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The ACP 1™ Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The ACP 1™ system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Trauma (including fractures)
Tumors
Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
Pseudarthrosis
Failed previous fusion
Decompression of the spinal cord following total or partial cervical vertebrectomy
Spondylolisthesis
Spinal stenosis

The ACP 1TM Anterior Cervical Plating System are one-, two-, three- and four-level plate configurations ranging in lengths 10mm to 22mm for the one-level plates, 24mm to 46mm for the two-level plates, 39mm to 69mm for the three-level plates and 56mm to 96mm for the four-level plates. A locking screw is utilized as an anti-backout mechanism to lock the bone screws in place. The bone screws are provided with either fixed or variable angles available in self-tapping or self-drilling designs. The variable angle bone screws allow the screw to be placed into bone at various degrees of angulation, while the fixed bone screws are inserted at a defined angle. Any combination of bone screws can be used to secure the cervical plate. The bone screws are offered in 4.0mm and 4.5mm diameters in lengths 10mm - 20mm. The implants (bone screws and cervical plates) are provided as single-use, sterile devices manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.

This document is a 510(k) summary for the Stryker Corporation's ACP 1™ Anterior Cervical Plating System. The information provided heavily emphasizes the substantial equivalence of the new device to previously cleared predicate devices, rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way one might see for a diagnostic AI device.

Therefore, the response below is structured to reflect the information available in the provided text, primarily focusing on the comparison to predicate devices and the mechanical testing performed, as a direct AI-style acceptance criteria and study section isn't explicitly present.

Acceptance Criteria and Study for the ACP 1™ Anterior Cervical Plating System

The ACP 1™ Anterior Cervical Plating System's acceptance criteria and the study proving it meets these criteria are primarily based on demonstrating substantial equivalence to existing predicate devices through risk analysis and mechanical testing, rather than a clinical performance study with specific diagnostic accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Study Description:

The provided document describes a "510(k) Summary" process which is a regulatory pathway to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The "study" in this context refers to the assessment performed to support this claim.

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

• Sample Size for Mechanical Testing: The document does not specify the exact number of test samples (e.g., number of plates or constructs) used for the static and dynamic mechanical tests per ASTM F1717-14.
• Data Provenance: The data provenance for the mechanical testing is not explicitly stated (e.g., country of origin, specific lab). It is implicitly prospective testing conducted by the manufacturer to support the 510(k) submission. There is no patient data involved in this assessment as it's a mechanical device.

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

This type of information is not applicable for the ACP 1™ Anterior Cervical Plating System as described in this document. The assessment is for a physical implantable medical device and relies on engineering principles and mechanical testing standards (ASTM F1717-14), not on expert clinical interpretation of data or diagnostic accuracy.

4. Adjudication Method for the Test Set:

This is not applicable. There is no "test set" in the sense of a dataset requiring expert adjudication, as the study involves mechanical performance testing of a physical device against predefined engineering standards.

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

An MRMC study is not applicable here. This study type is typically used for diagnostic devices (e.g., AI in radiology) to evaluate the performance of human readers with and without AI assistance. The ACP 1™ System is an implantable surgical device, not a diagnostic tool.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

This concept is not applicable to the ACP 1™ Anterior Cervical Plating System. The device is a physical implant, not an algorithm. Its performance is evaluated through mechanical testing and comparison to predicate devices, not as a standalone AI system.

7. Type of Ground Truth Used:

The "ground truth" for the performance evaluation of the ACP 1™ System is based on established engineering standards and requirements for spinal intervertebral body fixation orthoses, specifically the ASTM F1717-14 standard for static and dynamic compression and torsion testing. The ultimate "ground truth" for regulatory clearance is substantial equivalence to legally marketed predicate devices, meaning the new device performs as safely and effectively as the existing ones.

8. Sample Size for the Training Set:

This is not applicable. The ACP 1™ System is a physical medical device. It does not involve a "training set" in the context of machine learning or AI.

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

This is not applicable, as there is no "training set."

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The X-Spine ACP4 System is intended for anterior screw fixation to the cervical spine (C2-C7 inclusive). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

• Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
• Spondylolisthesis,
• Trauma (i.e., fractures or dislocations),
• Tumors,
• Deformity (defined as kyphosis, lordosis, or scoliosis) .
• Pseudoarthrosis, and/or
• Failed previous fusions.

The X-Spine ACP4 System includes titanium alloy anterior cervical plates and bone screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine, levels C2 to C7. The implant components are provided clean and non-sterile.

The request is about the acceptance criteria and study proving the device meets the criteria. Specifically, it requests:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number and qualifications of experts for ground truth establishment (test set).
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details (if applicable).
6. Standalone performance study details (if applicable).
7. Type of ground truth used.
8. Sample size for the training set.
9. Ground truth establishment for the training set.

Based on the provided documents for K092360, the device is the "ACP4™ Spinal Implant System," which is a traditional medical device (cervical plating system) and not an AI/ML-based device. Therefore, the requested information, which pertains to AI/ML device performance criteria, ground truth, and expert evaluation, is not applicable to this submission.

The "PERFORMANCE DATA" section states: "Biomechanical testing indicates that the ACP4 system is capable of performing in accordance with its intended use." This indicates that the device's performance was evaluated through biomechanical tests, rather than clinical studies involving human readers, ground truth, or training sets as relevant for AI/ML systems.

Therefore, I cannot fulfill the request for information specifically tailored to AI/ML device evaluations based on the provided document. The document describes a traditional medical device submission, which does not typically include these types of performance evaluations.

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This device is intended to for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pains, minor arthritis pain and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue and to temporarily increase local blood circulation

OmniProbe Infrared Lamp, OmniProbe 500 Infrared Lamp Control Unit

The provided FDA letter for K060191 describes the OmniProbe Infrared Lamp and OmniProbe 500 Infrared Lamp Control Unit. However, it is a 510(k) clearance letter, which determines substantial equivalence to a legally marketed predicate device. This type of regulatory submission typically does not contain detailed information about specific acceptance criteria, performance studies with sample sizes, or ground truth establishment in the way that would be found in a De Novo or PMA submission for novel devices or higher-risk devices.

Therefore, many of the requested details about acceptance criteria and study particulars are not present in the provided text. The letter focuses on the regulatory determination of substantial equivalence based on the device's indications for use and general controls.

Here's a breakdown of what can and cannot be answered based on the provided document:

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

• Not available in the provided text. The 510(k) clearance is based on substantial equivalence to a predicate device, not on specific acceptance criteria and performance metrics for the new device as would be detailed in a PMA or De Novo.

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

• Not available in the provided text. The document does not describe any specific clinical or performance studies with test sets, sample sizes, or data provenance.

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 available in the provided text. A 510(k) clearance, especially for an infrared lamp, typically does not involve establishing ground truth by a panel of experts in the way an AI/CAD device would. The safety and effectiveness are inferred from the predicate device.

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

• Not applicable/Not available in the provided text. No adjudication method for a test set is mentioned as no such study 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/Not available in the provided text. The device is an infrared lamp, not an AI/CAD system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• Not applicable/Not available in the provided text. The device is not an algorithm; it's a physical medical device (an infrared lamp).

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

• Not applicable/Not available in the provided text. Ground truth in the context of diagnostic or AI devices is not relevant to an infrared lamp's 510(k) submission.

8. The sample size for the training set

• Not applicable/Not available in the provided text. This device does not involve a training set as it is not an AI/machine learning product.

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

• Not applicable/Not available in the provided text. As there is no training set, there is no ground truth establishment for one.

Summary based on the provided document:

The provided document is an FDA 510(k) clearance letter for the OmniProbe Infrared Lamp and OmniProbe 500 Infrared Lamp Control Unit. Its purpose is to state that the device is "substantially equivalent" to legally marketed predicate devices. This regulatory pathway primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and similar safety and effectiveness profile as a previously cleared device. It does not typically require or describe the detailed performance studies, specific acceptance criteria, sample sizes, or ground truth establishment that would be associated with novel or higher-risk devices, especially those incorporating AI or complex diagnostic algorithms.

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An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in serum.

Acid Phosphatase is an in vitro diagnostic assay for the quantitative determination of total and prostatic acid phosphatase in human scrum. The Acid Phosphatase assay is a clinical chemistry assay in which the acid phospliatase in the sample catalyzes the hydrolysis of alpha-naphthylphosphate liberating the alpha-naphthol and phosphate. The alpha-naphthol is then coupled with diazotized 2-amino-5-chlorotoluene (Fast Red TR) to form a diazo dye. The absorbances measured at 412 and 660 nm are directly proportional to the amount of acid phosphatase present in the sample. The addition of I .- Tartrate inhibits prostatic acid phosphatase, but does not inhibit other isocnzymes. The difference between the two protocols (Total Acid Phosphatasc and Non-Prostatic Acid Phosphatase) is the level of prostatic acid phosphatase in the sample.

Acceptance Criteria and Device Performance for ACP (Acid Phosphatase) Assay

Study Proving Acceptance Criteria:

The study conducted to prove the device meets the acceptance criteria is a comparative performance study demonstrating substantial equivalence to a legally marketed predicate device.

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The document refers to "comparative performance studies" and "precision studies conducted using two levels of control material," but the precise number of patient samples or runs for method comparison is not provided.
   • Data Provenance: Not explicitly stated. However, given the context of a 510(k) submission for a clinical chemistry assay in the US, the data would likely be from prospective studies conducted in a laboratory setting for regulatory submission in the United States.

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

   • Not applicable in this context. The "ground truth" for this type of in vitro diagnostic assay typically refers to the results obtained from the predicate device (Trace® Acid Phosphatase Assay on Hitachi® 717 Analyzer), which itself is a validated and legally marketed device. Expert human interpretation, as found in imaging or pathology studies, is not the primary method for establishing ground truth in clinical chemistry assays measuring analyte concentrations.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) where there might be disagreement among experts. In this case, the comparison is made between quantitative measurements of two assays.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study focuses on human reader performance, often with and without AI assistance, which is irrelevant for a quantitative clinical chemistry assay where results are generated by an instrument.

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

   • Yes, this was a standalone performance study in the sense that it evaluates the instrument and reagent system (the ACP assay) itself. There isn't a "human-in-the-loop" component in the direct measurement process of a clinical chemistry assay in the same way there might be for an AI-assisted diagnostic tool for image interpretation. The performance characteristics (correlation, precision, linearity, sensitivity) are intrinsic to the assay system.

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

   • The "ground truth" for comparative studies in clinical chemistry is typically established by the legally marketed predicate device's performance results. In this case, the Trace® Acid Phosphatase Assay on the Hitachi® 717 Analyzer served as the comparator or "gold standard" against which the new ACP assay's performance was measured for substantial equivalence.

7. The sample size for the training set:

   • Not applicable. This device is an in vitro diagnostic assay, not an AI/ML algorithm that requires a "training set" to learn from data. The performance characteristics are determined by the chemical reagents and instrument design.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" for this type of device.

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The ACPii Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

The ACPii Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy as described by ASTM F-136 and may be supplied either sterile or non-sterile.

The provided text describes a 510(k) summary for the ACPii Anterior Cervical Plate System. This is a submission for a medical device (a spinal implant) to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. The information requested in your prompt (acceptance criteria, details of a study using AI, human readers, ground truth establishment, sample sizes, etc.) is typically associated with the evaluation of AI/ML-based medical devices or diagnostic tools, often involving performance metrics like sensitivity, specificity, or AUC.

The ACPii Anterior Cervical Plate System is a physical medical device (implant). Its approval process focuses on mechanical performance and material safety, as well as demonstrated substantial equivalence to existing predicate devices.

Therefore, the information you're asking for is not applicable to this type of device and its 510(k) summary. There is no mention of AI, diagnostic imaging, human readers, or any of the study design elements typically found in AI/ML device evaluations.

Here's why each point isn't relevant to the provided text:

1. A table of acceptance criteria and the reported device performance: For a spinal implant, "acceptance criteria" and "device performance" would relate to mechanical strength (e.g., fatigue strength, pull-out strength of screws), biocompatibility, and perhaps surgical success rates if clinical data were submitted. The summary only states "Mechanical test data were provided in support of this notification." It does not provide specific acceptance criteria or detailed performance results in the summary itself.
2. Sample size used for the test set and the data provenance: This usually refers to patient data for AI/ML models. For a physical implant, "test set" would refer to the number of implants tested mechanically. This information is not provided in the summary.
3. Number of experts used to establish the ground truth... and qualifications: Ground truth establishment by experts is relevant for diagnostic accuracy or image interpretation. It's not applicable to a spinal implant's mechanical properties.
4. Adjudication method: Again, relevant for diagnostic interpretations, not for mechanical testing of an implant.
5. Multi reader multi case (MRMC) comparative effectiveness study: This is for evaluating diagnostic performance with and without AI assistance. Not applicable.
6. Standalone (i.e. algorithm only without human-in-the loop performance): This refers to AI algorithm performance. Not applicable.
7. The type of ground truth used: For an implant, "ground truth" would be the actual mechanical performance measurements or clinical outcomes, not expert consensus on an image.
8. The sample size for the training set: Training set for AI/ML models. Not applicable.
9. How the ground truth for the training set was established: Ground truth for AI/ML models. Not applicable.

In summary, the provided 510(k) summary is for a physical orthopedic implant. The questions you've asked are designed for AI/ML-driven diagnostic devices. As such, the information you're looking for is not present in this document because it pertains to a different category of medical device evaluation.

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