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The SP-LINK™ System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for single level plate attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The SP-LINK™ System is intended for use with bone graft material, and not for stand-alone use.

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The provided text is a 510(k) clearance letter from the FDA for the SP-LINK™ System, a spinal interlaminal fixation orthosis. It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory provisions.

Crucially, this document does NOT contain any information regarding acceptance criteria or the study that proves the device meets specific performance criteria for AI-related tasks. The device described is a physical medical implant, not an AI/software as a medical device (SaMD). Therefore, it would not have the types of acceptance criteria or performance studies (like MRMC, standalone AI performance, ground truth establishment for AI, etc.) that would apply to an AI-driven medical device.

The information you are asking for (e.g., acceptance criteria tables, sample sizes for AI test/training sets, expert adjudication methods, MRMC studies) is directly relevant to the validation of AI/ML-driven medical devices, especially those involved in image analysis or diagnostic support. Since the SP-LINK™ System is a hardware device, these concepts are not applicable as described in this FDA clearance letter.

Therefore, I cannot fulfill your request based on the provided text.

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The Fixated Asfora BULLET CAGE® (FABC) is indicated for spinal fusion procedures in skeletally mature patients for the treatment of degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems 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 I spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The FABC devices are used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

When used with the two fixation screws, the FABC System is a stand-alone system and requires no additional supplemental fixation. When used without the fixation screws, the FABC System should be used with supplemental fixation cleared for use in the lumbar spine. When only one device is implanted, the FABC System must be used with supplemental fixation cleared for use in the lumbar spine.

The Fixated Asfora BULLET CAGE® (FABC) System is comprised of a threaded titanium alloy interbody fusion cage and two optional fixation screws. The implants are available in an assortment of diameter and length combinations to accommodate a variety of anatomic requirements. The instrumentation for implantation is manufactured from medical grades of stainless steel per ASTM F899 with some having silicone handles.

This document is a 510(k) premarket notification for the Fixated Asfora BULLET CAGE® (FABC) system, an intervertebral body fusion device. The focus is on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria for an AI/ML device or conducting a study to prove it meets them. Therefore, many of the requested categories related to AI/ML device performance and ground truth establishment are not applicable.

Here's the information that can be extracted from the provided text, categorized as per your request, with "N/A" for those not relevant to this type of submission:

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: This refers to mechanical testing of "worst case FABC System devices." The specific number of devices tested is not provided in this summary.
• Data Provenance: The document does not specify the country of origin of the data or whether the mechanical testing was retrospective or prospective. It is generally understood that such testing would be conducted in a laboratory setting by the manufacturer.

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)

• N/A. This is a medical device (implant) submission, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device's performance is derived from standardized mechanical testing.

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

• N/A. As this is not an AI/ML device with human interpretation, an adjudication method is not relevant.

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

• N/A. This is not an AI-assisted device.

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

• N/A. This is a physical medical implant, not an algorithm.

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

• For the performance testing, the "ground truth" is established by adherence to recognized ASTM (American Society for Testing and Materials) standards for mechanical performance of intervertebral body fusion devices (ASTM F2077, ASTM F2267, and an ASTM draft standard for expulsion). These standards define the methods and criteria for evaluating the physical properties of the device.

8. The sample size for the training set

• N/A. This is not an AI/ML device requiring a training set.

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

• N/A. This is not an AI/ML device.

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The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as 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 or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Asfora Anterior Cervical Plate System is composed of plates of varying lengths to accommodate surgical procedures from one to four levels. The plates are designed for application to the anterior aspect of the cervical spine and have three locking tabs to reduce the potential for screws to back out of the vertebral body. The screws are provided in diameters of 4.0mm (Variable Angle Implant Screw and Fixed Angle Implant Screw) and 4.4mm (Rescue Screw) and lengths of 12mm, 14mm and 16mm.

This document is a 510(k) premarket notification for the Asfora Anterior Cervical Plate System. It describes a medical device, and the information requested pertains to the performance evaluation and regulatory approval of AI/ML-driven medical devices. Therefore, a direct extraction of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML device performance is not applicable to this document.

However, I can extract the relevant information about the non-AI device's performance testing as described in the document.

Acceptance Criteria and Device Performance for the Asfora Anterior Cervical Plate System (Non-AI device):

The document does not explicitly present acceptance criteria in a table format with corresponding performance results. Instead, it states that "Mechanical testing was conducted, in accordance with Guidance for Industry and FDA Staff: Spinal System 510(k)s and ASTM F 1717-14 to ensure the device performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose."

The types of tests performed indicate the areas where performance had to be satisfactory to meet the specified standards.

Table of Performance Testing (Interpreted from the document):

Regarding the specific questions about AI/ML device studies:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document describes mechanical testing of a medical implant, not an AI/ML device analyzing data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus on data interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is objective physical measurement against established engineering standards (ASTM F 1717-14) and FDA guidance for spinal systems.
7. The sample size for the training set: Not applicable. There is no AI/ML model for which to describe a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary for this document:

The document K143688 is a 510(k) premarket notification for a physical medical device (Asfora Anterior Cervical Plate System), not an AI/ML device. Therefore, the specific questions related to AI/ML device performance evaluation (such as test set sample size, data provenance, expert ground truth, MRMC studies, training set details) are not applicable to the information provided in this regulatory submission.

The "study" proving the device meets acceptance criteria is described as "Mechanical testing was conducted, in accordance with Guidance for Industry and FDA Staff: Spinal System 510(k)s and ASTM F 1717-14". The acceptance criterion is implied that the device "performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose" as defined by those standards. Specific quantitative results are not included in this summary document.

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The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems 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 I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.

The Asfora Bullet Cage (ABC) is a threaded titanium alloy interbody fusion device (cage) with a threaded titanium end cap. The ABC is a threaded, self-tapping, bullet-shaped, hollow-body, device designed to immobilize adjacent vertebrae and promote arthrodesis (fusion) across the disc space. The Asfora Bullet Cage is available in ten sizes: 5 diameters (10mm, 12mm, 14mm, 16mm, and 18mm) and 2 lengths (21mm or 25mm).

The provided text is related to a 510(k) submission for a medical device called the "Asfora Bullet Cage™ System, Intervertebral Body Fusion Device." This submission is a request for substantial equivalence to previously cleared devices.

Key takeaway: This document is a 510(k) summary and clearance letter, which focuses on demonstrating substantial equivalence to predicate devices, not on a new, formal study with specific acceptance criteria and performance data for the device itself. Therefore, many of the requested points below about specific performance metrics and study design are not applicable to this type of regulatory submission. The document explicitly states: "No significant changes to the design of the device were made. Risk assessment was performed which concluded no additional testing was required."

Here's a breakdown based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable: This 510(k) submission is for substantial equivalence without new performance testing. There is no "test set" of patients or data from a clinical study for this specific submission to demonstrate novel device performance. The clearance is based on comparison to predicate devices, which would have undergone their own testing previously.

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

• Not Applicable: As there was no specific "test set" or clinical study for this submission, there was no ground truth to be established by experts for new performance data. The regulatory decision was made by FDA reviewers (e.g., Mark N. Melkerson, Director Division of Surgical, Orthopedic and Restorative Devices).

4. Adjudication method for the test set

• Not Applicable: No clinical or performance study with a test set requiring adjudication was conducted for this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: This device is an implantable medical device (intervertebral body fusion device), not an imaging or AI-assisted diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant to its evaluation, and no such study was conducted or reported here.

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

• Not Applicable: This is an implantable medical device, not an algorithm. Standalone algorithm performance is not relevant to this submission.

7. The type of ground truth used

• Not Applicable (in the context of new device performance): The "ground truth" for this 510(k) submission is the pre-existing FDA clearance and established safety and effectiveness of the identified predicate devices. The new device demonstrates "substantial equivalence" to these known safe and effective devices.

8. The sample size for the training set

• Not Applicable: This is an implantable medical device. The concept of a "training set" is usually associated with machine learning algorithms, which is not applicable here.

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

• Not Applicable: As there is no training set for a machine learning algorithm, there is no ground truth to be established for it.

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The Asfora Bullet Cage™ (ABC) is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two levels from L2 to S1. The DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ABC cage devices are used with autogenous bone graft and are implanted via an open posterior approach. Patients should have had at least six (6) months of non-operative treatment prior to implant.

The Asfora Bullet Cage™ is comprised of two hollow, threaded, self-tapping titanium fusion devices (cages) with closed tapered medial ends. The distal end has a small orifice that can be closed with a threaded cap. There are six equidistant slit apertures along the longitudinal axis of the device for placement of autogenous bone graft material. The cage has large cutting threads, angled toward the proximal end. The Asfora Bullet Cage™ is available in ten sizes: 5 diameters (10mm, 12mm, 14mm, 16mm, and 18mm) and 2 lengths (21mm or 25mm). This device, with associated instrumentation is intended for use in posterior lumbar interbody fusion to immobilize adjacent vertebrae and promote arthrodesis (fusion) across the disc space.

The provided document is a 510(k) summary for the Asfora Bullet Cage™. It details device description, indications for use, and a statement of substantial equivalence to predicate devices. However, the document does not contain information about:

• Specific acceptance criteria for device performance (e.g., success rates, mechanical thresholds in a clinical context).
• Any studies involving patient data or device performance against such criteria. The "testing" mentioned in the summary refers to technical characteristics comparison, not clinical or performance outcome studies that would generate the requested metrics.
• Sample sizes for test or training sets, data provenance, expert ground truth establishment, or adjudication methods for an AI/device performance study.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Specific types of ground truth used (e.g., pathology, outcomes data).

Therefore, based only on the provided text, it's not possible to answer most of the prompt's questions as they pertain to clinical performance studies or AI/device performance metrics against acceptance criteria. The document describes a device comparison/equivalence filing, not a study demonstrating performance against specific clinical acceptance criteria.

The "study" that proves the device meets acceptance criteria, in this context, is the assessment of substantial equivalence to predicate devices. This is based on comparing technical characteristics and intended uses, implying that if the device is substantially equivalent to legally marketed and safe predicate devices, it also meets the necessary safety and effectiveness "acceptance criteria" for market clearance via the 510(k) pathway.

Here's an attempt to answer the questions based only on the available text, highlighting where information is absent:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No information provided in the document regarding a test set or data provenance for performance evaluation. The "testing" refers to technical comparisons, not clinical performance data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method 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. This is a medical device clearance document, not an AI performance study.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices based on their prior marketing clearance.

8. The sample size for the training set
Not applicable. No training set is described for device performance evaluation.

9. How the ground truth for the training set was established
Not applicable. No training set is described.

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Use of the Subdural Evacuating Port System Cranial Access Kit is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The Subdural Evacuating Port System Cranial Access Kit is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.

The Subdural Evacuating Port System Cranial Access Kit is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and liquid-state subdural hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the Subdural Evacuating Port System Cranial Access Kit's "SEPS Components" are designed to promote gradual brain reexpansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir. The completeness of the Subdural Evacuating Port System Cranial Access Kit saves time and eliminates the need to gather supplies; this convenience can be critical in an emergency situation.

The Subdural Evacuating Port System Cranial Access Kit is available in three (3) kit configurations:

1. SEPS-CA, Catalog # 11-0401-CA (Standard Kit)
2. SEPS-CAL, Catalog # 11-0401-CAL (Standard Kit with Lidocaine w/epinephrine)
3. SEPS-CAND, Catalog # 11-0401-CAND (Standard Kit without Lidocaine, ChloraPrep® One-Step, or PVP (Povidone-Iodine) ointment -- no drugs).

The provided text describes a 510(k) submission for the Subdural Evacuating Port System Cranial Access Kit (SEPS Cranial Access Kit). This is a medical device, not an AI/ML algorithm or software that would typically have acceptance criteria based on performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested categories in the prompt are not applicable to this type of traditional medical device submission. The 510(k) process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a study with clearly defined statistical endpoints for sensitivity/specificity.

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present or relevant to this type of device submission:

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 explicitly stated for the current device. The submission refers to "successful performance testing and clinical data presented and accepted for the predicate device (510(k) # K002970)." This implies that the data relied upon was from studies previously conducted for the predicate device.
• Data Provenance (country of origin, retrospective/prospective): Not provided in this summary. The data provenance would relate to the predicate device's studies.

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

• Number of Experts: Not applicable/Not provided. The 510(k) submission for this device type does not involve establishing ground truth through expert reads of images for performance evaluation in the way an AI diagnostic device would. Performance is demonstrated through substantial equivalence to existing devices.
• Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not provided. Adjudication is typically used in studies involving human readers or AI output where discrepancies need resolution, which is not the primary assessment method described for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. This type of study is specifically designed for evaluating the impact of AI assistance on human reader performance, which is not relevant for this physical medical device.
• Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: No. This device is a physical surgical kit, not a software algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable/Not provided in the context of typical AI performance evaluation. For this device, the "ground truth" for demonstrating safety and effectiveness is primarily established through the regulatory approval of the predicate device(s) and their associated clinical performance data. The current submission relies on the established safety and performance of the predicate.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical medical kit and does not involve AI model training.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of Performance Testing (as per document):

The manufacturer (Medical Designs, LLC) states that the Subdural Evacuating Port System Cranial Access Kit is "substantially equivalent to the Subdural Evacuating Port System Kit (Predicate Device #1) based on the successful performance testing and clinical data presented and accepted for the predicate device (510(k) # K002970)."

This means that the current device's safety and effectiveness were demonstrated by showing that it is essentially the same as a device already approved by the FDA, which had its own performance testing and clinical data submitted previously. No new specific clinical trials or performance studies unique to the "SEPS Cranial Access Kit" itself (as described in the 510(k) summary) were conducted beyond demonstrating its equivalence to the predicate. Biocompatibility was also confirmed by noting that components are FDA approved or substantially equivalent to approved components.

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