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E3D™ -A Static Interbody Devices are thoraco-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 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. Devices 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.

E3D™ -A Integrated Interbody Devices are integrated 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. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Devices 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 three screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g., facet screws or posterior fixation). Hyperlordotic implants (≥20° lordosis) are intended for use with supplemental fixation (e.g., facet screws or posterior fixation). When used without screws or anchors, these devices are intended for use with supplemental fixation (e.g., facet screws or posterior fixation).

When used for multilevel degenerative scoliosis or sagittal deformity, supplemental fixation 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) must be used.

The E3D™ -A Interbody System provides interbody fusion devices designed to provide structural stability during spinal fusion. The E3D™-A Interbody System consists of interbodies offered in various sizes to accommodate surgical needs and anatomic requirements. The E3D-A Interbodies were designed to be placed via an anterior approach. All interbodies in the system are additively manufactured from titanium alloy powder, per ASTM F3001. The System offers both Static and Integrated Interbodies. The Integrated version is to be used in conjunction with three (3) screws that are subtractively manufactured from titanium alloy, per ASTM F136.

The E3D-A Interbody System's implants are available with and without HA®®º Surface®, a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface.

The provided text describes a medical device, the E3D™-A Interbody System, and its clearance by the FDA based on substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria through clinical performance or AI/software analysis.

Therefore, the information required to answer the prompt (acceptance criteria for device performance, sample sizes, expert involvement, ground truth, etc.) is not present in the provided text. The document focuses on regulatory clearance for an interbody fusion device, primarily detailing its physical characteristics, indications for use, and comparison to existing similar devices.

Specifically:

• No acceptance criteria or device performance report is provided in the context of a study for clinical efficacy or AI performance. The "Performance Data" section solely refers to physical and material testing (ASTM F2077 for dynamic compression shear testing and Promimic's protocols for the HA surface treatment), not clinical outcomes or AI model performance.
• No mention of a test set, training set, or data provenance for any AI/software component. The device is an interbody fusion system, a physical implant.
• No information on experts, ground truth, or adjudication methods as these are not relevant to the type of regulatory submission described (510(k) for a physical implant based on substantial equivalence).
• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned, as this device does not involve human readers interpreting images with or without AI assistance.
• No standalone algorithm performance is mentioned, as there is no algorithm described.

In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device (an interbody fusion system), not a document detailing the performance evaluation of an AI or software device.

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The Innovasis HAtetracell™-C Titanium Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

This device is to be used in patients who have had six weeks of non-operative treatment. The HAtetracell™-C device is to be used with supplemental fixation, such as the Innovasis Oryx® Cervical Plate System. The HAtetracell™-C device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.

The HAtetracell™-C Titanium Cervical IBF System is an intervertebral body fusion (IBF) device with associated instrumentation, used with bone graft material, intended to stabilize a cervical spinal segment to promote fusion which restricts motion and decreases pain. The HAtetracel™ -C Titanium Cervical IBF System is implanted via an Anterior Cervical Discectomy and Fusion (ACDF) surgical aproach. The HAtetracel™ - C implants are an additive mane from titanium alloy Ti-6Al-4V ELI per ASTM F3001 and are coated with a hydroxyapatite HAnano surface. The trabecular structures on the endplate contact surfaces , micro-, and nanofeatures that are designed to mimic cortical and cacellous bone to help facilitate intervertebral fusion. The HAtetracell™-C implant features a tapered nose to aid in insertion and protect the porous layer during insertion, a graft cavity to provide volume for bone graft, and the open lattice structure is designed to radiographic signature. The implant is available in multiple size options to match vertebral anatomy and is designed to restore height in the cervical spinal column during the fusion process. Implants are supplied sterile. Reusable instruments to support the surgery are provided with the implants in sterilization trays.

{
  "acceptance_criteria_and_performance_table": {
    "title": "Summary of Mechanical Testing and Acceptance Criteria",
    "headers": [
      "Test Type",
      "Standard",
      "Acceptance Criteria",
      "Reported Device Performance"
    ],
    "rows": [
      [
        "Static and dynamic torsion testing",
        "ASTM F2077",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Static and dynamic axial compression testing",
        "ASTM F2077",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Static and dynamic compression shear testing",
        "ASTM F2077",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Static subsidence testing",
        "ASTM F2267",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Particulate analysis after dynamic testing",
        "ASTM F1877",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Static expulsion testing",
        "FDA guidance special controls document",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Abrasive resistance testing",
        "ASTM F1978",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ]
    ]
  },
  "sample_size_test_set_provenance": "Not applicable as no clinical data or test set involving human subjects was used. All testing was non-clinical (mechanical).",
  "num_experts_ground_truth_qualifications": "Not applicable as no clinical data or ground truth established by experts was used.",
  "adjudication_method": "Not applicable as no clinical data or ground truth adjudication was performed.",
  "mrmc_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.",
  "standalone_performance": "Not applicable, as this is a physical intervertebral body fusion device and not a software algorithm.",
  "type_of_ground_truth_used": "Not applicable. The 'ground truth' for the mechanical tests was established by adherence to industry standards (ASTM) and FDA guidance for performance criteria.",
  "sample_size_training_set": "Not applicable as no training set was used for this device's evaluation (no AI/machine learning component).",
  "how_ground_truth_for_training_set_established": "Not applicable as no training set was used."
}

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Align anterior cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Align anterior cages are intended for use at ether one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Align 2-screw anterior cages may be used as a stand alone device only when two (2) vertebral body bone screws are used. Align 4-screw anterior cages may be used as a stand alone device only when at least two (2) vertebral body bone screws are inserted in the two medial fixation holes with one superior screw trajectory. If the physician chooses to use Align anterior cages with fewer than two (2) screws in the two medial fixation holes with one inferior and one superior screw trajectory, then an additional spinal fixation system cleared for use in the lumbosacral spine must be used.

Align anterolateral cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Align anterolateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Align anterolateral cages are intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.

Align lateral cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Align lateral cages are intended for use at either one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Align lateral cages are intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.

Align implants are intervertebral body fusion devices intended for lumbar interbody fusion using an anterior lumbar interbody fusion surgical approach (ALIF), anterolateral (i.e., oblique) lumbar interbody fusion surgical approach (OLIF), or a lateral lumbar interbody fusion surgical approach (LLIF). The devices are intended to improve stability of the spine while supporting fusion. The Align constructs are intended for use at one or two contiguous levels in the lumbar spine (L2-S1). Components are offered in different shapes and sizes to meet the requirements of the individual patient's anatomy and are provided sterile. Align devices are available in six configurations: modular constructs, standard constructs, fully round ALIF (FRA) constructs, and open constructs for ALIF approach, anterolateral (i.e., oblique) constructs for OLIF approach, and lateral constructs for LLIF approach. Align cages are secured on the vertebral bodies using bone screws. A cover plate assembly prevents the screws from backing out after insertion. The cages and cover plates are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Alulminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion. The bone screws and cover plate screws are made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. All constructs are zero profile, reducing potential for vessel interference with the anterior column. With the exception of the modular constructs, all cages and bone screws are also available with a hydroxyapatite coating.

The provided text is related to a 510(k) premarket notification for a medical device called "Align" by Acuity Surgical Devices, LLC. It describes the device, its indications for use, and a comparison to a predicate device. However, it explicitly states that no clinical data was provided to demonstrate substantial equivalence. This means there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such a study is not part of this 510(k submission. The submission relies on non-clinical testing and substantial equivalence to a predicate device and reference devices to demonstrate safety and effectiveness.

Here’s what I can extract based on the document:

1. A table of acceptance criteria and the reported device performance:
Not applicable as no clinical acceptance criteria or performance study results are provided. The submission focuses on demonstrating substantial equivalence through non-clinical testing.

2. Sample size used for the test set and the data provenance:
Not applicable as no clinical study with a test set is described. Non-clinical testing was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical study requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no clinical study with adjudication is described.

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. The device is an intervertebral body fusion device, 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 a surgical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable as no clinical study requiring a ground truth is described.

8. The sample size for the training set:
Not applicable as no clinical study or AI model with a training set is described.

9. How the ground truth for the training set was established:
Not applicable as no clinical study or AI model with a training set and ground truth establishment is described.

Summary of Non-Clinical Testing (as provided in the document):

The device's substantial equivalence is supported by non-clinical testing, which includes:

• Performance testing per ASTM F2077 for Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, and Dynamic Compression Shear.
• Performance testing per ASTM F2267 for Subsidence and Expulsion testing.
  • Note: These tests performed on the predicate device (K201671) are deemed applicable to the modified devices because there is no difference in size, dimension, raw material, or manufacturing method/equipment, except for a nanometer-thin layer of hydroxyapatite applied to the surface.
• Performance testing of HA®® Surface integrity was conducted per the Promimic protocol, which was accepted by FDA for the clearance of reference devices K201614, K170392, and K101225.
• Performance testing of the break-off cover plate screw per the protocol accepted by FDA for the clearance of the reference device K130958.

The document concludes that these non-clinical tests indicate that "Align" is substantially equivalent to the predicate and reference devices.

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The DJO EMPOWR POROUS FEMUR WITH HAnano Surface™ is indicated for use in total knee arthroplasty patients, receiving total joint replacement because of disability or suffering due to:

· degenerative, post-traumatic or rheumatoid arthritis;

· avascular necrosis of the femoral condyle:

post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;

· moderate valgus, varus or flexion deformities;

· treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. The device is intended for uncemented applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Porous Femur with HA"™ Surface is a line extension to the EMPOWR Knee Platform and EMPOWR Porous Knee Platform (cleared via K143242 and K171991), to include a hydroxyapatite-coated porous femoral component in the system.

The EMPOWR Porous Femur with HA"" Surface™ has an adjunct hydroxyapatite (HA) coating on the 3D Matrix® porous coating inside the cement pocket. Since the device is porous coated, it is indicated for cementless use.

This document, K210308, is a 510(k) Premarket Notification for a medical device. It describes a new iteration of a total knee implant, the EMPOWR POROUS FEMUR with HAnano Surface™. The document focuses on demonstrating substantial equivalence to a predicate device, as clinical testing was not required for this submission. Therefore, the information provided primarily concerns non-clinical testing and comparisons, rather than a detailed study proving the device meets an extensive set of acceptance criteria through clinical trials.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence through non-clinical testing, rather than explicit performance metrics derived from a clinical trial with pre-defined success/failure thresholds. The reported performance is framed in terms of meeting these comparison points.

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

• Sample Size for Test Set: Not applicable in the context of human clinical data for this 510(k) submission. The "test set" here refers to non-clinical laboratory tests on device components or full devices. The document does not specify the number of samples used for each non-clinical test (e.g., how many devices were subjected to abrasion testing).
• Data Provenance: The data comes from non-clinical laboratory testing performed by the manufacturer, DJO Surgical (Legal Name: Encore Medical, L.P.). The document does not specify the country of origin for these lab tests, but it is implied to be internal testing or contracted testing performed under the manufacturer's oversight. The testing is not retrospective or prospective clinical data, but rather bench and material testing.

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

• This question is not applicable as there was no "ground truth" derived from human experts for a clinical test set. The ground truth in this context would be the results of the non-clinical tests (e.g., passing or failing a fatigue test, measured wear rates). These results are obtained through standardized testing protocols, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

• This question is not applicable. There was no human "test set" in need of adjudication. The non-clinical tests have objective outcomes based on established methods and criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement with AI vs. Without AI Assistance

• Not applicable. This device is a medical implant (total knee prosthesis), not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant. No AI component is described in the provided text.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• As discussed, "ground truth" here refers to the outcomes of the non-clinical tests. The types of "ground truth" used are:
  • Engineering Test Results: Measurements from abrasion testing, pin-on-disk wear testing, fatigue testing, contact area testing.
  • Biocompatibility/Safety Testing: Bacterial endotoxin assessment results compared against pre-defined specifications (20 EU/device).
  • Material and Geometric Specifications: Confirmation that the new device's substrate material, geometry, and porous coating are identical to the predicate.
  • Predicate Device Performance: Reliance on the previously cleared predicate's mechanical testing results for identical geometries.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this 510(k) submission as it does not involve machine learning or AI.

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

• Not applicable. See point 8.

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