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The SPICCA Stand-Alone Cervical Fusion Cages are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine.

lmplants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

The SPICCA Stand-Alone Cervical Fusion Cages are single-use, sterile, PEEK (ASTM F560) anterior cervical interbody fusion cages with integrated Ti-6Al-4V ELI (ASTM F136) screws that are intended to be implanted between two adjacent vertebral bodies as part of single or multilevel Anterior Cervical Discectory and Fusion (ACDF) procedures. The SPICCA Stand-Alone Cervical Fusion Cages which are offered in the SPICCA-SP version and SPICCA-S2 version are offered in a variety of sizes to accommodate various patient anatomies (Note: SPICCA-S2 differ in footprint options and endplate-contacting surface shape). The cages include Tantalum (ASTM F560) radiographic markers and are offered uncoated or coated with titanium plasma spray (ASTM F1580).

The provided text is a 510(k) premarket notification for a medical device called "SPICCA Stand-Alone Cervical Fusion Cages." This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets specific acceptance criteria based on studies involving AI performance or human-in-the-loop assessments as typically seen in AI/ML medical device submissions.

Therefore, the information requested in the prompt, which is primarily applicable to an AI/ML enabled device, cannot be found or inferred from this document.

Specifically, this document does not contain:

• A table of acceptance criteria and reported device performance related to an AI/ML algorithm.
• Details about sample sizes for test sets, data provenance, ground truth establishment methods (e.g., expert consensus, pathology, outcome data), or training set details.
• Information on experts used to establish ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

Instead, the performance data presented here refers to mechanical testing of the physical implant (e.g., Static & Dynamic Axial Compression, Subsidence), demonstrating its structural integrity and substantial equivalence to predicate devices in terms of mechanical strength for its intended use as an intervertebral fusion device.

In summary, this document describes a traditional medical device (implant) 510(k) submission, not an AI/ML-enabled device submission, and therefore does not contain the information requested about AI performance acceptance criteria and validation studies.

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SPICCA Cervical Fusion Cages are cervical interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is intended to be used in combination with an anterior cervical plating system.

The SPICCA Cervical Fusion Cages system is an intervertebral spinal fusion system comprised of cervical interbody spacers which are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The implant includes a variety of footprints, heights, and lordosis options to optimize patient fit. All implants are manufactured from PEEK per ASTM F560 with tantalum (ASTM F2026) markers. All the implants are offered with a titanium powder coating per ASTM F1580 and some of the implants are also offered without the coating.

The provided document describes a 510(k) premarket notification for the "SPICCA Cervical Fusion Cages," a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria related to diagnostic performance or efficacy for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI-powered device is not applicable to this submission.

However, I can extract information related to the device's physical performance testing as described:

Report on SPICCA Cervical Fusion Cages Performance (K230607)

The SPICCA Cervical Fusion Cages are intervertebral spinal fusion systems intended for cervical spine procedures. The device's performance was evaluated through non-clinical mechanical testing to demonstrate its safety and substantial equivalence to predicate devices. The document does not specify quantitative acceptance criteria or reported values for these tests, only that the device's strength was found sufficient and substantially equivalent to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical acceptance criteria or reported values for the mechanical tests. It only states that the device's strength was "sufficient for its intended use" and "substantially equivalent to legally marketed predicate devices."

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated for the mechanical tests. Mechanical testing typically involves a set number of samples for each test mode (e.g., 3-6 samples per test).
• Data Provenance: The data is from non-clinical laboratory testing performed by the manufacturer or a certified testing facility, as part of the 510(k) submission process. It is not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a non-clinical mechanical performance study of a physical device, not an AI/ML diagnostic device requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for mechanical testing is derived from the physical properties and performance metrics measured during the tests.

4. Adjudication method for the test set

• Not Applicable. As a non-clinical mechanical study, there is no expert adjudication method like those used for clinical assessments or AI model evaluations. The results are based on objective physical measurements against established ASTM standards and benchmarks (predicate devices).

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 medical device, not an AI diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance with or without AI assistance was not conducted.

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

• Not Applicable. This is a physical medical device. There is no algorithm for standalone performance testing in the context of diagnostic or assistive AI.

7. The type of ground truth used

• For mechanical tests, the "ground truth" is typically defined by the physical test parameters, load applications, displacement measurements, and ultimate failure points, compared against specified ASTM standards (e.g., ASTM F2077, ASTM F2267) and the performance of an equivalently intended predicate device.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of AI/ML model development.

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

• Not Applicable. As there is no training set for an AI/ML model, there is no ground truth establishment method for it.

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The Axis Anterior Cervical Plate System is in skeletally mature patients for anterior screw fixation to the cervical spine (C2-T1) as an adjunct to fusion for the following indications: (a) degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); (b) trauma (including fractures); (c) tumours; (d) deformity (defined as kyphosis); (e) spondylolisthesis; (f) spinal stenosis; (g) pseudarthrosis and (h) revision of previous surgery.

The Axis Anterior Cervical Plate System (also called the Axis2 Anterior Cervical Fusion Plate in markets outside the US) is intended for anterior screw fixation to the cervical spine. The Axis Anterior Cervical Plate System consists of a variety of sizes of bone plates and screws to accommodate anatomical needs. The components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The implants are provided in sterile and non-sterile packaging.

The provided text is a 510(k) summary for the Axis Anterior Cervical Plate System. It describes the device, its indications for use, and its technological characteristics. However, the document does not contain information about software, AI, or diagnostic performance studies that would involve acceptance criteria, test sets, expert ground truth, or MRMC studies for a device with those functionalities.

The performance data mentioned in the document is exclusively for non-clinical mechanical testing of the implant's structural integrity. Therefore, I cannot provide the requested information related to the acceptance criteria and study that proves a device meets diagnostic performance criteria because such data is not present in the provided text.

The closest information related to "acceptance criteria" is that the device was tested per ASTM F1717 for mechanical properties and the results showed "sufficient" strength and substantial equivalence to predicate devices.

Here's an overview of what is in the document regarding performance, and why it doesn't match your request:

Performance Data Section from Document:
"The Axis Anterior Cervical Plate System has been tested in the following test modes:

• Static & Dynamic Compression Bending per ASTM F1717
• Static Torsion per ASTM F1717
  The results of this non-clinical testing show that the strength of the Axis Anterior Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

This information pertains to material science and mechanical engineering, not diagnostic accuracy or AI performance.

Therefore, I cannot populate the table or answer the questions related to diagnostic performance or AI effectiveness.

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The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family (PLIF Caliber Lordotic, TLIF Bullet, and TLIF Camber) are indicated for use as interbody fusion devices in the lumbar spine, auxiliary to supplementary lumbar spinal fixation systems, such as posterior pedicle screw and rod systems. The PLIF Caliber Lordotic devices are designed to be implanted bi-laterally following a posterior approach. The devices are intended to be used with autograft to facilitate fusion.

The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The devices may also be used in patients with pseudarthrosis / nonunion from previous unsuccessful fusion surgery. Patients should have undergone at least six months of nonoperative treatment.

The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family including the PLIF Caliber Lordotic, the TLIF Bullet, and the TLIF Camber consists of implants with various widths, heights, and lengths to accommodate individual patient anatomy. The Southern TLIF family implants are offered with straight or curved profiles. The straight profiles include the PLIF Caliber Lordotic (a PLIF) implanted from the posterior approach and the TLIF Bullet (a T-PLIF or straight TLIF) implanted from the transforaminal approach. The curved version is the TLIF Camber (a curved TLIF) implanted from the transforaminal approach.

The implants are to be packed with autogenous bone graft to facilitate fusion. The devices are intended to provide mechanical support to the implanted level until biologic fusion is achieved. The Southern TLIF family implants are manufactured from PEEK per ASTM F2026 with tantalum markers per ASTM F560. The curved TLIF designs include a titanium alloy hinge (Ti-6Al-4V per ASTM F136). The Southern TLIF family implants are provided sterile.

Here's a summary of the acceptance criteria and study information based on the provided FDA 510(k) summary, structured to answer your questions.

It's important to note that this document is an FDA 510(k) Summary for a medical device (intervertebral body fusion device), not an AI/ML-driven diagnostic or therapeutic device. Therefore, many of your questions, particularly those related to AI/ML performance, ground truth establishment, expert adjudication, and MRMC studies, are not applicable to this type of medical device submission. The performance testing for these devices primarily focuses on mechanical and biological characteristics, not diagnostic accuracy.

Description of the Acceptance Criteria and Performance Study for Southern Transforaminal Lumbar Interbody Fusion (TLIF)

This 510(k) submission describes the Southern Transforaminal Lumbar Interbody Fusion (TLIF) device family. The acceptance criteria and performance study for this type of device are centered on demonstrating mechanical strength, durability, and biocompatibility, as opposed to diagnostic accuracy or AI performance. The study aims to prove that the device is substantially equivalent to legally marketed predicate devices.

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

For interbody fusion devices, acceptance criteria are generally based on meeting or exceeding the mechanical performance and safety standards demonstrated by legally marketed predicate devices, as well as relevant ASTM standards. The reported performance indicates that the device met these criteria.

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

• Sample Size for Mechanical Testing: The specific number of devices tested for each mechanical test (axial compression, compression shear, subsidence) is not provided in this summary. It would typically follow the guidance within the respective ASTM standards (F2077, F2267).
• Data Provenance: The mechanical testing (non-clinical testing) would typically be conducted in a laboratory setting. The summary refers to the manufacturer's location as South Africa, but does not specify the testing location. This is not patient-derived data; it's device performance data.

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. For this type of mechanical device (interbody fusion device), "ground truth" is established through engineering and material science principles, laboratory testing against established standards, and comparison to predicate devices, not through expert clinical consensus on patient data.

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

Not applicable. Adjudication methods are typically associated with clinical studies, especially those involving expert review of patient data (e.g., imaging). Mechanical testing results are objective measurements from laboratory experiments.

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 submission is for a physical implantable device, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI assistance are not relevant.

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.

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

The "ground truth" for this device's performance is based on:

• Engineering Standards: Adherence to ASTM standards (F2077 for static/dynamic compression and shear, F2267 for subsidence) which define acceptable mechanical properties for spinal implants.
• Material Specifications: Use of materials (PEEK, Tantalum, Titanium Alloy) that meet established ASTM standards for biocompatibility and mechanical properties (e.g., ASTM F2026, F560, F136).
• Predicate Device Performance: Benchmarking against the known, safe, and effective mechanical performance of legally marketed predicate interbody fusion devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As the device does not involve a training set, the establishment of ground truth for such a set is irrelevant.

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The Southern Anterior Screw Fixated Cages are indicated for use as stand-alone anterior interbody fusion devices in the lumbar spine. The devices are designed to be used with the bone screws provided and the interior cavity must be filled with autograft. Supplementary spinal fixation is not required.

The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The devices may also be used in patients with pseudarthrosis / non-union from previous unsuccessful fusion surgery. Patients should have undergone at least six months of non-operative treatment.

The Southern Anterior Screw Fixated Cage (SASCA) is intended to treat pain and functional disorders of the lumbar spine by supporting, stabilizing, and immobilizing the affected segment and facilitating fusion. The SASCA devices are stand-alone devices offered in a variety of sizes to accommodate individual patient anatomy. The SASCA cages are manufactured from PEEK per ASTM F2026 with tantalum markers per ASTM F560. The fixation screws are manufactured from Ti-6A1-4V per ASTM F136. Note: The subject SASCA device is also labeled in markets outside the United States as the Sasca 2 Anterior Lumbar Standalone Fusion Cage.

The provided text describes a 510(k) summary for the Southern Anterior Screw Fixated Cage (SASCA), an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting clinical study data for device performance against specific acceptance criteria.

Therefore, many of the requested details regarding acceptance criteria, study design, ground truth, and human reader performance are not applicable in this context, as they would typically be found in a clinical study report for novel devices or those requiring higher levels of evidence.

However, I can extract the information that is present in the document.

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

The document does not specify quantitative acceptance criteria in the way one would for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, it states that the device's performance was evaluated through non-clinical mechanical testing, and the "results of this non-clinical testing show that the strength of the SASCA is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the 'acceptance criterion' was essentially meeting or exceeding the performance of the predicate device in these mechanical tests.

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 applicable as the provided document describes non-clinical mechanical testing, not a clinical study involving a "test set" of patients or data provenance in that sense. The tests were performed on prototypes of the SASCA devices.

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)

This information is not applicable. Ground truth, expert consensus, and expert qualifications are relevant for clinical studies, especially those involving image interpretation or diagnostic accuracy. The submitted document focuses on mechanical engineering performance.

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

This information is not applicable as there was no clinical test set requiring 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

This information is not applicable. This submission is for an intervertebral fusion device, not an AI-assisted diagnostic tool.

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

This information is not applicable. This is for a spinal implant, not an algorithm.

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

This information is not applicable. The "ground truth" for mechanical testing is established by the specifications of the ASTM standards and validated testing methodologies, not clinical ground truth methods.

8. The sample size for the training set

This information is not applicable. There is no "training set" in a mechanical testing scenario.

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

This information is not applicable. There is no "training set" or establishment of ground truth in the context of mechanical testing.

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