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The Tornier Pyrocarbon Humeral Head associated with the Tornier Flex Stem is indicated for use as a replacement of deficient humeral heads disabled by:

• Non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis) .
• . Traumatic arthritis.

The Tornier Pyrocarbon Humeral Head Shoulder Prosthesis, combined with the Tornier Flex Humeral Stem, are to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain.

Note: The coated humeral stem is intended for cementless use. The noncoated humeral stem is for cemented use only

The Tornier Pyrocarbon Humeral Head is a prescription use device that is comprised of the pyrolytic carbon (pyrocarbon) articulating surface and a cobalt chromium alloy double taper neck. The humeral head is provided pre-assembled to the double taper to the end user and is compacted onto 510(k) cleared compatible humeral stems (K151293) for replacement of deficient humeral heads disabled by noninflammatory arthritis, or traumatic arthritis. The pyrocarbon articulating surface is made of a graphite substrate core, coated with a layer of pyrolytic carbon deposited onto the substrate via chemical vapor deposition. The pvrocarbon articulating surface is pressed into the cobalt chromium alloy double taper neck during the manufacturing process, is provided as a singular construct to the end user, and is not intended to be disassembled by the end user. Compatible monoblock humeral stems are available in titanium plasma spray coated or uncoated versions. The humeral stems are designed with a female taper connection to accept the mating male taper connection of the pyrocarbon humeral heads.

The provided text describes the acceptance criteria and a clinical study that proves the Tornier Pyrocarbon Humeral Head device meets these criteria. However, it does not detail a study involving AI or human readers for diagnostic image analysis. Instead, the "study" referenced is a clinical trial evaluating the safety and effectiveness of a medical implant.

Therefore, many of the requested points related to AI model evaluation, such as "number of experts used to establish ground truth," "adjudication method," and "MRMC comparative effectiveness study," are not applicable to this document's content.

I will provide the information that is available in the document regarding the acceptance criteria and the clinical study of the implant.

Acceptance Criteria and Device Performance for Tornier Pyrocarbon Humeral Head (Hemiarthroplasty Implant)

The acceptance criteria for this medical device are primarily defined through bench testing (non-clinical performance) and clinical study endpoints (safety and effectiveness in patients).

1. Table of Acceptance Criteria and Reported Device Performance

A. Bench Testing (Non-Clinical Mechanical Performance)

B. Clinical Performance (Primary Endpoint for Clinical Success at 24 Months)

1. Change in Constant score is ≥ 17;
2. No revision surgery;
3. No radiographic evidence of system disassembly or fracture;
4. No system-related serious adverse event. | Composite Clinical Success (CCS):

• Intent to Treat (ITT): 82.7%
• Per Protocol (PP): 87.9%

Component Success Rates:

• Free of Revision: 98.1% (154/157)
• Constant Score improved 17+ points (among those with evaluable scores): 84.6% (121/143)
• Free of disassembly or fracture: 100.0% (157/157)
• Free of device related SAE: 96.8% (152/157) | Composite Clinical Success (CCS):
• Intent to Treat (ITT): 66.8%
• Per Protocol (PP): 63.1%

Component Success Rates:

• Free of Revision: 94.7% (160/169)
• Constant Score improved 17+ points (among those with evaluable scores): 73.1% (49/67)
• Free of disassembly or fracture: 100.0% (169/169)
• Free of device related SAE: 94.7% (160/169) |

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

• Sample Size (Test Set):
  • Pyrocarbon (Investigational) Group: 157 subjects enrolled.
  • Control Group: 169 subjects selected after Propensity Score (PS) matching from a historical dataset.
• Data Provenance:
  • Pyrocarbon Group: Prospective, multi-center, single-arm investigational study (IDE G140202 - Pyrocarbon IDE Study). Data collected from 18 sites within the US.
  • Control Group: Retrospective, derived from the Aequalis Post-Market Outcomes Study dataset. The exact country of origin for the Aequalis dataset is not explicitly stated, but given context with US-based clinical trials, it is likely also primarily US data or from similar western healthcare systems.

3. Number of Experts and Qualifications for Ground Truth

This question is not applicable as the document describes a clinical trial for a medical implant, not an AI model requiring human expert labeling of data. The "ground truth" for the clinical study is the patient's actual clinical outcome, measured through direct observation (e.g., revision surgery, radiographic findings) and patient-reported outcomes (e.g., Constant score changes).

4. Adjudication Method for the Test Set

This question is not applicable in the context of diagnostic performance evaluation for an AI model. For the clinical study of the implant:

• The primary endpoint was a composite outcome, objectively defined.
• "Unanticipated Adverse Device Effects" were determined by an independent medical monitor.
• Clinical data collection and evaluation would have followed standard clinical trial protocols, typically involving investigators at sites and a data monitoring committee. Explicit "adjudication" in the sense of resolving disagreements among multiple human readers of image data is not relevant 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 is specific to evaluating the diagnostic performance of AI or other tools when used by human readers (e.g., radiologists interpreting images). The study described is a clinical trial comparing a new implant to a historical control.

6. If a Standalone (Algorithm Only) Performance Study was done

No, this question is not applicable as the document is about a physical medical implant, not an AI algorithm. Its "standalone performance" is demonstrated through bench testing (mechanical performance, biocompatibility, sterility) rather than diagnostic accuracy.

7. The Type of Ground Truth Used

For the clinical study:

• Clinical Outcomes Data: This includes hard endpoints such as occurrence of revision surgery, radiographic evidence of system disassembly or fracture, and presence of system-related serious adverse events.
• Patient-Reported Outcomes (PROs): These are quantitative measures of patient experience and function, such as the Constant score, ASES score, SANE, EQ-5D, and VAS pain scale. Improvement in these scores contributes to the definition of "success."

For the bench testing:

• Direct Measurement/Observation: Mechanical properties are empirically measured (e.g., force to cause disassembly, visual inspection for cracks, measured ROM).
• Comparative Data: For some tests without absolute acceptance criteria (e.g., taper disassembly, fretting/corrosion, third-body wear), performance was compared to another cleared humeral head with the same intended use.

8. The Sample Size for the Training Set

This question is not applicable as the document describes a physical medical device (implant) and its clinical evaluation, not an AI model that requires a "training set" of data in the machine learning sense. The "training" for this device would refer to its manufacturing process and quality control, and the "data" is the clinical and bench testing data.

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

This question is not applicable for the reasons stated above.

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Biomet Microfixation Twist Drills are intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

Biomet Microfixation manufactures and distributes a variety of single use twist drills to aid in the implantation of Biomet Microfixation implants. Biomet Microfixation Twist Drills are intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures. The drills are manufactured from Stainless Steel. Some drills contain flutes along the majority of the drill length, while others contain a "stop" feature which prevents further drilling past a designated length. Additionally, some drills contain an "adjustable stop" feature which allows to surgeon to set the stop length intraoperatively. Twist Drills are distributed non-sterile and are intended for single-patient use. Cleaning should only be performed on new or uncompromised drills. The drills should be steam sterilized by the health-care facility prior to use.

This FDA 510(k) summary is for a medical device (Twist Drills), not an AI/ML algorithm. Therefore, many of the requested categories related to algorithm performance, training data, and expert review are not applicable.

Here's an analysis of the provided document based on the available information:

This document describes the FDA's decision to clear the Biomet Microfixation Twist Drills (K213208) as substantially equivalent to a predicate device (Twist Drills K062842).

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

The document states that "Design verification and validation testing were performed on the subject devices" and "The results from all design verification and validation tests confirmed that the subject devices met the predetermined acceptance criteria." However, the specific, quantitative acceptance criteria themselves are not provided in this summary document. The performance is reported as meeting these unspecified criteria.

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

This document discusses performance testing for a physical medical device, not a data-driven AI/ML algorithm. Therefore, terms like "test set" and "data provenance" in the context of data analysis are not directly applicable. The document refers to "design verification and validation testing," which would involve physical samples of the drill. The sample size for these physical tests is not specified in this summary.

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 as the document describes a physical medical device, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth.

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

This is not applicable for a physical medical device without a diagnostic component.

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 as the document describes a physical medical device, not an AI-assisted diagnostic tool.

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

This is not applicable as the document describes a physical medical device.

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

For a physical medical device like a drill, "ground truth" generally refers to objective physical and mechanical properties. The validation would typically involve comparing the device's performance against predefined engineering specifications and safety standards, rather than expert consensus on diagnostic images or pathology. The document generally refers to "predetermined acceptance criteria" and "design verification and validation tests."

8. The sample size for the training set

This is not applicable as the document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable as the document describes a physical medical device.

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The SOLE™ Medial Column Fusion Plate is intended to provide bone fixation. The SOLE™ Medial Column Fusion Plate is indicated for orthopedic applications within the anatomical area of the foot and ankle, including but not limited to the medial column (consisting of the first metatarsal, medial cuneiform, navicular and talus). Specific indicated procedures include: - Arthrodesis; - Joint depression stabilization; - Fracture and/or osteotomy fixation; - Reconstruction; - Revision to be performed for conditions such as Charcot neuroarthropathy.

The SOLE™ Medial Column Fusion Plate consists of plate's sizes and shapes ranges, designed to accept locking and non-locking bone screws, which are available in a variety of diameters and lengths, in order to address demands of stabilization, fixation and fusion of small bones and small joints within the anatomical area of the foot and ankle. The implants will be offered both in sterile and non-sterile packaging configurations. Plates and screws are intended for single use only. Screws are not intended for use in the spine. The Subject device implants, bone plates and bone screws, are made from Stainless Steel AISI 316 LVM according to Standard ISO 5832-1/ASTM F138. Surgical procedures with the use of the subject implants may be performed with the support of general orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The instruments offered by Orthofix are classified as class I devices Exempt from 510(k), under the product code LXH, according to 21CFR 888.4540 Orthopedic Manual surgical instrument. These instruments are made by medical grade stainless steel (AISI 316LVM, AISI 630, AISI 301, AISI 303, X15TN) and Aluminum alloy (EN-AW 6082 T6). SOLE™ Medial Column Fusion Plate is designed to be used in the operating theatre only.

The provided document is a 510(k) premarket notification for a medical device called the SOLE™ Medial Column Fusion Plate. This documentation focuses on establishing substantial equivalence to existing predicate devices through non-clinical performance data and does not involve AI or machine learning. Therefore, many of the requested criteria (e.g., sample size for test/training set, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth for AI) are not applicable to this submission.

However, I can extract the acceptance criteria and the study type used to prove the device meets these criteria based on the information provided in the "Performance Analysis" section.

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

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

The document primarily relies on bench testing and engineering assessments and a review of current clinical literature on predicates and similar devices. It does not describe a clinical study with human subjects, therefore, traditional "test set" and "data provenance" in the context of clinical data are not applicable. The bench testing would involve physical samples of the device; the number of samples is not specified.

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

Not applicable. This is a device submission based on non-clinical performance data and substantial equivalence to predicates, not a study requiring expert-established ground truth for diagnostic accuracy.

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

Not applicable. No clinical test set requiring adjudication 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 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 or AI device.

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

For the mechanical performance testing, the "ground truth" or reference for acceptable performance are the specified requirements of the referenced ASTM and ISO standards. For the substantial equivalence argument, the performance of the predicate devices serves as a comparative ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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The WITTENSTEIN intens GmbH FITBONE® TAA intramedullary lengthening system is intended for limb lengthening of the femur and tibia.

The FITBONE®TA A intramedullary lengthening system is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.

The FITBONE® TAA System is a fully implantable intramedullary lengthening device. Changes to the existing FITBONE® TAA (K163368) have been introduced to extend the current portfolio by new Subject FITBONE® TAA09 intramedullary lengthening nail model fixed to the bone by new Subject Locking Screws and a new Subject Receiver connected to the Subject nail by a bipolar feed line with new Subject external Retraction Control Set consisting of a control electronics with a Retraction Transmitter. New Subject surgical tools are provided to facilitate the surgical process.

The Subject FITBONE® TAA09 intramedullary lengthening nail model, line extension of the primary predicate FITBONE® TAA (Κ163368) models is implanted into the medullary canal of the femur or tibia. The nail is fixed to the bone by Locking Screws through longitudinal openings in the nail.

The Subject FITBONE® TAA09 intramedullary lengthening nail consists of a telescoping system that allows it to expand. It is powered by hermetically enclosed electromagnetic motor which draws the telescope apart, during which the extension is externally steered via electronic impulses. The Subject FITBONE® TAA09 intramedullary lengthening nail elongation is propelled by a highly sensitive gear and spindle mechanism which converts the rotation of the motor into an axial movement with high force.

The energy needed for the distraction process of the nail is transmitted from the outside by placing the external Transmitter over the implanted Receiver which is placed in the subcutaneous tissue during FITBONE® surgery. The energy transmission will be triggered by pressing the "Patient" button on the control electronics by the patient. There is no transcutaneous contact between the implanted intramedullary nail and the outer surface of the patient's body.

The nail and Receiver are offered in sterile conditions and the Locking screws and non-implantable external electronic controlling components in non-sterile packaging configurations.

The Subject FITBONE® TAA09 nail model is fixed to the bone by Locking Screws, made from Stainless steel AISI 316LVM, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)".

Surgical procedures with the use of the Subject FITBONE® TAA09 model shall be performed with the support of orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The surgical instruments offered by WITTENSTEIN intens GmbH as part of this submission under product code: LXH (21 CFR 888.4540).

The orthopedic instruments are made by medical grade stainless steel, Aluminum and Silicone.

The Subject FITBONE® TAA09 and the Subject external electronic controlling components are designed to be used in the operating theatre and home environment.

The FITBONE® TAA intramedullary lengthening system is intended for limb lengthening of the femur and tibia. It is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device (FITBONE® TAA, K163368) and other similar devices, rather than establishing specific, quantified acceptance criteria for a new clinical performance study. The "Performance Analysis" section summarizes that the device performs "as well as or better than the predicate devices" based on various testing.

Therefore, the table below reflects what can be inferred as "acceptance criteria" based on the substantial equivalence argument, which inherently means meeting or exceeding the predicate's performance. Specific quantitative targets for clinical outcomes are not explicitly stated in this document.

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

The document describes non-clinical performance data, specifically engineering, electrical, bench, and human factors testing. It does not mention a test set from a clinical study with human subjects.

• Sample Size: Not applicable as no clinical test set is described. The performance assessment relies on engineering and bench testing, for which sample sizes (e.g., number of nails tested for fatigue) are not specified in this summary.
• Data Provenance: Not applicable as no clinical data (e.g., country of origin, retrospective/prospective) is associated with a "test set" in the context of this 510(k) summary. The testing appears to have been conducted by the manufacturer, WITTENSTEIN intens GmbH.

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

This information is not provided in the document. As no clinical "test set" is described for algorithm evaluation, the concept of establishing ground truth by experts is not applicable to the data presented. The "ground truth" for the engineering and bench testing would be defined by established standards and internal validation protocols.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable as no clinical "test set" requiring expert adjudication is described in the document.

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. The submission is based on engineering, electrical, bench, and human factors testing to demonstrate substantial equivalence to a predicate device, not on a clinical effectiveness study involving human readers or AI assistance.

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

This is not applicable. The device, FITBONE® TAA, is an intramedullary lengthening system, a physical medical device, not an AI algorithm or software device. Therefore, a "standalone algorithm performance" study is not relevant.

7. The Type of Ground Truth Used

The "ground truth" in this submission is established through:

• Engineering Standards and Bench Testing Results: Compliance with established mechanical, material, and electrical performance standards (e.g., ASTM F138-13 for stainless steel). The performance of the predicate device also serves as a benchmark for equivalence.
• Risk Management Activities: Identification and control of potential hazards.
• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (FITBONE® TAA, K163368) forms the basis for demonstrating substantial equivalence.

No pathology, expert consensus, or outcomes data from a new clinical study are used as ground truth for a test set in this 510(k) summary.

8. The Sample Size for the Training Set

This information is not applicable. The FITBONE® TAA is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The design and development of the device would involve engineering principles and prototypes, but not a data-based "training set."

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

This information is not applicable as there is no "training set" in the context of this medical device submission.

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The Balex Bone Expander System is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

The Balex Bone Expander System is designed to reduce compression fracture and create a void in cancellous bone in the spine. By creating a space in the operating point, the major benefits of the Balex Bone Expander System are the reduction in pain and the increase of patient`s functional abilities, which allow for the patient's return to the previous level of activity.

The Balex Bone Expander System consists of the Balloon Expander and Balloon Catheter. They are used with Cement Dispenser System, Cement Mixer System and Syringe which are Class I, 510k exempt devices.

The Balloon Catheter consists of an inner-outer tube, inflatable balloon located at the balloon tip. The radiopaque markers located at the balloon tip end allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Expander consists of a pressure gauge, compression cylinder, a connect Line and a 3 way valve. The Balloon Expander is used for inflating the balloon by rotating the plunger clockwise. The lock mechanism maintains pressure. All the components are supplied sterile and are disposable.

The provided document is a 510(k) summary for the Balex Bone Expander System. It describes the device, its intended use, and a comparison to predicate devices, but it does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and performance tests for safety and biocompatibility. It lists several non-clinical performance tests conducted, but it does not provide specific acceptance criteria values for these tests or detailed results demonstrating compliance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: While a list of performance tests is provided, specific quantitative acceptance criteria and corresponding reported device performance values are not included.
2. Sample size used for the test set and the data provenance: The document mentions "non-clinical tests" but does not specify sample sizes or data provenance for these tests.
3. Number of experts used to establish the ground truth... and their qualifications: This is not applicable as the document describes a non-clinical evaluation, not a study involving human or image-based ground truth established by experts.
4. Adjudication method for the test set: Not applicable for non-clinical performance and safety tests.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or implied. The evaluation is for a physical medical device (bone expander), not an AI algorithm.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
7. Type of ground truth used: Not applicable in the traditional sense. The "ground truth" for the non-clinical tests would be defined by the standards and specifications against which the device is tested (e.g., burst pressure limits, material strength requirements).
8. Sample size for the training set: Not applicable as this is a physical medical device, not an AI model.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information (related to your questions, but not directly answering them due to content limitations):

The document lists the following performance tests and standards, implying that these are the areas where the device's performance was evaluated to ensure safety and effectiveness:

• Sterilization Validation Tests in accordance with ISO 10993-7
• Shelf Life Tests in accordance with ASTM F1980, ASTM F88, ISO11737-2
• Biocompatibility Tests in accordance with ISO 10993 (Cytotoxicity, Maximization sensitization, Material-mediated pyrogenicity, Acute Systemic toxicity, Intracutaneous reactivity)
• Extraction Test (Non-volatile Residue, Residue on Ignition, Heavy Metals, Buffering Capacity)
• EO Gas Sterilization Residual
• Appearance for Balloon
• Balloon Dimensions
• Burst Pressure (constrained and unconstrained)
• Balloon leakage
• Pressure gauge precision
• Inflation and deflation time
• Insertion force and withdrawal force
• Tensile and tensile bond strength
• Balloon fatigue test

The document concludes that "The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences." This indicates that the device met the internal specifications and regulatory requirements based on these tests, but the specific numerical acceptance criteria and performance data are not disclosed in this summary.

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The Spineology Interbody Fusion System (SIFS) is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. SIFS with compatible allograft and autograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

The Spineology Interbody Fusion System (SIFS) is a lumber intervertebral body fusion device comprised of a PET (polyethylene terephthalate) mesh bag designed to contain compatible allograft and autograft as an adjunct to fusion for the treatment of degenerative disc disease. The device is placed into the prepared intervertebral disc space and then is packed with bone graft. The resulting SIFS implant is used with posterior supplemental fixation systems forming the completed SIFS construct.

The provided text describes the acceptance criteria and the study that proves the Spineology Interbody Fusion System (SIFS) meets these criteria. It does not describe an AI/ML device but rather a medical implant. Therefore, the questions related to AI/ML specific aspects (e.g., test set ground truth, MRMC study, standalone algorithm performance, training set) are not applicable to this document. The focus below will be on the information provided regarding the device's clinical and non-clinical performance and acceptance criteria.

Acceptance Criteria and Device Performance for Spineology Interbody Fusion System

This document outlines the evaluation of the Spineology Interbody Fusion System (SIFS), an intervertebral body graft containment device, for De Novo classification. The acceptance criteria are derived from both non-clinical/bench testing and a clinical study designed to demonstrate the device's safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established through a combination of non-clinical performance benchmarks (where applicable) and primary clinical endpoints.

2. Sample Sizes and Data Provenance

• Clinical Study Sample Size:
  • Test Set (Clinical Study Cohort): 102 subjects were enrolled and treated across 10 clinical sites.
  • Follow-up at 24 Months: 96 subjects provided complete data in-window (95.0% follow-up rate). Fusion assessment was conducted on 97 subjects (considering 12- and 24-month assessments).
• Data Provenance: The data is from a 24-month, prospective, single-arm, multi-center clinical study (G140140). The location of the clinical sites is not specified beyond "multi-center," but typically for FDA De Novo, such studies are conducted in the US or with data acceptable to the FDA. The study was based on a previously conducted prospective, randomized, multi-center study (G030106) for the same device. Given the context of a US FDA De Novo submission, it is highly likely that the centers were primarily in the United States, and the data is prospective.

3. Number of Experts and Qualifications for Ground Truth (Clinical Study)

• Ground Truth for Fusion: "Fusion was assessed by independent radiologists at the 12-month time point, and again at 24 months for those subjects who had not fused."
• Number of Experts: Not explicitly stated how many independent radiologists assessed each case, nor is their specific qualification (e.g., years of experience) mentioned. However, "independent radiologists" implies qualified medical professionals specialized in interpreting spinal imaging.

4. Adjudication Method (Clinical Study Test Set)

• The document implies that "independent radiologists" assessed fusion, but it does not specify an adjudication method (e.g., 2+1, 3+1 consensus process) for discrepancies between readers if multiple readers were used per case. It states fusion was "assessed by independent radiologists," which could mean one radiologist per case or multiple without a defined consensus process in the provided text.

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

• No MRMC study was conducted. This was a single-arm study evaluating the device's performance, not a comparative effectiveness study involving human readers with/without AI assistance. The device is an implant, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance

• Not Applicable. This is a medical implant, not an algorithm. Therefore, "standalone (i.e., algorithm only without human-in-the-loop performance)" is not relevant.

7. Type of Ground Truth Used (Clinical Study)

• Combination of Clinical Outcome Measures and Radiographic Assessment:
  • Pain and Function: Ground truth derived from patient-reported outcomes (Visual Analog Scale for pain, Oswestry Disability Index for function).
  • Fusion: Ground truth established through "bridging bone demonstrated on CT Scan," assessed by independent radiologists. This is a radiographic ground truth.
  • Safety: Ground truth based on the occurrence and classification of adverse events, assessed by a Clinical Events Committee (CEC). This involves medical record review and expert medical judgment.

8. Sample Size for the Training Set

• Not Applicable. This is a human-implanted medical device, not an AI/ML algorithm. There is no concept of a "training set" in the context of device development as described here. The clinical study served as the primary evidence to demonstrate safety and effectiveness for regulatory approval.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The clinical study's data, as described in point 7, formed the basis of the evidence for the device's performance.

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The Wiggins Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.

The Wiggins Medical Surgical Instruments are manufactured from 420 and 304 stainless-steel conforming to ASTM F899. Instruments are available in both Stainless Steel and Titanium Aluminum Nitride (AITiN) coated Stainless Steel configurations. They are packaged non-sterile and can be reprocessed per the instructions for use. Surgical instruments consist of Kerrison and Pituitary Rongeurs, and are available in numerous sizes and configurations including:

• Different handles (Large, Standard, for use with Rotating Shafts)
• Different shaft lengths (6-14 inches)
• Different Bite Sizes (0.5-6 mm)
• Different Angles (40° and 90°, up and down)
• Different Footplates (Standard, Thin and Ultra-Thin)
• With or without ejector
• Different shaft styles (Standard, Bayonet, Rotating, Endoscopic, Detachable, Curved)

The provided text is an FDA 510(k) summary for Wiggins Medical Surgical Instruments. It details a submission for manual surgical instruments (rongeurs) used for cutting or biting bone during skull or spinal column surgery.

Here's an analysis of the acceptance criteria and study data based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a separate "test set" for the Wiggins Medical Surgical Instruments in the context of typical AI/software device evaluation. Instead, the testing relies heavily on the predicate device (Fehling Punches) for mechanical strength and biocompatibility.

• Mechanical Strength: The predicate device was tested. The sample size for this testing is not specified. Data provenance is implied to be from the manufacturer of the predicate device (Gebruder Zepf Medizentechnik GmbH & Co. KG), which is also the manufacturer of the subject device. The nature of these tests (e.g., specific number of cycles for fatigue) is not detailed.
• Cleaning: "Worst case instrument" was tested. The specific number of instruments or samples is not specified. The test was performed by the manufacturer of the subject device.
• Sterilization: Performed using the "half-cycle approach." The number of samples or cycles is not specified.
• Biocompatibility: Relied on the biocompatibility of the predicate device. The underlying data provenance for the predicate's biocompatibility is not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this submission. The device is a manual surgical instrument, not an AI/software device that requires expert-established ground truth for its performance evaluation (e.g., diagnostic accuracy). The evaluations are based on physical and biological performance characteristics.

4. Adjudication Method for the Test Set

This is not applicable as there is no mention of a "test set" that requires expert adjudication for diagnostic or interpretive outcomes.

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

This is not applicable. The device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies are typically conducted.

6. Standalone Performance Study (Algorithm Only)

This is not applicable as the device is a manual surgical instrument, not an algorithm or software.

7. Type of Ground Truth Used

The "ground truth" for this type of device is established through:

• Objective physical testing: Mechanical strength (fatigue resistance, cutting displacement).
• Chemical/Biological testing: Cleaning validation (absence of soil, protein, hemoglobin), sterilization (sterility assurance level), and biocompatibility (lack of adverse biological response).
• Comparison to a legally marketed predicate device: Substantial equivalence claimed based on identical materials, manufacturing, design, function, and intended use as the predicate device.

8. Sample Size for the Training Set

This is not applicable as the device is a manual surgical instrument and does not involve AI or machine learning models that require training sets.

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

This is not applicable.

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The Ace Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.

The Ace Medical Surgical Instruments are manufactured from 420 and 304 stainless-steel conforming to ASTM F899. Instruments are available in both Stainless Steel and Titanium Aluminum Nitride (ATTiN) coated Stainless Steel configurations. They are packaged non-sterile and can be reprocessed per the instructions for use. Surgical instruments consist of Kerrison and Pituitary Rongeurs, and are available in numerous sizes and configurations including:

• Different handles (Large, Standard, for use with Rotating Shafts)
• Different shaft lengths (6-14 inches)
• Different Bite Sizes (0.5-6 mm)
• Different Angles (40° and 90°, up and down)
• Different Footplates (Standard, Thin and Ultra-Thin)
• With or without ejector
• Different shaft styles (Standard, Bayonet, Rotating, Endoscopic, Detachable, Curved)

Here's a breakdown of the acceptance criteria and study information for the Ace Medical Surgical Instruments, based on the provided FDA 510(k) summary:

This device is a manual surgical instrument (rongeur), not an AI/ML-driven device. Therefore, many of the typical AI/ML study components (like expert ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable. The studies focus on the physical and functional characteristics of the surgical instrument.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Mechanical Strength: The summary indicates that the predicate device (Fehling Punches) was subjected to static and dynamic mechanical testing. The specific sample size for this predicate testing is not provided in this document. The subject device was deemed identical, so no separate test set was used for mechanical strength for the subject device.
• Cleaning: A cleaning validation was performed on a "worst case instrument." This implies a single instrument or a very small sample to represent the most challenging cleaning scenario.
• Sterilization: The validation used a "half-cycle approach," which is a common method for sterilization cycle validation, but the exact sample size (number of devices or cycles performed) is not specified.
• Biocompatibility: No specific test set was used for the subject device as it was determined to be identical to the predicate.

Data Provenance: Not applicable in the context of clinical data for a manual surgical instrument. The tests are laboratory/benchtop validations.

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

Not applicable for tests related to mechanical, cleaning, sterilization, and biocompatibility of a manual surgical instrument. Ground truth is established by test standards and laboratory measurements.

4. Adjudication Method for the Test Set

Not applicable for these types of benchtop tests. Results are typically determined by measurement against established standards rather than expert adjudication.

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 manual surgical instrument, not an AI-driven device.

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

Not applicable. This is a manual surgical instrument.

7. The Type of Ground Truth Used

• Mechanical Strength: Ground truth is based on the performance characteristics of the predicate device as demonstrated through static and dynamic mechanical testing against engineering specifications for fatigue and cutting displacement.
• Cleaning: Ground truth is established by adherence to a recognized standard: AAMI TIR 30:2011 for protein and hemoglobin content, and visual inspection for soil.
• Sterilization: Ground truth is established by achieving a specific sterility assurance level (SAL) of 10^-6, which is a recognized regulatory benchmark for sterility.
• Biocompatibility: Ground truth is established by the predicate device's proven biocompatibility and the material equivalence of the subject device. Compliance with material standards (ASTM F899) is also implied.

8. The Sample Size for the Training Set

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

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

Not applicable.

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The JPS JuniOrtho Plating System™ is internal fixation and stabilization of fractures, osteotomies, mal-unions and non-unions of long bones of the lower limb.

The JPS JuniOrtho Plating System™ is indicated for internal fixation of femoral and tibial fractures, osteotomies, mal-unions and non-unions.

Indications include:

• Varus, valgus, rotational and/or shortening osteotomies
• Femoral neck and/or pertrochanteric fractures
• Proximal and distal metaphyseal fractures
• Pathological and impeding pathological fractures

Use of the JPS JuniOrtho Plating System™ is indicated in pediatric (excluding newborns) and small stature adult patients.

The JPS JuniOrtho Plating System™ consists of plate's sizes and shapes ranges, designed to accept locking and cortical bone screws, which are available in a variety of diameters and lengths, in order to support internal fixation and stabilization of fractures, osteotomies, mal-unions and non-unions in long bones of lower limbs. The JPS JuniOrtho Plating System™ is designed according to the anatomic region of clinical application: femur and tibia. The implants would be offered both in sterile and non-sterile packaging configurations.

The subject device implants, bone plates and bone screws, are made from Stainless steel AISI 316LVM, according to ASTM F138 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)".

Surgical procedures with the use of the subject implants may be performed with the support of general orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The instruments and accessories offered by Orthofix are classified as class I devices exempt from 510(k), under the product code LXH, according to 21 CFR 888.4540 Orthopedic Manual Surgical Instrument, and product code FSM according to 21 CFR 878.4800 Manual surgical instrument for general use.

These instruments are made by medical grade stainless steel (AISI 316LVM, AISI 630, AISI 420B, AISI 303, X15TN), Aluminum alloy (EN-AW 6082 T6), and plastic material (PP-H PROPILUX).

JPS JuniOrtho Plating System™ is designed to be used in the operating theatre only.

This is a medical device 510(k) summary, not a study report for an AI/ML powered device. As such, it does not contain any information about:

• Acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes or data provenance for a test set.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

This document describes a traditional medical device, the "JPS JuniOrtho Plating System™," which consists of physical plates and screws for internal fixation of bones. The performance analysis mentioned refers to bench testing and engineering assessments of the mechanical properties of the hardware, compared to predicate devices, to demonstrate substantial equivalence.

Therefore, I cannot provide the requested table and information based on the provided text.

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The SX-One MicroKnife is a disposable device intended to create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.

The Sonex Health SX-One MicroKnife is a mechanical device that uses a blade to manually transect the transverse carpal ligament. The device is provided sterile and intended for single use.

The SX-One MicroKnife® consists of a thin stainless-steel shaft connected to a handpiece that is designed to be ambidextrous. A lever on the handle is activated to unlock the blade actuator and inflate the two balloons located on the lateral sides of the tip of the device. The blade actuator is used to activate a cutting blade that transects the TCL. The cutting blade is manually moved proximally and distally along a track. The purpose of the blade is to transect the transverse carpal ligament to treat carpal tunnel syndrome.

This document describes the Sonex Health SX-One MicroKnife, a manual surgical instrument for carpal tunnel release. The information provided is primarily related to its regulatory clearance (510(k) submission) and does not contain details about acceptance criteria, clinical study results, or AI/software performance.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or MRMC studies, as the provided text explicitly states "No clinical data was required" and describes a mechanical device with no mention of AI or software.

The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance testing related to sterilization, biocompatibility, and shelf life for a mechanical surgical instrument.

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