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The OW100S (model OW100S-US) is intended for:

• Relief of minor muscle aches and pains

• Temporary increase in local blood circulation

• Activation of connective tissue

The OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a high voltage spark in water which creates the acoustic waves that rapidly expand, which in turn are propagated through a coupling membrane attached to the hand-held applicator, which is water-filled. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.

The modification to the OrthoGold 100 (OW100) , identified as model OW100S and applicator OP155S, includes the addition of a "break circuit" added to the acoustic wave generator which increases the available pulses per handheld applicator/electrode from 100K pulses to 500K pulses at low energy flux density in the device (increase from 70K to 350K pulses at higher energy flux density). As a consequence of this change, there are minor changes to the applicator and its connection, software and water cartridge of the device. Minor labeling changes are limited to product information and set-up details with regard to attachment and detection of the applicator, and water cartridge handling.

There are no changes to the power output performance, electrode and reflector geometry, total primary electrical energy, energy flux density or penetration as a result of this change. New pressure measurements show little differences to previous measurements, however differences are of statistical nature.

The provided documents describe the medical device OW100S (model OW100S-US), a therapeutic massager, and its substantial equivalence to a predicate device, the TRT, OrthoGold 100 (OW100). The submission does not contain information about a study with acceptance criteria and device performance results as typically described for software or AI-enabled medical devices.

Instead, this submission is a 510(k) premarket notification that demonstrates substantial equivalence to a legally marketed predicate device. The core of the submission relies on:

• Identical Indications for Use.
• Similar technological characteristics, with minor modifications to improve durability (e.g., increased electrode lifetime).
• Performance and bench testing to ensure the modified device meets design specifications and relevant safety standards.

Therefore, many of the requested details, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC comparative effectiveness studies, are not applicable or not provided within this type of submission for a non-software/AI device.

However, I can extract the information that is available about performance and the basis for equivalence.

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

The submission does not explicitly state "acceptance criteria" in the format of specific quantitative benchmarks (e.g., sensitivity > X%, specificity > Y%). Instead, the acceptance is based on demonstrating that the subject device (OW100S) is substantially equivalent to the predicate device (OrthoGold 100) and meets applicable safety and performance standards. The "reported device performance" is essentially a comparison of the OW100S's physical and operational characteristics to those of the predicate device, showing that any differences do not impact safety or effectiveness.

Here's a table based on the comparison provided in the submission:

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

This submission does not discuss a clinical "test set" in the context of patient data. The performance evaluation was based on bench testing and verification and validation (V&V) testing of the device's engineering specifications. Therefore, data provenance from a patient population (country, retrospective/prospective) is not applicable here.

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. The submission focuses on hardware modifications and engineering performance, not on diagnostic accuracy requiring expert interpretation of patient data.

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

Not applicable. No clinical test set requiring adjudication was used.

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-enabled device, and no MRMC study was performed or required.

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

Not applicable. This is not an algorithm-only device. Performance was demonstrated through V&V and bench testing of the physical device.

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

The "ground truth" for this submission is implicitly the engineering specifications and demonstrated performance of the predicate device, alongside international consensus standards (e.g., IEC 61846, AAMI / ANSI ES60601-1, IEC 60601-1-2) for safety and performance testing. The "truth" is that the device, after modifications, still operates safely and effectively within expected parameters compared to the predicate and standard requirements.

8. The sample size for the training set

Not applicable. This is not a machine learning device and therefore does not have a training set.

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

Not applicable. No training set was used.

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The OrthoGold 100 is intended for:

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

The OrthoGold 100™ is a pulsed acoustic wave device. It includes an electrically powered generator to generate transient compressed air that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached to the hand-held applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.

The provided FDA 510(k) summary for the OrthoGold 100 device does not describe a study involving an artificial intelligence (AI) component or its acceptance criteria.

Instead, this document is a premarket notification for a Class I therapeutic massager, which is a physical device (a pulsed acoustic wave device). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance testing of the physical device to ensure it meets design specifications, safety standards, and is substantially equivalent to a predicate device.

Therefore, many of the specific questions you asked about AI-related acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable to the information provided in this document.

Here's an analysis based on the document, focusing on the engineering and performance testing described for a Class I medical device, and explaining why the AI-related questions are not relevant here:

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

The document does not present a formal table of acceptance criteria with corresponding performance results in the way one might see for an AI model's clinical endpoints. Instead, it describes various performance tests and compliance with standards as evidence of meeting design specifications and safety requirements.

Here's a summary of the performance claims:

• Max penetration depth: 25.4 mm at energy level 16
• Energy flow density: 0.00017 - 0.04403 mJ/mm2 at energy level 1-16
• Peak compressional acoustic pressure: 0.43 - 9.27 MPa at energy level 1-16. |
  | Probe Cover Testing & Transport Verification/Validation | "In addition, probe cover testing and transport verification and validation was also conducted." (Page 5) – No specific results detailed, but implied successful. |
  | Substantial Equivalence | "The performance testing demonstrated that the OrthoGold 100 is substantially equivalent to the predicate device." (Page 5) "The bench testing demonstrates that the performance characteristics of the OrthoGold 100 are equivalent to those of other legally marketed therapeutic massagers, and therefore supports a determination of Substantial Equivalence for the proposed indications for use." (Page 9) |
  | Clinical Data | "Clinical performance data is not relied upon to establish the substantial equivalence of the subject and predicate device." (Page 6) |

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 describes engineering and laboratory performance testing, not a clinical trial or AI model validation using patient data. Therefore, the concept of "sample size for the test set" (referring to patient data) and "data provenance" (country, retrospective/prospective) is not applicable. The "test set" would be the device itself and its components undergoing various mechanical, electrical, and physical tests.

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 physical device testing for safety and performance, not diagnostic AI. "Ground truth" here relates to physical measurements and engineering specifications, established by standard test methods and calibrated equipment, not by medical experts interpreting data for diagnostic purposes.

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

This is not applicable for the same reasons as above. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI model validation when multiple human readers assess data and their consensus forms the ground truth for comparison. This document describes physical device testing.

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

This is not applicable. An MRMC study is relevant for assessing the impact of a diagnostic AI tool on human clinician performance. The OrthoGold 100 is a therapeutic massager, not a diagnostic AI device, and the document explicitly states clinical data was not relied upon for substantial equivalence (Page 6).

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

This is not applicable. This question refers to the performance of a diagnostic algorithm without human interaction. The OrthoGold 100 is a physical therapeutic device.

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

The "ground truth" for the device's performance is based on engineering specifications, verified physical measurements (e.g., force, penetration depth, acoustic pressure), and compliance with recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2). These are objective measurements and adherence to established safety and performance benchmarks for therapeutic medical devices, not clinical outcomes or expert consensus for diagnostic interpretation.

8. The sample size for the training set

This is not applicable. The OrthoGold 100 is a physical device, not an AI model that requires a training set.

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

This is not applicable as there is no AI training set.

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The OrthoGold 100™ is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years and older). The OrthoGold 100 is indicated for use in conjunction with standard of care burn treatment(s).

The OrthoGold 100™ is a pulsed acoustic wave device. It includes an electrically powered generator to generate transient compressed air that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached to the hand-held applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.

The provided document describes the FDA 510(k) clearance for the OrthoGold 100 device, an extracorporeal shock wave device. The information details the device's indications for use, a comparison to a predicate device, and performance data including non-clinical, animal, and clinical studies.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly demonstrated through the clinical study's primary endpoint, which showed a statistically significant improvement in the time to epithelialization. The safety was also assessed by monitoring adverse events.

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The OrthoGold 100™ 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 OrthoGold 100 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 OrthoGold 100™ is a pulsed acoustic wave device. It includes an electrically powered generator to generate transient compressed air that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached to the hand-held applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.

The provided document is a 510(k) Premarket Notification from the FDA regarding the OrthoGold 100 device. While it attests to the device's substantial equivalence based on non-clinical performance and a literature review, it does not contain the kind of detailed information typically found in a clinical study report for an AI/device performance evaluation that would include acceptance criteria, specific performance metrics for the device, and detailed information about test sets, ground truth establishment, or multi-reader studies.

Therefore, I cannot extract the specific information requested in your prompt regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details (effect size of human reader improvement with AI).
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document discusses "Performance Data – Non-Clinical" (electrical safety, EMC, pressure field measurements) and "Performance Data – Clinical" which refers to a literature review demonstrating successful clinical use and efficacy. It states:

• Clinical Performance: "A literature review represents the published literature with the subject device through systematic, comprehensive literature searches and those articles known to the manufacturer. These studies demonstrate the successful clinical use with the OrthoGold technology in 224 diabetic foot ulcers. The studies show significant results in complete wound healing and reduction of wound area. The data from these studies establish the efficacy of the subject device to treat 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 and the safety of the device as shown with the lack of adverse events."

This describes the basis for efficacy and safety claims, but not a specific study with defined acceptance criteria and performance metrics for a device (especially an AI-driven one, which this is not) against a held-out test set as per your prompt's requirements. The OrthoGold 100 is an extracorporeal shock wave device, not an AI/software as a medical device (SaMD) that would typically have the metrics and study designs you are asking for.

The core of this document is a 510(k) submission seeking substantial equivalence to a predicate device, not necessarily a de novo clinical trial proving novel performance against specific statistical targets like an AI model would need.

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The OrthoGold 100 is intended for the activation of connective tissue.

The OrthoGold 100™ is a pulsed acoustic wave device. It includes an electrically powered generator to generate transient compressed air that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached to the hand-held applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.

This document is a 510(k) summary for the OrthoGold 100™ therapeutic massager. It does not provide information specific to an AI/ML device, therefore, many of the typical acceptance criteria and study details for such devices are not applicable.

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

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

The document does not specify quantitative acceptance criteria in the typical sense of a human-in-the-loop or standalone AI performance study (e.g., specific sensitivity, specificity, or AUC thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through various performance tests.

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

Not applicable. This device is a therapeutic massager, not an AI/ML diagnostic tool that would typically use a "test set" of patient data for performance evaluation. The testing involved in-vitro performance measurements, electrical safety, and electromagnetic compatibility.

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 an AI/ML diagnostic device, there was no need for experts to establish ground truth on a test set of medical images or patient data.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication of ground truth was used.

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/ML assisted device for human readers.

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

Not applicable. This is a physical medical device (therapeutic massager), not a standalone algorithm.

7. The type of ground truth used

For the in-vitro performance testing, the "ground truth" was established by objective measurements against known physical standards and comparison data from the predicate device. For example, measurements of applicator displacement, force, and penetration depth would have physical accuracy.

8. The sample size for the training set

Not applicable. This product is a physical device, not an AI/ML model that requires a training set. The "training" for such a device would refer to its engineering, design, and manufacturing processes.

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

Not applicable. As above, this is not an AI/ML device.

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The LithoGold is an extracorporeal shock wave lithotripsy device intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower).

The LithoGold is an extracorporeal shock wave therapy device designed for the non-invasive fragmentation of urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle and lower ureter). The LithoGold employs an electrohydraulic method of shock wave generation with both ECG gating and fixed frequency capabilities. The LithoGold unit will be combined with the Modularis Uro Plus (table) and Arcadis NUW -- 2 2005 Varic (C-arm) or Siremobil Compact L (C-arm), all products manufactured by Siemens Medical Solutions, Inc .; and the ECG Monitor Infinity Gamma (ECG) manufactured by Draeger Medical systems, Inc. These components have each been cleared for distribution in the U.S.

Due to the limited information in the provided text, a full and detailed description of acceptance criteria and a study proving the device meets them cannot be generated for all aspects. However, I can extract and infer what is available.

The provided text describes a 510(k) summary for the LithoGold extracorporeal shock wave lithotripsy (ESWL) device. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove efficacy against pre-defined acceptance criteria in the same way a PMA study might.

Here's an attempt to answer your request based on the provided text:

Acceptance Criteria and Study for LithoGold

The primary "acceptance criteria" for a 510(k) device like LithoGold are to demonstrate substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. The study described focuses on achieving this substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The text only mentions "The confirmatory clinical study." It does not provide the number of patients or cases included in this study.
• Data Provenance: Not explicitly stated. It is a "confirmatory clinical study," which generally implies a prospective study conducted for regulatory submission. The country of origin is not mentioned.

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

This information is not provided in the given text. For a lithotripsy device, "ground truth" often relates to stone fragmentation success or clearance, which would typically be assessed by treating physicians and follow-up imaging. However, the details of how this was established are absent.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, and 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 done. This device is an ESWL device for stone fragmentation, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

This is not applicable as the LithoGold is a medical device for treatment, not an algorithm. Its performance is evaluated on its ability to fragment stones, a function directly delivered by the device in conjunction with human operation.

7. The Type of Ground Truth Used

The "ground truth" implicitly referred to in the clinical study is the safety and effectiveness outcomes for treating patients with renal or ureteral calculi. This would typically involve clinical outcomes data such as:

• Stone fragmentation success (e.g., size reduction, number of fragments)
• Stone clearance rates
• Complications/adverse events
  These outcomes would be assessed by clinical examination, imaging studies (e.g., X-ray, ultrasound), and patient follow-up.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device in the same way it would be for an AI algorithm. The LithoGold is a hardware device. Its design and manufacturing processes are likely informed by engineering principles, bench testing, and potentially prior clinical experience with similar devices, but not a "training set" in the machine learning sense.

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

As the concept of a "training set" is not applicable, the method for establishing its "ground truth" is also not applicable.

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