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The Opticage® Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

The Opticage Expandable Interbody Fusion Devices are provided gamma sterilized and are for single use only. The devices are designed for lumbar intervertebral body fusion via posterior, transforaminal or lateral approach. They are fabricated from titanium alloy (Ti-6AI-4V) as per ASTM F136. Each device consists of five components: an upper and lower titanium plate, two titanium wedges and a central shaft. The faces of the upper and lower plates of the devices contain teeth and fenestrations to enhance bony in growth. The two titanium wedges are connected by the central shaft. The shaft can be rotated clockwise to move the wedges toward the center of the device thereby increasing the distance (i.e. height) between the upper and lower titanium plates. Alternatively, the shaft can be rotated counter clockwise to move the wedges away from the center of the device causing the distance (i.e. height) between the upper and lower plates to decrease. In this manner, the height of the construct can be continuously adjusted through a range of 5mm. A cavity internal to each device is intended to hold autogenous bone graft. The Opticage is available in a variety of configurations.

This appears to be a 510(k) summary for the Opticage® Expandable Interbody Fusion Device. Based on the provided text, the submission is a "special 510(k)" to obtain market clearance for additional models of the device, implying that the fundamental device design and efficacy have been previously established.

Therefore, the "acceptance criteria" and "study" described herein refers specifically to the new models' performance relative to the predicate device, rather than a de novo clinical trial demonstrating the primary safety and effectiveness of interbody fusion devices in general.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The text explicitly states: "Design verification testing was conducted via Finite Element Analysis (FEA) to assess the device modification."

• Sample Size for the Test Set: This refers to the number of simulations/analyses performed in the FEA. The document does not specify a numerical sample size for the FEA. It implies a single, comprehensive FEA study comparing the modified designs to the predicate.
• Data Provenance: This is not applicable in the traditional sense of patient data. The "data" here are the computational results from the Finite Element Analysis. As this is a simulation, there is no "country of origin" or "retrospective/prospective" aspect beyond the origin of the device manufacturer and the analysis itself.

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

Not applicable. The "ground truth" for the performance of the modified device, in this context, is established through the engineering principles and computational models used in the Finite Element Analysis, and then compared to the known performance of the predicate device. There is no mention of experts establishing a ground truth in the context of interpreting patient data or clinical outcomes for this specific submission.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication. The assessment of substantial equivalence relies on the analytical results of the FEA.

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

No, an MRMC comparative effectiveness study was not done. This submission is for additional models of an implantable medical device, and the performance assessment was conducted via Finite Element Analysis, not clinical (human reader) studies.

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

This question is typically relevant for AI/software as a medical device. For this implantable device, the closest equivalent is the Finite Element Analysis (FEA), which is a standalone computational simulation of the device's mechanical performance without human-in-the-loop interaction in the performance assessment itself. The analysis determines the mechanical properties of the device.

7. The Type of Ground Truth Used

The ground truth for this special 510(k) submission is the mechanical performance of the legally marketed predicate device (K152156). The FEA of the modified device is compared to this established performance to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning model. The "training" for the Finite Element Analysis (if one were to use that analogy) would be the development and validation of the FEA model itself, which is a complex engineering task and not typically described in terms of a "training set sample size" in this context.

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

Not applicable. As above, this is not a machine learning context. The FEA models are developed based on established engineering principles, material properties (e.g., Ti-6Al-4V per ASTM F136), and validated against physical testing methods, but the document does not detail this specific validation process for the FEA model used.

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The Opticage® Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. Candidates for surgery should be skeletally mature and have had six months of conservative treatments. may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

Not Found

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or any study that proves the device meets specific acceptance criteria. This document is a 510(k) clearance letter from the FDA for the Opticage® Expandable Interbody Fusion Device, which primarily states that the device is substantially equivalent to legally marketed predicate devices.

The document includes:

• The device name and regulation information.
• Indications for Use.
• A statement that the device is cleared for marketing subject to general controls provisions of the Act.

It does not contain details about:

1. Acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithmic performance studies.
7. Type of ground truth used in studies.
8. Training set sample size or how its ground truth was established.

This type of information is typically found in a summary of safety and effectiveness, clinical study reports, or performance testing sections, which are not part of this specific FDA clearance letter.

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The Opticage™ Expandable Interbody Fusion Device is a lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Expandable Interbody Fusion Device can be implanted via posterior, transforaminal, or lateral approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

The Opticage™ Expandable Interbody Fusion Devices, Model Series 9070 are designed for lumbar intervertebral body fusion via posterior, transforaminal or lateral approach. The devices are fabricated from titanium alloy (Ti-6AI-4V) as per ASTM Fl36. Each device consists of an upper and lower titanium plate, two titanium wedges and a central shaft. The two titanium wedges are connected by the central shaft. The shaft can be rotated to move the wedges toward the center of the device thereby increasing the distance (i.e. height) between the upper and lower titanium plates. Alternatively, the shaft can be rotated in the opposite direction to move the wedges away from the center of the device causing the distance (i.e. height) between the upper and lower plates to decrease. In this manner, the height of the construct can be continuously adjusted. The devices are available in a several footprint sizes. The top and bottom of the devices are fenestrated and each contain windows to enhance bony in growth. A cavity internal to each device is intended to hold autogenous bone graft.

The Opticage Expandable Interbody Fusion Devices in Model Series 9070 are provided in both sterile and non-sterile versions.

This document (K140716) is a 510(k) premarket notification for a medical device called the Opticage™ Expandable Interbody Fusion Device. As such, it focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing acceptance criteria and proving the device meets those criteria through a primary clinical study.

The FDA 510(k) pathway does not typically require clinical trials in the same way a PMA (Premarket Approval) does, especially for Class II devices like this one. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of typical AI/diagnostic device performance metrics (like sensitivity, specificity, etc., with associated sample sizes, ground truths, and reader studies) is not directly applicable or present in this 510(k) submission.

However, I can extract the information related to the performance data provided to support the claim of substantial equivalence. This "performance data" serves the purpose of demonstrating that the new device functions similarly and is as safe as the predicate devices.

Here's a breakdown based on the provided document, addressing the closest analogues to your request:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there aren't "acceptance criteria" in the traditional sense of a diagnostic performance study (e.g., minimum sensitivity). Instead, the performance claims are based on meeting established standards for intervertebral body fusion devices, and demonstrating comparable performance to predicate devices.

• Static compression
• Dynamic compression
• Static compression shear
• Dynamic compression shear
• Static torsional
• Dynamic torsional |
  | ASTM F2267 | Subsidence testing completed for Opticage™ Model Series 9070. |
  | ISO 17853 | Evaluation of wear debris/particulates completed for Opticage™ Model Series 9070. |
  | ASTM F1877 | Evaluation of wear debris/particulates completed for Opticage™ Model Series 9070. |
  | Not explicitly listed, but implied | Expulsion testing completed for Opticage™ Model Series 9070. |
  | Not explicitly listed, but implied | Finite Element Analysis (FEA) conducted to confirm worst-case performance configuration. |
  | Overall Comparison to Predicates | "Test performance data demonstrated substantial equivalence to the predicate devices." (Specifically Caliber® Spacer (K123231), L-Varlock Lumbar Cages (K080537), Caliber™ Spacer (K102293), and referenced Opticage models (K113527, K132479, K133583)). The device has similar size, shape, and material composition (Ti-6AL-4V) to predicates, with similar operational characteristics. |

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

This document describes mechanical and material testing, not clinical or diagnostic performance testing with human subjects. Therefore, the concept of a "test set" in terms clinical data or patient images (as would be relevant for an AI device) does not apply. The "samples" would be the physical devices or components tested according to the ASTM and ISO standards. The document does not specify the number of devices or components tested, nor their manufacturing origin (country). This type of testing is generally performed in a lab setting by the manufacturer or contracted labs.

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

Not applicable.

• For mechanical and material testing, ground truth is established by the physical properties and performance characteristics of the materials and device components as measured against established engineering standards (ASTM, ISO). There are no "experts" establishing a "ground truth" in the clinical sense.

4. Adjudication Method for the Test Set

Not applicable.

• There is no "adjudication" in the context of mechanical device testing; the results are typically quantitative and objective measurements against predefined criteria in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not applicable.

• This is a mechanical implant device, not a diagnostic imaging device or an AI algorithm intended to assist human readers. Therefore, an MRMC study is outside the scope of this submission.

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

Not applicable.

• This device is a physical implant for spinal fusion, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established engineering and material science standards (e.g., ASTM F2077-03, ASTM F2267, ISO 17853, ASTM F1877) that dictate acceptable performance ranges for intervertebral body fusion devices. The device's performance against these standards, and its similarity to predicate devices, forms the basis for demonstrating safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable.

• There is no "training set" as this is not an AI/machine learning device.

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

Not applicable.

• No training set exists for this type of device submission.

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The Opticage Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior or transforaminal approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

The Opticage™ Expandable Interbody Fusion Device, Model Series 9070 is composed of lumbar intervertebral body fusion implants manufactured from implant grade titanium alloy and ranging in widths from 9 mm x 12 mm and lengths from 21 x 30 mm. Each implant consists of an upper and lower titanium plate and two titanium wedges that interact to change the height of the construct from a minimum of 9 mm to a maximum of 14 mm. The top and bottom plates are fenestrated and contain a window to enhance bony in-growth. A cavity internal to the device is intended to hold autogenous bone graft.

Here's an analysis of the provided text regarding the Opticage™ Expandable Interbody Fusion Device, Model Series 9070, focusing on acceptance criteria and supporting studies.

Based on the provided 510(k) summary, the device is being cleared for additional sizes of an already cleared product. Therefore, the "study" described is a demonstration of substantial equivalence for these new sizes, rather than a clinical trial for a novel device.

Acceptance Criteria and Reported Device Performance

Study Details

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 applicable in the traditional sense of a clinical trial with patient data. The "test set" here refers to the parameters and simulations run within the Finite Element Analysis (FEA) model. The specific number of simulations or variations tested within the FEA is not disclosed.
• Data Provenance: The FEA model itself is a computational model, not based on human patient data for this submission. The validation of the FEA model would ideally refer to correlations with physical testing data of the predicate devices, but the details of this validation are not provided. There is no mention of country of origin as no patient data was used for this part of the submission. It is a prospective analytical study using computational modeling.

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

• Not applicable. Ground truth, in this context, would relate to the accuracy and validity of the FEA model. This would typically be established by engineers and biomechanics experts, but no specific number or qualifications are mentioned for the development or validation of the FEA model.

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

• Not applicable. Adjudication methods are relevant for human interpretation of data, like radiology reads. For an FEA, the "adjudication" would be in the rigorous validation of the model's assumptions and results against established engineering principles and possibly physical test data, but no specific adjudication method is described.

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

• Not applicable. This device is an implant, not an AI diagnostic or assistive tool. Therefore, an MRMC study is irrelevant to this submission.

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

• Not applicable. The FEA model can be considered a "standalone" computational analysis, but it's not an algorithm in the AI sense, nor does it have human-in-the-loop performance implications described here.

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

• The "ground truth" for the FEA model would be its ability to accurately predict the mechanical behavior of the physical device. This would typically be established by comparing FEA predictions against:
  • Physical bench testing data (e.g., compression, torsion, fatigue testing) of the predicate devices.
  • Established engineering principles and material properties.
    The document states the FEA model was "developed and validated," implying such comparisons were made, but specific details of this validation are not provided.

8. The sample size for the training set

• Not applicable in the context of machine learning. If "training set" refers to the data used to validate the FEA model, it would be the data from physical mechanical tests of the predicate devices. The size of this dataset is not specified.

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

• Not applicable for a "training set" in the machine learning sense. For the validation of the FEA model, the ground truth would have been established through physical mechanical testing of the previously cleared Opticage devices (K113527 and K132479) and adherence to recognized engineering standards for medical devices.

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The Opticage Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior or transforaminal approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

The Opticage Interbody Fusion Device is a lumbar intervertebral body fusion device manufactured from implant grade titanium alloy. The Opticage Interbody Fusion Device consists of an upper and lower titanium plate and two titanium wedges that interact to change the height of the device. The device is available in a single configuration that ranges in length from 29mm (closed) to 21mm (expanded) and ranges in nominal height from 9mm (closed) to 14mm (expanded). The top and bottom of the device are fenestrated and contain openings to enhance bony in growth. The Opticage Interbody Fusion Device is provided non-sterile, for single use only.

Here's an analysis of the provided text regarding the Opticage™ Interbody Fusion Device, focusing on acceptance criteria and study details:

This document is a 510(k) summary and the FDA's clearance letter for a medical device. It does not describe a study involving device performance related to diagnostic accuracy, AI, or human-in-the-loop scenarios. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices through engineering performance testing. Therefore, many of the requested categories (like AI assistance, reader study details, ground truth for training/test sets) are not applicable to this type of submission.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Opticage™ Interbody Fusion Device primarily revolve around meeting established mechanical and biological performance standards for intervertebral body fusion devices, demonstrating substantial equivalence to its predicate devices.

Study Details (Based on available information)

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

   • This submission describes engineering performance testing, not a clinical study with patient data or a diagnostic test set. Therefore, "sample size for the test set" typically refers to the number of devices or test samples fabricated and subjected to mechanical testing. The document does not specify the exact number of devices tested for each mechanical parameter (e.g., how many devices underwent static compression).
   • Data Provenance: The mechanical and material testing would have been conducted in a laboratory setting, likely in the country of manufacture or a qualified testing facility, but the specific origin is not stated in the provided text. This is not "retrospective" or "prospective" in the clinical sense.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not Applicable. For mechanical testing of an implant, "ground truth" is typically defined by the specified engineering standards (e.g., ASTM F2077, F2267) and the physical properties of the materials and device design. The "experts" in this context would be the engineers and technicians conducting the tests and interpreting the results against established mechanical criteria, rather than medical specialists establishing diagnostic truth.

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

   • Not Applicable. This concept primarily applies to clinical studies or diagnostic performance evaluations where human assessors or multiple methods establish a truth. For mechanical testing, the results are typically objectively measured against pre-defined engineering thresholds.

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

   • Not Applicable. This device is a physical surgical implant, not a diagnostic imaging device or AI software. Therefore, no MRMC study, AI assistance evaluation, or human reader improvement analysis was performed or is relevant to this submission.

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

   • Not Applicable. This is a physical interbody fusion device, not an algorithm.

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

   • The "ground truth" for this device's performance, as demonstrated in the submission, is based on engineering standards and specifications (e.g., ASTM F2077, ASTM F2267) for mechanical properties, material composition, and biocompatibility.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device. The concept of a "training set" is irrelevant here.

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

   • Not Applicable. As above, no training set or associated ground truth establishment is relevant to this device submission.

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The PERPOS™ FCD-2 System isindicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by rediographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis, or failed previous fusion.

The intended use of the PERPOS™ FCD-2 Anchor and Stabilizer is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The PERPOS™ FCD-2 may be used to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construction as an aid to fusion. The PERPOS FCD-2 is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1-S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the PERPOS™ FCD-2 Anchor and Stabilizer.

The PERPOS™ FCD-2 Single Use System consists of two each of a double-helix facet screw with a compression-locking collar, retaining ring and a self-retaining polymer washer packaged in a single use tray with the associated manual instruments. Modifications from the predicate device include changes to the washer configuration, instrumentation and packaging.

The provided text describes a 510(k) submission for a medical device (PERPOS™ FCD-2 System), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in terms of performance metrics.

Therefore, the input does not contain the information requested in the prompt regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document explicitly states:
"Documentation was provided to demonstrate that the PERPOS™ FCD-2 System is identical or similar to the predicate device in technological characteristics. The PERPOS™ FCD-2 System is identical to the predicate device in intended use and identical or substantially equivalent to the predicate device in materials, design and technological characteristics."

And "Risk analysis was conducted on the impact of the changes and appropriate design verification and validation was conducted under the company's design controls."

This indicates that the submission relies on demonstrating similarity to an already approved device and internal design controls, rather than a clinical study with specific performance metrics and acceptance criteria for the new device.

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The 4.5mm BONE-LOK® PLS IMPLANT is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis, or failed previous fusion.

The intended use of the 4.5mm BONE-LOK® PLS Implant is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 4.5mm BONE-LOK® PLS Implant may be used to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construction as an aid to fusion. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm BONE-LOK® PLS Implant is intended for lumbar bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the 4.5mm BONE-LOK® PLS Implant.

The 4.5mm BONE-LOK® PLS Implant is a double-helix screw with a compressionlocking collar made of medical grade titanium alloy and is provided "STERILE". The Single use PERPOS™ PLS System contains the 4.5mm BONE-LOK® PLS Implant and disposable surgical instruments for use in implanting the device and is provided "STERILE". The re-usable Compression Tool is provided separately in a "NONSTERILE" condition; sterilization is by moist heat (steam autoclave) and is performed on-site.

The provided text is a 510(k) summary for a medical device (Single Use PERPOS™ PLS System, BONE-LOK® PLS Implant). It describes the device, its intended use, and claims substantial equivalence to predicate devices.

However, the document does NOT contain any information regarding acceptance criteria, study details, or performance data of the device.

The document discusses:

• Device Identification: Trade names, common names, classification, product codes.
• Predicate Devices: Lists previously cleared devices to which the current device claims substantial equivalence.
• Device Description: Materials and general characteristics of the implant and associated instruments.
• Intended Use/Indications for Use: Specifies the medical conditions the implant is used for and its role in spinal fusion.
• Technological Characteristics and Substantial Equivalence: Asserts that the device is similar to predicates in these aspects.
• FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested information, which includes a table of acceptance criteria and device performance, sample sizes for test and training sets, data provenance, ground truth establishment, expert details, adjudication methods, or results of MRMC or standalone studies.

The 510(k) pathway for medical device clearance in the US primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies against predefined acceptance criteria for novel device functions. Performance data, if present, would typically be found in more detailed sections of the 510(k) submission, which are not included in this publicly available summary.

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