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The Cross Medical Bone Plate System is intended for non-spinal applications only in the treatment of internal fixation of pelvic fractures.

3.5 mm x 8 mm Bone Screw through 3.5 mm x 30 mm Bone Screw in 2 mm increments
4.0 mm x 8 mm Bone Screw through 4.0 mm x 30 mm Bone Screw in 2 mm increments
C-Plates Assorted Sizes
Device specific instrumentation is necessary for the insertion and anchoring of the CM Bone Plate System. System instrumentation includes: Plate Holder, Plate Cutter, Plate Bender, Plate Shaper, Plate Template, Drill Guide, Drill Bits, Driver Handle, Screw Taps, Screwdriver, Screw Holder, Sterilizer Case.
The implants of the new system are made from titanium alloy (6A1, 4V, ELI) and CP titanium or from 22-23-5 Stainless Steel.
The titanium bone plates are made from commercially pure titanium meeting ASTM F67-89. This material is also known as Commercially Pure Titanium (CP Ti, Grade 2). The stainless steel bone plates are made from ASTM F-1314, also known as 22-23-5 Stainless Steel.
The titanium bone screws are made from the industry standard alloy Ti 6A1-4V ELI, ASTM F-136-92. The stainless steel bone screws are made from ASTM F-1314, also known as 22-23-5 Stainless Steel.
The surface of both the titanium screws and titanium plates are anodized and/or matte finished. The surface of both the stainless steel screws and stainless steel plates are matte finished.
The CP titanium plates are offered for their ease of contouring and their mechanical performance.

This document is primarily a premarket notification (510(k)) for the Cross Medical Bone Plate System, seeking to establish substantial equivalence to previously marketed devices. It is not a study that proves a device meets specific acceptance criteria in the way a clinical trial or performance study for a novel device would. Instead, the "acceptance criteria" here are the regulatory requirements for showing substantial equivalence.

Therefore, many of the requested fields regarding detailed study design, sample sizes, expert qualifications, and comparison with AI performance are not applicable to this type of regulatory submission. The document focuses on demonstrating that the device is as safe and effective as existing legally marketed devices, primarily through comparison of design, materials, and intended use.

Here's an attempt to answer the questions based on the provided text, with clarifications on applicability where necessary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This document is a 510(k) premarket notification. It does not describe a clinical study with a "test set" in the sense of patient data. The basis for substantial equivalence relies on material properties, design comparisons, and mechanical testing (mentioned but not detailed). The "data provenance" would refer to the standards and engineering analyses performed.
• The document states: "mechanical testing" was included in the reasoning for substantial equivalence. However, no specific details like sample size, methodology, or results of these tests are provided in the summary.

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

• Not Applicable. As this is not a clinical study involving diagnosis or interpretation, there is no "ground truth" established by experts in this context. The determination of substantial equivalence is made by the FDA based on the provided technical information and comparison to predicate devices. The expertise involved would be in engineering, materials science, and orthopedics for the design and manufacturing, and regulatory affairs for the submission.

4. Adjudication Method for the Test Set

• Not Applicable. No test set or expert adjudication in the context of clinical data interpretation 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 a passive implant (bone plate and screw system) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is irrelevant to this submission.

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

• Not Applicable. This device is a physical, surgical implant and does not involve an algorithm.

7. The Type of Ground Truth Used

• For the purpose of this 510(k) submission, the "ground truth" is effectively the established safety and effectiveness of the identified predicate devices (Ace Brand Bone Plates and Screws, Synthes Brand Bone Plates and Screws). The manufacturer demonstrates that their device is sufficiently similar to these legally marketed devices that it raises no new questions of safety or effectiveness.
• The document also implies reliance on engineering standards (ASTM F67-89, ASTM F-1314, ASTM F-136-92, ASTM F-899-84, A276-91) for material composition and HIMA/AORN protocols for sterilization, which serve as benchmarks for performance and safety.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an algorithm or AI-driven device.

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

• Not Applicable. See point 8.

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Intended Use. For use in oral/dental procedures for the incision, ablation, vaporization and hemostasis of soft tissue.

Specific Indications for Use:

1. Gingivoplasties
2. Ginaivectomies
3. Frenectomies
4. Benign and malignant lesion removal
5. Biopsies
6. Leukoplakia
7. Fibrotomy

Pharos Optics, Inc. offers a dental laser system known as the FutureLase zooo/goo2 Erbiurm Laser System. The device utilizes laser radiation energy produced at a frequency of 2.94น. This laser system is intended for intraoral or dental soft tissue surgery including the marginal and interdental gingiva. The FutureLase zooo/zoo2 Erbium Laser System is used to assist the dentist or oral surgeon with the following general intended use and/or specific indications for use:

The provided text does not contain information about the acceptance criteria and the study that proves the device meets them in the context of performance metrics like sensitivity, specificity, or accuracy. This document, a 510(k) premarket notification for the FutureLase 3000/3002 Erbium Laser System, is focused on demonstrating substantial equivalence to legally marketed predicate devices.

The information primarily discusses:

• Device Name and Classification: FutureLase 3000/3002 Erbium Laser System, Class II, Product Code 79GEX.
• Intended Use and Specific Indications for Use: For oral/dental procedures involving incision, ablation, vaporization, and hemostasis of soft tissue, including gingivoplasties, gingivectomies, frenectomies, benign/malignant lesion removal, biopsies, leukoplakia, and fibrotomy.
• Device Description: Details on the laser head, power supply, cooling system, control system, control panel, and beam delivery.
• Substantial Equivalence: A comparison table showing that the FutureLase 3000/3002 has similar technical specifications (Laser Type, Wavelength, Pulse Rate, Pulse Duration, Max Pulse Energy, Power, Beam Delivery, Fiber Material, Electrical Requirements, and Indications) to predicate devices (TriLase 2940 Erbium Laser System, MedLite Erbium Laser System, and PulseMaster™ Dental Laser System).

Missing Information:

The document does not include:

1. A table of acceptance criteria and reported device performance related to specific clinical outcomes or statistical metrics.
2. Sample sizes for test sets, their provenance, or whether the study was retrospective or prospective.
3. The number or qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. Results of Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or the effect size of AI assistance.
6. Results of standalone (algorithm-only) performance studies.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This is typical for a 510(k) submission, where the primary objective is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than to prove absolute safety and effectiveness through extensive clinical trials with specific performance endpoints. The equivalence is primarily established through technical characteristics and similar intended use.

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1. Converts Ail Standard Keyed Metal Chuck Head Surgical Drives Into Keyless Chuck Drives.

The device is a simple barrel shaped plastic outer sleeve that is designed in such a way that when it is in place over a standard ¼" metal head orthopaedic chuck, it allows the surgeon or assistant to quickly and easily insert, drive and or remove any size (up to ¼" dia.) orthopaedic bit or pin. The device eliminates the necessity to use the usual chuck key such drives ordinarily require. This feature significantly reduces the chance that a glove could be cut or pinched in the exposed metal gears of the chuck and key. Pin holes in surgical gloves have been shown to a potential source of bacterial and/or viral contamination placing patients and health care providers at risk.

This 510(k) premarket notification (K964252) focuses on establishing substantial equivalence for the ORTHOCHUCK™, a device designed to convert standard keyed metal chuck head surgical drives into keyless chuck drives. The submission primarily relies on a comparison to existing predicate devices rather than independent performance studies with detailed acceptance criteria and standalone performance metrics.

Here's a breakdown of the requested information based on the provided document:

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

The document does not explicitly state formal quantitative acceptance criteria for device performance. Instead, it uses a comparison table to demonstrate how the ORTHOCHUCK™ is functionally equivalent to or improves upon predicate devices. The "reported device performance" is essentially its functional characteristics relative to these predicates.

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 does not describe a formal performance study with a "test set" in the sense of clinical or laboratory data for statistical analysis. The determination of substantial equivalence is based on a comparison of design, materials, and intended use with legally marketed predicate devices.

• Sample Size: Not applicable as no specific test set data is presented.
• Data Provenance: Not applicable. The "data" consists of the features and characteristics of the device and its predicate devices, as described in the comparison table and device description.

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)

No external experts were used to establish "ground truth" for a test set, as no test set data was presented. The ground truth, in this context, refers to the established functional characteristics of existing surgical chucks, which are common knowledge in the orthopaedic surgical field. The comparison is made against these known characteristics.

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

Not applicable. There was no test set requiring 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 device is a mechanical surgical accessory, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant to its evaluation.

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

Not applicable. The ORTHOCHUCK™ is a mechanical accessory designed to be used by a human surgeon or assistant. It does not operate as an algorithm or autonomously.

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

The "ground truth" implicitly used for this submission is the established functional performance and safety characteristics of existing legally marketed predicate devices (both keyed and keyless chucks), combined with the detailed design and material specifications of the ORTHOCHUCK™ itself. This reflects an engineering and functional comparison, rather than a clinical outcomes study.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning system, so there is no concept of a "training set."

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

Not applicable. As there is no training set.

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The SYNERGY™ Posterior Spinal System, when using the screws as pedicle screws, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

Except for situations where screws are attached to the pedicles of the lumbar and sacral spine via a posterior approach for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the SYNERGY™ Posterior Spinal System are:

1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
2. Idiopathic scoliosis.
3. Kyphotic deformities of the spine.
4. Paralytic scoliosis and/or pelvic obliquity treated in combination with anterior instrumentation.
5. Lordotic deformities of the spine.
6. Neuromuscular scoliosis associated with pelvic obliquity.
7. Vertebral fracture or dislocation.
8. Tumors.
9. Spondylolisthesis.
10. Stenosis.
11. Pseudarthrosis.
12. Unsuccessful previous attempts at spinal fusion.

The SYNERGY™ Posterior Spinal System implants are intended to stabilize the spinal operative site during the development of a solid fusion with bone graft, and are intended to be removed after the development of a solid fusion mass. The implantable portions are made from surgical implant grade stainless steel, commercially pure titanium, and titanium alloy meeting ASTM specifications. The surgical instruments are made from 17-4, 420, 440 and 455 series stainless steels (ASTM F-899-84 and A276-91). Established medical grade plastics (Ultem and Radel) are used to construct the handles, cases, etc. The system is made up of INTEGRAL™ screws, spinal hooks, adjustable and fixed transverse connectors, closed and axial rod connectors, lateral connectors, rods, instruments, and sterilization case(s).

This document is a 510(k) Summary of Safety and Effectiveness for the SYNERGY™ Posterior Spinal System. It describes the device, its intended use, indications, contraindications, and comparisons to predicate devices. However, this document does not contain acceptance criteria or detailed study results demonstrating that the device meets specific performance criteria.

Here's why and what information is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated in the document. For a medical device, these would typically include specific performance metrics like strength, fatigue life, corrosion resistance, biocompatibility, etc., often with numerical thresholds or pass/fail conditions.
• Reported Device Performance: The document mentions that the implants are made from materials meeting ASTM specifications and have "excellent strength, fatigue and corrosion resistance characteristics." It also states "mechanical testing" was done, but no specific results or performance values are provided.
  • Missing Information: Quantitative data from mechanical tests (e.g., maximum load at failure, cycles to failure in fatigue tests), specific corrosion rates, or biocompatibility test results.

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned. It's implied that "mechanical testing" and "pre-production quality assurance planning and engineering analysis" were performed by CROSS® Medical Products, Inc., but details on where (e.g., country) or how (retrospective/prospective) are absent. This document focuses on the summary of safety and effectiveness based on equivalence, not a detailed research study protocol or results.

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

• Not Applicable. This device is a surgical implant, not a diagnostic or AI-driven device that requires "ground truth" established by human experts in the context of image interpretation or similar tasks. The "truth" for this device lies in its material properties, mechanical performance, and clinical safety/effectiveness for its intended use, typically assessed through engineering tests and clinical experience with predicate devices.

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.

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 (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. For a spinal implant, the "ground truth" for proving substantial equivalence primarily relies on:
  • Material Specifications: Adherence to established ASTM standards for surgical implant materials.
  • Mechanical Testing: Demonstrating equivalent (or superior) mechanical properties (strength, fatigue) compared to predicate devices, often simulated or in vitro.
  • Design Similarity: Comparison of features and dimensions to legally marketed predicate devices.
  • Clinical Experience/Literature: Relying on the known safety and effectiveness of the predicate devices for similar indications.
  • The document states "mechanical testing" was performed, and "engineering analysis" was used to establish substantial equivalence.

8. The sample size for the training set:

• Not Applicable. This device does not use a "training set" in the machine learning sense. The "training" for such a device typically refers to the accumulated knowledge and design principles from prior similar devices and material science.

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

• Not Applicable. See point 8.

In summary:

This 510(k) summary is a regulatory document asserting "substantial equivalence" to predicate devices, a common pathway for medical device approval. It focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, primarily through:

• Similarity in design and intended use.
• Use of well-known, established materials (meeting ASTM specifications).
• Mechanical testing (though no specific results are provided in this summary).
• Comparison of indications and contraindications.

The level of detail requested in your prompt regarding specific acceptance criteria, test set sizes, ground truth establishment, and MRMC studies is typically found in detailed test reports, design verification and validation documents, or clinical study reports, which are part of the full 510(k) submission but are not always included in the publicly available summary documents.

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Reduction and stabilization of grades III & IV spondylolisthesis of the fifth lumbar to first sacral vertebral interspace only. The Webb-Morley Spine System is for temporary use and must be accompanied by the application of autogenous source bone graft only. Once solid fusion is achieved, surgical removal of the device system is recommended. Planned removal of the device occurs within one year of the original surgery in adults and within two years of reaching skeletal maturity for adolescents.

The Webb-Morley Spine System is made from surgical implant grade Stainless steel meeting ASTM F-138-86 requirements. The Webb-Morley Spine System has the same indications for use as the recently cleared TSRH® and PLSA systems. The use of the Webb-Morley Spine System as a pedicle screw system involves screw attachment at the sacrum, the L5 vertebral pedicles, the L4 vertebral pedicles and in isolated cases, the L3 vertebral pedicles. The inclusion of additional pedicular levels may sometimes be necessary in order to reduce the spondylolisthetic deformity at L5 - S1 and maintain adequate correction. The Screws of this system are limited to L3-S1 or iliac screw fixation.

Acceptance Criteria and Device Performance for Webb-Morley Spine System

This document summarizes the acceptance criteria and study proving the Webb-Morley Spine System meets these criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The Webb-Morley Spine System's acceptance criteria are implicitly defined by its claim of "Substantial Equivalence" to two predicate devices: the TSRH® Posterior Spine System (K932029) and the Posterior Lumbar Sacral Attachment (PLSA) Spine System (K945064). The acceptance criteria, therefore, are that the Webb-Morley system performs equivalently or superiorly to these predicate devices in terms of mechanical strength, fatigue, and corrosion resistance, and shares the same indications for use, contraindications, and other design features.

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

The study primarily relies on physical testing of the device components and a comparison against predicate devices.

• Test Set Sample Size: Not explicitly stated as a number of devices or components. The testing appears to have been conducted on an unspecified number of Webb-Morley Spine System implants.
• Data Provenance: The data comes from in-house engineering review and commercial laboratories that performed static and fatigue testing. This is likely prospective testing specifically conducted for this submission. The origin of the data is the company (Electro-Biology, Inc.) and the commercial laboratories they contracted. No patient data or clinical trial data is mentioned for this specific device. The clinical experience listed for the Webb-Morley system is "European," suggesting that some observational data or initial use might have occurred there, but this is not part of the described "physical testing."

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

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., expert consensus on medical images) is not applicable here. The "ground truth" for this device's performance acceptance is based on:

• Engineering Standards: Established ASTM, ISO, and BS standards for implant materials and design.
• Performance of Predicate Devices: The established safe and effective performance of the TSRH® and PLSA systems.
• Qualified Commercial Laboratories: These labs performed the physical testing (static and fatigue) to objective engineering criteria. Their qualifications are mentioned as "qualified commercial laboratories," but specific expert numbers or individual qualifications (e.g., "bioengineers with 10 years of experience") are not provided.

4. Adjudication method for the test set

Not applicable. The evaluation is based on objective physical testing results against established engineering criteria and direct comparison with predicate device performance, not on subjective expert review requiring 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted and is not applicable to this type of device (spinal implant system). This device is a physical medical implant, not an AI-powered diagnostic or assistive tool for human readers.

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

No, a standalone algorithm performance study was not conducted. This device is a physical medical implant.

7. The type of ground truth used

The ground truth for this submission is based on:

• Objective Engineering Test Results: Data from static and fatigue testing.
• Compliance with Recognized Standards: Adherence to ASTM, ISO, and BS material and performance standards.
• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (TSRH® and PLSA systems), against which the Webb-Morley system demonstrated equivalence or superiority.

8. The sample size for the training set

Not applicable. This submission concerns a physical medical device, not an AI or machine learning algorithm requiring a training set.

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

Not applicable. This submission concerns a physical medical device, not an AI or machine learning algorithm.

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