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The Sterispine™ PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct of fusion. Sterispine™ PS system is intended for posterior non-cervical, pedicle and nonpedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation) ; spinal stenosis ; tumor ; pseudoarthrosis and failed previous fusion.

The cleared range of Sterispine™ PS system includes multiaxial screws and cannulated multiaxial screws with or without extended head (Ø5.5, 6.5 and 7.5mm, lengths from 25 to 85mm) and straight and prebent rods (Ø5.5, 6.5 and 7.5mm, lengths from 30 to 380mm). Sterispine™ PS implants are supplied sterile with a sterile single-use set of surgical instruments supplied in kits. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

Here's an analysis of the provided text regarding acceptance criteria and device performance.

Important Note: The provided document is a 510(k) summary for a medical device (Sterispine™ PS) and focuses on demonstrating substantial equivalence to a predicate device. It does not present a study proving an AI device meets acceptance criteria. The document pertains to a traditional orthopedic implant system, not an AI-powered diagnostic or therapeutic device. Therefore, many of the requested elements for an AI device (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.

The document primarily discusses non-clinical mechanical testing of a physical implant (pedicle screw system).

Based on the provided text, here's what can be extracted and what cannot:

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

The document mentions specific non-clinical mechanical tests and states the general outcome. It does not provide a quantitative table of specific acceptance criteria values and corresponding performance results.

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: Not specified quantitatively. The tests are mechanical in nature, likely on a set number of implants/components per test (e.g., n=5 or n=10 per ASTM standard).
• Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. This refers to lab testing of physical devices, 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 (e.g., radiologist with 10 years of experience)

• Not applicable. This document describes mechanical device testing against engineering standards, not clinical diagnosis or AI model evaluation requiring human expert ground truth.

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

• Not applicable. Adjudication methods are relevant for subjective human interpretations, typically in clinical studies or AI model ground truth establishment. This is 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 relates to AI-assisted human performance in diagnostic tasks. The device in question is a surgical implant.

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

• Not applicable. This relates to the performance of an AI algorithm as a standalone diagnostic tool. The device is a surgical implant.

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

• The "ground truth" for this device's performance is adherence to established mechanical testing standards (e.g., ASTM F1798, ASTM F1717) and functional engineering requirements. It's engineering/mechanical performance standards, not clinical ground truth.

8. The sample size for the training set

• Not applicable. This refers to AI model training data.

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

• Not applicable. This refers to AI model training data.

Summary regarding the provided document:

The provided K201648 510(k) summary is for a traditional surgical implant (pedicle screw system). The "acceptance criteria" and "study" described are focused on non-clinical mechanical and functional testing to demonstrate the device's physical properties and performance against established engineering standards, and its substantial equivalence to previously cleared predicate devices. It does not involve AI technology or clinical performance studies in the way envisioned by the posed questions.

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The Sterispine™ PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct of fusion.

Sterispine™ PS system is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis and failed previous fusion.

The cleared range of Sterispine™ Ps system include multiaxial screws and cannulated multiaxial screws with or without extended head (Ø5.5, 6.5 and 7.5mm, lengths from 25 to 60mm) and straight and prebent rods (Ø5.5, 6.5 and 7.5mm, lengths from 30 to 380mm). Components of Sterispine™ PS range of products is supplied sterile with a sterile single-use set of surgical instruments.

This looks like a 510(k) summary for a medical device called "Sterispine™ PS", which is a thoracolumbosacral pedicle screw system. From the information provided, it's clear that this is not a software device or an AI/ML powered device, and therefore does not have acceptance criteria or a study related to software performance.

The document describes premarket notification for a traditional medical device (implants for spinal fusion) and focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "Discussion of testing" section refers to mechanical and biocompatibility testing for the physical device components, not software performance.

Here's why the requested information about acceptance criteria and studies for device performance (in the context of AI/ML) cannot be found in this document:

• Device Type: This is a physical implant (pedicle screw system), not a diagnostic algorithm, image analysis tool, or any other type of software that would typically have performance metrics like sensitivity, specificity, or AUC.
• Regulatory Pathway: A 510(k) for a physical medical device like this often relies on demonstrating substantial equivalence to legally marketed predicate devices through material comparisons, mechanical testing, and functional similarities, rather than clinical performance studies of a software output.
• "Device Performance" Context: When the document refers to "testing," it's discussing the physical properties of the implant (e.g., static compression, torsion, bacterial endotoxin) to ensure it's safe and performs as intended mechanically, not the accuracy of an algorithm.

Therefore, since the request is based on the assumption of an AI/ML driven device, which this is not, I cannot extract the requested information.

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The SteriSpine™PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. SteriSpine™PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

SteriSpine™PS system includes pedicle screws (multiaxial and cannulated) and rods (straight and prebent). Implantable components of SteriSpine™PS system are made of Titanium Ti-6Al-4V ELI according to ASTM F136. The SteriSpine™PS range of products is supplied sterile with a sterile single-use set of surgical instruments.

This document is a 510(k) premarket notification for the SteriSpine™ PS, a pedicle screw spinal system. It describes the device, its indications for use, and the data presented to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request about acceptance criteria and study proving device meets them, specifically for an AI/ML device.

Crucially, this document does not describe an AI/ML device. It describes a physical medical device (a spinal implant system). Therefore, the questions related to AI/ML device performance (like multi-reader multi-case studies, standalone algorithm performance, number of experts for ground truth, training set details) are not applicable to this submission.

The "Performance data" section refers to mechanical testing and packaging/sterilization validation for the physical implant, not AI algorithm performance.

Let's break down what is present and what is not for this specific device submission:

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

The document states:

• Acceptance Criteria (Implicit via "conforms to special control"): The device "conforms to special control established for Pedicle Screw spinal system." This implies meeting design specifications and performance standards for such systems, primarily mechanical integrity and safety.
• Reported Device Performance: "Mechanical testing was conducted according to ASTM F1717 and ASTM F1798 Standard. Performed mechanical testing includes the following: Static Compression, static torsion, dynamic torsion, static slipping, static bending and static rotation."
  • No specific numerical results are provided in this summary, but the "Discussion of Testing" states: "Mechanical testing demonstrates comparable mechanical properties to the predicate devices." This implies that the 'acceptance criteria' were met by demonstrating equivalence to the predicate's performance under these tests.

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

• Test Set Sample Size: For mechanical testing of a physical device, "sample size" typically refers to the number of devices or components tested. This specific numerical sample size is not provided in the document.
• Data Provenance: Not explicitly stated, but given the manufacturer is French ("Parc des Bellevues, Eragny sur Oise - FRANCE") and the testing standards are international (ASTM, ISO), the testing would have been conducted in a lab, likely in France or a certified testing facility elsewhere. This is "pre-market" testing, 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:

• N/A. This applies to AI/ML devices where human expert annotations are used to establish ground truth for diagnostic or prognostic tasks. For this physical device, "ground truth" is established by physical measurement against engineering standards.

4. Adjudication method for the test set:

• N/A. This applies to AI/ML devices where inconsistencies in human expert annotations need to be resolved. Not relevant for 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:

• No. This applies to AI/ML devices assessing clinical images/data. This device is a physical implant. The document explicitly states: "No clinical data has been presented."

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

• N/A. This applies to AI/ML devices. Not relevant for this physical device.

7. The type of ground truth used:

• For mechanical properties: Engineering standards and physical measurements (e.g., force applied, deformation, yield strength, fatigue life) as defined by ASTM F1717 and ASTM F1798.
• For packaging and sterilization: International standards (ISO 11607-1, 11607-2, 11137-1, 11137-2, 11137-3) for sterility and package integrity.

8. The sample size for the training set:

• N/A. This applies to AI/ML devices. This is a physical device; there is no "training set" in the AI sense.

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

• N/A. Applies to AI/ML devices.

In summary: This document is typical for a 510(k) for a physical implant device, focusing on substantial equivalence through material properties, mechanical performance, and manufacturing processes (sterilization, packaging) compared to predicate devices. It explicitly states "No clinical data has been presented," confirming that no human-in-the-loop or clinical efficacy studies were part of this specific submission for clearance. The questions posed in your prompt are primarily geared towards AI/ML medical devices, which this product is not.

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The SteriSpine™PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. SteriSpine™PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

SteriSpineTMPS system includes pedicle screws (multiaxial and cannulated) and rods (straight and prebent). Implantable components of SteriSpineTMPS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. The SteriSpineTMPS range of products is supplied sterile with a sterile single-use set of surgical instruments.

I am sorry, but the provided text is a 510(k) summary for a medical device (SteriSpine™ PS) and focuses on regulatory clearance, not on a study that establishes acceptance criteria for performance metrics of an AI/ML powered device.

The document discusses:

• The device's indications for use.
• Its classification and regulatory details.
• Comparisons to previously cleared predicate devices.
• Changes made to surgical instruments and packaging.
• Non-clinical tests performed (biocompatibility, packaging validation, sterilization revalidation) to ensure conformance to standards.

There is no mention of:

• Acceptance criteria related to AI/ML performance metrics (e.g., sensitivity, specificity, accuracy).
• A study with a test set, ground truth, expert readers, or training set relevant to an AI/ML algorithm's performance.
• A multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets them, as this information is not present in the provided text.

Ask a specific question about this device

The SteriSpine™PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion.

SteriSpine™PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

The cleared range of SteriSpineTM PS system include multiaxial screws and cannulated multiaxial screws with or without extended head (ø5.5, 6.5 and 7.5mm, lengths from 25 to 60 mm) and straight and prebent rods (ø 5.5, 6.5 and 7.5mm, lengths from 30 to 380 mm). Components of SteriSpineTM PS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. The SteriSpineTM PS range of products is supplied sterile with a sterile single-use set of surgical instruments. The Percutaneous Ancillary Kit added within this submission include (trocar needle, dilators, rod measurer, protection sleeve, funnel body, funnel shaft and funnel impactor). These instruments are supplied as a sterile single-use set to be used with the previously cleared Ancillary Kits.

This document is a 510(k) premarket notification for a medical device called the SteriSpine™ PS Pedicle Screw. It seeks to establish substantial equivalence to a previously cleared predicate device.

Based on the provided text, there is NO study described that proves the device meets specific acceptance criteria in terms of performance (e.g., diagnostic accuracy, efficacy).

The "Discussion of Testing" explicitly states: "No testing has been performed for the added components."

This 510(k) submission is for the addition of a "Percutaneous Ancillary Kit" to an already cleared SteriSpine™ PS product range. The submission argues for substantial equivalence based on the intended use, material, design, mechanical properties, and function being similar to the predicate device, not on new performance studies for the added components.

Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document, as such studies were not conducted or reported for this specific submission.

Here's an attempt to answer the questions based only on the provided text, acknowledging the significant limitations:

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

This information is not present in the document. The document states "No testing has been performed for the added components," meaning no performance criteria have been tested or reported for the new ancillary kit.

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

Not applicable. No performance testing involving a test set was conducted or reported for the added components.

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 performance testing was conducted.

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

Not applicable. No performance testing was conducted.

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 pedicle screw system and an ancillary kit, not an AI-based diagnostic tool. No MRMC study was conducted or reported.

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

Not applicable. This device is a pedicle screw system and an ancillary kit, not an algorithm. No standalone performance study was conducted or reported.

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

Not applicable. No performance testing was conducted.

8. The sample size for the training set

Not applicable. This device is a pedicle screw system and an ancillary kit, not an AI/ML model that requires a training set.

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

Not applicable. This device is a pedicle screw system and an ancillary kit, not an AI/ML model.

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The SteriSpine™PS system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.
SteriSpine™PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

SteriSpineTMPS system includes Pedicle Screws and Rods. Components of SteriSpineTMPS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. Components added within this submission include multi-axial extended head screws and multi axial extended head cannulated screws Ø 5.5, 6.5 and 7.5 (length from 25 to 60 mm), additional lengths for straight and prebent rods ø5.5mm, additional surgical instruments (screw head breakage tip, set screw holder and racking compression pliers, Ratchet module).
The SteriSpineTMPS range of products is supplied sterile with a sterile single-use set of surgical instruments.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study details for the SteriSpine™PS Pedicle Screw:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (SteriSpine™PS Pedicle Screw), the acceptance criteria are not presented in a quantitative, pass/fail manner. Instead, the study focuses on demonstrating substantial equivalence to predicate devices. The performance is reported in terms of comparability to established predicate devices under specific mechanical tests.

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

The document does not explicitly state a "test set" in the context of clinical trials or data analysis that would typically have a defined sample size and provenance. Instead, it refers to:

• Mechanical Testing: Performed on the device itself. The sample size for each specific mechanical test (e.g., number of constructs tested for static compression) is not specified.
• Cadaver Testing: Performed to validate the instrumentation. The number of cadavers or tests is not specified.
• Clinical Data: "Clinical data from a review of the literature has been presented in the class III summary." This indicates a retrospective literature review rather than a prospective clinical study with a defined sample size. The provenance of this literature data (e.g., country of origin) is not specified.

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

Since there is no "test set" in the typical sense of human-reviewed data, and the primary assessment is mechanical and literature-based, this information is not applicable to this submission. Ground truth, if considered, would be derived from the mechanical standards and the documented performance of the predicate devices.

4. Adjudication Method for the Test Set

As there is no "test set" requiring human review or ground truth establishment in this context, the adjudication method is not applicable.

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

A MRMC comparative effectiveness study was not done. The submission primarily relies on mechanical testing and a literature review for clinical data. This type of study would typically be relevant for imaging or diagnostic AI devices where human reader performance is being evaluated.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done. This device is a physical pedicle screw system, not an algorithm or software-only device.

7. Type of Ground Truth Used

For the mechanical testing, the "ground truth" implicitly refers to:

• Engineering Standards: Adherence to ASTM F1717 and ASTM F1798.
• Reference Device Performance: The established mechanical properties of the legally marketed predicate devices (K112453, K121299, K130632).

For the clinical data, the "ground truth" is derived from:

• Clinical Literature: Published evidence regarding the performance and safety of similar pedicle screw systems.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical implant, not an AI/ML algorithm that requires a training set. The term "training set" is typically used in the context of machine learning model development.

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

This information is not applicable for the reasons stated in point 8.

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The SteriSpine" PS system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.

SteriSpine"PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

system includes Pedicle Screws and Rods. Components SteriSpine™PS of SteriSpine™PS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. SteriSpine™PS components are supplied sterile with a single-use set of surgical instruments. Components added within this submission include multi-axial pedicle screws with extended head and associated instruments.

This document describes a 510(k) premarket notification for a medical device, the "SteriSpine™ PS (Pedicle Screw) System." It is a class III device, which means it carries a higher risk than class I or II devices. The submission concerns a modification to an existing device (K112453 and K121299). The information provided is not for an AI/ML powered device, but rather a traditional medical device (pedicle screw spinal system). Therefore, several of the requested sections related to AI/ML device performance criteria, data provenance, expert ground truthing, and MRMC studies are not applicable.

Here's the breakdown of the available information:

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)

• Test Set Sample Size: Not specified for mechanical or cadaver testing. For the clinical data, it states "Clinical data from a review of the literature has been presented in the class III summary," but no specific sample size from this literature review is provided in the extract.
• Data Provenance:
  • Mechanical Testing: Not specified (country of origin). This is typically performed in a lab setting.
  • Cadaver Testing: Not specified (country of origin).
  • Clinical Data: "a review of the literature" implies retrospective data, but the specific origins are not detailed.

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. This is a traditional mechanical device, not one that relies on expert interpretation for ground truth. The "ground truth" here is adherence to mechanical standards and performance comparable to a predicate device.

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

Not applicable. This is not a study requiring adjudication of expert interpretations.

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, an MRMC comparative effectiveness study was not done. This is not an AI-powered device.

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

Not applicable. This is not an algorithm. The performance is the mechanical integrity of the device itself.

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

The "ground truth" for this device's performance is established through:

• Mechanical Standards: Adherence to ASTM F1717 and ASTM F1798 standards.
• Predicate Device Performance: Direct comparison of mechanical properties to the legally marketed predicate devices (SteriSpine™ PS K112453 and K121299).
• Cadaver Testing: Validation of instrumentation.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning.

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

Not applicable. There is no training set for this type of device.

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