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The Deploy™ Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion in patients with degenerative disease (DDD) at one level or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients should be skeletally mature and have at least six months of non-operative treatment prior to being treated with this system. Additionally, the Deploy™ implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Deploy™ implants are intended to be used with supplemental spinal fixation systems that are cleared for use in the lumbosacral spine.

The Deploy™ Expandable Interbody System is comprised of the interbody implant cages, surgical instruments which include trial instruments to aid in the selection of the appropriate implant size for the patient's anatomy, and sterilization trays. The implants are manufactured from titanium alloy Ti-6AI-4V (ASTM F136, ASTM F3001) and are offered with various heights and shapes for different patient anatomy. Each implant is designed to be inserted and then rotate in-situ, providing immediate fixation and the arm deployed for the graft containment area. Ridges on the superior and inferior surfaces of the titanium implants contact the endplates to resist expulsion forces. The implants are designed to be used in conjunction with supplemental spinal fixation instrumentation. The surgical instruments are manufactured from stainless steel (ASTM F899. ISO 7153-1). The implants and surgical instruments are provided non-sterile and require sterilization prior to use within sterilization trays following validated sterilization parameters as provided within the Instructions for Use.

The provided text is a 510(k) summary for the Deploy™ Expandable Interbody System, which is a medical device. This document focuses on the regulatory clearance for the device and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of AI/software performance.

Therefore, the requested information regarding acceptance criteria, reported device performance in a clinical study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document as it is not a clinical study report for an AI/Software as a Medical Device (SaMD).

The document discusses:

• Device Description: The Deploy™ Expandable Interbody System is comprised of interbody implant cages and surgical instruments, manufactured from titanium alloy.
• Indications for Use: Intervertebral body fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1), and for patients diagnosed with degenerative scoliosis, used with autograft and/or allogenic bone graft and supplemental spinal fixation systems.
• Technological Characteristics: Similar to predicate devices in principle of operation, design, intended use, material composition, and function.
• Summary of Testing: Biocompatibility risk assessment (ISO 10993-1, Part 5) and mechanical testing including static axial compression (ASTM F2077), static compressive shear (ASTM F2077), dynamic axial compression (ASTM F2077), dynamic compressive shear (ASTM F2077), static subsidence (ASTM F2267), and wear debris testing (ASTM F1877). These are engineering performance tests, not clinical performance for diagnostic accuracy.
• Substantial Equivalence Conclusions: The device was shown to be substantially equivalent to predicate systems based on indications for use, design, function, material composition, sizes, and mechanical performance.

This document is a regulatory submission demonstrating the safety and effectiveness of a physical medical implant, not an AI/software product, and thus does not contain the information requested about acceptance criteria and studies for AI/software performance.

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This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Lumbar Interbody Fusion System consists of instruments and VESTAKEEP PEEK (per ASTM F2026) implants which will be offered in four (4) configurations of various sizes to accommodate individual patient anatomy. The configurations are designed pursuant to a specific surgical approach, and consist of the following: 1) Anterior Lumbar Approach (ALIF); 2) Posterior Lumbar Approach (PLIF); 3) Lateral Lumbar Approach (LLIF) and 4) Transforaminal Posterior Lumbar Approach (TPLIF). The implants are single use and the system is provided non-sterile.

This document is a 510(k) Premarket Notification for a Lumbar Interbody Fusion System. It describes the device and its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device submission. This document is for a traditional medical device (an implant) and the performance data described are related to mechanical testing, not a clinical study to evaluate diagnostic accuracy or human reader performance.

Therefore, many of your requested points are not applicable to the information provided in this document. I will fill in what I can and note where the information is not present.

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

Note: The document states that "The above listed pre-clinical testing on the Subject device indicate that the Lumbar Interbody Fusion System is substantially equivalent to its predicate device(s)." This means the performance met the thresholds demonstrated by the predicate devices or relevant standards. Specific numerical acceptance values and actual measured performance data are not provided in this summary.

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

• Sample Size for Test Set: Not applicable. This document describes mechanical bench testing of an implant, not a clinical study with a "test set" of patient data. The "sample size" would refer to the number of devices tested, which is not specified but would be dictated by the ASTM standards.
• Data Provenance: Not applicable. The data comes from bench testing in a laboratory setting, 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 device is an implant, and its performance is evaluated based on engineering and mechanical standards, not expert interpretation of diagnostic images or clinical outcomes in the context of an AI/ML device.

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

• Not applicable. No expert adjudication method is mentioned as this is not an AI/ML device or a diagnostic study.

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 is not an AI/ML medical device. No MRMC study was conducted.

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

• No. This is not an AI/ML medical device.

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

• Not applicable in the sense of clinical ground truth for an AI/ML device. The "ground truth" for this device's performance is defined by established engineering and mechanical testing standards (ASTM F2077-14 for mechanical properties, ASTM F2267-04 for subsidence, and a "widely accepted and validated methodology" for expulsion).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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The Alamo T device is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a transforaminal approach.

The Alamo T device is used for spinal fusion surgery to provide support and structural stability at the fusion site following discectomy. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. Supplemental fixation and autograft is required to facilitate fusion.

The device footprint has a hollow center to accommodate bone graft and is implanted via a transforaminal (TLIF) surgical approach. The device is available in various heights and lengths to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.

The purpose of this submission is to introduce a range of line extension sizes and make dimensional modifications to the implants and inserter instrument. The new sizes and design modifications do not affect the device's intended use or alter the device's fundamental scientific technology.

The provided document is a 510(k) premarket notification for a medical device called the "Alamo T Intervertebral Body Fusion Device." This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective as the predicate. In such submissions, the acceptance criteria and study data are presented somewhat differently than for a novel device undergoing clinical trials.

Here's an analysis based on the provided text, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission asserting substantial equivalence (SE) for modifications to an existing device and new sizes, the "acceptance criteria" are intrinsically tied to demonstrating that the new device performs similarly to, or no worse than, the predicate device, especially concerning mechanical and biological integrity. The performance is assessed against the established safety and efficacy of the predicate, rather than novel clinical endpoints.

2. The device's ability to maintain structural stability at the fusion site following discectomy is preserved.
3. The risk of migration or back-out is not increased. | "Finite element analysis and engineering rationale were used to demonstrate that the modifications and new sizes did not present a new worst case and that no additional testing was necessary."

The FMEA (Failure Modes and Effects Analysis) would identify potential failure modes due to changes and assess their mitigation. The engineering rationale would involve comparing the mechanical characteristics of the new sizes/designs to the predicate, likely using established biomechanical principles and potentially referencing existing test data for the predicate.

Specific performance metrics (e.g., stiffness, compressive strength, torsional stability) against a target (e.g., "equal to or greater than predicate") are implied but not explicitly stated in this summary. |
| Biocompatibility & Material Safety | The materials used (PEEK Optima® LT1 and Tantalum markers) are biocompatible and safe for long-term implantation, consistent with established materials in the predicate devices and per relevant ASTM standards. | The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. These are the same materials as the predicate. This reliance on established materials compliant with ASTM standards implies biocompatibility and material safety are met. No new testing explicitly detailed, relying on existing material characterization. |
| Functional Equivalence (Graft Accommodation, Fixation) | 1. The hollow center accommodates bone graft effectively.
2. Inferior and superior surfaces with ridges ("pyramid pattern" and "teeth") improve fixation and stability and prevent back-out and migration.
3. Graft volume and window size are adequate and comparable to appropriate predicates. | "The device footprint has a hollow center to accommodate bone graft..." and "the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration."

The document states: "Sythes OPAL was used as a predicate for graft volume and Surgical Supplies-Biolign was used as a predicate for graft windows." This indicates comparison to established functional benchmarks in similar devices. New sizes were validated using Life Spine's PLATEAU system as a "dimensional predicate." The "Teeth" feature is also compared to the predicate Alamo T. |
| Indicated Use & Clinical Application | The device performs its intended function for spinal fusion in skeletally mature patients with DDD at L2-S1, requiring supplemental fixation and autograft, implanted via a transforaminal approach, without altering the fundamental scientific technology or increasing risks. | "The new sizes and design modifications do not affect the device's intended use or alter the device's fundamental scientific technology." The "Indications for Use" statement is identical to the predicate (K120401). This statement implicitly confirms that the device is expected to perform equivalently in a clinical setting based on its design and material similarity and validated mechanical properties. No clinical testing was required to demonstrate substantial equivalence, implying the modifications are considered minor enough not to necessitate new human studies. |
| Sterilization & Radiographic Visualization | 1. Sterilization method (steam by end user) is effective and validated.
2. Tantalum markers allow for adequate radiographic visualization. | Sterilization: "End User (Steam)" - stated to be the same as the predicate.
Radiographic Markers: "Yes" - stated to be the same as the predicate. The use of ASTM F560 compliant tantalum implies established radiographic visibility. |

Note: For 510(k) clearances, "acceptance criteria" are not always explicit performance thresholds like in a clinical trial. Instead, they are often about demonstrating that the modifications do not introduce new safety concerns or alter the fundamental technology such that the device is no longer substantially equivalent to a legally marketed predicate. The "study" described is primarily non-clinical: FMEA, FEA, and engineering rationale based on predicate comparisons.

Study Details from the Document:

Due to the nature of this 510(k) submission (a line extension with dimensional modifications), the "study" described is primarily non-clinical.

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

• Test Set Sample Size: Not applicable. No physical "test set" of devices was used for direct comparative bench testing in the provided summary for performance. The "test set" here refers to the new sizes and dimensional modifications themselves that were analyzed via FMEA, FEA, and engineering rationale.
• Data Provenance: The data provenance is internal engineering analysis and comparison to existing data/specifications of predicate devices. This is not external patient data (e.g., country of origin). The evaluation is based on component-level design and material properties. The analysis is prospective in the sense that it's evaluating the proposed changes before marketing, but it leverages retrospective data/knowledge from predicate devices.

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

• Number of Experts: Not specified. "Engineering rationale" implies input from qualified engineers or biomechanical experts within the manufacturer's team or consultants.
• Qualifications: "Quality and Regulatory Consultant" (Kellen Hills) and "Frank Morris (Alliance Partners, LLC)" are listed as contact persons. The FMEA and FEA would be conducted by engineers with relevant expertise (e.g., mechanical engineering, biomechanics). Specific qualifications are not detailed beyond their roles.

4. Adjudication Method for the Test Set:

• Not applicable as there was no independent clinical or expert review of a "test set" of cases. The assessment was internal through FMEA and FEA. This is a technical assessment rather than a clinical adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." This type of study is for evaluating human performance influenced by a diagnostic aid (AI), which is not the nature of this interbody fusion device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This device is a physical medical implant, not an algorithm or AI system. Therefore, "standalone performance" in the context of AI does not apply. The "standalone" performance here relates to the mechanical properties of the device itself, which were evaluated via FEA and engineering rationale, not algorithms.

7. The Type of Ground Truth Used:

• For the non-clinical assessment, the "ground truth" is a combination of:
  • Established mechanical properties and design specifications of the predicate devices.
  • Biomechanical principles and engineering calculations.
  • Regulatory standards (e.g., FDA's 2007 Special Controls guidance for Intervertebral Body Fusion Devices, ASTM F2026 for PEEK, ASTM F560 for Tantalum).
  • Clinical experience and safety profiles of the predicate devices (implied by their prior clearance and market use).

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of an algorithm or AI system for a physical implant device submission like this. If we consider analogous concepts, the "training" for demonstrating substantial equivalence comes from the extensive historical data, design principles, and performance of existing predicate devices, which allows for leveraging FMEA/FEA rather than requiring de novo testing.

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

• Not applicable. As there is no training set as understood in AI/algorithm development, the concept of establishing ground truth for it doesn't apply. The device's "ground truth" (its safety and effectiveness claim) is based on its similarity to legally marketed devices whose safety and effectiveness have already been established through prior regulatory review and clinical use.

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The Idys™ LIF Cages are indicated for use with autologous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by FDA for use in the lumbar spine.

The Idys™ LIF Cages consist of PEEK lumbar cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The Idys™ LIF Cages also feature markers made of Tantalum according to ASTM F560.

The Idys™ LIF Cages have different anatomic shapes and dimensions based on the surgical approach: PLIF (posterior lumbar interbody fusion); TLIF (transforaminal lumbar interbody fusion); and PTLIF (posterior approach and oblique-TLIF approach).

The Idys™ PLIF Cage is a hollow spacer with openings for autograft on the top, bottom, and sides of the device.

the Idys™ TLIF Cage has a bullet tip to facilitate introduction. The TLIF Cage Holder instrument has a clamp that affixes to the axle to enable rotation of the device during its introduction in situ.

The Idys™ PTLIF Cage is inserted in an oblique position. It can be introduced with a PLIF approach or a TLIF approach to the convenience of the surgeon and with taking into account the profile of the patient.

The Idys™ LIF Cage procedures are performed using a set of surgical instruments common for PLIF and TLIF approaches. Most of the instruments provided are common surgical tools used in these types of interbody fusion procedures. Those instruments are considered Class I, general purpose, manual orthopedic instruments encompassed within the regulation in 21 CFR 888.4540.

This document describes the acceptance criteria and the study that proves the device meets those criteria for CLARIANCE's Idys™ LIF Cages.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each of the performance tests (static/dynamic axial compression, static/dynamic compression shear, subsidence, expulsion, and wear testing). It only mentions that performance testing was conducted per ASTM F2077 and ASTM F2267.

The data provenance is not specified beyond indicating that the studies were performed by CLARIANCE, a French company. It does not state whether the data was retrospective or prospective.

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

For this type of device (intervertebral body fusion cages), the "ground truth" is typically established through recognized industry standards for mechanical performance rather than expert consensus on medical images or patient outcomes. The document indicates that performance testing was conducted per ASTM F2077 and ASTM F2267. These ASTM standards define the methodologies and acceptance criteria for mechanical testing of spinal intervertebral body fusion devices. Therefore, the "experts" in this context would be those who interpreted and conducted the tests according to these established standards. The document does not specify the number or qualifications of the individuals who performed or interpreted these tests.

4. Adjudication Method for the Test Set

Not applicable for a device performance study based on engineering standards. The performance is objectively measured against the criteria defined by ASTM F2077 and ASTM F2267, rather than requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices to assess human performance with and without AI, not for mechanical devices like intervertebral body fusion cages.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm only without human-in-the-loop performance) study was done. This concept is not applicable to an intervertebral body fusion device, which is a physical implant, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's performance was the mechanical performance standards specified in ASTM F2077 and ASTM F2267. This includes metrics like static and dynamic axial compression, static and dynamic compression shear, subsidence, expulsion, and wear.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not an AI model that requires a training set. The term "training set" is typically used in the context of machine learning and artificial intelligence.

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

Not applicable, as there is no training set for this device.

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When used as an intervertebral body fusion device, the InterForm Lumbar Interbody Cage System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Lumbar Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The InterForm PLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm PLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior approach and used with supplemental fixation and autogenous bone graft.

The InterForm TLIF Interbody Fusion Implants consists of cage footprints widths of 9, 11, 13mm , lengths of 22, 24, 26, 28, 30, 32mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm TLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, transforaminal approach and used with supplemental fixation and autogenous bone graft.

The InterForm OTLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30, 32, 34mm, ranging in height from 7mm to 14mm with lordosis of 0°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm OTLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior or transforaminal approach and used with supplemental fixation and autogenous bone graft.

The InterForm LLIF Interbody Fusion Implants consists of cage footprint widths of 18, 20, 22, 24mm, lengths of 40, 45, 50, 55, 60mm, ranging in height from 8mm to 18mm with lordosis of 0° or 7°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm LLIF Interbody Fusion devices are intended to be implant via a lateral approach and used with supplemental fixation and autogenous bone graft.

The InterForm ALIF Interbody Fusion Implants consists of cage footprints of 30x24mm, and 39x30mm (DxW), ranging in height from 10mm to 20mm with lordosis of 0°, 7° or 12° which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm ALIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, anterior approach and used with supplemental fixation and autogenous bone graft.

All implants are packaged non-sterile to be sterilized at the hospital.

Materials:

PEEK Optima LT1 conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.

Function:

Maintain adequate disc space until fusion occurs.

The InterForm Interbody Cage System is intended for spinal fusion procedures.
Here's a breakdown of the acceptance criteria and the study done:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The documentation explicitly states that the device is considered "substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances." The acceptance criteria, while not explicitly numerical, are therefore met by demonstrating performance comparable to the already legally marketed predicate devices. The study concludes that the results indicate the InterForm Interbody Cage System is equivalent.

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

This information is not provided in the document. The studies listed are non-clinical tests (mechanical testing), not studies involving human or animal subjects that would generate a "test set" of data in the typical sense of evaluating AI or clinical outcomes. The provenance of the samples (e.g., specific batches of PEEK and tantalum used in testing) is not detailed, nor is it relevant given the mechanical nature of the tests.

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

This information is not applicable as the studies are non-clinical mechanical tests, not clinical evaluations requiring expert interpretation or ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical mechanical tests.

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. The document explicitly states: "No clinical studies were performed." This device is a physical medical implant, not an AI or imaging device that would typically involve human reader studies.

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

This information is not applicable as the device is a physical medical implant and not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the established mechanical properties and performance standards outlined in the ASTM F2077 and ASTM F2267 standards, and the performance characteristics of the predicate devices. For mechanical tests, the ground truth is objectively measured physical properties and behaviors of the material and device under specific conditions.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical implant and would not have a "training set" in the context of machine learning or AI. For mechanical testing, the "samples" would be the manufactured devices or materials subjected to the tests. The exact number of units tested for each non-clinical test (static compression, dynamic compression, subsidence, expulsion) is not specified, but it would typically be a statistically significant number of physical samples to ensure reliability and reproducibility of the results according to the ASTM standards.

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

This information is not applicable for the same reasons as #8. The "ground truth" for material and device properties in mechanical testing is established through standardized testing procedures and validated measurement techniques, as defined by organizations like ASTM.

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The SynCage Evolution spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the SynCage Evolution spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The Synthes SynCage Evolution spacer is a radiolucent device for use in interbody fusion. It is to be used in conjunction with supplemental fixation to provide structural stability in skeletaly mature individuals. The Synthes SynCage Evolution spacer is fabricated from Invibio® PEEK-OPTIMA® LT-1 (ASTM F2026-10) with four anterior and one posterior tantalum (ASTM F560-08) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant. Implantation is through an anterior or anterolateral approach. The Synthes SynCage Evolution spacer is provided sterile. The Synthes SynCage Evolution spacer is available in three footprints (Small: 32x25mm; Medium, 36x28mm; Large, 40x31mm), four lordotic angles (6°, 10°, 14°, 18°), and a range of heights (9-19mm) to suit individual pathology and anatomical conditions. Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. The open architecture of the device allows it to be packed with autogenous bone graft material (i.e., autograft).

The provided text describes a 510(k) summary for the Synthes SynCage Evolution Spacer, an intervertebral body fusion device. It details the device's description, intended use, and a comparison to predicate devices, focusing on non-clinical performance data.

Here's an analysis based on your request:

1. Acceptance Criteria and Reported Device Performance

The document does not specify explicit acceptance criteria in terms of numerical thresholds or performance targets for a device meeting clinical or diagnostic accuracy. Instead, it states that the device's performance was evaluated through non-clinical bench testing and compared to predicate devices for substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

2. Sample Size for the Test Set and Data Provenance

The document explicitly states: "Clinical data and conclusions were not needed for this device."
Therefore, there was no test set of clinical data used to evaluate the device's performance in humans. The evaluation was based solely on non-clinical bench testing.

• Sample Size for Test Set: Not applicable (no clinical test set).
• Data Provenance: Not applicable (no clinical data).

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

As no clinical data was used for evaluation, there was no ground truth established by experts for a test set. The evaluation relied on engineering principles and bench testing standards.

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Since no clinical test set was used, there was no adjudication method employed.

• Adjudication Method: Not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study was conducted. The document states: "Clinical data and conclusions were not needed for this device."

• MRMC Study: No.
• Effect Size of Human Readers with vs. without AI: Not applicable.

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

This device is an intervertebral fusion spacer, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's performance was evaluated through bench testing.

• Standalone Study: Not applicable (device is not an algorithm).

7. The Type of Ground Truth Used

For the non-clinical performance evaluation, the "ground truth" was established by standardized engineering testing protocols as defined by ASTM F2077-11 and ASTM F2267-04. The performance was then compared to that of legally marketed predicate devices, implying that their established performance under these tests served as a reference for "substantial equivalence."

• Type of Ground Truth: Bench testing standards (ASTM F2077-11 and ASTM F2267-04) and performance of predicate devices.

8. The Sample Size for the Training Set

This document describes a physical medical device, not an AI or machine learning model. Therefore, the concept of a "training set" is not applicable.

• Sample Size for Training Set: Not applicable.

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

As there is no training set mentioned or implied for this physical device, this question is not applicable.

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

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The PLIF Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

PLIF Cage is a hollow, generally rectangular box made The of polyetheretherketone (PEEK) and having titanium x-ray markers. It is provided in a variety of shapes and sizes, and is intended to be filled with a bone graft material. The smallest footprint of the device is 8mm medial-lateral x 20mm anterior-posterior. The largest footprint is 12mm medial-lateral x 30mm anteriorposterior. Available heights range from 7mm to 16mm. The device is available either in a non-lordosed configuration, or with a built-in six degree lordotic angle.

The PLIF cage may be inserted via an open or minimally invasive approach. It may be placed singly or in pairs.

Bone graft volume of the device is variable depending on the device size; larger sizes have more volume for graft. The smallest graft volume, in the 20x8x7mm non-fordotic device is approximately 354.1mm² (0.4cc), while the largest in the 30x12x16 lordotic device is approximately 3,530mm3 (3.5cc).

The surface area of the device contacting the endplates ranges from 118mm² to 220mm2 for the smallest and largest footprint devices, respectively.

The PLIF cage may be made either from Zeniva PEEK (Solvav Advanced Polymers, Alpharetta, GA USA) or PEEK Optima (Invibio, Inc., West Conshohocken, PA USA). The particular grade of PEEK used is tracked via product lot numbering and is displayed on the package label.

The provided text does not describe acceptance criteria for a diagnostic device or a study validating its performance in the context of medical imaging or AI. Instead, it details the 510(k) summary for a medical device called "PLIF Cage," which is an intervertebral fusion device, and the FDA's decision regarding its substantial equivalence to predicate devices.

Therefore, I cannot extract the information requested as it is not present in the provided document. The document focuses on the mechanical testing and material equivalence of a physical implant (PLIF Cage) rather than the performance metrics of a diagnostic tool or an AI algorithm.

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When used as an intervertebral body fusion device, the PILLAR™ Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous nonfusion surgery at the involved level(s).

The PILLAR™ Spacer System is intended for use with autograft and supplemental internal fixation, e.g .: the Blackstone Medical ICON Modular Pedicle Screw System, or the Blackstone Medical Inc. SFS Spinal Fixation System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLARTM Spacer System.

The PILLARTM PL spacer is used singly or in pairs, and is implanted using a posterior approach.

The PILLARTM TL spacer is used singly or in pairs, and is implanted using a transforaminal approach.

The PILLARTM AL spacer is used singly, and is implanted using an anterior approach.

When used as a Partial Vertebral Body Replacement (VBR) System, the PILLARTM Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLARTM Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR™ Spacer System is designed to restore the biomechanical integrity of the anterior. middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.

The PILLAR™ Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the PILLAR™ Spacer System is the Blackstone Medical Spinal Fixation System.

The PILLAR Spacer System components consist of:

1. A PEEK Spacer

2. Tantalum Markers

Here's an analysis of the provided text regarding the acceptance criteria and study for the Blackstone Medical, Inc. PILLAR™ Spacer System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K081177) is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices. In the context of a 510(k), explicit "acceptance criteria" for performance metrics like sensitivity, specificity, or reader agreement are typically not presented as they would be for a novel device. Instead, the primary "acceptance criterion" is that the device's technological characteristics and performance are sufficiently similar to predicate devices such that it does not raise new questions of safety or effectiveness.

Therefore, the table reflects this approach:

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

The document does not provide information regarding a specific "test set" in the way one might expect for a diagnostic or AI-driven device. As this is a 510(k) for an implantable medical device, the "test set" primarily refers to the samples used in the mechanical testing.

• Sample Size for Test Set: Not explicitly stated for mechanical testing, but the context implies sufficient samples were tested to demonstrate substantial equivalence.
• Data Provenance: Not applicable in the sense of patient data. The "study" here is mechanical testing of the device itself, likely conducted in a lab setting.

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

This information is not applicable to this 510(k) submission. "Ground truth" in the context of expert consensus is typically relevant for diagnostic devices that interpret images or other patient data. For an implantable device like the PILLAR™ Spacer System, the "ground truth" for mechanical testing is established by engineering standards and validated testing protocols, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

This is not applicable to this 510(k) submission. Adjudication methods like "2+1" or "3+1" are used to resolve discrepancies among multiple expert readers in diagnostic studies. Mechanical testing does not involve such an adjudication process.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic tools (especially those with human-in-the-loop components) and comparing reader performance with and without AI assistance. This document describes an implantable device, not a diagnostic algorithm.

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. This document pertains to a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this 510(k) is based on engineering standards and established mechanical testing methodologies. The device's components (PEEK Spacer, Tantalum Markers) and overall system are subjected to tests that simulate the forces and conditions they would experience in vivo, and the results are compared against performance benchmarks established by predicate devices and relevant standards.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an implantable medical device like this. Training sets are used for machine learning algorithms.

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

This is not applicable. As there is no training set, there is no ground truth for it to be established.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described in the 510(k) summary is mechanical testing of the Blackstone Medical, Inc. PILLAR™ Spacer System.

• Purpose: To demonstrate that the device is substantially equivalent to legally marketed predicate devices (DePuy Acromed Saber™ Lumbar I/F Cage®, Surgical Dynamics, Inc. Ray Threaded Fusion Cage, Synthes Spine Opal Spacer System) in terms of safety and effectiveness.
• Methodology: Mechanical testing was performed on the PILLAR™ Spacer System. The document states that "The only technological differences between the PILLAR Spacer System and its predicates are minor dimensional characteristics and have been addressed mechanical verification testing."
• Results: The mechanical testing demonstrated that the PILLAR™ Spacer System is substantially equivalent to the predicate devices. The minor technological differences do not present any new issues of safety or effectiveness.

In essence, the entire 510(k) process is the "study" by which the device's acceptance (i.e., substantial equivalence) is proven, primarily through comparison to established, safe, and effective predicate devices, supported by mechanical performance data.

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