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The Nerve Monitoring Cable in conjunction with dilators, pedicle probes, taps, awls or screw drivers, are intended for tissue dilation/dissection and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery.

The dilators are also intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the intended surgical site to allow passage of current from a point on the proximal end to an uninsulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The dilators are offered sterile/single use.

The Nerve Monitoring Cable System, which consists of Nerve Monitoring Cables in conjunction with various stimulation accessories, allow for tissue dilation and stimulation of peripheral nerve roots for location and identification during open and percutaneous / minimally invasive spinal surgery. The Nerve Monitoring Cable includes a 1.5 mm female DIN connector for use with a stimulating console with a Type BF or CF rating. The other end of the Nerve Monitoring Cable includes a clip for connection to the stimulation accessories of this system.

The stimulation accessories include general manual orthopedic surgical instruments previously cleared via K073227 (i.e. pedicle probes, taps, awls and screw drivers) and also include sterile/ single-use dilators which are subject of this submission. The subject dilators are a series of hollow tubes that fit over one another for the purpose of dilating tissue in preparation for spinal surgery. Similar to the predicate instrument accessories, they are made from a conducting metal (Aluminum 6061-T6) with an insulated outer coating (Parylene C) to allow passage of current from a point on the proximal end where it connects to the Nerve Monitoring Cable to an un-insulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The subject dilators are offered sterile/single-use.

The provided text describes the 510(k) premarket notification for the Pioneer Surgical Technology, Inc. Nerve Monitoring Cable System (K142438). This submission focuses on demonstrating substantial equivalence to predicate devices, particularly for new sterile/single-use dilators.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to predicate devices across various characteristics, including safety, electrical performance, and biocompatibility. The performance data presented in the 510(k) summary serves as the "reported device performance."

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

• Test Set Sample Size:
  • Biocompatibility: Not explicitly stated, but typically involves a defined number of samples per test type (e.g., cytotoxicity, irritation, sensitization, systemic toxicity) as per ISO 10993-1.
  • Electrical/Resistance Bench Testing: Not explicitly stated.
  • In-process Hipot Testing: Not explicitly stated, but likely represents a portion or all units from a production run.
  • Porcine Animal Study: Not explicitly stated, but standard animal study protocols would define the number of animals.
  • Sterilization, Packaging, Shelf-life Validations: Not explicitly stated, but these involve statistical sampling as per the relevant ISO and ASTM standards.
• Data Provenance: The document does not specify the country of origin for the testing data. Given it's a U.S. FDA submission, it's highly probable the testing was conducted in the USA or by facilities recognized by the manufacturer as compliant with relevant standards. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate the device's performance characteristics.

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

This document describes a medical device seeking 510(k) clearance, which is based on demonstrating substantial equivalence to existing legally marketed predicate devices. It is not an AI/ML device that typically requires human expert consensus for "ground truth" to evaluate diagnostic or predictive performance.

• For Biocompatibility: Ground truth is established by standardized laboratory tests and interpretation by qualified toxicologists/biocompatibility specialists against ISO 10993-1 criteria.
• For Electrical Performance: Ground truth is established by physics principles, engineering specifications, and comparison against established predicate device performance specifications.
• For Animal Study (Functionality/Safety): Ground truth is established by observations and measurements taken during the veterinary surgical procedure, interpreted by veterinarians and potentially surgeons specialized in the relevant field.

Therefore, the concept of "number of experts used to establish ground truth" as it applies to AI/ML clinical studies is not directly applicable here. The "experts" would be the scientists, engineers, and medical professionals conducting and interpreting the various technical and animal studies.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies, especially those involving human judgment (like image interpretation in AI diagnostics), to resolve disagreements in ground truth determination. Since this 510(k) submission is for a physical device and relies on technical and animal studies, no such adjudication method is mentioned or typically required. The results of the technical studies (biocompatibility, electrical, mechanical) are generally objective measurements against predefined criteria or established scientific methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specific to diagnostic or interpretive AI/ML devices where human readers (e.g., radiologists) interpret cases (e.g., medical images) both with and without AI assistance to measure the impact of the AI on their performance. The Nerve Monitoring Cable System is a surgical accessory, not an interpretive diagnostic device, and therefore this type of study is irrelevant to its evaluation.

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

No, a standalone algorithm performance study was not done. Again, this device is a physical surgical accessory, not an algorithm or AI system. Its performance is evaluated through physical and biological testing, not through algorithmic output.

7. The Type of Ground Truth Used

The "ground truth" for evaluating this device primarily comes from:

• Standardized Test Results/Specifications: For biocompatibility (ISO 10993-1), electrical performance (IEC 60601-1, engineering calculations), mechanical durability, sterilization efficacy, packaging integrity, and shelf-life. These are objective measurements against established international and industry standards.
• Animal Study Observations: For in-vivo performance, functionality, and safety, observations from the porcine animal study serve as empirical ground truth.

8. The Sample Size for the Training Set

This device is not an AI/ML device and therefore does not have a "training set." The concept of a training set is specific to machine learning algorithms where data is used to teach the algorithm to perform a task.

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

As there is no training set for this device, the question of how its ground truth was established is not applicable.

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NanOss™ is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities, posterolateral spine, and pelvis). NanOss must be mixed with autogenous blood or sterile saline for use in the extremities or pelvis. NanOss must be mixed with bone marrow aspirate and autograft bone as a bone graft extender in the posterolateral spine. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NanOss™ is a resorbable bone void filler (BVF) consisting of calcium phosphate and a porcine gelatin carrier provided in granular form. The BVF is radiopaque, provided sterile and is intended for single use only. The product is provided pre-filled in a mixing container as NanOss™ or in a mixing chamber/syringe as NanOss™ Loaded.

The purpose of this submission is to obtain clearance for a merged indications for use statement and new packaging configuration (NanOssTM Loaded Kit). In addition, instrument accessories previously cleared for MIS graft placement in the posterolateral spine through a small incision are now available for graft placement in the skeletal system (i.e., extremities, pelvis).

This document is a 510(k) premarket notification for a medical device called NanOss™, NanOss™ Loaded, and NanOss™ Loaded Kit. It is a resorbable calcium salt bone void filler device.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the device is cleared based on demonstrating "substantial equivalence" to predicate devices, rather than meeting specific quantifiable performance acceptance criteria in clinical studies. The "testing" section lists non-clinical tests.

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

The document does not describe a clinical study with a "test set" in the context of device performance metrics (e.g., sensitivity, specificity for an AI device). The non-clinical tests mentioned do not specify sample sizes or data provenance in the way a clinical trial would. This submission is for a bone void filler, which typically undergoes biocompatibility, mechanical, and degradation testing, but these details (including sample sizes and provenance) are not provided in this summary. The "testing" section lists only non-clinical tests (packaging, shelf-life, sterilization, instrument validation).

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

Not applicable. This is not a study involving expert assessment to establish ground truth (e.g., for image interpretation).

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI/software device undergoing an MRMC study.

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

Not applicable. This is a medical device (bone void filler), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the substantial equivalence determination for this bone void filler is based on the characteristics and performance of the legally marketed predicate devices (FortrOss Bone Void Filler K110561 and NanOss™ BVF-E K100361), as demonstrated through non-clinical testing. For the non-clinical tests (packaging, sterilization, etc.), the ground truth would be established by the specifications and standards (e.g., ASTM, ISO) they are tested against.

8. The Sample Size for the Training Set

Not applicable. This is a bone void filler device, not an AI/machine learning model that requires a training set.

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

Not applicable.

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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery.

The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine.

The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.

The Streamline OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System) using connectors.

The Streamline OCT Occipito-Cervico-Thoracic System consists of a variety of rods, hooks, polyaxial pedicle screws, high-angle pedicle screws, locking caps, occipital bone screws, occipital plates and connecting components used to build an occipito-cervico-thoracic spinal construct.

The purpose of this submission is to add components to the system.

This is a medical device submission (K133374) for the Streamline OCT Occipito-Cervico-Thoracic System, which is a spinal fixation system. The provided text primarily focuses on demonstrating substantial equivalence to predicate devices through various comparisons, including pre-clinical testing.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:
   The provided text describes pre-clinical performance data which typically refers to laboratory or bench testing, not human subject testing. Therefore, there is no "test set" in the sense of patient data. The "samples" would be the spinal implant components themselves, tested in a lab setting. The provenance is the testing conducted by Pioneer Surgical Technology, Inc. There is no information regarding the number of components tested in the provided summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This section is not applicable as the "testing" described is mechanical bench testing, not expert review of clinical data to establish ground truth. The "ground truth" here is the specific mechanical properties and failure points determined by the standardized ASTM tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods are used for clinical studies involving interpretation of data by multiple experts. This submission focuses on engineering and mechanical testing.

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 a spinal implant, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a spinal implant. Performance is evaluated through mechanical testing and comparison to predicate devices, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the mechanical testing, the "ground truth" is defined by the objective, quantitative criteria established in the ASTM standards (ASTM F1717 and ASTM F1798). These standards define acceptable levels of performance for spinal fixation devices related to static and dynamic compression, bending, torsion, and connector integrity.

8. The sample size for the training set:
   Not applicable. This is a medical device submission for a physical implant, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:
   Not applicable (no training set for an AI model).

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