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The Signature Orthopaedics PEEK RCI, Bio-Composite and SignaLoc Screws intended for use in fixation of soft tissue including ligament or tendon to bone for cruciate ligament reconstruction surgeries of the knee. The screws are also intended for use in the following procedures:

• · ACL repairs
• · PCL repairs
• · Extra-capsular repairs
  • · Medial collateral ligament
  • Lateral collateral ligament
  • · Posterior oblique ligament
• · Patellar realignment and tendon repairs
  • Vastus medialis obliquus advancement
• · Illiotibial band tenodesis

The PEEK RCI, Bio-Composite and SignaLoc Screws are interference screws which provide compression of the graft or tendon to the bony wall for biological fixation of the ligament, tendon or soft tissue to bone. The screws feature an internal cannulation to accept a guide wire and have the same drive feature. The screws have an external variable thread along the length of the tapered shape and a rounded head. Each screw is provided individually packaged sterile for single use. The PEEK RCI is manufactured from unreinforced PEEK and the SignaLoc and Bio-Composite is manufactured from a PEEK/Hydroxyapatite composite.

The provided document is a 510(k) premarket notification decision letter from the FDA for the PEEK RCI, Bio-Composite, and SignaLoc Screws. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical performance testing. It does not describe a study involving an AI device or human-in-the-loop performance.

Therefore, the requested information regarding acceptance criteria and study details for an AI-powered device, multi-reader multi-case studies, standalone algorithm performance, and ground truth establishment for AI training sets is not applicable to this document.

However, I can provide the acceptance criteria and study information related to the non-clinical performance of the PEEK RCI, Bio-Composite, and SignaLoc Screws as detailed in the document.

Acceptance Criteria and Device Performance for PEEK RCI, Bio-Composite, and SignaLoc Screws (Non-Clinical)

The document primarily states that "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the PEEK RCI, Bio-Composite and Signaloc Screws are adequate for anticipated in-vivo use." The acceptance criteria for these tests are implied to be meeting the requirements and performance characteristics of the referenced ASTM and ISO standards, and demonstrating substantial equivalence to the predicate devices. Specific quantitative acceptance values are not explicitly stated in this FDA letter but would have been part of the manufacturer's detailed testing report.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not specified in the provided document. Non-clinical testing typically involves a sufficient number of samples to ensure statistical validity per the relevant standards, but exact numbers are not disclosed here.
• Data Provenance: The tests are non-clinical (laboratory/bench top) and engineering evaluations performed by the manufacturer, Signature Orthopaedics Pty Ltd. The country of origin for the data generation would be Australia (where the manufacturer is based) or potentially related testing facilities. The data is prospective in the sense that it was generated specifically for this submission to support the device's performance.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. This document describes non-clinical performance testing of medical screws, not an AI device or a study requiring human expert ground truth for image interpretation or diagnosis.

4. Adjudication Method for Test Set:

• Not applicable. As this is non-clinical bench testing, there is no "adjudication method" in the context of expert consensus or dispute resolution. The results are typically determined by calibrated equipment and adherence to standard protocols.

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

• No. An MRMC study was not done as this is for a physical medical device (screws) and not an AI-assisted diagnostic or interpretative system.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This device is a physical medical implant, not a software algorithm.

7. Type of Ground Truth Used:

• Not applicable in the context of expert consensus or pathology for clinical conditions. For non-clinical testing, the "ground truth" is established by the specifications and performance requirements defined in the referenced industry standards (ASTM, ISO, AAMI) and the properties of the predicate devices. The screws' ability to meet these specified physical and biological material properties serves as the ground truth.

8. Sample Size for Training Set:

• Not applicable. This device is not an AI algorithm that requires a training set.

9. How Ground Truth for Training Set was Established:

• Not applicable. This device is not an AI algorithm.

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The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The VECTOR Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.50mm and Ø4.00mm and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.

The VECTOR Hammertoe Correction System is a medical device designed for the fixation of osteotomies and reconstruction of lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The provided text describes the regulatory filing for this device, not a study evaluating its performance against specific acceptance criteria. Therefore, most of the requested information cannot be extracted directly from this document.

However, based on the "SUMMARY OF NON-CLINICAL TESTING" section, we can infer the types of tests performed to demonstrate safety and equivalence to predicate devices, which serve as the implicit acceptance criteria for this type of regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify the sample size for individual tests (e.g., number of implants tested for torsion, pullout, etc.). It describes non-clinical laboratory testing. The data provenance is from laboratory testing conducted by the manufacturer, Nvision Biomedical Technologies, LLC. Since these are non-clinical (mechanical and biological) tests, "country of origin of the data" and "retrospective or prospective" are not directly applicable in the same way they would be for clinical studies with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical study involving mechanical and biocompatibility testing, not human expert evaluation of clinical images or diagnoses. The "ground truth" here is established by the specifications of the ASTM standards and regulatory limits (e.g., endotoxin levels).

4. Adjudication method for the test set
Not applicable. There was no expert adjudication process as this was non-clinical laboratory 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 document describes the regulatory filing for a medical fixation device, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI-based device.

7. The type of ground truth used
The "ground truth" for the non-clinical tests is based on:

• Engineering specifications and recognized consensus standards: Specifically ASTM F543, which outlines standard test methods for metallic medical bone screws.
• Regulatory limits for biocompatibility: Recommended Bacterial Endotoxins limits (20 EU/device).
• Comparison to predicate devices: The "substantially equivalent" determination implies that the test results met or exceeded the performance characteristics of the predicate devices.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device.

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The Innovasis PEEK IBF System (Px, Px HA and TxHA) is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine. Px® and Px HA® devices are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach. TxHA™ devices are placed via a transforaminal (TLIF) approach.

This device is intended to be used with internal spinal fixation systems such as the Imovasis Excella® Spinal System. The interior of the implant is intended to be packed with autograft.

The Innovasis TxHA PEEK IBF Spinal System is a line extension of the Px Posterior Spinal IBF System, an intervertebral body fusion device with associated instrumentation for use in Transforaminal Lumbar Interbody Fusion (TLIF) surgeries. The Px IBF was submitted to FDA under K150500 in February 2015, and was cleared for sale in the USA on June 19, 2015. The Px HA design manufactured using Invibio® PEEK-Optima® HA Enhanced was cleared under K151785 on October 14, 2015. In this material, hydroxyapatite (HA), is integrated with Invibio's PEEK-OPTIMA Natural.

The single use implant devices feature an open cavity in the interior geometry to accommodate bone graft and maximize bone through-growth, with anti-migration teeth to engage the vertebral endplates and prevent expulsion. The implants have a slightly convex profile and are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support PLIF/TLIF surgeries are provided with the implants in sterilization trays.

The Px implants are machined from medical grade Solvay Zeniva ZA-500 or Evonik VESTAKEEP i4R PEEK. The Px HA and TxHA implants are machined from Invibio® PEEK-OPTIMA® HA Enhanced* polyetheretherketone with hydroxyapatite. The radiographic markers meet ASTM F560 for unalloyed Tantalum. HA is a naturally occurring mineral in bone and is widely used in the orthopedic field.

The provided text is a 510(k) Premarket Notification from the FDA regarding an intervertebral body fusion device. It primarily discusses the device's substantial equivalence to previously cleared predicate devices based on non-clinical performance testing.

It does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of clinical performance or algorithm-based performance. The document focuses on regulatory approval based on mechanical and material equivalence to existing devices.

Therefore, I cannot provide the requested information from the given text.

If this were a document about an AI/ML medical device, the information I'd look for to answer your questions would typically be in sections detailing clinical studies, algorithm validation, or performance evaluation.

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The Innovasis Ax Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The Ax Stand-Alone interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.

The Innovasis Ax Stand-Alone ALIF implant will be provided in two configurations. The first is an HA PEEK caqe with an integrated titanium faceplate. The second is an all titanium version of the same implant. Both designs will feature screws, a locking mechanism, and instruments. The implant is a stand-alone anterior intervertebral body fusion device indicated for use in patients with degenerative disk disease (DDD) at one or two contiquous levels from L2 to S1. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s).
The interior of the device will be packed with autograft.
Intended to support restoration of the sagittal balance.
It is intended to be used with bone screws and will not require additional supplementary fixation for implants with a lordotic angle less than 20°.
Implants with a lordotic angle ≥20° are indicated for use with supplementary fixation, such as the Excella Spinal System.
It is intended for use with the standard anterior approach

The provided document is a 510(k) premarket notification from the FDA for a medical device called the Ax™ Stand-Alone ALIF System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes.

Therefore, the document does not contain the information requested for acceptance criteria and the study that proves the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance (in terms of diagnostic metrics).
• Sample size used for a test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Information on a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document details non-clinical performance data (mechanical testing) demonstrating substantial equivalence to predicate devices.

Here's what the document does provide regarding performance data and substantial equivalence:

1. Acceptance Criteria and Device Performance (Non-clinical):

2. Sample size used for the test set and the data provenance: Not applicable. The document discusses non-clinical mechanical testing, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical testing, the "ground truth" is defined by the established industry standards (ASTM F2077-14 and F2267-04) and the performance of the predicate device.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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The VertebraLINK Fusion Platform is indicated for use 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 implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via posterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The VertebraLINK Fusion Platform is a comprehensive suite of generally box shaped devices which can be implanted into the prepared disc space when performing an intervertebral body fusion. The devices are manufactured from Invibio's PEEK Optima LT1 or PEEK Optima HA Enhanced per ASTM F2026. The devices contain a central axial opening for packing of bone graft material as well as teeth on the inferior and superior surfaces to resist expulsion. The platform will be offered in multiple lengths, widths, heights and lordoses to accommodate varying anatomies, pathologies, surgeon preferences, or techniques (i.e., TLIF, PLIF, or Oblique PLIF). Additionally, the device contains radiographic markers made from tantalum per ASTM F560.

The provided document is a 510(k) summary for the VertebraLINK Fusion Platform, an intervertebral body fusion device. While it indicates that performance testing was conducted, it does not provide specific acceptance criteria or the detailed results (performance data) that would allow for the completion of the requested table. It only states that the results "show that the strength of the VertebraLINK Fusion Platform is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Therefore, based solely on the provided text, I cannot fill in the table of acceptance criteria and reported device performance. Additionally, most of the other requested information regarding the study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this regulatory document, as it focuses on demonstrating substantial equivalence through non-clinical testing.

Here's what can be extracted and noted about the unavailable information:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that testing was completed, but does not provide specific numerical acceptance criteria or the quantitative reported performance of the device against those criteria. It only offers a general conclusion of sufficiency and substantial equivalence.

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 specified. The performance data section refers to "the results of this non-clinical testing," but does not mention the number of samples or devices tested for each type of test.
• Data provenance: Not explicitly stated, as these are non-clinical (mechanical) tests rather than clinical studies with patient data.

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 information is relevant for studies involving human interpretation (e.g., radiological reads for AI diagnostics). The provided document describes premarket non-clinical mechanical testing, not a study involving experts to establish ground truth for a diagnostic output.

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

• Not applicable. As above, this pertains to studies involving human interpretation or clinical decision-making.

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 describes non-clinical mechanical performance testing of an intervertebral fusion device, not an AI-enabled diagnostic device requiring human reader assessment.

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

• Not applicable. This device is an implantable medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance tests mentioned (Static axial compression, Dynamic axial compression, Expulsion, Subsidence, Bacterial Amebocyte Lysate) are indeed "standalone" in the sense that they evaluate the device itself without human interaction or a system loop, but this is a different context than what is typically implied by "standalone algorithm performance."

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

• For the non-clinical mechanical tests, the "ground truth" would be defined by engineering standards and specifications (e.g., specific load requirements, displacement limits, or bacterial count thresholds outlined in the ASTM and AAMI standards referenced). There isn't a "ground truth" in the clinical sense of a disease state.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm that requires a training set. The performance testing described is for physical characteristics.

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

• Not applicable. As this is not an AI algorithm requiring a training set, this question is not relevant.

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