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The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is indicated to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is a combination of two FDAcleared Surgicraft Products, the Surgicraft LOCKDOWN Mesh (K072370) and the Surgicraft LOCKDOWN Screw (K080447). The new product for this indication is designated as the LOCKDOWN™ Acromioclavicular (AC) device and will have a new indication to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

It is not intended that the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device be used as the sole means of reconstructing a chronic acromioclavicular joint dislocation.

The Surgicraft LOCKDOWN Mesh device is a woven mesh 11mm wide by 4 to 20 cm in length with loops at both ends. The Surgical Mesh is made from braided Polyethyleneterephthalate (Polyester) fibers (PET).

The Surgicraft LOCKDOWN Screw is manufactured from stainless steel and titanium alloy. The self-tapping 3.5 mm screws are available in lengths from 14- 40 mm in 1 mm increments. The washers have a hole with an inner diameter of 4.2 mm and an outer diameter ranging from 7 to 9 mm in 1 mm increments.

The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is provided sterile.

The provided document is a 510(k) summary for the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device. It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed. However, it explicitly states that no clinical testing was performed. Therefore, several sections of your request related to acceptance criteria proved by clinical studies, sample sizes for test sets, expert involvement, and ground truth for clinical outcomes cannot be addressed.

Here's a breakdown of the available information based on your request:

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

No explicit quantitative acceptance criteria or detailed reported device performance metrics were provided in the document in a way that would allow for a direct comparison table. The document states that "side-by-side testing was performed with the named predicate device in appropriate cadaver models and indicated that the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is substantially equivalent to predicate device." This implies performance comparable to the predicate, but specific quantitative metrics comparing acceptance criteria to performance are not available.

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 explicitly stated. The document mentions "appropriate cadaver models" were used for side-by-side testing. The number of cadaver models is not specified.
• Data Provenance: The cadaveric testing would be considered prospective in the context of the study design; however, details on the origin of the cadaver models (e.g., country) are not provided.

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, as no clinical testing with human subjects or expert assessment of clinical outcomes was performed. The testing involved mechanical and cadaveric models.

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

Not applicable, as no clinical testing with human subjects or expert assessment of clinical outcomes was performed.

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

Not applicable. This device is a surgical implant, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. This is a medical device, not a software algorithm. The "standalone" performance would refer to the mechanical and biocompatibility testing of the device itself.

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

For the non-clinical testing:

• Biocompatibility testing (per ISO 10993): Ground truth would be established by the ISO 10993 standards for material safety.
• Screw pull-out testing, mesh burst strength, and suture attachment strength: Ground truth would be established by engineering specifications and benchmarks to ensure the device's mechanical integrity meets required safety and performance thresholds, likely compared against the predicate device's known performance.
• Cadaveric model testing: Ground truth for substantial equivalence would be based on direct mechanical comparison of the device's performance (e.g., stability, fixation strength) against the predicate device in a simulated anatomical environment.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI model that requires a training set.

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

Not applicable, as no training set was used.

Summary of Device Acceptance Criteria and Study:

The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device gained regulatory clearance (K091207) based on demonstrating substantial equivalence to a predicate device, the Arthrex TightRope® Acromioclavicular device (K052776).

Acceptance Criteria (Implied by Substantial Equivalence):

The device must demonstrate similar:

• Indications for use.
• Function.
• Materials (braided Polyethyleneterephthalate (Polyester) fibers (PET), stainless steel, and titanium).
• Mechanical performance (screw pull-out strength, mesh burst strength, suture attachment strength).
• Biocompatibility.
• Performance in a cadaveric model, matching the predicate device's performance.

Study Proving Acceptance Criteria:

The study was a non-clinical comparative study against the predicate device.

• Mechanical Testing:

  • Tests Performed: Biocompatibility testing (per ISO 10993), screw pull-out testing, mesh burst strength, and suture attachment strength.
  • Methodology: These tests would involve standard engineering and biocompatibility protocols to assess the physical properties and material safety of the device and its components.
  • Ground Truth: Established by adherence to ISO 10993 standards and engineering specifications for material strength and performance, likely benchmarked against the known performance of the predicate device.
  • Sample Size: Not explicitly stated for each mechanical test, but typically these involve a statistically relevant number of samples for each component.

• Cadaveric Model Testing:

  • Methodology: "Side-by-side testing was performed against the predicate device in an appropriate cadaveric model." This would involve implanting both the Surgicraft device and the predicate device in cadaveric shoulder models and subjecting them to mechanical stress to compare their fixation capabilities and stability.
  • Ground Truth for Comparison: The performance of the predicate device within the cadaveric model. The Surgicraft device was deemed equivalent if its performance matched that of the predicate.
  • Sample Size: Not explicitly stated, but implies multiple applications and comparisons within these models.
  • Data Provenance: Cadaver models, assumed to be prospective in nature.

Conclusion: The device met its acceptance criteria by demonstrating substantial equivalence to the predicate device through a series of non-clinical mechanical and cadaveric model tests. No clinical studies were deemed necessary for this 510(k) clearance.

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The Surgcraft Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery. The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair.

The Surgicraft Surgical Mesh System consists of a series of specialized shapes of surgical mesh made from commercially available polyester suture fibers. All sizes incorporate regions of reinforced holes to assist secure anchoring of the mesh to tissue. The devices are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided text is a 510(k) summary for the Surgicraft Surgical Mesh System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria, performance metrics, or study details in the way requested by the prompt.

Instead, it lists types of tests performed (biocompatibility and mechanical testing) without providing the results or the acceptance criteria for those tests. It explicitly states "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act applicable to this device" and "Clinical Testing Not applicable to this device."

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided document.

Here's what can be extracted based on the document:

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

• Cannot be provided. The document lists types of tests performed (Biocompatibility, Dynamic Tensile Fatigue, Static Tensile, Burst Strength, Suture Attachment Strength, Screw Pullout Strength, Tear Resistance, Screw Resistance) but does not provide specific acceptance criteria or reported performance values for these tests. It concludes "substantially equivalent" rather than reporting specific performance against criteria.

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

• Cannot be provided. The document does not specify sample sizes for any of the non-clinical tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned.

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 a surgical mesh, not an AI/diagnostic device that would require ground truth established by experts for a test set. Clinical testing was deemed "not applicable."

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

• Not applicable. See point 3.

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-assisted diagnostic device. Clinical testing was deemed "not applicable" and no human reader studies were conducted.

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

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

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

• Not applicable. For the non-clinical tests, the "ground truth" would be the measured physical properties or biological responses compared against established standards or predicate device properties, but specific details are not provided.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

• Not applicable. See point 8.

Summary of available information regarding compliance/testing:

• Study Type: Non-clinical testing only (Biocompatibility and Mechanical Testing). Clinical testing was explicitly stated as "Not applicable to this device."
• Biocompatibility Testing: Conducted according to ISO 10993 and Directive 93/42/EC, EN ISO 1099-1 FDA. Specific tests included:
  • Sensitization extract (0.9% sodium chloride)
  • Sensitization extract (sesame oil)
  • Genotoxicity (dimethyl sulfoxide extract)
  • Genotoxicity (0.9% sodium chloride extract)
  • Muscle Implantation study - 4 weeks
  • Cytotoxicity (according to EN ISO 10993-5, -12, EN ISO 9363-1, LM SOP 4-06-01)
  • Chemical Analysis (characterization of organic leachables, according to EN ISO 10993-1, -12, -18, LM P 8-01, LM SOP 9-01-01)
• Mechanical Testing: Included:
  • Dynamic Tensile Fatigue
  • Static Tensile
  • Burst Strength
  • Suture Attachment Strength
  • Screw Pullout Strength
  • Tear Resistance
  • Screw Resistance
• Conclusion: Based on engineering drawings, labeling, laboratory and mechanical testing, the device was found to be "substantially equivalent" to its predicate devices in terms of design, materials, indications for use, and other characteristics.

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The Surgicraft Screw Fixation System and is a single-use, soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Capsular Shift/Capsulolabral Reconstruction, Biceps Tenodesis, Deltoid Repair. Foot and Ankle: Medial Instability Repair/Reconstruction, Lateral Instability Repair/Reconstruction, Achilles Tendon Repair/Reconstruction, Midfoot Reconstruction, Hallux Valgus Reconstruction. Elbow. Wrist. Hand: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Biceps Tendon Reattachment. Knee: Extra Capsular Repairs - Medial Collateral Ligament, Lateral Collateral Ligament, Posterior Oblique Ligament, Illiotibial Band Tenodesis, Patellar Tendon Repair. Pelvis: Bladder Neck Suspension Procedures. Single patient use only

The Surgicraft Screw Fixation System is manufactured from stainless steel and titanium. The self-tapping 3.5 mm screws are available in lengths from 20- 40 mm in 1 mm increments. The washers have an inner hole diameter of 4.2 mm and an outer diameter ranging from 7 to 9 mm in 1 mm increments.

The provided text is a 510(k) Summary for the Surgicraft Screw Fixation System. It outlines the device description, intended use, and substantial equivalence to predicate devices, focusing on non-clinical mechanical testing. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/algorithm performance.

Therefore, I cannot populate the requested table and answer the specific questions related to AI/algorithm performance, ground truth, sample sizes for test/training sets, expert qualifications, or MRMC studies.

The document states:

• "Non-Clinical Testing: The Surgicraft Screw Fixation System was tested as follows: • Mechanical Testing ASTM - F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws"
• "Clinical Testing: Not applicable to this device"

This means the device's performance was evaluated through mechanical testing against an ASTM standard, not a study involving AI or human interpretation of medical images/data. The absence of clinical testing further confirms this.

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The STALIFTM TT Intervertebral Body Fusion System is indicated for use with autogenous bonc 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 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.

The STALIFTM TT is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

The STALIFTM TT system may be used with bone grafting material (autograft only).

The Surgicraft STALIF"M TT is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws and is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIFTM TT is similar to that of the vertebral body endplate with a central cavity than can be packed with bone graft (autograft). The STALIFTMTT IBF System consists of varying sizes to include different widths, heights and hole positions to accommodate individual pathology and anatomical conditions.

This is a 510(k) premarket notification for the STALIF™ TT Intervertebral Body Fusion System. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through clinical studies. Therefore, many of the requested data points related to clinical study design and performance metrics are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This section is Not Applicable in the traditional sense of a clinical performance study with predefined acceptance criteria and measured device performance against those criteria. For medical devices pursuing 510(k) clearance, the "acceptance criteria" revolve around demonstrating substantial equivalence to a legally marketed predicate device.

The study presented here asserts that the STALIF™ TT system meets the "acceptance criteria" of being substantially equivalent to its predicates based on:

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

• Sample Size for Test Set: Not applicable. This submission relies on engineering drawings and non-clinical mechanical testing, not a clinical "test set" of patient data.
• Data Provenance: Not applicable for a clinical test set. The mechanical testing standards (ASTM F 2077-03 and ASTM F 2267-04) are international standards. The origin of the actual test samples would likely be from the manufacturer (Surgicraft Limited, UK). The study is not retrospective or prospective in the clinical sense.

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

• This is Not Applicable as no clinical test set with ground truth established by medical experts was used or described. The "ground truth" in 510(k) for mechanical testing is adherence to the specified ASTM standards.

4. Adjudication Method for the Test Set

• Not Applicable. No clinical test set requiring expert adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a medical device clearance, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used

• For the non-clinical testing, the "ground truth" is defined by the ASTM standards (ASTM F 2077-03 for static and dynamic tests, and ASTM F 2267-04 for subsidence tests). The device's mechanical performance is compared against the requirements and typical performance characteristics for intervertebral fusion devices as outlined in these standards and generally accepted for substantial equivalence to predicate devices. There is no pathology, outcomes data, or expert consensus used as ground truth in the clinical sense for this submission.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not a machine learning or AI device. The physical device is manufactured based on design specifications and then tested.

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

• Not Applicable. See point 8.

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The STALIF C is intended to be used as an intervertebral body fusion cage as a stand alone system used with the bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. STALIFTM C is intended to be used at one level.

The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

STALIFTM C is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws and is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIFTM C is similar to that of the vertebral body endplate with a central cavity that can be packed with autograft. STALIFTM C is manufactured from PEEK-Optimad LTI.

This 510(k) summary does not contain the kind of information typically found in acceptance criteria or a study proving a device meets those criteria, particularly for an AI/ML powered device. This document is for a medical device called the STALIFT™ C, which is an intervertebral body fusion device (a physical implant) and not an AI/ML system.

Therefore, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set ground truth) are not applicable to the provided text.

However, I can extract the information that is present:

Acceptance Criteria and Device Performance for STALIFT™ C

Based on the provided 510(k) summary, the device's acceptance criteria are primarily defined by its substantial equivalence to predicate devices and its ability to meet recognized performance standards for physical medical implants.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
Not applicable. This is a physical implant device, not an AI/ML algorithm requiring a test set of data. The "testing" involved engineering drawings, labeling, and mechanical testing of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a physical implant's mechanical properties is established through standardized engineering tests, not expert consensus on data sets.

4. Adjudication method for the test set
Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical implant; there are no human readers or AI involved in its direct function.

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
For the physical device, the "ground truth" is based on:

• Mechanical Test Standards: Compliance with ASTM standards (ASTM 2077-03, ASTM F2267-04, ASTM F1877-98(03)) for materials and device performance.
• Physical Properties: Specifications regarding material composition (PEEK-Optimad LTI) and physical dimensions/design.
• Bench Testing: Mechanical testing to ensure the device meets predefined specifications and performs equivalently to predicate devices.

8. The sample size for the training set
Not applicable. This is a physical implant, not an AI/ML system.

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

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The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction or partial destruction by tumor or fracture/trauma leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device is intended for use as a vertebral body replacement or partial replacement in the thoracolumbar spine (from T9 to L5). The STALIF™ TT device may be used with bone graft.

The Surgicraft STALIF™ TT is a radiolucent vertebral body replacement device used in coniunction with cancellous bone screws and is designed to restore biomechanical integrity from thoracic (T9 to T12) and lumbar spine (L1 to L5) following vertebrectomy or corpectomy for patients with spine tumors or traumal fracture. The system provides anterior column support both immediately after surgery and for prolonged periods in the absence of bone fusion.

This document is a 510(k) Premarket Notification summary for the STALIF TT™ System, a spinal intervertebral body fixation orthosis. It does not contain information typically found in a study proving a device meets acceptance criteria. A 510(k) submission generally relies on demonstrating substantial equivalence to a predicate device, rather than detailed performance study data against specific acceptance criteria.

Therefore, the requested information elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) cannot be extracted from this document as it is not a study report.

The document states: "Performance data were provided" under the "Substantial Equivalence" section, implying that some data was submitted, but the detailed results and methodology are not included in this summary.

Summary of available information:

• Device Name: STALIF TT™ System
• Intended Use: Replacement, partial vertebrectomy, and/or augmentation of a vertebral body due to destruction or partial destruction by tumor or fracture/trauma, to restore planar alignment, height, and facilitate neural decompression. Designed to restore biomechanical integrity of the spinal column (T9 to L5) for prolonged periods, even without fusion.
• Predicate Devices: DePuy AcroMed Stackable Cage™ System and Interpore Cross International GEO Structure.
• Substantial Equivalence: Claimed based on provided "Performance data." (Details of this data are not in this document).

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The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction by tumor or fracture leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T9 to L5).

The STALIF ™ TT device is intended for use with supplemental internal fixation.

The supplemental internal fixation systems that may be used with the STALIF TT device, include but are not limited to, DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M2, Isola, VSP, Moss Miami, TiMx, Monarch and Profile).

The Surgicraft STALIFTM TT is a radiolucent vertebral body replacement device used in conjunction with cancellous bone screws and is designed to restore biomechanical integrity from thoracic (T9 to T12) and lumbar spine (L1 to L5) following vertebrectomy or corpectomy for patients with spine tumors or traumal fracture. The system provides anterior column support both immediately after surgery and for prolonged periods in the absence of bone fusion. Material: PEEK-OPTIMA LT1

This is actually an FDA 510(k) summary for a medical device (STALIF TT™ SYSTEM), not a study analyzing AI performance. Therefore, most of the requested information about acceptance criteria and study design for AI models does not apply.

However, I can extract the relevant information from the provided document regarding device performance and its regulatory approval process, which serves as a form of "acceptance criteria" for medical devices.

Here's a breakdown of the available information:

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

For a medical device like the STALIF TT, "acceptance criteria" are typically based on demonstrating substantial equivalence to a legally marketed predicate device, as well as meeting established performance standards through various testing. The document states "Performance data were submitted." This implies that the device underwent various tests to prove its safety and effectiveness, likely against a set of predetermined criteria based on engineering standards and expected biological response.

However, the specific quantitative acceptance criteria (e.g., minimum compression strength, fatigue life cycles) and the detailed results are not disclosed in this summary. The summary only confirms that performance data was submitted and found acceptable by the FDA for its 510(k) clearance.

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

This information is not provided in the 510(k) summary. For medical devices, "test sets" typically refer to mechanical, biocompatibility, and potentially animal studies, not human clinical data in the same way an AI study would. The data provenance would refer to the testing lab and the standard(s) adhered to.

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)

This is not applicable to a medical device 510(k) submission in the context of expert consensus for ground truth. Ground truth for a device like this would be established through engineering specifications, material properties, and pre-clinical testing protocols.

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

This is not applicable to a medical device 510(k) submission. Adjudication methods are typically for subjective assessments or disagreements in clinical trials or AI validation.

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

This is not applicable. The STALIF TT is a physical medical implant, not an AI diagnostic tool that assists human readers.

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

This is not applicable. The STALIF TT is a physical medical implant, not a software algorithm.

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

For this device, the "ground truth" for its performance would be established through a combination of:

• Engineering specifications and standards: Confirming material properties, mechanical strength (e.g., compression, fatigue, subsidence), and dimensional accuracy.
• Biocompatibility testing: In vitro and potentially in vivo (animal study) testing to ensure the material is safe for implantation.
• Pre-clinical (benchtop) testing: Simulated use conditions to verify the device's mechanical performance under expected physiological loads.

8. The sample size for the training set

This is not applicable. The STALIF TT is a physical medical implant, not an AI model that requires a training set.

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

This is not applicable. The STALIF TT is a physical medical implant, not an AI model.

In summary: The provided document is a regulatory notice for a medical device, not a study evaluating an AI system. The "acceptance criteria" here refer to meeting FDA requirements for market clearance through demonstrating substantial equivalence and submitting adequate performance data, rather than specific performance metrics for an AI algorithm.

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Surgical stabilization and fusion of the cervical spine for the correction of spinal deficiencies.

Indications For Use:

1. Spinal deformity
2. Spinal tumors
3. Spinal fracture
4. Dislocations
5. Subluxations
6. Spondylolisthesis

The TITANIUM HARTSHILL SYSTEM consists of the following items:
REF SIZE
HTR 4025 - 4mm x 25mm
HTR 4035 - 4mm x 35mm
HTR 4045 - 4mm x 45mm
HTR 4065 - 4mm x 65mm
HTR 4075 - 4mm x 75mm
HTR 4085 - 4mm x 85mm
Surgical instruments designed to implant the device are also available.
Fixation Wire and Braided Fixation Cable are available in both stainless steel and titanium alloy for use with the appropriate implant type.

The provided document is a 510(k) Premarket Notification for the TITANIUM HARTSHILL SYSTEM, a spinal implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study dedicated to proving performance against those criteria. Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes for test/training sets, expert adjudication, and MRMC studies is not present in this document, as it is not typically required for a 510(k) submission for this type of device.

However, I can extract information related to the device's comparison to its predicate and the basis for its safety and effectiveness.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial. Instead, the "acceptance criteria" can be inferred as being substantially equivalent in terms of intended use, indications for use, materials, surgical approach, and method of attachment to the predicate device. The "reported device performance" is the demonstration that these equivalencies hold.

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

• Sample Size: Not applicable/not provided. This submission relies on demonstrating substantial equivalence through design and material comparison, and a review of existing literature and mechanical test data, rather than a prospective clinical "test set" for performance evaluation.
• Data Provenance: The document mentions "review of peer literature concerning physiological loading of the cervical spine" and "available mechanical test data comparing the Titanium Hartshill SysTEM to the literature and the substantially equivalent predicate device." This suggests a combination of retrospective literature review and mechanical (bench) testing. No specific country of origin for this data is provided, but the manufacturer is based in England.

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

• Not applicable/not provided. As there's no clinical "test set" and a formal "ground truth" derived from expert consensus for device performance in the context of this 510(k) submission, this information is not included. The FDA's review committee (Orthopaedics and rehabilitation devices panel) serves as the expert body reviewing the submission.

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

• Not applicable/not provided. This pertains to a clinical study design that is not part of this 510(k) submission.

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/not provided. The device described is a physical spinal implant, not an AI-assisted diagnostic tool.

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

• Not applicable/not provided. This is a physical medical device, not an algorithm.

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

• For the demonstration of substantial equivalence, the "ground truth" is primarily based on established engineering and design principles, materials standards (BS, ISO, ASTM), and the performance history of the predicate device (Stainless steel Hartshill Spinal Fixation System - K853033). The statement "Testing and clinical performance demonstrate that TITANIUM HARTSHILL SYSTEM will perform substantially the same as the stainless steel Hartshill Spinal Fixation System" implies reliance on prior clinical evidence for the predicate and mechanical testing for the new device.

8. The sample size for the training set:

• Not applicable/not provided. This refers to machine learning, which is not relevant to this device.

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

• Not applicable/not provided. This refers to machine learning, which is not relevant to this device.

In summary: The provided document is a 510(k) notification for a spinal implant. Its primary purpose is to establish substantial equivalence to an existing marketed device. Therefore, it does not contain the detailed information typically found in a clinical study report that establishes performance against specific acceptance criteria for a novel device or AI-based system. The "study" referenced is largely a comparison to mechanical test data and a review of existing peer literature to support the claim of substantial equivalence and safety/effectiveness based on the predicate's history.

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Intended Use:
Fixation of bone fragments

Indications For Use:

• 1. Bone fractures
• 2. Bone reconstructions
• 3. Bone traction

Not Found

The provided text is a 510(k) Premarket Notification for a medical device called "The Bone Tie." This type of document is for regulatory approval and does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The 510(k) submission process is primarily about demonstrating "substantial equivalence" to a predicate device already on the market, rather than proving the device meets specific performance acceptance criteria through a clinical study. It focuses on the device's design, materials, and intended use being similar to an already approved device.

Therefore, I cannot provide the requested information based on the input text. The document describes:

1. Device Name: THE BONE TIE
2. Intended Use/Indications For Use: Fixation of bone fragments for bone fractures, bone reconstructions, and bone traction.
3. Classification: Class II, Product Code HTY, as a "Smooth or threaded metallic bone fixation fastener."
4. Regulatory Approval: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

To answer your request, I would need a different type of document, such as a clinical study report or a detailed design verification and validation document, which would explicitly describe acceptance criteria and present study results against those criteria.

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Surgical stabilization to assist bony fusion of the cervical spine and cervical occipital junction.

Indications For Use:

1. Degenerative disk disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
2. spondylolisthesis of the cervical vertebrae
3. Spinal stenosis of the cervical vertebrae
4. Atlanto/axial fracture with instability
5. Cervical-occipital dislocation
6. Revision of previous cervical spine surgery
7. Tumors

The Ransford Cervical Fixation System consists of various loops (in stainless steel and titanium, with different angles and lengths), stainless steel and titanium cross links, and surgical instruments. These implants are designed for use with annealed stainless steel wire 0.9mm diameter (20swg) or multi-filament braided titanium alloy (6A),4V) cable, 0.045 inch (1.1mm) diameter, 19 inches long with a 3 inch, soft, pure titanium mono-filament lead wire. The system is based on sublaminar wires and contoured rods placed posteriorly.

The provided text is a 510(k) Premarket Notification for the RANSFORD CERVICAL FIXATION SYSTEM™, which is a medical device. The primary method for proving the device meets acceptance criteria in a 510(k) submission is to demonstrate substantial equivalence to an already legally marketed predicate device. This is achieved through comparison of design, materials, intended use, and performance data.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the characteristics of the predicate device, the Hartshill Spinal Fixation System (K853033). The RANSFORD CERVICAL FIXATION SYSTEM™ must perform "substantially the same" as the predicate device.

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

The "test set" in this context refers to the samples used in the static mechanical tests. The document does not explicitly state the exact sample sizes for each mechanical test (Axial Torsion, Axial Extension, Axial Compression, Cable/Wire Tensile Test). It refers to "tests conducted" without providing N numbers.

The data provenance is laboratory-based mechanical testing, comparing the RANSFORD CERVICAL FIXATION SYSTEM™ components (titanium Ransford Loop and titanium cables) directly to components of the Hartshill Spinal Fixation System (stainless steel Hartshill Cervical Rectangle and stainless steel wires). There is no mention of human subject data, animal data, or clinical data in this safety and effectiveness summary. The tests were "conducted by qualified commercial laboratories." The country of origin for the testing is not specified, but the manufacturer is based in England.

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

This information is not applicable in this context. Ground truth is typically established in studies involving diagnostic devices or algorithms that interpret data (e.g., medical images). For a mechanical fixation system like this, the "ground truth" is defined by the physical properties and performance characteristics measured in static mechanical tests. The "experts" are the "qualified commercial laboratories" that conducted the tests, and their "qualifications" implicitly relate to their ability to perform such mechanical testing according to established protocols.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human readers or experts in diagnostic studies. For mechanical tests, the results are quantitative measurements, and statistical comparisons determine whether differences are significant. There is no human interpretation or adjudication in the sense described here.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers (e.g., radiologists, pathologists) evaluating cases, often with and without AI assistance, to assess diagnostic performance. The RANSFORD CERVICAL FIXATION SYSTEM™ is a spinal implant, not a diagnostic device, so such a study would not be relevant.

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

This question is not applicable as the RANSFORD CERVICAL FIXATION SYSTEM™ is a physical surgical implant, not an algorithm or AI system. Its performance is assessed through mechanical testing, not through standalone algorithm performance.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical testing is based on direct physical measurement of mechanical properties (stiffness, torque, force, angular rotation, extension) under controlled laboratory conditions, as compared to the established performance of the predicate device. It is a performance benchmark against a known, legally marketed device.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical implant, not an AI system, and therefore has no training set.

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

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

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