertebral body replacement system indicated for use in skeletally mature patients to replace a collapsed, damaged, diseased, or unstable vertebral body due to tumor or trauma (i.e. fracture) or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues. The device is intended for use in the cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5). The device is intended for use with supplemental fixation cleared by the FDA for use in the cervical, thoracic, or lumbar spine and is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

The Omnia Medical VBR is manufactured from PEEK-OPTIMA™ HA Enhanced and tantalum markers conforming to ASTM F560. This implant is available in two footprint sizes and offers spacers and endplates which allow for fine adjustments of the height and lordosis to accommodate various patient anatomy. The device features a hollow center and through holes for use with autograft to encourage formation of new bone. The device is intended to be used with supplemental fixation.

Based on the provided text, the document is a 510(k) Premarket Notification from the FDA to Omnia Medical, LLC, regarding their VBR (Vertebral Body Replacement) system. This document is a clearance letter, not a study report, and therefore does not contain the detailed information typically found in a study proving a device meets acceptance criteria for an AI/ML powered device. The document focuses on establishing substantial equivalence to existing predicate devices based on design, materials, and mechanical testing for a physical medical implant, not a diagnostic or prognostic algorithm that would require human-in-the-loop or standalone performance studies against acceptance criteria related to accuracy, sensitivity, or specificity.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as these are not relevant to the approval of this type of device (a spinal implant) based on the provided text.

The closest relevant information is about "Mechanical Testing," which supports the device's substantial equivalence.

Mechanical Testing Information (as described in the document, which serves as the "study" for this type of device):

• Study Purpose: To demonstrate substantial equivalence to predicate devices.
• Tests Conducted:
  • Static and dynamic compression per ASTM F2077
  • Static and dynamic torsion per ASTM F2077
  • Subsidence per ASTM F2267
  • Expulsion testing
• Data Provenance: The data for these tests was "presented in the reference predicate submission (K172323)." This implies the data was collected previously for another submission and reused, rather than newly generated for this specific K191778 submission.
• Device Status: "No new device designs or worst-case sizes are being introduced."
• Conclusion: The previously submitted data supports the expanded indications for use.

Summary of absent information (and why, given the document type):

1. A table of acceptance criteria and the reported device performance, sample size, data provenance: Not applicable in the context of an FDA 510(k) clearance letter for a physical implant, where performance is demonstrated through mechanical testing against standards, not clinical accuracy metrics.
2. Number of experts, qualifications, adjudication method: Not applicable for mechanical testing of a physical implant. These relate to human interpretation of data, typically for AI/ML or diagnostic devices.
3. MRMC comparative effectiveness study: Not applicable. This is for assessing the impact of AI assistance on human readers, relevant for diagnostic AI.
4. Standalone (algorithm only) performance: Not applicable. This identifies if a device is a standalone AI algorithm.
5. Type of ground truth: Not applicable in the traditional sense. The "ground truth" for a physical implant's mechanical properties is adherence to established ASTM standards under specific testing conditions.
6. Sample size for training set & how ground truth for training set was established: Not applicable. These pertain to the development of AI/ML algorithms.

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The Omnia Medical Rotary PLIF System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Omnia Medical Rotary PLIF System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.

The Omnia Medical Rotary PLIF is manufactured from PEEK-OTIMA™ LT1 conforming to ASTM F2026 and tantalum markers conforming to ASTM F560. The Omnia Rotary PLIF is rectangular in shape and available in various sizes with heights ranging from 9mm to 17mm and 0° or 7° of lordosis. The leading end is tapered or bulleted for ease of insertion. All devices are 25mm in length. The device has six tantalum markers for radiographic confirmation of device position and orientation. The device is intended to be used with supplemental fixation.

This document is a 510(k) premarket notification decision letter and a summary for the Omnia Medical Rotary PLIF System. It does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it provide details about a test set, expert involvement, or ground truth establishment.

The document mentions that "Engineering rationales were provided to leverage the mechanical testing of the predicates for this submission" and that "Mechanical testing on the predicate included static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267, and expulsion testing." It concludes that "These rationales and performance tests support substantial equivalence."

However, this is a summary of what was submitted for the predicate device, not the Omnia Medical Rotary PLIF System itself, and it does not detail the acceptance criteria or the specific results of those tests for the predicate or the new device.

Therefore, I cannot fulfill your request for the specific details you've asked for based solely on the provided text. The document acts as a regulatory approval notice based on the manufacturer's submission, not a detailed study report.

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