Search Results

The MAGNETOLITH Muscle Stimulator is indicated for:

-Relaxation of muscle spasms,

-Prevention or retardation of disuse atrophy,

-Increase local blood circulation.

-Muscle re-education,

-Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,

-Maintaining or increasing range of motion.

The MAGNETOLITH delivers electromagnetic pulses to stimulate muscle tissues by applying the Magnetic Induction Field Principle (high-energy magnetic pulses) directly over (but not in direct contact with) the patient in order to achieve the same powered muscle stimulation without having to place adhesive electrode pads directly onto the patient's body. Key components of the device are the Control Unit, Handpiece Applicator, Applicator holder, a Mains cable, and a Trolley. These device components are provided non-sterile and are intended to be reusable.

The principle of operation of the MAGNETOLITHis by the application of a treatment coil to generate electromagnetic induction. i.e., the production of voltage across an electrical conductor in a changing magnetic field. The duration of the individual pulses is short and therefore the system does not increase temperature within the tissues. In addition, the MAGNETOLITH Applicator is cooled by circulating water.

It seems there are no specific acceptance criteria or details of a study proving the device meets those criteria provided in the document. The document is a 510(k) summary for the Storz Medical MAGNETOLITH Muscle Stimulator, demonstrating substantial equivalence to predicate devices, rather than a report on specific performance acceptance criteria.

The "PERFORMANCE TESTING" section (Page 4-5) states that: "Verification and validation testing was performed and demonstrated that the MAGNETOLITH meets the design specifications and is safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed." However, it does not explicitly list the acceptance criteria or refer to a specific clinical study with patient data and ground truth establishment.

Instead, the performance testing focuses on:

• Software Validation: The MAGNETOLITH software was validated and demonstrated to be of a moderate level of concern.
• Risk Management: Hazard analysis/risk management was performed, and all risks were mitigated to an acceptable level.
• Biocompatibility: Not performed as there are no body-contacting components.
• Conformity to Standards: The device was tested and demonstrated to conform to general safety requirements of IEC 60601-1:2012, IEC 60601-6:2013, electromagnetic compatibility requirements of IEC 60601-1-2:2014, ISO 14971:2000/A1:2007, IEC 62304:2015, and ISO 13485:2016.

The document then provides a comparison table of the MAGNETOLITH with its predicate devices (HPM-6000 and Bemer Classic & Pro) to establish substantial equivalence based on technological characteristics and safety standards. This comparison is not a study proving specific performance criteria with clinical outcomes.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets those criteria based on the provided text. The document focuses on demonstrating substantial equivalence through technical comparisons and adherence to regulatory standards, not on a clinical performance study with specific acceptance criteria, sample sizes, expert ground truth, or MRMC studies.

Ask a specific question about this device

The DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The DUOLITH SD1 with C-ACTOR is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The DUOLITH SD1 with the C-ACTOR Sepia Handpiece uses an electromagnetically generated shock wave produced within the hand-held applicator. The shock wave is generated by discharging a high voltage capacitor located in the Control Unit into a cylindrically shaped coil system in the C-ACTOR Handpiece which is surrounded by a cylindrical metallic membrane. The transient magnetic field produced by the coil induces eddy currents in the metal membrane, causing it to repel from the coil, producing a pressure wave. The membrane is immersed in water and the pressure wave produced by the membrane propagates through the water to a concentric parabolic reflector, where it is reflected to a focal point outside of the Handpiece in front of the reflector. The DUOLITH SD1 with C-ACTOR incorporates micro-processor control of the operating parameters.

Here's an analysis of the provided text regarding the DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly list "acceptance criteria" in a quantitative, measurable format for performance, as might be found in a clinical trial protocol. Instead, it describes compliance with design specifications, safety standards, and then reviews clinical literature to demonstrate effectiveness.

Here's an interpretation of the performance claims based on the clinical literature review:

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document refers to a "review of published literature" that included "89 chronic soft tissue wounds having a range of etiologies including diabetes mellitus." This suggests that the clinical evidence is based on data from 89 patients (cases), at least, with a focus on chronic diabetic foot ulcers within that group. It's unclear if all 89 specifically had diabetic foot ulcers, but the indications for use focus on this specific condition.
• Data Provenance: The document states "The reports from five independent studies." This implies the data were collected from multiple sources, likely different medical institutions or research groups. The country of origin is not specified, nor is whether the studies were retrospective or prospective, though typical clinical studies used for such purposes are prospective.

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

This information is not provided in the document. As this relies on a literature review of previously published studies, the methodology for establishing ground truth within those original studies is not detailed here.

4. Adjudication Method for the Test Set

This information is not provided. As this relies on a literature review, the adjudication methods of the individual studies are not described.

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

No, an MRMC comparative effectiveness study was not done, or at least not described in this 510(k) summary. The document focuses on the device's standalone performance based on existing clinical literature, not on how human readers would improve with AI assistance. The DUOLITH SD1 is a therapeutic device, not a diagnostic AI tool, so an MRMC study comparing human reader performance with and without AI assistance would not be applicable here.

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

Yes, in essence. The entire clinical performance section describes the standalone effectiveness of the DUOLITH SD1 device in treating diabetic foot ulcers. The device itself is a therapeutic modality, and its "performance" is its ability to heal wounds or reduce wound area, independent of any human interpretive intervention like with an AI diagnostic algorithm. The results presented (wound healing rates, wound area reduction) represent the direct outcomes of using the device.

7. The Type of Ground Truth Used

The "ground truth" used in the clinical studies reviewed would be clinical outcomes data. Specifically:

• Complete wound healing (defined clinically, likely by visual inspection and measurement).
• Reduction of wound area (measured clinically).

8. The Sample Size for the Training Set

This information is not applicable/not provided because the DUOLITH SD1 is a medical device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves iterative design, engineering, and nonclinical testing to meet specifications, not data-driven machine learning.

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

This information is not applicable. As explained above, the device does not employ a machine learning model that would need a "training set" with established ground truth. Its development relies on engineering principles and nonclinical testing to ensure it meets performance specifications and safety standards.

Ask a specific question about this device

The D-ACTOR® 200 Vibration Massage System is intended for:

• · Relief of minor muscle aches and pains
• Temporary increase in local blood circulation
• · Activation of connective tissue

The D-ACTOR® handpiece uses pressurized air pulses to accelerate a projectile within a guiding tube. The accelerated projectile hits a skin-contacting steel activator which is dampened by elastic O-rings that affix it to the distal end of the handpiece and a vibration absorber at proximal end of the handpiece. When the projectile impacts the activator, slow-rising, low-amplitude pressure pulses are generated. Standard coupling gel is typically used to reduce the loss of pulse amplitude to surrounding air. The D-ACTOR 200 System consists of a Control Unit, Handpiece, Mains Cable, Commercially available coupling gel, Foot switch (optional), and Tablet PC (optional). The password protected GUI interface software allows the operator to create, save and edit treatment programs for application to various muscle groups, and permits the operator to create, edit and save individual patient treatment program routines and progress notes. Various software features permit the operator to: (1) adjust energy level, number of pulses, frequency and total pulses delivered, (2) display and adjust skin contact intensity of the applicator, (3) save treatment images/videos to track progress, and (4) utilize Visible Body® interactive 3D musculature to allow the operator to "mark" and save treatment regions to patient records.

The Storz Medical AG D-ACTOR® 200 Vibration Massage System, as described in K173692, is a Class I medical device intended for the relief of minor muscle aches and pains, temporary increase in local blood circulation, and activation of connective tissue. The provided documents detail its substantial equivalence to predicate devices based on technological characteristics and performance testing rather than acceptance criteria for clinical efficacy.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the traditional sense of performance metrics (like sensitivity, specificity, accuracy) for a diagnostic AI device, nor does it define specific clinical performance endpoints with associated thresholds for a therapeutic device. Instead, the "performance testing" section and the "Substantial Equivalence Comparison" table demonstrate that the D-ACTOR® 200 meets design specifications and is functionally equivalent to its predicate devices.

The acceptance criteria here appear to be primarily focused on meeting design specifications, safety standards, and demonstrating technological equivalence to legally marketed predicate devices.

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

The provided document describes performance testing related to device characteristics (e.g., electrical safety, EMC, biocompatibility, in-vitro physical parameters) and comparisons to predicate devices, but not a clinical study with a "test set" of patients or data. Therefore, typical sample size and data provenance (country of origin, retrospective/prospective) for a study evaluating diagnostic or treatment efficacy in a patient population are not applicable here.

The "testing" mentioned is for engineering verification and validation, involving laboratory measurements and comparisons to established standards and predicate device specifications.

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

This information is not applicable as there is no clinical "test set" requiring expert ground truth establishment for patient outcomes or conditions. The "ground truth" in this context would be the measured physical properties of the device and compliance with engineering standards.

4. Adjudication Method for the Test Set

This information is not applicable as there is no clinical "test set" 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

This information is not applicable. The D-ACTOR® 200 Vibration Massage System is a therapeutic device, not an AI-powered diagnostic tool used by human readers for interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

This information is not applicable. The D-ACTOR® 200 is a physical therapeutic device, not an algorithm, and its performance inherently involves human operation and interaction with a patient.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is based on:

• Engineering Specifications and Design Requirements: The device's internal design parameters and intended operational characteristics.
• International Consensus Standards: Compliance with recognized standards like IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 14971, and IEC 62304.
• Predicate Device Characteristics: Direct comparison of physical and operational parameters (e.g., intensity, frequency, penetration depth) with the legally marketed predicate devices (AW module of Dermablate Effect and TattooStar Effect Y).
• In-vitro Measurements: Laboratory measurements of physical properties such as applicator displacement, force, and penetration depth.

8. The Sample Size for the Training Set

This information is not applicable. The D-ACTOR® 200 is a physical therapeutic device, not an AI/machine learning algorithm, and thus does not have a "training set" in the context of data-driven model development. Its development and testing follow traditional engineering verification and validation processes.

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

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

Ask a specific question about this device

STOMA bone block screws are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process in the oral cavity and maxillomandibular surgical field.

STOMA bone block screws are not intended to remain in the body permanently. After they have fulfilled their supportive function such as is the case after healing of a transplant, or healing of a fracture, for example, they need to be removed completely.

The screw head has either an inner square, or a cross slot. The screw thread is self-tapping and has two different thread leads. Dimensions: Length: 4 mm, 6 mm, 8 mm, 10 mm, 12 mm, 14 mm, 16 mm; Diameter: ø1.0 mm, ø1.2 mm, ø1.6 mm. The screws can be delivered in a cassette along with suitable accessories such as a screwdriver and pilot drill as basic equipment or re-ordered separately in different packaging units.

The provided 510(k) summary does not describe a study involving a device that uses AI or machine learning, nor does it provide acceptance criteria and performance data in the format typically associated with such studies (e.g., sensitivity, specificity, accuracy, F1-score).

This document pertains to the STOMA Bone Block Screws, Steel, which are described as non-active bone surgery implants used for the fixation of transplanted bone blocks during augmentation processes. The submission focuses on demonstrating substantial equivalence to a predicate device (STOMA Bone Screws, K51871) based on material composition, intended use, and functional properties.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: No specific quantitative performance metrics or acceptance criteria for statistical evaluation are present. The "performance" is implicitly demonstrated through substantial equivalence to an already marketed device.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no test set for clinical performance evaluation described.
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, as this is a physical medical device, not an AI or imaging diagnostic tool.
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: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Acceptance and "Study" Information (as applicable to this document):

The acceptance of the STOMA Bone Block Screw, Steel is based on demonstrating substantial equivalence to a predicate device, the STOMA Bone Screws (K51871). This is a common pathway for medical device clearance by the FDA for Class II devices.

The "study" or justification provided relies on comparing the new device to the predicate device in terms of:

• Intended Use: Both are for the treatment of bone fractures, specifically for the fixation of transplanted bone blocks during augmentation in the oral cavity and maxillomandibular surgical field.
• Technological Characteristics: The new device (and implicitly the predicate) are bone screws with similar designs (screw head types, self-tapping threads) and dimensions (length and diameter ranges).
• Materials: Both use biocompatible materials (though specific material is not detailed beyond "Steel," and the biocompatibility requirement is stated as met through raw material composition).
• Sterilization: Both are delivered non-sterile and require user sterilization via a validated steam-sterilization process.

Conclusion stated in the 510(k) summary: "Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that STOMA Bone Screws are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act."

In essence, for this type of device and submission, the "acceptance criteria" revolve around successfully arguing and demonstrating that the new device is as safe and effective as a legally marketed predicate device, thereby meeting the requirements for substantial equivalence. There is no performance study in the traditional sense involving human patients or complex data analysis as would be expected for AI/ML devices.

Ask a specific question about this device

STOMA Bone Screws are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process and / or in combination with bone plates and bone meshes in the oral cavity and maxillomandibular surgical field.

STOMA Bone Screws are developed and manufactured to be used as non-active bone surgery implants. The bolt head of the STOMA Bone Screw is either self tapped by a square, hexagon or cross slot. The screws will be delivered in a cassette / container including accordingly screw driver and pilot drill. The bone screws are available in 1.3mm in length 4 mm to 1.6mm and 2.0mm diameter and lengths ranging from 4mm to 16mm.

This document describes the STOMA Bone Screws, a medical device used for the fixation of bone fractures and transplanted bone blocks in oral and maxillomandibular surgery. The provided text is a 510(k) premarket notification and subsequent FDA letter, which primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a detailed study proving performance against specific acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria and a dedicated study to prove device performance is not explicitly available in the provided text. The submission relies on demonstrating that the STOMA Bone Screws are substantially equivalent to predicate devices, implying that if the predicates are safe and effective, then the new device, being substantially equivalent, also meets safety and effectiveness requirements.

Here's an attempt to answer the questions based on the available information:

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

The document does not specify quantitative acceptance criteria or report specific performance metrics for the STOMA Bone Screws. The primary "performance" reported is its substantial equivalence to predicate devices.

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

Not applicable/Not provided. The 510(k) submission does not describe a performance study with a test set of data. The submission focuses on a comparison of device characteristics (design, materials, indications for use) to predicate devices.

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

Not applicable/Not provided. Since no performance study with a test set generating a ground truth is described, information on experts is not available.

4. Adjudication method for the test set

Not applicable/Not provided. There is no described test set or adjudication method.

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 physical bone screw and not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

Not applicable. This device is a physical bone screw, not an algorithm.

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

Not applicable/Not provided. No specific clinical performance study requiring a "ground truth" for a test set is described. The "ground truth" in a 510(k) substantial equivalence submission, in a broader sense, is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable/Not provided. As this is a physical medical device and not an AI/ML algorithm requiring a training set, this information is not relevant or provided.

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

Not applicable/Not provided. See answer to #8.

Summary of the "Study" (510(k) Submission):

The "study" presented here is a Substantial Equivalence Comparison (as stated in Section 4 of the document). This is a regulatory pathway where the applicant demonstrates that their new device is as safe and effective as a legally marketed predicate device, without needing to conduct extensive new clinical trials.

The basis for proving substantial equivalence for the STOMA Bone Screws includes:

• Comparison of Indications for Use: The STOMA Bone Screws are indicated for "treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process and / or in combination with bone plates and bone meshes in the oral cavity and maxillomandibular surgical field." This would have been compared to the indications of the predicate devices.
• Comparison of Device Properties/Technology: The physical characteristics, materials, and method of sterilization are compared. STOMA Bone Screws are made of titanium alloy, similar to the predicate devices.
• Biocompatibility: The material (titanium alloy) used is noted to be "also used in many other medical devices, especially implants," and meets biocompatibility requirements. This implies reliance on established knowledge and data for this material.
• Predicates Referenced: The document explicitly lists examples of predicate devices: OSTEOMED CORP. (K961418), KLS-Martin MMF Screw (K980760), and/or Synthes (USA) 1.3 Craniofacial Screws (K021850). The FDA's decision letter confirms that the device was found substantially equivalent to the indications referenced against legally marketed predicate devices.

In essence, the "study" is a regulatory comparison, not a direct performance study of the STOMA Bone Screws themselves.

Ask a specific question about this device

The Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack are intended to be used as accessory devices with the Storz DAISY® (K854508), PREMIERE® (K894278, K921460 and K946227), Protege® (K921758 and K950114), and Millennium™ (K961310) Ophthalmic Microsurgical Systems. Both accessory packs facilitate use of Storz phaco handpieces (K935926) and Storz I/A handpieces (K951463) with the above referenced microsurgical systems in various anterior segment ophthalmic surgical procedures, e.g., phacoemulsification and residual cortical material removal following a planned Extracapsular Cataract Extraction.

The Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack are intended to be used as accessory devices with the Storz DAISY® (K854508), PREMIERE® (K894278, K921460 and K946227), Protege® (K921758 and K950114), and Millennium™ (K961310) Ophthalmic Microsurgical Systems. Both accessory packs facilitate use of Storz phaco handpieces (K935926) and Storz I/A handpieces (K951463) with the above referenced microsurgical systems in various anterior segment ophthalmic surgical procedures, e.g., phacoemulsification and residual cortical material removal following a planned Extracapsular Cataract Extraction.

The Storz DP4210 Venturi Economy Anterior Pack is provided non-sterile and contains reusable components consisting of an anterior collection cassette, I/A tubing set, and I/A test chambers. The Storz DP5000 ASC Daypack is provided sterile and contains both reusable and single use components. The DP5000 reusable items include an anterior collection cassette, I/A test chambers, needle wrench, and infusion sleeve. The DP5000 single use items include an I/A tube assembly and a BSS administration tube assembly.

This document is a 510(k) premarket notification for two ophthalmic accessory packs, the Storz DP4210 Venturi Economy Anterior Pack and the Storz DP5000 ASC Daypack. It focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a study with performance metrics.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text because this type of 510(k) submission generally relies on demonstrating similarity to legally marketed devices, not on new clinical performance studies with defined acceptance criteria and statistical analysis as would be required for a novel device or a Premarket Approval (PMA) application.

Here's what can be extracted and what is missing based on the provided text:

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

• Not explicitly stated in the document. The document's purpose is to demonstrate substantial equivalence to predicate devices, not to present performance metrics against predefined acceptance criteria. The "performance" is implicitly deemed equivalent to the predicate devices if substantial equivalence is established.

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

• Not applicable/Not provided. This is a 510(k) premarket notification for accessory packs, which typically does not involve a "test set" and performance data in the way a clinical study for a drug or novel device would. The assessment is based on comparing device characteristics and intended use to predicate devices. There is no mention of a clinical study or data provenance.

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/Not provided. No "ground truth" establishment by experts for a test set is mentioned, as this is not a performance study.

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

• Not applicable/Not provided. No adjudication method is mentioned.

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. MRMC studies are not relevant to this type of device and submission. There is no AI component mentioned.

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

• Not applicable/Not provided. This device does not involve algorithms or AI.

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

• Not applicable/Not provided. No ground truth determination is described.

8. The sample size for the training set

• Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning or algorithms.

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

• Not applicable/Not provided. No training set or ground truth establishment relevant to this context is described.

Summary of what the document does provide in relation to regulatory acceptance:

The document outlines a process of demonstrating substantial equivalence to existing legally marketed predicate devices, which is the "acceptance criteria" for a 510(k) submission.

• Predicate Devices:
  • Storz DP4210 Venturi Economy Anterior Pack: Substantially equivalent to Storz DP4210 Universal I/A and Phaco Pack (K882240).
  • Storz DP5000 ASC Daypack: Substantially equivalent to Storz DP4210 Universal I/A and Phaco Pack (K882240) and Storz DP4310 Deluxe Phaco Pack (K955901).
• Method of "Proof": Device comparison charts (Pages 2-3) are used to highlight similarities in:
  • 510(k) reference (i.e., previous clearance)
  • Pack Name
  • Intended Use
  • Individual Pack Components
  • Anterior Collection Cassette design (for DP4210 comparison)
  • Reusable Components
  • Limited Reuse (number of times)
  • Pack Provided Sterile (Yes/No)
  • Pack Sterilization method (for DP5000 comparison)
• Result of "Study" (FDA Outcome): The FDA reviewed the 510(k) notification and determined the device (both packs) to be substantially equivalent for its stated indications for use (Page 4). This determination allows the device to be marketed.

This document serves as an example of a 510(k) submission where "acceptance criteria" and "study" are framed by the regulatory concept of substantial equivalence, rather than a clinical trial with specific performance endpoints.

Ask a specific question about this device

The Storz Millennium™ High Speed Vitrectomy System is a new device intended for removal of vitreous matter from the posterior vitreous cavity during ophthalmic vitrectomy surgery. The Storz high speed vitrectomy system consists of the Storz CX5800 module to be used with the Storz Millennium™ Microsurgical System, Storz CX5810 handpiece, and the Storz CX4804 sterile single use accessory pack.

The Storz Millennium™ High Speed Vitrectomy System is intended for the aspiration of vitreous matter from the eye during ophthalmic vitrectomy surgery. The system consists of the Storz CX5800 Millennium™ System High Speed Vitrectomy module used with the Storz Millennium™ Microsurgical System, Storz CX5810 High Speed Vitrectomy handpiece, and the Storz CX4804 High Speed Vitrectomy single use disposable pack.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting studies for the Storz Millennium™ High Speed Vitrectomy System:

Summary of Acceptance Criteria and Study Information:

This 510(k) submission, K980488 for the "Storz Millennium™ High Speed Vitrectomy System," is a premarket notification for a new device claiming substantial equivalence to existing predicate devices. It does not contain information about specific performance acceptance criteria for the new device as a standalone product, nor does it detail a study that directly proves specific numerical performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence in design, materials, and intended use to already legally marketed predicate devices. The "performance" assessment is implied through the comparison of characteristics and specifications against these predicates. This is a common approach for 510(k) submissions, where the new device is not required to meet novel performance criteria but rather to demonstrate it is as safe and effective as a legally marketed device.

Therefore, the table below will reflect the comparison of characteristics rather than specific "acceptance criteria" and "reported device performance" in the traditional sense of a clinical or analytical study with defined endpoints.

1. Table of Acceptance Criteria and Reported Device "Performance" (as presented in the 510(k) for substantial equivalence):

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

• This 510(k) submission does not refer to a "test set" or a formal clinical study with human subjects designed to evaluate the performance of the new device.
• The data provenance is based on published information and specifications of legally marketed predicate devices, as maintained by the manufacturers and available to the FDA through previous 510(k) clearances (e.g., K961310, K961078, K961738). There is no mention of country of origin for specific "data," as it's a comparison of specifications.
• The approach is a retrospective comparison against existing predicate device characteristics, not a prospective study.

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

• Given that no "test set" or clinical study for the new device is described, no experts were used to establish ground truth in this context.
• The "ground truth" here is effectively the accepted specifications and intended uses of the predicate devices as cleared by the FDA.

4. Adjudication Method for the Test Set:

• Not applicable. No test set was described.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices to assess the impact of AI on human reader performance, which is not applicable to a vitrectomy system.

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

• Not applicable. The device is a surgical instrument and system; it is not an algorithm, and the concept of "standalone performance" for an algorithm does not apply.

7. The Type of Ground Truth Used:

• The "ground truth" for demonstrating substantial equivalence relies on the established specifications, intended uses, and safety/effectiveness profiles of the identified legally marketed predicate devices, as detailed in their respective 510(k) clearances. There is no external clinical ground truth (like pathology or outcomes data) directly generated for this new device's submission.

8. The Sample Size for the Training Set:

• Not applicable. This device is a vitrectomy system, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

• Not applicable. As there is no training set mentioned, no ground truth needed to be established for one.

Ask a specific question about this device

The Storz Millennium™ Viscous Fluid System is intended for the injection and aspiration of viscous fluids into and out of the eye during posterior ophthalmic vitreoretinal surgery. The system is designed to inject and aspirate viscous fluids, such as silicone oil which act as a tamponade in fixating large retinal tears and detachments.

The Storz Millennium™ Viscous Fluid System is intended for the injection and aspiration of viscous fluids into and out of the eye during posterior ophthalmic vitreoretinal surgery. The system is designed to inject and aspirate viscous fluids, such as silicone oil which act as a tamponade in fixating large retinal tears and detachments. The Storz viscous fluid system consists of the Storz CX5700 Millennium™ Viscous Fluid System Module and the Storz CX5710 Viscous Fluid Injection Pack. The Storz CX5700 module is a self-contained pump system used as an individual module with the Storz Millennium™ Microsurgical System for the injection and aspiration of viscous fluids. The Storz CX5710 is the disposable accessory pack intended for single use to be used with the Storz viscous fluid module.

The provided text is a 510(k) premarket notification for the Storz Millennium™ Viscous Fluid System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial or performance study report would for an AI/ML device.

Therefore, many of the requested points regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission.

The document primarily relies on predicate comparison to establish substantial equivalence.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not define explicit "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI/ML devices. Instead, the acceptance is based on demonstrating substantial equivalence to existing legally marketed predicate devices. The "performance" is implied by demonstrating similar design, intended use, and operational characteristics to these predicates.

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

This is a premarket notification for a medical device (a pump system for ophthalmic surgery), not an AI/ML diagnostic or prognostic tool. Therefore, there is no "test set" or "data provenance" in the context of evaluating algorithm performance on a dataset of patient cases. The evaluation is based on comparing the device's design and functional specifications to legally marketed predicate devices.

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

Not applicable. There is no "ground truth" establishment in the context of a dataset for an AI/ML device. The "truth" for this submission is based on the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. No test set or adjudication method as described for AI/ML performance evaluation.

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

No, this is not an AI/ML device requiring an MRMC study.

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

Not applicable. This is not an AI/ML algorithm. It's a medical pump system.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the regulatory acceptance and established safety/effectiveness of the predicate devices. The submission essentially argues that the new device is sufficiently similar to these predicates that it can be considered equally safe and effective.

8. The Sample Size for the Training Set:

Not applicable. As this is not an AI/ML device, there is no training set.

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

Not applicable. There is no training set or ground truth in the context of AI/ML for this device.

Ask a specific question about this device

The Storz MicroFlow Plus, MicroFlow Plus Angled, and Standard Angled Phacoemulsification Needles are accessories to a phacoemulsification handpiece, intended for use in the ultrasonic surgical removal of the cataractous crystalline lens.

A phaco needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece. The needle is the component of a phaco system which, as driven by the ultrasonic handpiece, contacts and fragments the crystalline lens. Irrigation fluid flows between the external surface of the needle and the internal surface of an irrigation sleeve and into the eye. The emulsified lens material and irrigant are aspirated from the eye through the lumen of the phaco needle.

The provided document is a 510(k) summary for Storz MicroFlow Plus, Storz MicroFlow Plus Angled, and Storz Standard Angled Phacoemulsification Needles. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that a device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain information about acceptance criteria, a specific study proving the device meets them, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established in the context of a clinical performance study.

Instead, the document focuses on demonstrating substantial equivalence based on device characteristics, intended use, and materials compared to several predicate devices.

Here's a breakdown of why the requested information cannot be fully provided from this document:

1. A table of acceptance criteria and the reported device performance: This document does not establish new acceptance criteria. It compares the device's characteristics to those of predicate devices to establish substantial equivalence. The tables provided (on pages 2 and 3) are "Substantial Equivalence Charts" comparing device characteristics, not performance against pre-defined acceptance criteria.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or clinical data is presented for this 510(k) submission.

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 ground truth established by experts is mentioned as this is not a study assessing diagnostic or clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there is no test set or clinical study.

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. The device is a phacoemulsification needle, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth was established for a performance study.

8. The sample size for the training set: Not applicable as there's no machine learning algorithm involved requiring a training set.

9. How the ground truth for the training set was established: Not applicable as there's no machine learning algorithm involved requiring a training set.

Summary based on the document:

The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. The "study" referenced in the prompt (if considering the 510(k) process as a form of "study" for regulatory clearance) is a comparison of device characteristics to existing, legally marketed devices.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the Substantial Equivalence Charts):

While not framed as "acceptance criteria" in the traditional sense of a clinical trial, the tables compare characteristics of the new devices to predicates. The "acceptance criteria" in this context are implicitly that the new devices share similar fundamental technological characteristics and intended use with the predicate devices, thereby demonstrating safety and effectiveness.

Study to Prove Acceptance Criteria:

The "study" is implicitly the submission of the comparison charts and other descriptive information to the FDA, which then determined substantial equivalence. No separate, formal clinical study or performance study is detailed in this 510(k) summary as proof against quantitative acceptance criteria for the new devices. The FDA's letter (pages 4-5) confirms the determination of substantial equivalence.

Ask a specific question about this device

The Storz E8010 ErgoTec™/Premiere® Adaptor is a new device accessory designed to adapt the Storz ErgoTecTM Vitreoretinal Instrument Tips to the Storz D7108 Microscissors Handpiece for general use in posterior segment vitreoretinal ophthalmic surgery.

The Storz E8010 ErgoTec™/Premiere® Adaptor is composed of stainless steel and serves to allow connection of the existing Storz D7108 Microscissors Handpiece to the existing Storz ErgoTecTM Vitreoretinal Instrument Tips. The adaptor features an anterior rotation knob which allows the tip to be adjusted into optimal alignment.

The provided document is a 510(k) summary for the Storz E8010 ErgoTec™/Premiere® Adaptor. This type of document is for a medical device regulatory submission and focuses on demonstrating substantial equivalence to a predicate device, not on presenting results of a study that establishes acceptance criteria for performance metrics in the way one might see for an AI/ML medical device.

Therefore, the information requested in your prompt (e.g., acceptance criteria, device performance metrics, sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable to this document as it describes a physical surgical instrument accessory, not a software-based or AI/ML device.

The document primarily provides:

• Device Description and Intended Use: The adaptor allows existing Storz ErgoTec™ Vitreoretinal Instrument Tips to be used with the Storz D7108 Microscissors Handpiece.
• Predicate Device: Storz D7108 Microscissors Handpiece (K960061), and Storz CX7100 and CX7150 Microscissors Handpieces (K961310).
• Predicate Comparison Table: This table compares the characteristics of the new device (Storz D7108 Microscissors HP with the new adaptor) to the predicate devices, highlighting similarities in intended use, materials, mechanism, and compatibility. The purpose of this comparison is to establish substantial equivalence for regulatory approval, not to demonstrate performance against specific numerical acceptance criteria.

To directly answer your prompt based on the provided text, but acknowledging the difference in device type:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implicit for a 510(k) submission): Substantial equivalence to predicate devices in terms of intended use, technological characteristics (materials, design, function), and safety/effectiveness. There are no explicit numerical performance criteria stated for this mechanical adaptor.
   • Reported Device Performance: The device performs its intended function of adapting the ErgoTec tips to the D7108 handpiece, allowing for cutting and manipulation of posterior intraocular tissue, similar to the predicate devices. The comparison chart asserts equivalency across numerous features (see provided table in the document).

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI/ML algorithm requiring a data test set. Its safety and effectiveness are established through comparison to a legally marketed predicate 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 as typically defined for AI/ML performance evaluation is not relevant here. The "ground truth" for a physical device like this is its physical properties, functionality, and established safety/effectiveness (or that of its predicate).

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 not an AI-assisted device.

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

7. The type of ground truth used: Not applicable. For this type of device, the "ground truth" is typically engineering and materials testing, biocompatibility assessments (if new materials), and a demonstration of equivalent function to predicate devices, rather than a clinical "ground truth" for diagnostic accuracy.

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

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

Ask a specific question about this device